Últimas noticias sobre Roche Holding (OTC:RHHBY) Bolsa

Roche Holding

ROCHE HLDG LTD SPONS

Roche is a Swiss biopharmaceutical and diagnostic company. The firm's bestselling pharmaceutical products include a variety of oncology therapies from acquired partner Genentech, and its diagnostics group was bolstered by the acquisition of Ventana in 2008. Oncology products account for 50% of pharmaceutical sales, and centralized and point-of-care diagnostics for more than half of diagnostic-related sales.

Novo Nordisk

Equities

FTXH

iShares Dow Jones US Pharmaceuticals Index Fund

KURE

PILL

Merrill Lynch Pharmaceutical HOLDRs Trust

RHHBY

Los aranceles de Trump podrían afectar a Novo Nordisk y otros gigantes farmacéuticos. Barclays advierte de impacto en márgenes y suministro.

Novo Nordisk, en la mira por los posibles aranceles farmacéuticos de Trump

Medical,Billing,Document,And,Dollar,Banknote,,Calculator,,Stathoscope.,Medical,Treatment

Health Care

Markets

AMGN

REGN

Trump anuncia una orden ejecutiva para reducir precios de medicamentos hasta un 80 %, aplicando la política de &#34;Nación Más Favorecida&#34;.

Trump firma orden ejecutiva histórica para reducir precios de medicamentos en EE. UU.

Cannabis

News

El cannabis medicinal reduce el uso de ansiolíticos: ¿Qué impacto tendrá en las grandes farmacéuticas?

ROCHE HOLDING LTD S/ADR by Roche Holding Ltd

Roche Holding AG

As the Donald Trump administration plans up to 200% tariffs on pharmaceutical companies, Emily Field, head of European pharma research at Barclays, has said that it&#8217;s hard to predict which firm would be affected the most by these tariffs, except for Novo Nordisk A/S (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/NVO#NYSE">NVO</a>).
Check out the current price of&nbsp;<a href="https://www.benzinga.com/quote/NVO">NVO stock here</a>.
What Happened: Explaining that the pharmaceutical companies as a whole are &#8220;out of favor&#8221; for tariffs, Field <a href="https://www.cnbc.com/video/2025/07/14/barclays-the-pharma-sector-is-very-out-of-favor-for-tariffs.html">told</a> CNBC that it was hard to single out a company that could be the most affected by the levies.
&#8220;It&#8217;s really difficult to say because they have really complex supply chains and companies like to keep it under the wraps,&#8221; she said, adding that &#8220;Novo Nordisk has been called out just because we know a lot of active pharmaceutical ingredients for Wegovy are manufactured in Denmark, so that&#8217;s just one that investors have highlighted.&#8221;
She adds, &#8220;But that could also just be because we have a more concrete idea of how their drug flows. But for the most part, this sector is just very out of favor for tariffs.&#8221;
Talking about the European pharma companies that were planning to invest in the U.S., Field mentioned Novartis AG (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/NVS#NYSE">NVS</a>), Roche Holdings AG (OTCQX:<a class="ticker" href="https://www.benzinga.com/stock/RHHBY#OTCQX">RHHBY</a>), and AstraZeneca PLC (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/AZN#NASDAQ">AZN</a>).
&#8220;We have seen from a number of European companies very significant announcements about manufacturing investments in the United States. We have seen that from Novartis, Roche, and we also know that the companies are working with the administration on this &#8216;Most Favored Nation&#8217; (MFN) drug pricing policy,&#8221; she said.
She also added that AstraZeneca is likely considering changing its registration to the U.S. &#8220;All of the companies based in Europe are emphasizing that they are very committed to the U.S. and manufacturing in the U.S.&#8221;
According to Field, this is all connected in some way. &#8220;It could be a combination of tariffs and drug pricing that the industry and administration can strike a deal that is favorable to both parties,&#8221; Field explained.
See Also: <a href="https://www.benzinga.com/markets/tech/25/07/46400448/dan-ives-bets-on-cybersecurity-as-biggest-subsector-in-tech-for-2025-expects-strong-q2-earnings-from-crowdstrike-zscaler-palo-alto-check-point">Dan Ives Bets On Cybersecurity As &#8216;Biggest Subsector&#8217; In Tech For 2025; Expects Strong Q2 Earnings From CrowdStrike, Zscaler, Palo Alto, Check Point</a>
Why It Matters: Barclays has also <a href="https://www.benzinga.com/markets/equities/25/07/46364024/trump-threatens-200-pharma-tariffs-but-analyst-says-this-stock-is-immune-and-expected-to-benefit-from-levies">cautioned that a 200% pharma tariff</a> would &#8220;inflate production costs, compress profit margins, and risk supply chain disruptions." 
&#8220;We are waiting for the results of the Section 232 investigation from the Commerce Ministry, which is supposed to come by the end of the month. Prior to Trump saying that he was going to announce 200%, I think most have been expecting 25%; however, the industry&#8217;s response is that tariffs will be negative for patients, as it could result in drug shortages,&#8221; Feild said.
These are some pharma ETFs that could be impacted as the long-awaited industry-wide tariffs would be announced &#8220;very soon,&#8221; according to Trump.
<figure class="wp-block-table is-style-stripes"> 
<table class="has-fixed-layout">
<tbody>
<tr>
<td>Pharma ETFs</td>
<td>YTD Performance</td>
<td>One-Year Performance</td>
</tr>
<tr>
<td>VanEck Pharmaceutical ETF (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/PPH#NASDAQ">PPH</a>)</td>
<td>0.45%</td>
<td>-6.90%</td>
</tr>
<tr>
<td>iShares US Pharmaceuticals ETF (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/IHE#NYSE">IHE</a>)</td>
<td>1.01%</td>
<td>-3.91%</td>
</tr>
<tr>
<td>Invesco Pharmaceuticals ETF (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/PJP#NYSE">PJP</a>)</td>
<td>-1.22%</td>
<td>-3.19%</td>
</tr>
<tr>
<td>SPDR S&amp;P Pharmaceuticals ETF (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/XPH#NYSE">XPH</a>)</td>
<td>-1.95%</td>
<td>-1.55%</td>
</tr>
<tr>
<td>KraneShares MSCI All China Health Care Index ETF (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/KURE#NYSE">KURE</a>)</td>
<td>29.34%</td>
<td>33.78%</td>
</tr>
<tr>
<td>First Trust Nasdaq Pharmaceuticals ETF (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/FTXH#NASDAQ">FTXH</a>)</td>
<td>-3.88%</td>
<td>-8.36%</td>
</tr>
<tr>
<td>Direxion Daily Pharmaceutical &amp; Medical (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/PILL#NYSE">PILL</a>)</td>
<td>-18.59%</td>
<td>-24.16%</td>
</tr>
</tbody>
</table>
</figure>
The SPDR S&amp;P 500 ETF Trust (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/SPY#NYSE">SPY</a>) and Invesco QQQ Trust ETF (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/QQQ#NASDAQ">QQQ</a>), which track the S&amp;P 500 index and Nasdaq 100 index, respectively, ended mixed on Tuesday. The SPY was down 0.43% at $622.14, while the QQQ advanced 0.092% to $556.72, according to <a href="https://pro.benzinga.com/dashboard">Benzinga Pr</a>o data.
On Wednesday, the futures of the S&amp;P 500, Dow Jones, and Nasdaq 100 indices were trading lower.
Read Next:
<ul class="wp-block-list">
<li><a href="https://www.benzinga.com/markets/hedge-funds/25/07/46386374/stanley-druckenmillers-duquesne-dumps-palantir-bets-big-on-this-dividend-play-which-has-surged-nearly-50-in-2025">Stanley Druckenmiller&#8217;s Duquesne Dumps Palantir, Bets Big On This Dividend Play Which Has Surged Nearly 50% In 2025</a></li>
</ul>
Photo courtesy: JHVEPhoto / Shutterstock.com

Trump's Pharma Tariffs Can Hit Novo Nordisk, Says Barclays Expert, But It's 'Difficult' To Predict As Drugmakers Have 'Complex Supply Chains'

JPMorgan Chase CEO Jamie Dimon issued a stark message to European leaders this week: the continent is steadily falling behind the United States, and financial markets now expose just how wide <a href="https://www.benzinga.com/markets/eurozone">the gap has become.</a>
At a conference in Dublin organized by Ireland's foreign ministry, Dimon warned that Europe is slipping in the global economic race. Over the past 10 to 15 years, he noted, the region's share of global output has dropped sharply compared to the U.S.
"Europe has gone from 90% U.S. GDP to 65% over 10 or 15 years. That's not good. You're losing," Dimon said.
He pointed to sluggish growth, outdated regulation, and insufficient investment as key reasons why the EU is falling behind both the U.S. and China.
While Dimon's focus was on economic differences in terms of GDP, the numbers coming out of stock markets reveal an even deeper structural divide between the U.S. and Europe.
<h2 class="wp-block-heading">Market Caps Tell An Even Bigger Divergence Story</h2>
The combined market capitalization of America's Magnificent Seven—Nvidia Corp. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/NVDA#NASDAQ">NVDA</a>), Microsoft Corp. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/MSFT#NASDAQ">MSFT</a>), Apple Inc. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/AAPL#NASDAQ">AAPL</a>), Amazon.com Inc. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/AMZN#NASDAQ">AMZN</a>), Alphabet Inc. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/GOOGL#NASDAQ">GOOGL</a>), Meta Platforms Inc. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/META#NASDAQ">META</a>), and Tesla Inc. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/TSLA#NASDAQ">TSLA</a>)—has now soared past $18.3 trillion.
<figure class="wp-block-table is-style-stripes"> 
<table class="has-fixed-layout">
<thead>
<tr>
<th>Top U.S. Tech Giants</th>
<th>Market Cap</th>
</tr>
</thead>
<tbody>
<tr>
<td>Nvidia</td>
<td>$4.08T</td>
</tr>
<tr>
<td>Microsoft</td>
<td>$3.74T</td>
</tr>
<tr>
<td>Apple</td>
<td>$3.15T</td>
</tr>
<tr>
<td>Amazon</td>
<td>$2.39T</td>
</tr>
<tr>
<td>Alphabet</td>
<td>$2.20T</td>
</tr>
<tr>
<td>Meta</td>
<td>$1.81T</td>
</tr>
<tr>
<td>Tesla</td>
<td>$995B</td>
</tr>
<tr>
<td>Total</td>
<td>$18.37T</td>
</tr>
</tbody>
</table>
</figure>
By contrast, the top seven companies in Europe—including SAP SE (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/SAP#NYSE">SAP</a>), Novo Nordisk A/S (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/NVO#NYSE">NVO</a>), ASML Holding N.V. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/ASML#NASDAQ">ASML</a>), Hermès International SCA (OTCPK: HESAY), LVMH Moët Hennessy Louis Vuitton SE (OTCPK: LVMUY), Roche Holding AG (OTCPK: RHHBY), and Nestlé S.A. (OTCPK: NSRGY)—are worth just $2.1 trillion combined.
The gap is staggering. The U.S. tech giants are now worth over nine times as much as Europe's largest companies.
<figure class="wp-block-table is-style-stripes"> 
<table class="has-fixed-layout">
<thead>
<tr>
<th>Top EU Corporates</th>
<th>Market Cap</th>
</tr>
</thead>
<tbody>
<tr>
<td>SAP</td>
<td>$359B</td>
</tr>
<tr>
<td>Novo Nordisk</td>
<td>$317B</td>
</tr>
<tr>
<td>ASML</td>
<td>$314B</td>
</tr>
<tr>
<td>Hermès</td>
<td>$303B</td>
</tr>
<tr>
<td>LVMH</td>
<td>$295B</td>
</tr>
<tr>
<td>Roche</td>
<td>$265B</td>
</tr>
<tr>
<td>Nestlé</td>
<td>$252B</td>
</tr>
<tr>
<td>Total</td>
<td>$2.11T</td>
</tr>
</tbody>
</table>
</figure>
Over the past 20 years, the SPDR S&amp;P 500 ETF Trust (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/SPY#NYSE">SPY</a>) – which tracks the S&amp;P 500 – has outperformed the SPDR DJ Euro STOXX 50 ETF (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/FEZ#NYSE">FEZ</a>) by a staggering 244%.
<figure class="wp-block-image size-large"><img loading="lazy" decoding="async" width="1024" height="525" src="https://editorial-assets.benzinga.com/wp-content/uploads/2025/07/11124301/image-139-1024x525.png" alt="" class="wp-image-982188" srcset="https://editorial-assets.benzinga.com/wp-content/uploads/2025/07/11124301/image-139-1024x525.png 1024w,https://editorial-assets.benzinga.com/wp-content/uploads/2025/07/11124301/image-139-300x154.png 300w,https://editorial-assets.benzinga.com/wp-content/uploads/2025/07/11124301/image-139-768x394.png 768w,https://editorial-assets.benzinga.com/wp-content/uploads/2025/07/11124301/image-139-1536x788.png 1536w,https://editorial-assets.benzinga.com/wp-content/uploads/2025/07/11124301/image-139-2048x1051.png 2048w" sizes="(max-width: 1024px) 100vw, 1024px" /></figure>
"We've got this huge, strong market and our companies are big and successful, have huge kinds of scale that are global. You have that, but less and less," he said.
Dimon's comments add to growing concern across the continent. Last year, former European Central Bank chief Mario Draghi called for €800 billion per year in industrial investment to help Europe remain globally competitive.
Yet, despite repeated calls for reform, European stock markets continue to lag behind as U.S. firms dominate in scale, innovation and investor interest.
Read Next:
<ul class="wp-block-list">
<li><a href="https://www.benzinga.com/markets/eurozone/25/07/46354754/greece-stock-market-2025-rally-grek-etf-banks">The Market Everyone Gave Up On Is Crushing Nasdaq 100 In 2025 </a></li>
</ul>
Photo: lev radin / Shutterstock.com

Large Cap

Eurozone

Tech

AAPL

AMZN

ASML

GOOGL

HESAY

LVMUY

MSFT

Nestle Sponsored representing Registered Shares Series B

NSRGY

NVDA

TSLA

Magnificent 7 Crush EU Giants—Jamie Dimon Tells Europe: 'You're Losing'

While multinational pharmaceutical firm Eli Lilly and Company (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/LLY#NYSE">LLY</a>) represents one of the top drugmakers in the world, that status alone hasn't exempted its equity from underperformance. In the past 52 weeks, LLY stock finds itself down almost 16%. Since the beginning of this year, LLY has barely poked its head above parity. Nevertheless, the statistical winds may point to an eventual recovery which options traders could potentially exploit.
Fundamentally, in the post-pandemic era, sentiment toward Eli Lilly skyrocketed thanks to its <a href="https://www.benzinga.com/news/25/01/42933134/fda-approves-weight-loss-drug-zepbound-for-sleep-apnea-will-insurance-cover-this-1000-per-month-medication">weight-loss drug</a>. In 2023, the U.S. Food and Drug Administration (FDA) approved the Zepbound (tirzepatide), the first prescription medication for treating moderate-to-severe obstructive sleep apnea (OSA) in adults with obesity. An injectable prescription medication that helps adults with other weight-related problems, Zepbound's clinical trials showed promising results.
Thanks to this early success, Eli Lilly and Novo Nordisk A/S (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/NVO#NYSE">NVO</a>) effectively formed a duopoly in the weight-loss market. While this reality contributed to a significant valuation surge, competition started to heat up last year. With major pharmaceuticals like Pfizer Inc. (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/PFE#NYSE">PFE</a>) and Roche Holding Ltd (OTC:<a class="ticker" href="https://www.benzinga.com/stock/RHHBY#OTC">RHHBY</a>) announcing advancements in the <a href="https://www.benzinga.com/general/biotech/24/07/39849867/exclusive-weight-loss-duopoly-breaks-as-eli-lilly-novo-plummet-market-wont-be-dominated-by-just-2">development of obesity-fighting drugs</a>, LLY stock entered into a frustrating consolidation channel.
Still, with the pharmaceutical giant incurring an extended period of red ink in the market, JPMorgan analyst Chris Schott is essentially making the case that Eli Lilly is undervalued. Specifically, prescriptions for Zepbound and Mounjaro (an injectable <a href="https://www.lilly.com/news/media/media-kits/mounjaro">medicine</a> for adults with type 2 diabetes) are running ahead of expectations in the second quarter. As such, this performance may allow the pharmaceutical to beat and raise guidance throughout 2025.
Even with the <a href="https://www.benzinga.com/content/45261458/is-eli-lilly-a-buy-after-weak-earnings-and-cvs-novo-partnership">formulary change</a> by CVS Health (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/CVS#NYSE">CVS</a>) putting around 200,000 patients at risk of losing access, Schott states that Eli Lilly's market share — which stands at about 70% to 75% of new patients — and strong momentum may help the company easily absorb the impact.
<h2 class="wp-block-heading">Statistical Backdrop Could Point To A Recovery In LLY Stock</h2>
Although the fundamental narrative of LLY stock is intriguing, it may also be a presuppositional leap. Essentially, the conclusion that LLY is undervalued is already embedded in the premise (that the market is not fully pricing in the good news for Eli Lilly).
If one thinks about it, it's an extraordinary claim. LLY stock routinely ranks among the most actively traded securities. That the market is somehow mispricing the pharmaceutical giant is an assertion that requires extraordinary evidence. In my opinion, if such evidence exists, it will likely materialize in the statistical realm as it's the arena that few (if any) analysts venture into.
A significant barrier to statistical analysis of the financial markets is the deployment of continuous scalar signals, such as share price or various valuation ratios. Because these signals are non-stationary, it's difficult (if not outright impossible) to extract meaningful insights based on the frequency of past analogs. Especially for highly traded securities like LLY stock, the measurement metrics constantly fluctuate.
To remedy this problem, we can impose stationarity by converting scalar signals into discrete states. For analyzing securities, converting share price into market breadth or sequences of accumulative and distributive sessions carries significant advantages. First, market breadth is essentially a representation of demand and demand is effectively binary. Second, clusters of binary codes can form distinct behavioral states, which can then serve as past analogs for extracting forward probabilities.
As an example, in the trailing two months, the price action of LLY stock can be interpreted as a "6-4-D" sequence: six up weeks, four down weeks, with a negative trajectory across the 10-week period. Admittedly, this process pancakes LLY's magnitude dynamism into a simple binary code. But the benefit is that this code can be easily segregated into distinct market profiles. From there, we can observe the likelihood of transition from one state to another.
<figure class="wp-block-image size-large"><img loading="lazy" decoding="async" width="1024" height="576" src="https://editorial-assets.benzinga.com/wp-content/uploads/2025/07/07142726/LLY-stock-10wk-forecast-1024x576.jpg" alt="" class="wp-image-975331" srcset="https://editorial-assets.benzinga.com/wp-content/uploads/2025/07/07142726/LLY-stock-10wk-forecast-1024x576.jpg 1024w,https://editorial-assets.benzinga.com/wp-content/uploads/2025/07/07142726/LLY-stock-10wk-forecast-300x169.jpg 300w,https://editorial-assets.benzinga.com/wp-content/uploads/2025/07/07142726/LLY-stock-10wk-forecast-768x432.jpg 768w,https://editorial-assets.benzinga.com/wp-content/uploads/2025/07/07142726/LLY-stock-10wk-forecast.jpg 1280w" sizes="(max-width: 1024px) 100vw, 1024px" /><figcaption class="wp-element-caption">Image by author</figcaption></figure>
With the above framework, we can identify that since January 2019, the 6-4-D sequence has materialized 38 times. From past analogs, we can also determine that in 68.42% of cases, the following week's price action results in upside, with a median return of 2.47%.
Accounting for the volatility on Monday, a realistic target over the next three weeks — assuming that the bulls gain and maintain control of the market — is just under the $800 level.
<h2 class="wp-block-heading">Playing The Odds With Eli Lilly</h2>
Based on the market intelligence above, bold speculators may consider the 785/790 bull call spread expiring Aug. 1. This transaction involves buying the $785 call and simultaneously selling the $790 call, for a net debit paid of $255 (the most that can be lost in the trade). Should LLY stock rise through the short strike price ($790) at expiration, the maximum reward is $245, a payout of 96%.
To be sure, the 780/790 bull spread expiring on the same day offers a payout of nearly 113%. However, the net debit required is $470, which puts significantly more capital at risk for only a modest increase in payout. Therefore, the 785/790 call spread is arguably more tempting.
Either way, both transactions require LLY stock to hit or exceed $790 on Aug. 1, which empirically appears to be a reasonable target. As a baseline, the chance that a long position in LLY will be profitable on any given week is quite high at 60.29%. However, the market's response to the 6-4-D sequence amplifies the odds in favor of the bullish speculator, thus incentivizing a debit-based strategy.
The opinions and views expressed in this content are those of the individual author and do not necessarily reflect the views of Benzinga. Benzinga is not responsible for the accuracy or reliability of any information provided herein. This content is for informational purposes only and should not be misconstrued as investment advice or a recommendation to buy or sell any security. Readers are asked not to rely on the opinions or information herein, and encouraged to do their own due diligence before making investing decisions.
Read More:
<ul class="wp-block-list">
<li><a href="https://www.benzinga.com/markets/options/25/07/46253955/khc-stock-bearish-pressure-statistical-reversal">Options Corner: Why Kraft Heinz Could Flip The Script On The Bears</a></li>
</ul>
Photo: Shutterstock

Analyst Color

Long Ideas

Options

Options Corner: Bullish Traders Eye Eli Lilly As Market Signals Hint At A Turnaround

On Monday, HC Wainwright initiated coverage on Septerna, Inc. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/SEPN#NASDAQ">SEPN</a>), citing a next-generation drug design platform aimed at <a href="https://www.benzinga.com/general/health-care" target="_blank" rel="noreferrer noopener">hitherto-undruggable targets</a>.
Septerna is working on G protein-coupled receptor (GPCR) drug discovery powered by its proprietary Native Complex Platform. Its industrial-scale platform aims to unlock the full <a href="https://www.benzinga.com/pressreleases/25/05/g45450781/septerna-highlights-business-progress-and-reports-first-quarter-2025-financial-results" target="_blank" rel="noreferrer noopener">potential of GPCR therapies</a>.
It has led to the discovery and development of its deep pipeline of oral small molecule product candidates focused initially on treating patients in three therapeutic areas: endocrinology, immunology and inflammation, and metabolic diseases.
Also Read: <a href="https://www.benzinga.com/general/biotech/25/05/45407486/novo-nordisk-inks-22-billion-deal-with-septerna-to-develop-oral-weight-loss-and-diabetes-drugs" target="_blank" rel="noreferrer noopener">Novo Nordisk Inks $2.2 Billion Deal With Septerna To Develop Oral Weight Loss And Diabetes Drugs</a>
Analyst Raghuram Selvaraju, in his report, highlighted several compelling factors for investors.
He pointed out that &#8220;Septerna trades at a discount to its most recently reported cash position and upfront cash from a recently-inked partnership.&#8221; 
This, he argues, makes Septerna &#8220;a risk-mitigated opportunity with multiple shots on goal and catalysts constituting key value inflection points slated to accrue over the next six to 12 months.&#8221;
HC Wainwright has initiated coverage on the biotechnology firm with a Buy rating and a <a href="https://www.benzinga.com/quote/SEPN/analyst-ratings">price forecast of $26</a>.
The company&#8217;s most advanced drug candidate, SEP-631, is a selective oral small molecule MRGPRX2 negative allosteric modulator (NAM) in development for mast cell diseases, including chronic spontaneous urticaria (CSU).
Wainwright believes SEP-631 could offer a distinct treatment option for CSU patients. This is due to its selective inhibition of mast cells, convenient oral administration, and potential for combination therapy. 
Selvaraju further noted that if SEP-631 can replicate the efficacy of Novartis AG (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/NVS#NYSE">NVS</a>)/Roche Holdings AG&#8217;s (OTC:<a class="ticker" href="https://www.benzinga.com/stock/RHHBY#OTC">RHHBY</a>) Xolair (omalizumab) – an anti-IgE monoclonal antibody that generated nearly $3.9 billion in sales in 2023, it &#8220;could readily achieve blockbuster status based on an enhanced convenience profile.
Further solidifying its position, Septerna recently announced an exclusive global collaboration and license agreement with Novo Nordisk A/S (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/NVS#NYSE">NVS</a>) in May. 
This <a href="https://www.benzinga.com/general/biotech/25/05/45407486/novo-nordisk-inks-22-billion-deal-with-septerna-to-develop-oral-weight-loss-and-diabetes-drugs">significant pact</a> covers the discovery, development, and commercialization of oral small-molecule medicines for obesity, type 2 diabetes, and other cardiometabolic diseases, with<a href="https://www.novonordisk.com/content/nncorp/global/en/news-and-media/news-and-ir-materials/news-details.html?id=916006"> four development programs</a> initially commencing. 
HC Wainwright underscored the financial implications of this partnership, stating, &#8220;given the size of the upfront and near-term milestone payments, we feel that Septerna&#8217;s implied enterprise value is either negligible or actually negative, further mitigating risk and underscoring the extent to which the company appears undervalued.&#8221;
Price Action: SEPN stock is trading higher by 0.38% to $10.51 at last check Monday.
Read Next:
<ul class="wp-block-list">
<li><a href="https://www.benzinga.com/news/management/25/05/45466201/ozempic-maker-novo-nordisk-looks-for-new-chief-jorgensen-steps-down" target="_blank" rel="noreferrer noopener">Ozempic Maker Novo Nordisk Looks For New Chief, Jørgensen Steps Down From CEO Role</a></li>
</ul>
Photo via Shutterstock

Biotech

Price Target

Initiation

Analyst Ratings

Trading Ideas

General

SEPN

Analyst Flags Septerna As Undervalued Biotech Play With Significant Upside

On Sunday, Exelixis, Inc. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/EXEL#NASDAQ">EXEL</a>) revealed topline results from the STELLAR-303 phase 3 pivotal trial of zanzalintinib (100 mg) <a target="_blank" href="https://www.benzinga.com/pressreleases/25/06/b46044198/exelixis-announces-zanzalintinib-in-combination-with-an-immune-checkpoint-inhibitor-improved-overa" rel="noreferrer noopener">combined with atezolizumab</a>.
The study includes patients with previously treated non-microsatellite instability (MSI)-high <a target="_blank" href="https://www.benzinga.com/general/health-care" rel="noreferrer noopener">metastatic colorectal cancer (CRC)</a>.
Zanzalintinib in combination with Roche Holdings AG (OTC:<a class="ticker" href="https://www.benzinga.com/stock/RHHBY#OTC">RHHBY</a>) atezolizumab (Tecentriq) demonstrated a statistically significant improvement in overall survival (OS) versus Bayer AG (OTC:<a class="ticker" href="https://www.benzinga.com/stock/BAYRY#OTC">BAYRY</a>) Stivarga (regorafenib).
Also Read: <a href="https://www.benzinga.com/general/biotech/25/05/45418036/exelixis-stock-soars-as-analysts-applaud-raised-2025-guidance-q1-earnings-beat" target="_blank" rel="noreferrer noopener">Exelixis Stock Soars As Analysts Applaud Raised 2025 Guidance, Q1 Earnings Beat</a>
These topline findings are from the final analysis conducted by the Independent Data Monitoring Committee of one of the dual primary endpoints of the STELLAR-303 phase 3 trial.
The trial will proceed to the planned final analysis for the other dual primary endpoint of OS in patients without liver metastases (non-liver metastases, NLM).
The safety profiles of zanzalintinib in combination with atezolizumab and of regorafenib were generally consistent with what has been previously observed, and no new safety signals were identified.
Secondary endpoints of STELLAR-303 include progression-free survival, objective response rate and duration of response in the ITT population and in the NLM subgroup of patients. Exelixis plans to submit detailed results of STELLAR-303 for presentation at an upcoming medical conference.
Following this positive news, analysts at William Blair said that the announcement &#8220;represents the first pivotal success from the zanzalintinib program, and we are encouraged that the STELLAR-303 study met one of the dual primary endpoints of overall survival among the intent-to-treat population, representing the largest commercial opportunity (risk-adjusted U.S. peak sales of $875 million, according to our estimates).&#8221;
Management had earlier projected that zanzalintinib could reach $5 billion in U.S. net product sales by 2033, with 45% expected from genitourinary cancers, another 45% from gastrointestinal cancers, and the remaining 10% from head-and-neck cancers. Analyst Andy Hsieh asserted that the early positive results from the STELLAR-303 trial mark the first step toward reaching that target.
He added, &#8220;From a stock perspective, given its substantial and likely durable cash flow generation into early 2030, we continue to believe Exelixis provides investors with a highly defensive investment profile. We also believe that the strategic positioning outlined by Exelixis should drive moderate growth into the next decade.&#8221;
Adding to Exelixis&#8217; recent positive developments, its partner Ipsen also recently achieved a regulatory milestone.
On Friday, Exelixis&#8217; partner Ipsen received a positive opinion from the European Medicine Agency&#8217;s Committee for Medicinal Products for Human Use for Cabometyx (cabozantinib) for adult patients with unresectable or metastatic, well-differentiated extra-pancreatic and pancreatic neuroendocrine tumors who have progressed following at least one prior systemic therapy <a target="_blank" href="https://www.benzinga.com/pressreleases/25/06/b46022267/exelixis-partner-ipsen-receives-positive-chmp-opinion-for-cabometyx-cabozantinib-for-patients-with" rel="noreferrer noopener">other than somatostatin analogs</a>.
A regulatory decision by the European Medicines Agency is anticipated in 2025. In March 2025, the U.S. Food and Drug Administration approved <a href="https://www.benzinga.com/pressreleases/25/06/b46022267/exelixis-partner-ipsen-receives-positive-chmp-opinion-for-cabometyx-cabozantinib-for-patients-with" target="_blank" rel="noreferrer noopener">Cabometyx in this setting</a>.
Price Action: EXEL stock is trading higher by 11.1% to $44.85 at last check Monday.
Read Next:
<ul class="wp-block-list">
<li><a href="https://www.benzinga.com/markets/biotech/25/05/45703024/pfizer-reports-survival-gains-in-colorectal-cancer-study-combo-therapy-cuts-death-risk-by-over-50" target="_blank" rel="noreferrer noopener">Pfizer Reports Survival Gains In Colorectal Cancer Study, Combo Therapy Cuts Death Risk By Over 50%</a></li>
</ul>
Photo via Shutterstock

Movers

BAYRY

EXEL

Exelixis' Zanzalintinib Combo Boosts Survival In Colorectal Cancer, Stock Soars

<figure class="wp-block-image aligncenter size-full"><img loading="lazy" decoding="async" width="896" height="504" src="https://contributor-assets.benzinga.com/wp-content/uploads/2025/06/23064915/Syringes.jpg" alt="" class="wp-image-14732" srcset="https://contributor-assets.benzinga.com/wp-content/uploads/2025/06/23064915/Syringes.jpg 896w,https://contributor-assets.benzinga.com/wp-content/uploads/2025/06/23064915/Syringes-300x169.jpg 300w,https://contributor-assets.benzinga.com/wp-content/uploads/2025/06/23064915/Syringes-768x432.jpg 768w" sizes="(max-width: 896px) 100vw, 896px" /></figure>
Two Biotechs Poised For Big Moves On Monday (Sana Biotechnology &#x7C; Lineage Cell Therapeutics)
<hr class="wp-block-separator has-alpha-channel-opacity" />
<h3 class="wp-block-heading">1&#xFE0F;&#x20E3; Sana Biotechnology</h3>
Sana Biotechnology, Inc. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/SANA#NASDAQ">SANA</a>)
Catalyst: Invited six-month clinical update — ADA Scientific Sessions, Monday @ 10:30 a.m. CT <a href="https://ir.sana.com/news-releases/news-release-details/sana-biotechnology-announces-invited-oral-presentation-85th?utm_source=chatgpt.com" target="_blank" rel="noreferrer noopener">ir.sana.com</a><a href="https://www.globenewswire.com/news-release/2025/06/09/3096183/0/en/Sana-Biotechnology-Announces-Invited-Oral-Presentation-at-the-85th-Annual-American-Diabetes-Association-Scientific-Sessions.html?utm_source=chatgpt.com" target="_blank" rel="noreferrer noopener">globenewswire.com</a>
<figure class="wp-block-table"> 
<table class="has-fixed-layout">
<thead>
<tr>
<th>What we'll hear</th>
<th>Why it matters</th>
</tr>
</thead>
<tbody>
<tr>
<td>First-in-human data on UP421, a hypoimmune‐modified islet-cell therapy for Type 1 diabetes</td>
<td>• One treated patient is six months insulin- &amp; immunosuppression-free. • If replicated, UP421 could leapfrog donor-islet transplants, the current gold standard that still requires lifelong immunosuppression.</td>
</tr>
<tr>
<td>Safety &amp; durability profile through 180 days</td>
<td>• The ADA crowd is data‐driven: low adverse events and durable C-peptide levels would de-risk the platform.</td>
</tr>
<tr>
<td>Expansion path (multi-patient cohort)</td>
<td>• Positive signals open the door to "breakthrough" or RMAT dialogue with FDA, accelerating timelines.</td>
</tr>
</tbody>
</table>
</figure>
Why the stock could pop Monday
<ul class="wp-block-list">
<li>Audience effect: the ADA meeting pulls in ~11-12 k registrants; roughly 3–4 k are adult endocrinologists who influence treatment paradigms and often trade or recommend names they've just seen. <a href="https://www.breakthrought1d.org/news-and-updates/adas-85th-scientific-sessions/?utm_source=chatgpt.com" target="_blank" rel="noreferrer noopener">breakthrought1d.org</a></li>
<li>Scarcity value: no other public company has shown insulin independence without immunosuppression.</li>
<li>Float dynamics: SANA's free float is only ~24 % of shares outstanding; a modest uptick in buy-interest can move the tape quickly.</li>
</ul>
Watch-for: If the single-patient success extends to the next two patients in cohort B, look for sell-side upgrades and chatter about a pivotal trial design in H2-25.
<hr class="wp-block-separator has-alpha-channel-opacity" />
<h3 class="wp-block-heading">2&#xFE0F;&#x20E3; Lineage Cell Therapeutics</h3>
Lineage Cell Therapeutics, Inc. (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/LCTX#NYSE">LCTX</a>)
Catalyst window: Genentech PR "within weeks" + 36-month OpRegen&#xAE; read-out at CTS-2025 (June 27) <a href="https://www.businesswire.com/news/home/20250512395886/en/RG6501-OpRegen-Phase-12a-Clinical-Study-36-Month-Results-to-Be-Featured-at-Clinical-Trials-at-the-Summit-2025?utm_source=chatgpt.com" target="_blank" rel="noreferrer noopener">businesswire.com</a><a href="https://www.businesswire.com/news/home/20250605204221/en/Lineage-Cell-Therapeutics-Announces-Updates-to-the-3rd-Annual-Spinal-Cord-Injury-Investor-Symposium?utm_source=chatgpt.com" target="_blank" rel="noreferrer noopener">businesswire.com</a><a href="https://www.modernretina.com/view/lineage-to-announce-data-from-phase-1-2a-study-on-use-of-rg6501?utm_source=chatgpt.com" target="_blank" rel="noreferrer noopener">modernretina.com</a>
<figure class="wp-block-table"> 
<table class="has-fixed-layout">
<thead>
<tr>
<th>What could hit</th>
<th>Price-sensitive angle</th>
</tr>
</thead>
<tbody>
<tr>
<td>Roche Holding AG (OTC:<a class="ticker" href="https://www.benzinga.com/stock/RHHBY#OTC">RHHBY</a>) subsidiary Genentech/LCTX services-agreement milestones or data-share PR</td>
<td>• Prior Genentech press releases on OpRegen have triggered double-digit one-day moves in LCTX.</td>
</tr>
<tr>
<td>36-month functional vision data (phase 2a, GA secondary to AMD)</td>
<td>• If BCVA gains remain ≥7 letters and lesion growth stays slowed, analysts will start modelling blockbuster-size royalties.</td>
</tr>
<tr>
<td>Potential partner opt-in for spinal cord (SCIIS meeting)</td>
<td>• Separately, Lineage tees-up a June 27 investor symposium on spinal cord injury – any strategic partner news adds another risk-on spark.</td>
</tr>
</tbody>
</table>
</figure>
Why Monday could be the start of a new leg
<ul class="wp-block-list">
<li>Pattern set-up: the stock has been basing in the $1.60–1.80 zone; traders remember the May 2024 Genentech PR that drove a 40 % gap.</li>
<li>Valuation gap: LCTX trades at &lt; 3× 2026e OpRegen royalty sales versus cell-therapy peers at 8–10×.</li>
<li>Short-term IV low: front-month at-the-money calls imply a ±12 % move by July — well under the 20–30 % jumps we saw on the last three data bursts.</li>
</ul>
Watch-for: A Monday-morning 8-K or Genentech newsroom post; if nothing drops, option premiums may leak until later in the week — keep a trading tranche nimble.
<hr class="wp-block-separator has-alpha-channel-opacity" />
<h3 class="wp-block-heading">Tactical takeaways</h3>
<ol class="wp-block-list">
<li>SANA: momentum play into the ADA deck. Small float + novel cure angle = potential volatility.</li>
<li>LCTX: event-driven swing; even a "PR-then-data" one-two punch could squeeze shorts.</li>
<li>Risk management: both names are clinical-stage — size positions modestly, use stops, and consider call-spreads to bound downside.</li>
</ol>
<hr class="wp-block-separator has-alpha-channel-opacity" />
Bottom line: Monday's calendar lines up two asymmetric biotech shots: If Sana's six-month data look anything like the first patient's, endocrinologists will be talking — and buying — before lunch. If Lineage's big-pharma partner steps back into the headlines, we could see the May-style pop all over again.
<hr class="wp-block-separator has-alpha-channel-opacity" />
<h3 class="wp-block-heading">Our positions in both stocks</h3>
Portfolio Armor Substack subscribers and I are long SANA and LCTX via options. I wrote about SANA <a href="https://www.benzinga.com/general/biotech/25/05/45498697/the-end-of-the-diabetes-industry-this-small-cap-could-upend-the-business-models-of-pharma-giants">here</a>.
<figure class="wp-block-image size-full"><a href="https://portfolioarmor.substack.com/p/the-end-of-the-diabetes-industry"><img loading="lazy" decoding="async" width="828" height="812" src="https://contributor-assets.benzinga.com/wp-content/uploads/2025/06/23050427/SANA.jpg" alt="" class="wp-image-14724" srcset="https://contributor-assets.benzinga.com/wp-content/uploads/2025/06/23050427/SANA.jpg 828w,https://contributor-assets.benzinga.com/wp-content/uploads/2025/06/23050427/SANA-300x294.jpg 300w,https://contributor-assets.benzinga.com/wp-content/uploads/2025/06/23050427/SANA-768x753.jpg 768w" sizes="(max-width: 828px) 100vw, 828px" /></a></figure>
And I first wrote about LCTX <a href="https://portfolioarmor.substack.com/p/trade-alert-biotech-lotto-ticket">last Friday</a>. 
<figure class="wp-block-image size-full"><a href="https://portfolioarmor.substack.com/p/trade-alert-biotech-lotto-ticket"><img loading="lazy" decoding="async" width="833" height="733" src="https://contributor-assets.benzinga.com/wp-content/uploads/2025/06/23050717/LCTX.jpg" alt="" class="wp-image-14725" srcset="https://contributor-assets.benzinga.com/wp-content/uploads/2025/06/23050717/LCTX.jpg 833w,https://contributor-assets.benzinga.com/wp-content/uploads/2025/06/23050717/LCTX-300x264.jpg 300w,https://contributor-assets.benzinga.com/wp-content/uploads/2025/06/23050717/LCTX-768x676.jpg 768w" sizes="(max-width: 833px) 100vw, 833px" /></a></figure>
We plan on selling half of our positions into a strong upward move to lock in profits. 
If you would like a heads up when we place our next trade, feel free to subscribe to the Portfolio Armor Substack below. 
<figure class="wp-block-image aligncenter size-full"><a href="https://portfolioarmor.substack.com/"><img loading="lazy" decoding="async" width="581" height="372" src="https://contributor-assets.benzinga.com/wp-content/uploads/2025/06/23050929/Widget-2-1.jpg" alt="" class="wp-image-14726" srcset="https://contributor-assets.benzinga.com/wp-content/uploads/2025/06/23050929/Widget-2-1.jpg 581w,https://contributor-assets.benzinga.com/wp-content/uploads/2025/06/23050929/Widget-2-1-300x192.jpg 300w" sizes="(max-width: 581px) 100vw, 581px" /></a></figure>
And if you want to limit your downside risk, in light of the conflict in the Mideast, consider <a href="https://apps.apple.com/us/app/portfolio-armor/id394951144">the Portfolio Armor iPhone app</a> or <a href="https://apps.apple.com/us/app/portfolio-armor/id394951144">website</a>. Both will help you scan for the optimal hedge given your risk tolerance and time frame. 
<figure class="wp-block-image aligncenter size-large"><a href="https://apps.apple.com/us/app/portfolio-armor/id394951144"><img loading="lazy" decoding="async" width="1024" height="683" src="https://contributor-assets.benzinga.com/wp-content/uploads/2025/06/23051320/PA-JPEG-1-2-1024x683.jpeg" alt="" class="wp-image-14727" srcset="https://contributor-assets.benzinga.com/wp-content/uploads/2025/06/23051320/PA-JPEG-1-2-1024x683.jpeg 1024w,https://contributor-assets.benzinga.com/wp-content/uploads/2025/06/23051320/PA-JPEG-1-2-300x200.jpeg 300w,https://contributor-assets.benzinga.com/wp-content/uploads/2025/06/23051320/PA-JPEG-1-2-768x512.jpeg 768w,https://contributor-assets.benzinga.com/wp-content/uploads/2025/06/23051320/PA-JPEG-1-2.jpeg 1200w" sizes="(max-width: 1024px) 100vw, 1024px" /></a></figure>

Opinion

LCTX

SANA

Two Biotech Stocks Poised For Big Moves On Monday

<ul>
<li>Positive phase I/II data presented at the 2025 International Society on Thrombosis and Haemostasis (ISTH) Congress show NXT007 achieved no bleeds requiring treatment in the highest dose groups in people with haemophilia A1</li>
<li>The NXT007 clinical development programme aims to normalise haemostasis and minimise treatment burden2,3
<ul>
<li>Three phase III clinical studies on NXT007, a next-generation bispecific antibody, set to begin in 20261</li>
</ul>
</li>
</ul>

RHHBF

RHHVF

Roche's NXT007 Shows No Treated Bleeds In Highest Dose Groups, Advancing Toward Phase III Trials For Haemophilia A

Sarepta Therapeutics, Inc. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/SRPT#NASDAQ">SRPT</a>) stock experienced a steep decline of approximately 40% in premarket trading on Monday following a sobering safety update for its <a href="https://www.benzinga.com/general/health-care">Duchenne muscular dystrophy (DMD)</a> gene therapy, Elevidys.
<h2 class="wp-block-heading">What Happened</h2>
On Sunday, Sarepta provided a safety update regarding Elevidys (delandistrogene moxeparvovec-rokl), the only approved gene therapy for patients with Duchenne muscular dystrophy, and steps the company is taking to strengthen the safety profile in non-ambulatory patients.
These steps follow a second reported case of acute liver failure (ALF), <a target="_blank" href="https://www.benzinga.com/pressreleases/25/06/b45940036/sarepta-provides-safety-update-for-elevidys-and-initiates-steps-to-strengthen-safety-in-non-ambula" rel="noreferrer noopener">resulting in death</a>.
In March,&nbsp;Sarepta Therapeutics reported a patient death following treatment with Elevidys, having suffered <a target="_blank" href="https://www.benzinga.com/25/03/44376919/sarepta-therapeutics-reports-patient-death-post-elevidys-gene-therapy-treatment-stock-plunges" rel="noreferrer noopener">acute liver failure</a>.
The cases of ALF to date have both occurred in non-ambulatory (patients who cannot walk independently) individuals with Duchenne.
Sarepta and Roche Holdings AG (OTC:<a class="ticker" href="https://www.benzinga.com/stock/RHHBY#OTC">RHHBY</a>) temporarily halted several <a target="_blank" href="https://www.benzinga.com/25/04/44634689/sareptaroche-suspend-elevidys-gene-therapy-trials-in-europe-after-patient-death" rel="noreferrer noopener">clinical studies in April</a>.
During its first-quarter earnings release, Sarepta revised its 2025 total net product revenues guidance to $2.3-$2.6 billion <a target="_blank" href="https://www.benzinga.com/25/05/45261806/sarepta-therapeutics-stock-sinks-on-gloomy-forecast-analysts-cut-price-forecasts" rel="noreferrer noopener">from $2.9-$3.1 billion</a>.
William Blair writes that the revised guidance primarily concerns delayed Elevidys turnaround times.
Also Read: <a href="https://www.benzinga.com/general/biotech/25/05/45393806/ten-year-data-from-roches-breast-cancer-trial-shows-perjeta-based-regimen-cuts-death-risk-by-17" target="_blank" rel="noreferrer noopener">Ten-Year Data From Roche&#8217;s Breast Cancer Trial Shows Perjeta-Based Regimen Cuts Death Risk By 17%</a>
<h2 class="wp-block-heading">Key Safety Initiatives</h2>
As part of a comprehensive review of safety data, Sarepta is taking proactive steps to mitigate the risk of acute liver failure in non-ambulatory patients.
A panel will evaluate data and assess the company&#8217;s proposed regimen, which includes sirolimus and is supported by preclinical data demonstrating the effectiveness of additional immunosuppression in moderating liver enzyme elevations, a key factor in mitigating potential safety events.
Sarepta will share the panel&#8217;s recommendations with the U.S. Food &amp; Drug Administration (FDA), and implementation of any new regimen will be subject to FDA guidance and allowance.
In the meantime, Sarepta is temporarily suspending shipments of Elevidys for non-ambulatory patients.
For ambulatory patients, no treatment <a target="_blank" href="https://www.roche.com/investors/updates/inv-update-2025-06-15" rel="noreferrer noopener">changes</a> are being proposed and the current practice of administering corticosteroids before and after Elevidys infusion and post-treatment monitoring remains the same.
Sarepta has voluntarily paused dosing in the ENVISION clinical study (also known as Study SRP-9001-303).
ENVISION is a global, randomized, double-blind, placebo-controlled trial evaluating Elevidys in older ambulatory and non-ambulatory Duchenne muscular dystrophy patients.
In the U.S., it serves as the confirmatory trial required under the FDA&#8217;s accelerated approval pathway for non-ambulatory patients.
Price Action: SRPT stock is trading lower by 42.0% to $21.00 during the premarket session at last check Monday.
Read Next:
<ul class="wp-block-list">
<li><a href="https://www.benzinga.com/markets/biotech/25/06/45797348/early-wins-regenxbios-gene-therapy-helps-duchenne-patients-walk-stronger-longer" target="_blank" rel="noreferrer noopener">Early Wins: RegenXBio&#8217;s Gene Therapy Helps Duchenne Patients Walk Stronger, Longer</a></li>
</ul>
Photo via Shutterstock

SRPT

Sarepta Therapeutics Stock Plummets Over 40% On Second Fatal Case Linked To Its Gene Therapy

<ul>
<li>Results from Phase IIb PADOVA and longer term follow-up data suggest clinical benefit on top of symptomatic treatment in early-stage Parkinson's disease&nbsp;</li>
<li>Prasinezumab is a potential first-in-class anti-alpha-synuclein antibody, targeting a known biological driver of Parkinson's disease progression</li>
<li>Parkinson's disease affects over 10 million people globally and significant unmet need remainS</li>
</ul>

Roche's Genentech Advances Prasinezumab To Phase III After PADOVA And PASADENA Data Suggest Long-Term Benefit In Early Parkinson's Disease

Chugai Pharmaceutical Co. Ltd. (OTC:<a class="ticker" href="https://www.benzinga.com/stock/CHGCY#OTC">CHGCY</a>) believes its anti-muscle-wasting drug could be used alongside Eli Lilly And Co.&#8217;s (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/LLY#NYSE">LLY</a>) <a target="_blank" href="https://www.benzinga.com/topic/weight-loss" rel="noreferrer noopener">oral obesity pill</a>, orforglipron.
Roche Holdings AG (OTC:<a class="ticker" href="https://www.benzinga.com/stock/RHHBY#OTC">RHHBY</a>) is a major shareholder of Chugai, a Japanese pharmaceutical company. The company&#8217;s optimism stems from growing evidence that modern weight-loss drugs can lead to significant muscle loss, an issue Chugai thinks it can help address.
Hitoshi Iikura, a senior executive at Chugai, <a target="_blank" href="https://www.ft.com/content/4fd1fd94-0b70-48fb-861b-3bad6286ebae" rel="noreferrer noopener">told</a> the Financial Times the company has &#8220;high expectations&#8221; for combining GYM329, initially developed for spinal muscular atrophy (SMA), with orforglipron or similar therapies.
Also Read: <a target="_blank" href="https://www.benzinga.com/news/health-care/25/06/45769020/mounjaro-maker-eli-lilly-taps-swedish-firm-camurus-to-target-long-acting-obesity-market-in-870-million-deal" rel="noreferrer noopener">Mounjaro Maker Eli Lilly Taps Swedish Firm Camurus To Target Long-Acting Obesity Market In $870-Million Deal</a>
Orforglipron, which Lilly licensed from Chugai, showed strong late-stage trial results, matching the safety and efficacy of popular injectables like Novo Nordisk A/S&#8217; (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/NVO#NYSE">NVO</a>) Wegovy and Ozempic and Lilly&#8217;s Zepbound and Mounjaro.
The drug significantly <a target="_blank" href="https://www.benzinga.com/general/biotech/25/04/44934811/eli-lilly-positioned-to-dominate-obesity-market-with-oral-option-analyst-initiates-with-confidence" rel="noreferrer noopener">reduced weight and blood sugar levels</a> and is expected to hit the market next year.
Chugai began developing orforglipron in 2003 as part of an effort to enhance diabetes treatments, aiming to make them longer-acting and tablet-based. Although obesity wasn&#8217;t an initial target, the company saw broader potential as research evolved. &#8220;We didn&#8217;t anticipate it but it&#8217;s ballooning,&#8221; Iikura said, referring to the unexpectedly large obesity market.
Studies suggest that 25% to 39% of weight loss from obesity drugs may be due to lean mass reduction, which includes muscle. Chugai argues that maintaining muscle mass is vital, especially for aging populations, and its GYM329 drug could be a key component in preventing this loss during weight-loss treatment.
Despite Chugai&#8217;s success, Roche had previously passed on orforglipron due to setbacks with an earlier weight-loss drug. At the time, much of the pharmaceutical industry was hesitant to enter the obesity space, except companies like Lilly and Novo Nordisk with strong metabolic disease portfolios.
However, with market interest and scientific breakthroughs accelerating, Roche reversed course in 2023 and <a target="_blank" href="https://www.benzinga.com/general/biotech/24/08/40422774/roche-misses-out-on-weight-loss-blockbuster-drug-now-playing-catch-up-in-booming-market" rel="noreferrer noopener">reentered the field</a>.
Meanwhile, Bloomberg <a target="_blank" href="https://www.bloomberg.com/news/articles/2025-06-07/lilly-s-obesity-drug-sales-rise-60-in-india-amid-rising-demand" rel="noreferrer noopener">reported</a> that Eli Lilly saw a 60% jump in sales of its weight-loss and diabetes drug Mounjaro in India in May compared to April, marking its second full month on the Indian market.
India has the third-largest obese population in the world.
According to market research firm Pharmarack Technologies, the U.S. drugmaker made 126 million rupees ($1.5 million) from Mounjaro injections last month.
Sales of the 5 mg dose more than doubled to 75 million rupees, while the 2.5 mg version brought in 51 million rupees.
According to the Indian Council of Medical Research (ICMR), there are 101 million people with diabetes in India. Of these, at least 40 million are on medication.
Vishal Manchanda, SVP of institutional research at Systematix Group,&nbsp;told&nbsp;Livemint that even if 0.5% of 40 million use Mounjaro, it would fetch Eli Lilly sales of <a target="_blank" href="https://www.benzinga.com/25/04/44824190/eli-lillys-mounjaro-launch-triggers-weight-loss-craze-in-india-novo-nordisk-seeks-to-move-up-wegovy-launch" rel="noreferrer noopener">$1.5 billion annually</a>.
Novo Nordisk&nbsp;is also trying to move up the launch of Wegovy in India to better compete with Lilly.
Price Action: LLY stock closed up 0.55% at $769.88 on Friday.
Read Next:
<ul class="wp-block-list">
<li><a href="https://www.benzinga.com/markets/large-cap/25/06/45814068/novo-nordisks-wegovy-tied-to-increased-risk-of-rare-vision-loss-disorder-european-regulators-say" target="_blank" rel="noreferrer noopener">Novo Nordisk&#8217;s Wegovy Tied To Increased Risk Of Rare Vision-Loss Disorder, European Regulators Say</a></li>
</ul>
Photo via Shutterstock

CHGCY

Eli Lilly's Obesity Drug Success Spurs Japanese Biotech's Anti-Muscle-Wasting Combo Therapy

Jazz Pharmaceuticals plc (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/JAZZ#NASDAQ">JAZZ</a>) on Monday revealed results from the Phase 3 IMforte study of Zepzelca (lurbinectedin) in combination with Roche Holdings AG&#8217;s (OTC:<a class="ticker" href="https://www.benzinga.com/stock/RHHBY#OTC">RHHBY</a>) Tecentriq (atezolizumab) as a first-line maintenance treatment for extensive-stage small cell lung cancer (ES-SCLC), following induction therapy with carboplatin, <a href="https://www.benzinga.com/general/health-care" target="_blank" rel="noreferrer noopener">etoposide and atezolizumab</a>.
The study met both primary endpoints, demonstrating statistically significant improvements in progression-free survival (PFS) and overall survival (OS) compared to atezolizumab alone, <a href="https://www.benzinga.com/pressreleases/25/06/n45733928/jazz-pharmaceuticals-announces-zepzelca-lurbinectedin-and-atezolizumab-tecentriq-combination-signi">according to a press release</a>. 
IMforte is the first global Phase 3 trial to demonstrate clinically meaningful PFS and OS benefits in the first-line maintenance setting for ES-SCLC. It supports maintenance therapy with&nbsp;Zepzelca plus atezolizumab as a new standard of care for patients.
Also Read: <a target="_blank" href="https://www.benzinga.com/general/biotech/25/03/44140310/jazz-pharma-to-buy-chimerix-for-935-million-strengthening-rare-cancer-pipeline" rel="noreferrer noopener">Jazz Pharma To Buy Chimerix For $935 Million, Strengthening Rare Cancer Pipeline</a>
The data were presented at the 2025 American Society of Clinical Oncology Annual Meeting.
Following induction therapy with carboplatin, etoposide and atezolizumab, patients who did not have disease progression were randomized to receive&nbsp;Zepzelca&nbsp;plus atezolizumab or atezolizumab alone.
Four hundred and eighty-three patients were randomized after completion of four cycles of induction therapy with atezolizumab plus carboplatin and etoposide.
From the point of randomization, the median PFS was 5.4 months for the&nbsp;Zepzelca&nbsp;plus atezolizumab combination versus 2.1 months for atezolizumab alone, and the median OS was 13.2 months versus 10.6 months.
Compared to atezolizumab alone, the combination reduced the risk of disease progression or death by 46% and the risk of death by 27%. The&nbsp;Zepzelca&nbsp;plus atezolizumab combination had no new or unexpected safety signals.
The&nbsp;Zepzelca&nbsp;plus atezolizumab&nbsp;combination as maintenance therapy was generally well tolerated, and no new safety signals were identified.
In the&nbsp;Zepzelca&nbsp;plus atezolizumab&nbsp;and atezolizumab arms, respectively, treatment-related adverse events (TRAEs) occurred in 83.5% versus 40.0% of patients, with Grade 3-4 TRAEs in 25.6% versus 5.8% and Grade 5 TRAEs in 0.8% (two patients with sepsis and febrile neutropenia) versus 0.4% (one patient with sepsis).
AEs led to treatment discontinuation in 6.2% of patients in the Zepzecla plus atezolizumab&nbsp;arm and 3.3% in the atezolizumab arm.
JAZZ Price Action: JAZZ stock is up 2.07% at $110.53 at publication on Tuesday.
Read Next:
 • <a href="https://www.benzinga.com/markets/earnings/25/06/45746307/dollar-general-boosts-annual-outlook-despite-ongoing-tariff-uncertainty" target="_blank" rel="noreferrer noopener">Dollar General Boosts Annual Outlook Despite Ongoing Tariff Uncertainty</a>
Photo: Shutterstock

JAZZ

Jazz Pharma's Zepzelca Combo Shows Survival Edge In Lung Cancer Study

<ul>
<li>The Itovebi (inavolisib)-based regimen reduced the risk of death by more than 30% in people with PIK3CA-mutated HR-positive, HER2-negative advanced breast cancer, compared with palbociclib and fulvestrant alone –</li>
<li>The PIK3CA mutation is found in approximately 40% of HR-positive advanced breast cancers and is associated with a poor prognosis –</li>
<li>New data are being presented in an oral session at the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting and published in the New England Journal of Medicine</li>
</ul>

Reported Saturday, Genentech's Itovebi-Based Regimen Cuts Risk Of Death By Over 30% In PIK3CA-Mutated HR-Positive, HER2-Negative Advanced Breast Cancer, Phase III INAVO120 Data Show

Roche Holdings AG (OTC:<a class="ticker" href="https://www.benzinga.com/stock/RHHBY#OTC">RHHBY</a>) on Friday announced new 96-week data for fenebrutinib demonstrating that patients with relapsing multiple sclerosis (RMS) maintained no disability progression and low disease activity levels for up to two years.
The latest <a target="_blank" href="https://www.roche.com/media/releases/med-cor-2025-05-30" rel="noreferrer noopener">results</a> for this investigational Bruton&#8217;s tyrosine kinase (BTK) inhibitor from the Phase II FENopta open-label extension (OLE) study were presented at the Consortium of Multiple Sclerosis Centers (CMSC) Annual Meeting.
Ninety-nine patients entered the OLE and 93 remained in the OLE after 96 weeks.
Also Read: <a target="_blank" href="https://www.benzinga.com/general/biotech/25/05/45393806/ten-year-data-from-roches-breast-cancer-trial-shows-perjeta-based-regimen-cuts-death-risk-by-17" rel="noreferrer noopener">Ten-Year Data From Roche&#8217;s Breast Cancer Trial Shows Perjeta-Based Regimen Cuts Death Risk By 17%</a>
During the OLE period, patients treated with fenebrutinib for up to 96 weeks had a low annualised relapse rate (ARR) of 0.06, and during this time there was no disability progression, as measured by the Expanded Disability Status Scale (EDSS).
MRI scans showed that fenebrutinib treatment suppressed disease activity in the brain. At 96 weeks zero new T1 gadolinium-enhancing (T1-Gd+) lesions, which are markers of active inflammation, were detected.
In the treatment group that switched from placebo to fenebrutinib in the OLE, the annualized rate of new or enlarging T2 lesions, which represent chronic disease burden, decreased from 6.72 at the end of the 12-week double-blind period to 0.34 by 96 weeks.
The safety profile of fenebrutinib in the OLE was consistent with previously reported data, with no new safety concerns identified at 96 weeks.
During the OLE, one patient experienced asymptomatic alanine aminotransferase elevation at OLE week 4, after 16 weeks on treatment, which resolved with treatment discontinuation.
Three Phase 3 trials are ongoing, including the FENhance 1 and 2 trials in RMS and the FENtrepid trial in primary progressive multiple sclerosis (PPMS). The first data from these studies are expected at the end of 2025.
In April, Roche announced it would invest $50 billion in the U.S. over&nbsp;the <a target="_blank" href="https://www.benzinga.com/general/biotech/25/04/44934942/roche-plans-50-billion-us-investment-over-5-years-with-12000-new-jobs" rel="noreferrer noopener">next five years</a>.
These investments further strengthen Roche&#8217;s already significant U.S. footprint, which includes 13 manufacturing and 15 R&amp;D sites across the Pharmaceutical and Diagnostics Divisions.
The investment is expected to&nbsp;<a target="_blank" href="https://www.roche.com/media/releases/med-cor-2025-04-22?tblci=GiCUX7wvU_AgmIIiQduNYr6JQuJQLy6SZJGvpyeZuCzyqiCN1VcoxvTN4f7-y-PqATDviEo" rel="noreferrer noopener">create</a> over 12,000 new jobs, including nearly 6,500 construction jobs and 1,000 jobs at new and expanded facilities.
Price Action: RHHBY stock is trading higher by 1.83% to $40.25 at last check Friday.
Read Next:
<ul class="wp-block-list">
<li><a href="https://www.benzinga.com/trading-ideas/movers/25/05/45692578/regeneron-sanofi-stock-falls-after-uneven-smokers-lung-drug-data" target="_blank" rel="noreferrer noopener">Regeneron, Sanofi Stock Falls After Uneven Smoker&#8217;s Lung Drug Data</a></li>
</ul>
Photo by OleksSH via Shutterstock

Roche's Multiple Sclerosis Drug Shows Low Disease Activity Over Two Years

<ul>
<li>- Patients on fenebrutinib had low relapse rates with data showing no active brain lesions or disability progression after nearly two years of treatment -</li>
<li>- Phase III studies for fenebrutinib in relapsing and primary progressive multiple sclerosis are expected to start reading out at year end -</li>
</ul>

Roche's Genentech Reports Long-Term Data Showing Fenebrutinib Prevents Active Brain Lesions And MS Disability Progression Over 2 Years

<ul>
<li>Updated data from the pivotal Phase III STARGLO study continue to demonstrate a clinically meaningful improvement in overall survival with a 40% survival benefit for people with R/R DLBCL who are not candidates for transplant</li>
<li>89% of patients whose cancer had fully responded at the end of treatment with Columvi in combination with chemotherapy were still alive and 82% showed no signs of cancer one year post-treatment</li>
<li>Timely initiation of effective therapy at relapse or after initial therapy failure is critical for this aggressive, life-threatening disease&nbsp;</li>
<li>Results demonstrate potential of the Columvi combination as a much-needed, off-the-shelf and fixed-duration treatment option&nbsp;</li>
</ul>

Roche's Genentech Highlights Two-Year STARGLO Data: Columvi Plus Chemotherapy Delivers 40% Overall Survival Benefit In Transplant-Ineligible Relapsed Or Refractory DLBCL Patients

Contracts

Watching Roche; Reuters Reports Statement From Co Stating It Plans To Invest Up To 4 Billion Pesos In Clinical Investigation In Mexico In Next 5-Years

<a href="https://www.fda.gov/news-events/press-announcements/fda-clears-first-blood-test-used-diagnosing-alzheimers-disease#:~:text=The%20Lumipulse%20G%20pTau217%2F%C3%9F,and%20symptoms%20of%20the%20disease">https://www.fda.gov/news-events/press-announcements/fda-clears-first-blood-test-used-diagnosing-alzheimers-disease#:~:text=The%20Lumipulse%20G%20pTau217%2F%C3%9F,and%20symptoms%20of%20the%20disease</a>.

ACIU

ANVS

BIIB

DNLI

PRTA

SAVA

'FDA Clears First Blood Test Used In Diagnosing Alzheimer's Disease; New Test Provides Less Invasive Option, Reduces Reliance On Pet Scans And Increases Diagnosis Accessibility' - FDA

Merck&nbsp;&amp; Co Inc (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/MRK#NYSE">MRK</a>) on Thursday said the Phase 3 KEYNOTE-B96 trial (also known as ENGOT-ov65), met its primary endpoint of progression-free survival (PFS) for platinum-resistant recurrent ovarian cancer whose tumors expressed PD-L1 <a target="_blank" href="https://www.benzinga.com/general/health-care" rel="noreferrer noopener">and in all comers</a>.
The study also met a secondary endpoint of overall survival (OS) in patients whose tumors express PD-L1.
Also Read: <a target="_blank" href="https://www.benzinga.com/general/biotech/25/05/45418609/fda-approves-mercks-kidney-cancer-drug-for-rare-type-of-neuroendocrine-tumors" rel="noreferrer noopener">FDA Approves Merck&#8217;s Kidney Cancer Drug For Rare Type Of Neuroendocrine Tumors</a>
The study is evaluating Keytruda&nbsp;(pembrolizumab), Merck&#8217;s anti-PD-1 therapy, in combination with chemotherapy (paclitaxel) with or without Roche Holdings AG&#8217;s (OTC:<a class="ticker" href="https://www.benzinga.com/stock/RHHBY#OTC">RHHBY</a>) Avastin (bevacizumab) <a target="_blank" href="https://www.benzinga.com/pressreleases/25/05/b45431872/merck-announces-phase-3-keynote-b96-trial-met-primary-endpoint-of-progression-free-survival-pfs-in" rel="noreferrer noopener">for these patients</a>.
The trial continues, and OS for the full study population will be evaluated at a future analysis.
The Keytruda-based regimen demonstrated a statistically significant and clinically meaningful improvement in PFS regardless of PD-L1 status compared to placebo plus chemotherapy with or without bevacizumab.
The study also showed a statistically significant and clinically meaningful improvement in OS in patients whose tumors express PD-L1 (Combined Positive Score [CPS] ≥1) compared to placebo plus chemotherapy with or without bevacizumab.
&#8220;This marks the first time a KEYTRUDA-based regimen has shown the ability to help certain patients with platinum-resistant ovarian cancer live longer, and the first time an immune checkpoint inhibitor-based regimen has demonstrated an overall survival benefit in ovarian cancer,&#8221; said Dr. Gursel Aktan, vice president, global clinical development, Merck Research Laboratories.
Keytruda is not approved for ovarian cancer.
Lynparza (olaparib), jointly developed by AstraZeneca Plc (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/AZN#NASDAQ">AZN</a>) and Merck, has three approved ovarian <a href="https://www.benzinga.com/24/12/42393128/merck-reveals-mixed-data-from-keytrudalynparza-regime-in-ovarian-cancer" target="_blank" rel="noreferrer noopener">cancer indications in the U.S</a>.
In October, Merck&nbsp;announced that the Phase 3 KEYNOTE-689 trial of Keytruda, as a perioperative treatment for patients newly diagnosed with stage III or IVA, resected, locally advanced head and neck squamous cell carcinoma, met its primary endpoint of&nbsp;<a target="_blank" href="https://www.benzinga.com/general/health-care/24/10/41230591/merck-touts-phase-3-success-for-20b-cancer-drug-keytruda-in-untreated-head-and-neck-cancer-pa" rel="noreferrer noopener">event-free survival (EFS)</a>.
Price Action: MRK stock is
Read Next:
<ul class="wp-block-list">
<li><a href="https://www.benzinga.com/general/health-care/25/05/45443695/why-is-unitedhealth-stock-trading-lower-on-thursday" target="_blank" rel="noreferrer noopener">Why Is UnitedHealth Stock Trading Lower On Thursday?</a></li>
</ul>
Image: Shutterstock

Merck Data Shows Positive Outcomes For Ovarian Cancer Patients Treated With Keytruda

Sanofi SA (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/SNY#NASDAQ">SNY</a>) announced on Wednesday that it will invest at least $20 billion in the <a href="https://www.benzinga.com/general/health-care" target="_blank" rel="noreferrer noopener">U.S. through 2030</a>.
Research and development, plus U.S. manufacturing, will receive the bulk of the spending.
The company also expects higher job creation within the communities where Sanofi and its partners are located, which will help <a href="https://www.benzinga.com/pressreleases/25/05/n45414947/sanofi-to-invest-at-least-20-billion-in-the-us-through-2030-growing-investments-in-science-and-exp" target="_blank" rel="noreferrer noopener">enhance the U.S. supply chain</a>.
Also Read: <a target="_blank" href="https://www.benzinga.com/general/biotech/25/04/44981281/french-drugmaker-sanofi-clocks-20-q1-profit-growth-forecasts-strong-rebound-in-annual-profit" rel="noreferrer noopener">French Drugmaker Sanofi Clocks 20% Q1 Profit Growth, Forecasts Strong Rebound In Annual Profit</a>
Sanofi has 13,000 US-based employees, according to CEO Paul Hudson.
&#8220;Our expected investments in the US will be substantial and will help ensure the production of key medicines in the U.S.,&#8221; he added.
Sanofi also expects to partner with other domestic manufacturers to help ensure the production of medicines in the U.S.  
Earlier in May, U.S. President&nbsp;Donald Trump's&nbsp;signed an executive order to promote prescription drug manufacturing in the U.S., streamlining the path for companies to build new production sites as potential tariffs on&nbsp;<a target="_blank" href="https://www.benzinga.com/topic/tariffs" rel="noreferrer noopener">imported medicines loom</a>.
The White House wants facilities to come on board at a faster rate. It <a href="https://www.whitehouse.gov/presidential-actions/2025/05/regulatory-relief-to-promote-domestic-production-of-critical-medicines/?tblci=GiCUX7wvU_AgmIIiQduNYr6JQuJQLy6SZJGvpyeZuCzyqiCN1VcoxvTN4f7-y-PqATDviEo" target="_blank" rel="noreferrer noopener">estimates</a> that it can currently take five to 10 years to build new pharmaceutical manufacturing capacity, which it calls "unacceptable from a national-security standpoint.&#8221;
It&#8217;s not just Sanofi. <a href="https://www.benzinga.com/25/05/45234032/fda-expands-surprise-inspections-at-foreign-drug-and-food-facilities-targets-double-standards-in-overseas-manufacturing-oversight" target="_blank" rel="noreferrer noopener">Amid tariff uncertainty</a>, many drug companies are investing to boost production within the U.S.:
<ul class="wp-block-list">
<li>Eli Lilly And Co&nbsp;(NYSE:<a class="ticker" href="https://www.benzinga.com/stock/LLY#NYSE">LLY</a>) doubled&nbsp;<a href="https://www.benzinga.com/general/biotech/25/02/43982604/eli-lilly-doubles-capital-spending-on-us-drug-manufacturing-with-50-billion-target" target="_blank" rel="noreferrer noopener">domestic medicine production</a>.</li>
<li>Thermo Fisher Scientific Inc.&nbsp;(NYSE:<a class="ticker" href="https://www.benzinga.com/stock/TMO#NYSE">TMO</a>) announced it would invest an additional $2 billion in the U.S. over&nbsp;<a href="https://www.benzinga.com/general/health-care/25/04/44995428/thermo-fisher-doubles-down-on-us-manufacturing-in-2b-expansion-plan" target="_blank" rel="noreferrer noopener">the next four years</a>.</li>
<li>Medtech firm&nbsp;Becton, Dickinson, and Company&nbsp;(NYSE:<a class="ticker" href="https://www.benzinga.com/stock/BDX#NYSE">BDX</a>) also announced its intention to invest&nbsp;$2.5 billion&nbsp;in U.S. manufacturing capacity&nbsp;<a href="https://www.benzinga.com/general/health-care/25/05/45140102/potential-tariff-bites-into-becton-dickinson-2025-profit-outlook-company-will-invest-2-5-billion-to-boost-us-manufacturing" target="_blank" rel="noreferrer noopener">over the next 5 years</a>.</li>
<li>Regeneron Pharmaceuticals, Inc. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/REGN#NASDAQ">REGN</a>)  seeks to nearly double its manufacturing capacity through a new agreement with <a href="https://www.benzinga.com/general/biotech/25/04/44931246/regeneron-partners-with-japan-based-fujifilm-to-bolster-us-manufacturing-capacity-via-3-billion-deal" target="_blank" rel="noreferrer noopener">FUJIFILM Diosynth Biotechnologies</a>.</li>
<li>Novartis AG (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/NVS#NYSE">NVS</a>) unveiled a $23 billion investment plan to expand in the U.S. <a href="https://www.benzinga.com/general/biotech/25/04/44761201/novartis-commits-23-billion-to-expand-us-manufacturing-over-five-years-despite-tariffs-uncertaint" target="_blank" rel="noreferrer noopener">over the next five years</a>.</li>
<li>Johnson &amp; Johnson (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/JNJ#NYSE">JNJ</a>) plans to invest more than <a href="https://www.benzinga.com/markets/equities/25/03/44433978/johnson-johnson-to-invest-55-billion-in-us-to-boost-manufacturing-drug-discovery" target="_blank" rel="noreferrer noopener">$55 billion in the U.S. over the next four years</a>.</li>
<li>Roche Holdings AG&nbsp;(OTC:<a class="ticker" href="https://www.benzinga.com/stock/RHHBY#OTC">RHHBY</a>)&nbsp;announced that it will invest $50 billion in the U.S. over&nbsp;<a href="https://www.benzinga.com/topic/pharmaceuticals" target="_blank" rel="noreferrer noopener">the next five years.</a></li>
<li>Bristol-Myers Squibb &amp; Co.'s&nbsp;(NYSE:<a class="ticker" href="https://www.benzinga.com/stock/BMY#NYSE">BMY</a>)&nbsp;Christopher Boerner, chair and chief executive officer,&nbsp;<a href="https://www.statnews.com/2025/05/05/bristol-myers-squibb-pharmaceutical-policy-us-trump-administration-innovation-tariffs/?tblci=GiCUX7wvU_AgmIIiQduNYr6JQuJQLy6SZJGvpyeZuCzyqiCN1VcoxvTN4f7-y-PqATDviEo" target="_blank" rel="noreferrer noopener">shared</a>&nbsp;plans to invest $40 billion in U.S. R&amp;D, technology, and manufacturing over the next five years in an op-ed published by Statnews.</li>
</ul>
Pfizer Inc. (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/PFE#NYSE">PFE</a>) is one pharma company that did not highlight investments in new manufacturing plants. The company noted that they already have significant capacity and flexibility to manufacture <a href="https://www.benzinga.com/general/biotech/25/04/45118145/pfizer-ceo-albert-bourla-emphasizes-national-security-in-us-drug-manufacturing" target="_blank" rel="noreferrer noopener">products in the U.S</a>.
Price Action: Sanofi stock is down 1.53% at $49.20 at the last check on Wednesday.
Read Next:
<ul class="wp-block-list">
<li><a href="https://www.benzinga.com/general/biotech/25/05/45407486/novo-nordisk-inks-22-billion-deal-with-septerna-to-develop-oral-weight-loss-and-diabetes-drugs" target="_blank" rel="noreferrer noopener">Novo Nordisk Inks $2.2 Billion Deal With Septerna To Develop Oral Weight Loss And Diabetes Drugs</a></li>
</ul>
Image: Shutterstock

Sanofi To Navigate Tariff Impact With $20 Billion In Spending Through 2030

The U.S. Food and Drug Administration (FDA) granted accelerated approval to AbbVie&nbsp;Inc.&#8217;s (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/ABBV#NYSE">ABBV</a>) Emrelis&nbsp;(telisotuzumab vedotin-tllv) for adult patients with locally advanced or metastatic, non-squamous non-small cell lung cancer (NSCLC) with high c-Met protein overexpression (OE) who have <a target="_blank" href="https://www.benzinga.com/general/health-care" rel="noreferrer noopener">received a prior systemic therapy</a>.
High c-Met protein overexpression is defined as ≥ 50% of tumor cells with strong (3+) staining as determined <a target="_blank" href="https://www.benzinga.com/pressreleases/25/05/n45415840/u-s-fda-approves-emrelis-telisotuzumab-vedotin-tllv-for-adults-with-previously-treated-advanced-no" rel="noreferrer noopener">by an FDA-approved test</a>.
This indication is approved based on overall response rate (ORR) and duration of response (DOR).
Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s), the company said in a statement on Wednesday.
Also Read: <a target="_blank" href="https://www.benzinga.com//node/45079377" rel="noreferrer noopener">AbbVie Scores FDA Approval For Its Blockbuster Drug Rinvoq To Treat Type Of Arthritis</a>
Emrelis is a c-Met-directed antibody-drug conjugate (ADC) and the first and only treatment approved for this patient population.&nbsp;
ADCs are designed to target unique biomarkers such as the c-Met protein and deliver a potent &#8216;payload&#8217; directly to the biomarker-expressing cell.
Data from the Phase 2 LUMINOSITY study, designed to characterize the efficacy and safety of EMRELIS in c-Met overexpressing advanced NSCLC populations, support the FDA&#8217;s accelerated approval.
Findings from the study showed patients with high c-Met protein overexpression (n=84) who received Emrelis demonstrated a 35% Overall Response Rate (ORR) and Duration of Response (DOR) with a median of 7.2 months.
In&nbsp;December 2021, the FDA granted EMRELIS&nbsp;<a target="_blank" href="https://c212.net/c/link/?t=0&amp;l=en&amp;o=4408820-1&amp;h=2952437730&amp;u=https%3A%2F%2Fc212.net%2Fc%2Flink%2F%3Ft%3D0%26l%3Den%26o%3D4264002-1%26h%3D3470428670%26u%3Dhttps%253A%252F%252Fnews.abbvie.com%252F2022-01-04-AbbVie-Announces-U-S-FDA-Granted-Breakthrough-Therapy-Designation-BTD-to-Telisotuzumab-Vedotin-Teliso-V-for-Previously-Treated-Non-Small-Cell-Lung-Cancer%26a%3DBreakthrough%2BTherapy%2BDesignation%2Bby%2Bthe%2BFDA&amp;a=Breakthrough+Therapy+Designation" rel="noreferrer noopener">Breakthrough Therapy Designation</a> (BTD) based on Phase 2 LUMINOSITY study data.
Emrelis is being further evaluated as a monotherapy in patients with previously treated c-Met overexpressing NSCLC in the randomized Phase 3 confirmatory global study&nbsp;<a target="_blank" href="https://c212.net/c/link/?t=0&amp;l=en&amp;o=4408820-1&amp;h=741691694&amp;u=https%3A%2F%2Fclinicaltrials.gov%2Fstudy%2FNCT04928846&amp;a=TeliMET+NSCLC-01" rel="noreferrer noopener">TeliMET NSCLC-01</a>.
Enrollment in the study is underway and continues across global clinical trial sites.
The FDA has also approved Roche Holdings AG&#8217;s (OTC:<a class="ticker" href="https://www.benzinga.com/stock/RHHBY#OTC">RHHBY</a>) VENTANA&nbsp;MET (SP44) RxDx Assay, the only IHC companion diagnostic identifying patients eligible for Emrelis treatment.
On Wednesday, AbbVie&nbsp;and ADARx Pharmaceuticals announced a collaboration and license option agreement to develop small interfering RNA (siRNA) therapeutics across multiple disease areas, including neuroscience, <a target="_blank" href="https://www.benzinga.com/pressreleases/25/05/n45405186/abbvie-and-adarx-pharmaceuticals-announce-collaboration-and-license-option-agreement-to-develop-ne" rel="noreferrer noopener">immunology, and oncology</a>.
siRNA represents a class of molecules capable of regulating gene expression and protein production. Unlike traditional modalities such as antibodies and small molecules, siRNA regulates gene expression. These molecules are designed to prevent the production of disease-causing proteins by targeting the messenger RNA (mRNA) that encodes for such proteins.
ADARx will receive a&nbsp;$335 million&nbsp;upfront payment and is eligible to receive several billion dollars in additional contingent payments, including option-related fees, milestone payments, and royalties.
Price Action: ABBV stock is down 5.32% at $177.96&nbsp;at the last check on Wednesday.
Read Next:
<ul class="wp-block-list">
<li><a href="https://www.benzinga.com/25/05/45416148/pony-ai-shares-rise-after-report-of-confidential-hong-kong-ipo-to-fund-robotaxi-expansion" target="_blank" rel="noreferrer noopener">Robotaxi Service Pony AI Stock Falls Despite IPO Buzz &#8211; Here&#8217;s Why</a></li>
</ul>
Photo via Shutterstock

ABBV

FDA Fast-Tracks AbbVie's New Lung Cancer Therapy Emrelis For Tough Lung Cancer Cases

Press Releases

Genentech's Tecentriq Combined with Lurbinectedin Shows Significant Survival Benefit in Extensive-Stage Small Cell Lung Cancer

Genentech to Advance Prasinezumab Into Phase III Development for Early-Stage Parkinson's Disease

Genentech Provides Update on Phase III Verona Study

Genentech's Lunsumio and Polivy Combination Significantly Prolongs Remission for People With Relapsed or Refractory Large B-cell Lymphoma

Roche's Lunsumio and Polivy combination significantly prolongs remission for people with relapsed or refractory large B-cell lymphoma

Early data suggest Roche's NXT007 may have the potential to provide haemostatic normalisation in people with haemophilia A

Changes to the Roche Enlarged Corporate Executive Committee

Small Cap

Precision Genetic Medicine Platform Could Disrupt Standard of Care in Metastatic Cancer, Other Indications of Unmet Needs

Genentech Provides Update on Supplemental Biologics License Application for Columvi Combination for People With Relapsed or Refractory Diffuse Large B-cell Lymphoma

Comments

Roche Holding

Noticias

Últimas noticias sobre Roche Holding (OTC:RHHBY) Bolsa

Noticias

SOCIO/CONTRIBUIDOR

BENZINGA GLOBAL