AstraZeneca Option Alert: Apr 17 $73 Calls at the Bid: 3000 vs 11 OI; Earnings 4/29 Before Open 

AstraZeneca Option Alert: Apr 17 $73 Calls at the Bid: 3000 @ $1.95 vs 11 OI; Earnings 4/29 Before Open Ref=$73.265

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AstraZeneca

A merger between Astra of Sweden and Zeneca Group of the United Kingdom formed AstraZeneca in 1999. The firm sells branded drugs across a number of major therapeutic areas, including oncology (about 40% of total revenue), cardiovascular, renal, and metabolic (25%), rare disease (17%), and respiratory and immunology (15%). The majority of sales comes from international markets, with the United States representing close to one third of its sales.

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El Ibex 35 y las bolsas europeas cotizan estables este martes. El Ibex sube un 0,07% a 11.280 puntos, tras las alzas del lunes en Europa y Wall Street.

Ibex 35 sube ligeramente mientras los mercados europeos se estabilizan este martes

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Tempest Therapeutics, Inc. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/TPST#NASDAQ">TPST</a>) said on Thursday it had retained MTS Health Partners as a financial advisor. The company plans to explore strategic alternatives to advance its clinical-stage programs and maximize stockholder value.
Strategic alternatives may include M&amp;A, partnerships, joint ventures, licensing arrangements or <a href="https://www.benzinga.com/pressreleases/25/04/g44723521/tempest-announces-plan-to-explore-strategic-alternatives-to-advance-promising-pipeline-of-clinical" target="_blank" rel="noreferrer noopener">other strategic transactions</a>.
&#8220;Notwithstanding the positive randomized data set from the amezalpat Phase 2 and its blockbuster potential in first-line HCC, as well as the potential of TPST-1495 as it moves towards a Phase 2 in FAP, the capital markets have been unavailable to support the next stage of advancement,&#8221; said Stephen Brady, president and chief executive officer of Tempest.&nbsp;
Also Read: <a target="_blank" href="https://www.benzinga.com/general/biotech/24/08/40401811/why-is-small-cap-tempest-therapeutics-stock-trading-higher-on-thursday" rel="noreferrer noopener">Why Is Small-Cap Tempest Therapeutics Stock Trading Higher On Thursday?</a>
On Thursday, Scotiabank downgraded Tempest Therapeutics from Sector Outperform to Sector Perform while raising the price target from $7 to $9.
In October 2024, the company entered into an agreement with&nbsp;Roche Holdings AG&nbsp;(OTC:<a class="ticker" href="https://www.benzinga.com/stock/RHHBY#OTC">RHHBY</a>) to advance the evaluation of amezalpat (TPST-1120) in combination with atezolizumab (Tecentriq) and bevacizumab, the current standard of care for unresectable or metastatic hepatocellular carcinoma (HCC), into a Phase 3 trial for the first-line&nbsp;<a target="_blank" href="https://www.benzinga.com/general/biotech/24/10/41271516/why-is-cancer-focused-tempest-therapeutics-stock-trading-higher-on-thursday" rel="noreferrer noopener">treatment of liver cancer</a>.
Under the agreement, Roche will supply atezolizumab globally and Tempest will sponsor and lead the pivotal study.
Analyst George Farmer writes that Roche appears to have no financial interest in the Phase 3 evaluation of amezalpat in combination with atezo/bev, despite the quality of results that Tempest Therapeutics <a target="_blank" href="https://www.benzinga.com/general/biotech/24/06/39412888/whats-going-on-with-cancer-focused-tempest-therapeutics-stock-on-thursday" rel="noreferrer noopener">presented last June</a>.
Other potential partners with deep pockets, like AstraZeneca and Bristol Myers Squibb &amp; Co, with their own cancer immunotherapies, are uninterested.
&#8220;Lack of partner interest in this program, including negligible BD engagement from Roche beyond promise of providing a free Phase 3 supply of atezolizumab, indicates to us that this is probably a broken story that cannot be repaired without additional early-stage clinical exploration,&#8221; Farmer writes.
&#8220;We think the company may ultimately attract a buyer, but we would not expect a significant transaction premium above the current trading range,&#8221; Farmer adds.
HC Wainwright downgraded Tempest Therapeutics from Buy to Neutral while maintaining the price target of $16.
TPST Price Action: Tempest Therapeutics stock is down 6.93% at $6.65 at publication on Thursday.
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Tempest Therapeutics, Inc. - Common Stock

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Tempest Weighs M&A, Analyst Sees A "Broken Story" Despite Phase 2 Liver Cancer Study Success

U.S.&nbsp;President Donald Trump, on Tuesday, disclosed plans for a "major tariff" on <a target="_blank" href="https://www.benzinga.com/topic/tariffs" rel="noreferrer noopener">foreign pharmaceuticals</a>.
"We're&nbsp;going to be announcing very&nbsp;shortly a major tariff on&nbsp;pharmaceuticals… when they hear that&nbsp;they will leave China, they&nbsp;will leave other places because… most of their product&nbsp;is sold here," Trump expressed at&nbsp;a National Republican <a target="_blank" href="https://www.benzinga.com/25/04/44708204/trump-hints-at-major-tariff-on-imported-pharmaceuticals-us-pharma-stocks-tumble-in-wednesday-pre-market" rel="noreferrer noopener">Congressional Committee&nbsp;dinner</a>.
He also told reporters on board his Air Force One plane that "pharma" tariffs would arrive "at a level that you haven't really seen before," saying these would be announced "in the near future," BBC <a target="_blank" href="https://www.bbc.com/news/articles/cedyylj1v32o" rel="noreferrer noopener">report</a> added.
Also Read: <a target="_blank" href="https://www.benzinga.com/25/04/44698325/trump-tariff-strategy-self-inflicted-market-debacle-says-wedbush-analyst" rel="noreferrer noopener">Trump Tariff Strategy Creates ‘Self-Inflicted Market Debacle': Analyst</a>
When President Trump announced tariffs last week, he excluded pharmaceuticals from the new tariffs, likely a relief for the industry under pressure following his prior comments suggesting a 25% tariff&nbsp;<a target="_blank" href="https://www.benzinga.com/general/biotech/25/04/44652075/us-tariffs-spare-drugmakers-but-threaten-diabetes-device-industry" rel="noreferrer noopener">on pharmaceutical imports</a>.&nbsp;
On Wednesday, in a surprise announcement from President Donald Trump, a 90-day pause on tariffs for countries that have not retaliated <a target="_blank" href="https://www.benzinga.com/topic/tariffs" rel="noreferrer noopener">against U.S. trade measures.</a>
The news ignited a broad risk-on rally, catapulting major indices to multi-month highs and sending volatility plunging.
Trump's latest Truth Social post slammed China for showing "a lack of respect" and declared an immediate 125% tariff hike on Chinese goods.
"At some point, hopefully in the near future, China will realize that the days of ripping off the U.S.A. and other Countries is no longer sustainable or acceptable," he said.
He praised the over 75 countries that, in his words, "have not, at my strong suggestion, retaliated in any way, shape, or form."
As a reward, those countries would benefit from a temporary 10% reciprocal tariff and a 90-day pause on additional duties.
The biopharma industry has historically been shielded from tariffs, including during Trump's first term.
Although Trump didn't provide many details, his remarks have unsettled buyers, especially those who depend on medicines from India. India provides nearly half of all generic drugs used in the U.S., helping cut billions from healthcare costs.
The U.S. is a major market, buying about a third of India's $13 billion in yearly drug exports.
Indian drug companies warn that if tariffs are added, they'd have to raise prices—which could increase healthcare costs in the U.S.
Even though some companies like Cipla and Dr. Reddy's Laboratories Ltd (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/RDY#NYSE">RDY</a>) have factories in the U.S., most say it's too expensive to move production for low-profit generic drugs.
BofA Securities analyst says if the Trump administration plans to impose tariffs on the pharmaceutical industry, it would likely do so through a "Section 232 investigation" under the Trade Expansion Act of 1962 to determine whether importing certain goods threatens national security.
The typical timeline for a Section 232 investigation is about a year. If the same timeline applied here, tariffs on drug imports likely wouldn't take effect until late in the year—at the earliest.
It's unclear whether the Section 232 investigation into the drug industry is about to start, but based on recent comments from the administration, it seems possible. However, launching an investigation doesn't guarantee that tariffs will follow.
As the first quarter 2025 earnings season starts soon, analyst Tim Anderson says it will be worth watching whether companies discuss potential tariffs during earnings calls.
That said, any actual earnings impact likely wouldn't show up until sometime after 2025, which could leave investors with more questions than answers.
Wedbush analyst Daniel Ives <a target="_blank" href="https://www.benzinga.com/25/04/44698325/trump-tariff-strategy-self-inflicted-market-debacle-says-wedbush-analyst" rel="noreferrer noopener">on Tuesday wrote</a> that "saying we can just make this in the USA" understates how complex the supply chain in Asia really is—and how electronics, chips, semiconductors, hardware, and smartphones have been built for U.S. consumers over the past 30 years."
Shares of major drugmakers such as Gilead Sciences&nbsp;Inc (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/GILD#NASDAQ">GILD</a>), Merck&nbsp;&amp; Co Inc (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/MRK#NYSE">MRK</a>), Eli Lilly&nbsp;And Co (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/LLY#NYSE">LLY</a>), AstraZeneca&nbsp;Plc (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/AZN#NASDAQ">AZN</a>), Roche&nbsp;Holdings AG (OTC:<a class="ticker" href="https://www.benzinga.com/stock/RHHBY#OTC">RHHBY</a>), Sanofi&nbsp;SA (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/SNY#NASDAQ">SNY</a>), Novartis&nbsp;AG (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/NVS#NYSE">NVS</a>), Argenx&nbsp;SE (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/ARGX#NASDAQ">ARGX</a>), UCB&nbsp;SA (OTC:<a class="ticker" href="https://www.benzinga.com/stock/UCBJY#OTC">UCBJY</a>) (OTC:<a class="ticker" href="https://www.benzinga.com/stock/UCBJF#OTC">UCBJF</a>), Novo Nordisk&nbsp;A/S (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/NVO#NYSE">NVO</a>), Regeneron Pharmaceuticals Inc. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/REGN#NASDAQ">REGN</a>) GSK Plc (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/GSK#NYSE">GSK</a>) and Pfizer Inc (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/PFE#NYSE">PFE</a>) fell on Wednesday, only reverse course later after the 90-day tariff pause.
Read Next:
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Photo by MargJohnsonVA via Shutterstock

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Pharma Industry Faces Jitters As Trump Hints At Historic Tariffs, BofA Outlines Probable Timeline

President Donald Trump has declared that his administration is on the brink of imposing a significant tariff on <a href="https://in.benzinga.com/markets/25/04/44627820/trumps-reciprocal-tariffs-on-india-exempt-pharma-easing-mark-cubans-price-hike-concerns">pharmaceuticals imported from foreign countries.</a>
What Happened: President Trump, on Tuesday, disclosed plans for a &#8220;major tariff&#8221; on foreign pharmaceuticals. Trump is hopeful that this move will prompt drug companies to shift their operations to the U.S., <a href="https://www.theguardian.com/australia-news/2025/apr/09/donald-trump-flags-major-tariff-on-pharmaceuticals-as-us-senator-criticises-whack-on-australia">reported</a> The Guardian.
&#8220;We&#8217;re going to be announcing very shortly a major tariff on pharmaceuticals&#8230; when they hear that they will leave China, they will leave other places because&#8230; most of their product is sold here,&#8221; Trump expressed at a National Republican Congressional Committee dinner.
Despite exempting pharmaceuticals from the recent round of reciprocal tariffs, Trump has been hinting for a long time that the drug industry would be a target. The President is of the view that the tariff will drive drug companies to return to the U.S., considering it is a significant market for their products. &#8220;The advantage we have over everybody is that we&#8217;re the big market. So we&#8217;re going to be announcing very shortly a major tariff on pharmaceuticals,&#8221; Trump added.
The President, however, did not divulge any specifics regarding the tariff increase or its potential impact.
Pharmaceutical stocks across the globe, including GlaxoSmithKline, Sanofi and India&#8217;s Teva Pharmaceuticals, tumbled on Wednesday.
In the U.S. pharmaceutical stocks, Pfizer (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/PFE#NYSE">PFE</a>) declined 3.5%, while Eli Lilly And Co. (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/LLY#NYSE">LLY</a>) lost 3.2%. AstraZeneca Plc (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/AZN#NASDAQ">AZN</a>) fell 1.35%, while Amgen Inc. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/AMGN#NASDAQ">AMGN</a>) and Merck &amp; Co. Inc. (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/MRK#NYSE">MRK</a>) dropped 2.94% and 2.75%, respectively, during the Wednesday pre-market trading session.
SEE ALSO:&nbsp;<a href="https://benzinga.com/markets/25/04/44706492/trump-predicts-tremendous-thundering-landslide-in-2026-midterms-says-tariffs-will-help-republicans-win-bi" target="_blank" rel="noreferrer noopener">Trump Predicts &#8216;Tremendous, Thundering Landslide&#8217; In 2026 Midterms, Says Tariffs Will Help Republicans Win Big</a>
Why It Matters: The $1.7 trillion revenue prescription drug industry has demonstrated a strong resilience to tariffs. The U.S., being the largest and most profitable market globally for prescription drugs and generic products, imports most of these from overseas. In 2024, drug imports reached $213 billion, more than two and a half times the total 10 years earlier. The proposed tariff could, in theory, help bring business back onshore.
However, companies like&nbsp;AstraZeneca Plc and&nbsp;Pfizer&nbsp;have extensive global manufacturing networks, including Ireland, Germany, Canada, the UK, and the U.S and are not restricted to India and China. Sources told Reuters that it could take up to 10 years to build and equip a factory in the U.S., due to stringent regulatory requirements from the U.S. Food and Drug Administration (FDA). Therefore, Trump&#8217;s tariff might necessitate drugmakers to overhaul a complex, expensive manufacturing system.
Meanwhile, after Trump indicated major tariffs on pharmaceuticals, EU drugmakers have urged European Commission President Ursula von der Leyen to take "rapid and radical action" to address the growing "risk of an exodus" to the U.S., following a meeting in Brussels.
<ul>
<li>READ MORE: <a href="https://benzinga.com/25/04/44705972/ford-motor-general-motors-to-witness-higher-demand-as-american-automotives-reap-the-fruit-of-protectionism-says-e" target="_blank" rel="noreferrer noopener">Ford, GM To Witness &#8216;Higher Demand&#8217; As American Carmakers Set To &#8216;Reap The Fruit Of Protectionism,&#8217; Says Expert: Here&#8217;s A List Of Potential Gainers And Losers From Trump Tariffs</a></li>
</ul>
Image via Shutterstock
Disclaimer:&nbsp;This content was partially produced with the help of AI tools and was reviewed and published by Benzinga editors.

Trump Hints At 'Major Tariff' On Imported Pharmaceuticals: Pfizer, Eli Lilly, Amgen And Other Stocks Tumble In Wednesday Pre-Market

The European Commission on Friday approved AstraZeneca Plc (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/AZN#NASDAQ">AZN</a>) and Daiichi Sankyo's&nbsp;(OTC:<a class="ticker" href="https://www.benzinga.com/stock/DSKNY#OTC">DSKNY</a>) Enhertu (trastuzumab deruxtecan) as a monotherapy for a type of breast cancer.
The approval covers adult patients with unresectable or metastatic hormone receptor (HR)-positive, HER2-low or HER2-ultralow breast cancer who have received at least one endocrine therapy in the metastatic setting and who are not considered suitable for endocrine therapy as the next line of treatment.
Also Read: <a target="_blank" href="https://www.benzinga.com/25/03/44569107/fda-approves-astrazenecas-imfinzi-as-first-perioperative-immunotherapy-for-muscle-invasive-bladder-cancer-patients" rel="noreferrer noopener">FDA Approves AstraZeneca's Imfinzi As First Perioperative Immunotherapy For Muscle-Invasive Bladder Cancer Patients</a>
The <a target="_blank" href="https://www.astrazeneca.com/media-centre/press-releases/2025/enhertu-approved-in-eu-in-post-et-breast-cancer.html" rel="noreferrer noopener">approval</a> is based on results from the DESTINY-Breast06 Phase 3 trial.
In the trial,&nbsp;Enhertu&nbsp;showed a 38% reduction in the risk of disease progression or death versus chemotherapy in patients with chemotherapy-naïve HR-positive, HER2-low metastatic breast cancer with a median progression-free survival (PFS) of 13.2 months versus 8.1 months.
In the overall trial population, the median PFS was 13.2 months in patients randomized to&nbsp;Enhertu&nbsp;compared to 8.1 months in those randomized to chemotherapy.
In an exploratory analysis, results were consistent between patients with HER2-low expression and HER2-ultralow expression.
Following this approval for&nbsp;Enhertu&nbsp;in the EU, AstraZeneca is due to Daiichi Sankyo $125 million as a milestone payment.
The European Commission also <a target="_blank" href="https://www.astrazeneca.com/media-centre/press-releases/2025/imfinzi-approved-in-eu-for-aegean.html" rel="noreferrer noopener">approved</a> AstraZeneca's Imfinzi (durvalumab) in combination with chemotherapy for adults with resectable non-small cell lung cancer (NSCLC) at high risk of recurrence and no epidermal growth factor receptor (EGFR) mutations or anaplastic lymphoma kinase (ALK) rearrangements.
In this regimen, patients are treated with&nbsp;Imfinzi&nbsp;in combination with neoadjuvant chemotherapy before surgery and as adjuvant monotherapy after surgery.
Results from a planned interim analysis of event-free survival (EFS) showed a statistically significant and clinically meaningful 32% reduction in the risk of recurrence, progression events, or death versus neoadjuvant chemotherapy alone in patients treated with the&nbsp;Imfinzi-based perioperative regimen.
In a final analysis of pathologic complete response (pCR), treatment with&nbsp;Imfinzi&nbsp;plus neoadjuvant chemotherapy before surgery resulted in a pCR rate of 17.2% versus 4.3% for patients treated with neoadjuvant chemotherapy alone.
Additionally, interim overall survival (OS) results showed a favorable trend with the&nbsp;Imfinzi-based&nbsp;perioperative regimen. The OS data were not tested for statistical significance in this interim analysis and will continue to be assessed as a key secondary endpoint in the final analysis.
Price Action: AZN stock is down 6.37% at $69.21&nbsp;at the last check on Friday.
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Photo by JHVEPhoto via Shutterstock

DSKNY

European Drug Regulator Approves AstraZeneca's Two Flagship Cancer Drugs For Breast And Lung Cancer Settings

<ul>
<li>Based on DESTINY-Breast06 Phase III trial results which showed Enhertu demonstrated superiority vs. chemotherapy with a median progression-free survival of more than one year.</li>
<li>Approval brings AstraZeneca and Daiichi Sankyo's Enhertu earlier in the treatment of HR-positive, HER2-low breast cancer and broadens the eligible patient population to those with HER2-ultralow disease.</li>
</ul>

The European Commission Approves AstraZeneca And Daiichi Sankyo's Enhertu (Trastuzumab Deruxtecan) As Monotherapy For Adult Patients With Unresectable Or Metastatic Hormone Receptor-positive, HER2-low Or HER2-ultralow Breast Cancer Who Have Received At Least One Endocrine Therapy In The Metastatic Setting And Who Are Not Considered Suitable For Endocrine Therapy As The Next Line Of Treatment

In this regimen, patients are treated with Imfinzi in combination with neoadjuvant chemotherapy before surgery and as adjuvant monotherapy after surgery.
&nbsp;

The European Commission Approves AstraZeneca's Imfinzi (Durvalumab) In Combination With Chemotherapy For Adults With Resectable Non-small Cell Lung Cancer At High Risk Of Recurrence And No Epidermal Growth Factor Receptor Mutations Or Anaplastic Lymphoma Kinase Rearrangements

AstraZeneca's (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/AZN#NYSE">AZN</a>) short percent of float has fallen 10.91% since its last report. The company recently reported that it has 15.24 million shares sold short, which is 0.49% of all regular shares that are available for trading. Based on its trading volume, it would take traders 2.5 days to cover their short positions on average.
<h3>Why Short Interest Matters</h3>
Short interest is the number of shares that have been sold short but have not yet been covered or closed out. <a href="https://www.benzinga.com/money/how-to-short-a-stock?adType=benzinga-insights&amp;ad=short-interest&amp;campaign=wallstreetadvantage">Short selling</a> is when a trader sells shares of a company they do not own, with the hope that the price will fall. Traders make money from short selling if the price of the stock falls and they lose if it rises.
Short interest is important to track because it can act as an indicator of market sentiment towards a particular stock. An increase in short interest can signal that investors have become more bearish, while a decrease in short interest can signal they have become more bullish.
See Also: <a href="https://www.benzinga.com/short-interest?adType=benzinga-insights&amp;ad=short-interest&amp;campaign=wallstreetadvantage">List of the most shorted stocks</a>
<h3>AstraZeneca Short Interest Graph (3 Months)</h3>
<img src="https://www.benzinga.com/files/images/story/2025/1743525915_0.png" alt="short_fig" />
As you can see from the chart above the percentage of shares that are sold short for AstraZeneca has declined since its last report. This does not mean that the stock is going to rise in the near-term but traders should be aware that less shares are being shorted.
<h3>Comparing AstraZeneca's Short Interest Against Its Peers</h3>
Peer comparison is a popular technique amongst analysts and investors for gauging how well a company is performing. A company's peer is another company that has similar characteristics to it, such as industry, size, age, and financial structure. You can find a company's peer group by reading its 10-K, proxy filing, or by doing your own similarity analysis.
According to <a href="https://www.benzinga.com/pro/">Benzinga Pro</a>, AstraZeneca's peer group average for short interest as a percentage of float is 4.23%, which means the company has less short interest than most of its peers.
Did you know that increasing short interest can actually be bullish for a stock? <a href="https://www.benzinga.com/money/how-to-make-money-on-a-short-squeeze?adType=benzinga-insights&amp;ad=short-interest&amp;campaign=wallstreetadvantage">This post by Benzinga Money explains how you can profit from it.</a>
This article was generated by Benzinga's automated content engine and was reviewed by an editor.

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Peering Into AstraZeneca's Recent Short Interest

The U.S. Food and Drug Administration (FDA) on Monday approved AstraZeneca Plc's (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/AZN#NASDAQ">AZN</a>) Imfinzi&nbsp;(durvalumab) in combination with gemcitabine and cisplatin as neoadjuvant treatment, followed by Imfinzi&nbsp;as adjuvant monotherapy&nbsp;after radical cystectomy (surgery to remove the bladder) for adult patients with muscle-<a target="_blank" href="https://www.benzinga.com/general/biotech" rel="noreferrer noopener">invasive bladder cancer (MIBC)</a>.
The FDA approval was based on results from the <a target="_blank" href="https://www.benzinga.com/pressreleases/25/03/b44558058/imfinzi-durvalumab-approved-in-the-us-as-first-and-only-perioperative-immunotherapy-for-patients-w" rel="noreferrer noopener">NIAGARA Phase 3 trial</a>.
In a planned interim analysis, the Imfinzi-based&nbsp;perioperative regimen demonstrated a 32% reduction in the risk of disease progression, recurrence, not undergoing surgery, or death versus the comparator arm.
Also Read: <a target="_blank" href="https://www.benzinga.com/general/biotech/25/03/44188407/astrazenecas-imfinzi-based-regimen-shows-improved-event-free-survival-in-early-stage-gastric-cancer-patients" rel="noreferrer noopener">AstraZeneca's Imfinzi-Based Regimen Shows Improved Event-Free Survival In Early-Stage Gastric Cancer Patients</a>
The estimated median event-free survival (EFS) has not yet been reached for the Imfinzi arm versus 46.1 months for the comparator arm. An estimated 67.8% of patients treated with the regimen were event-free at two years compared to 59.8% in the comparator arm.
Results from the key secondary endpoint of overall survival (OS) showed that the Imfinzi-based perioperative regimen reduced the risk of death by 25% versus neoadjuvant chemotherapy with radical cystectomy.
Median survival was not yet reached for either arm. An estimated 82.2% of patients treated with the regimen were alive at two years compared to 75.2% in the comparator arm.
Concurrently, AstraZeneca's&nbsp;Calquence&nbsp;(acalabrutinib) in combination with bendamustine and rituximab was <a target="_blank" href="https://www.astrazeneca.com/media-centre/press-releases/2025/calquence-recommended-for-eu-approval-in-1l-mcl.html" rel="noreferrer noopener">recommended</a> for approval in the European Union for adult patients with previously untreated mantle cell lymphoma who are not eligible for autologous hematopoietic stem cell transplantation.
The positive opinion was based on the &nbsp;ECHO Phase 3 trial results.
Calquence&nbsp;plus bendamustine and rituximab reduced the risk of disease progression or death by 27% compared to standard-of-care chemoimmunotherapy.
Median PFS was 66.4 months for patients treated with the Calquence combination versus 49.6 with chemoimmunotherapy alone.
Price Action: AZN stock is down 0.86% at $73.16 at the last check Monday.
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</ul>
Image by Robert Way via Shutterstock

FDA Approves AstraZeneca's Imfinzi As First Perioperative Immunotherapy For Muscle-Invasive Bladder Cancer Patients

Durvalumab (Imfinizi) plus chemotherapy followed by single-agent durvalumab has been approved by the FDA for patients with muscle-invasive bladder cancer after radical cystectomy, according to a press release from the agency.1
The approval was based on results from the <a href="https://www.cancernetwork.com/view/neoadjuvant-durvalumab-chemo-adjuvant-durvalumab-improves-efs-in-cisplatin-eligible-mibc">phase 3 NIAGARA trial (NCT03732677),</a> in which updated results were recently presented at the <a href="https://www.cancernetwork.com/conference/asco-genitourinary-cancer-symposium">2025 ASCO Genitourinary Cancer Symposium</a>.2 Results presented here were focused on efficacy and safety, as well as the impact of pathological complete response (pCR) for patients in the aforementioned population.
Results presented at the <a href="https://www.cancernetwork.com/conference/esmo">2024 European Society of Medical Oncology Congress</a> and subsequently published in the New England Journal of Medicine highlighted that the event-free survival (EFS) was not reached (NR; 95% CI, NR-NR) in the durvalumab arm and 46.1 months (95% CI, 32.23-NR) in the comparator arm (HR, 0.68; 95% CI, 0.56-0.82; P &lt;.0001).3,4 The 12-month EFS rates in either arm included 76.0% vs 69.9%, and the 24-month rates were 67.8% vs 59.8%.

AstraZeneca Announces FDA Approves Adjuvant Durvalumab/Chemo In Muscle-Invasive Bladder Cancer

MRNA

President Trump Says Will Be Announcing Pharma Tariffs Soon

The Japanese Ministry of Health, Labour and Welfare on Thursday approved BridgeBio Pharma, Inc.&#8216;s (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/BBIO#NASDAQ">BBIO</a>) acoramidis, under the brand name Beyonttra, for adults with transthyretin-mediated amyloid <a href="https://www.benzinga.com/general/health-care" target="_blank" rel="noreferrer noopener">cardiomyopathy (ATTR-CM).</a>
Acoramidis is a selective small molecule, orally administered, near-complete (≥90%) <a target="_blank" href="https://www.benzinga.com/pressreleases/25/03/g44510729/beyonttra-acoramidis-the-first-near-complete-ttr-stabilizer-90-approved-in-japan-to-treat-attr-cm" rel="noreferrer noopener">transthyretin (TTR) stabilizer</a>.
ATTR-CM is a progressive, fatal disease that presents as an infiltrative, restrictive cardiomyopathy, resulting in heart failure.
AstraZeneca Plc&#8216;s (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/AZN#NASDAQ">AZN</a>) Alexion will be responsible for all commercial activity for Beyonttra in Japan.
Also Read: <a target="_blank" href="https://www.benzinga.com/24/11/42163927/fda-approves-bridgebio-pharmas-drug-for-rare-heart-disease-poised-to-challenge-pfizer-in-lucrative-yet-competitive-market" rel="noreferrer noopener">FDA Approves BridgeBio Pharma&#8217;s Drug For Rare Heart Disease, Poised To Challenge Pfizer In Lucrative Yet Competitive Market</a>
The approval in Japan is based on results from a Phase 3 open-label, single-arm study conducted in&nbsp;Japan by Alexion, AstraZeneca Rare Disease, and the global ATTRibute-CM Phase 3 study.
In the Japanese trial, acoramidis was generally well tolerated, and 0% mortality was reported during the 30-month acoramidis treatment period.
BridgeBio&#8217;s global ATTRibute-CM Phase 3 trial showed early separation at 3 months in time to the first event (all-cause mortality or cardiovascular-related hospitalization ACM or CVH) durably separated relative to placebo.
Furthermore, in the global ATTRibute-CM trial, acoramidis led to a 42% reduction in composite ACM and recurrent CVH events relative to placebo at Month 30 and a 50% reduction in the cumulative frequency of CVH events relative to placebo at Month 30.
Based on the terms of the agreement, BridgeBio will receive a $30 million milestone payment upon approval in Japan, as well as royalties in the low double digits on sales of acoramidis in Japan, with commercialization efforts planned in the first half of 2025.
Price Action: BBIO stock is up 1.6% at $36.70 at the last check Thursday.
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Photo: Shutterstock

Asia

BBIO

Japan Approves BridgeBio Pharma-AstraZeneca Partnered Rare Heart Disease Drug

Johnson &amp; Johnson&nbsp;(NYSE:<a class="ticker" href="https://www.benzinga.com/stock/JNJ#NYSE">JNJ</a>) announced results for the gold standard endpoint in cancer treatment of overall survival (OS) from the <a target="_blank" href="https://www.benzinga.com/general/health-care" rel="noreferrer noopener">Phase 3 MARIPOSA study</a>.
Head-to-head comparison data versus AstraZeneca Plc&#8216;s (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/AZN#NASDAQ">AZN</a>) Tagrisso (osimertinib) showed Rybrevant (amivantamab-vmjw) plus Lazcluze (lazertinib) significantly extended OS in the first-line treatment for locally advanced or metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 19 deletions (ex19del) <a href="https://www.benzinga.com/pressreleases/25/03/n44497192/rybrevant-amivantamab-vmjw-plus-lazcluze-lazertinib-outperforms-osimertinib-with-a-significant-and" target="_blank" rel="noreferrer noopener">or L858R substitution mutations</a>.
Also Read: <a target="_blank" href="https://www.benzinga.com/general/biotech/25/03/44440233/pharmaceutical-firms-say-uk-investment-is-unlikely-unless-payment-levy-is-adressed" rel="noreferrer noopener">Pharmaceutical Firms Say UK Investment Is &#8216;Unlikely&#8217; Unless Payment Levy Is Addressed</a>
Johnson &amp; Johnson said in a Wednesday press release that the median OS is projected to exceed one year beyond the median of three years observed with&nbsp;osimertinib and has not yet been reached.
The pharma giant says this is the first and only study to show a statistically significant and clinically meaningful OS improvement over osimertinib.
At a median follow-up of 37.8 months, patients treated with the chemotherapy-free regimen of first-line Rybrevant plus Lazcluze had a significantly longer OS than those receiving osimertinib.
Median OS for Rybrevant plus Lazcluze has not yet been reached, indicating that survival benefits continue to extend beyond the measured follow-up period.
Comparatively, median OS for osimertinib-treated patients was 36.7 months.
56% of patients treated with Rybrevant plus Lazcluze were alive at three and a half years, compared to 44% of patients on osimertinib.
The Rybrevant plus Lazcluze combination also prolonged multiple secondary endpoints vs. osimertinib, including intracranial PFS, intracranial duration of response (DOR) and intracranial overall response rate (ORR).&nbsp;
Rybrevant plus Lazcluze prolonged the time to symptomatic progression—the time from treatment randomization to the onset of lung cancer symptoms—by more than 14 months compared to osimertinib (43.6 months vs. 29.3 months).
The MARIPOSA study&nbsp;<a target="_blank" href="https://c212.net/c/link/?t=0&amp;l=en&amp;o=4389728-1&amp;h=3239710368&amp;u=https%3A%2F%2Fwww.jnj.com%2Fmedia-center%2Fpress-releases%2Flandmark-phase-3-mariposa-study-shows-rybrevant-amivantamab-vmjw-plus-lazertinib-resulted-in-30-percent-reduction-in-risk-of-disease-progression-or-death-compared-to-osimertinib-in-patients-with-egfr-mutated-non-small-cell-lung-cancer&amp;a=met+its+primary+endpoint" rel="noreferrer noopener">met its primary endpoint</a> in October 2023, showing a statistically significant and clinically meaningful improvement in PFS compared to osimertinib.&nbsp;
Rybrevant plus Lazcluze is approved in&nbsp;the United States,&nbsp;Europe&nbsp;, and other markets worldwide for patients with first-line&nbsp;EGFR-mutated NSCLC.
Price Action: JNJ stock is up 0.58% at $161.96 at the last check Wednesday.
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Photo: Shutterstock

J&J Drug Combo Outperforms Leading Lung Cancer Treatment In Survival Study

In LAURA Phase III trial, TAGRISSO continues to demonstrate improved overall survival trend in unresectable, Stage III setting
SAVANNAH and ORCHARD Phase II trials show the addition of savolitinib or datopotamab deruxtecan-dlnk to TAGRISSO upon disease progression demonstrates strong clinical activity LAURA Phase III trial of TAGRISSO in unresectable, Stage III EGFRm NSCLC after chemoradiotherapy (CRT) (LBA4).
<ul>
<li>SAVANNAH Phase II trial of TAGRISSO plus savolitinib in advanced EGFRm NSCLC with high levels of MET overexpression and/or amplification following disease progression on 1st-line TAGRISSO (#2O).</li>
<li>ORCHARD Phase II platform trial of TAGRISSO plus datopotamab deruxtecan-dlnk in advanced EGFRm NSCLC following disease progression on 1st-line TAGRISSO (#1O).</li>
<li>FLAURA2 Phase III trial of TAGRISSO plus chemotherapy as 1st-line treatment for advanced EGFRm NSCLC (#53P).</li>
</ul>

Reported Earlier, AstraZeneca's TAGRISSO Data from LAURA, SAVANNAH, And ORCHARD Trials Highlight Continued Survival Gains And Expanded Role in EGFR+ Lung Cancer

The Association of the British Pharmaceutical Industry (ABPI) is urging ministers to address excessive levies on manufacturers to ensure the sector remains competitive globally.
The life sciences industry, a key pillar of the UK&#8217;s economic strategy, could struggle to attract investment unless payment rates are adjusted.
Last week, the government <a href="https://www.abpi.org.uk/media/news/2025/march/uk-set-to-demand-a-third-of-pharmaceutical-company-revenue-in-second-half-of-2025/" target="_blank" rel="noreferrer noopener">proposed</a> raising the Statutory Scheme payment rate for newer branded medicines from 15.5% to 32.2% of subject companies&#8217; National Health Service (NHS) sales in the second half of 2025.
The payment rate is the revenue companies must hand back to the government on their sales of branded medicines to the NHS. It is an additional charge to the taxes paid by companies.
Also Read: <a target="_blank" href="https://www.benzinga.com/25/03/44362710/uk-pharma-industry-trade-association-restores-wegovyozempic-maker-novo-nordisks-membership-after-two-years-of-suspension" rel="noreferrer noopener">UK Pharma Industry Trade Association Restores Wegovy/Ozempic Maker Novo Nordisk&#8217;s Membership After 2 Years Of Suspension</a>
UK pharmaceutical leaders from Amgen Inc (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/AMGN#NASDAQ">AMGN</a>), AstraZeneca Plc (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/AZN#NASDAQ">AZN</a>), Biogen Inc (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/BIIB#NASDAQ">BIIB</a>), Boehringer Ingelheim, Bristol Myers Squibb &amp; Co (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/BMY#NYSE">BMY</a>), Daiichi Sankyo Ltd (OTC:<a class="ticker" href="https://www.benzinga.com/stock/DSNKY#OTC">DSNKY</a>), Gilead Sciences Inc (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/GILD#NASDAQ">GILD</a>), Johnson &amp; Johnson (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/JNJ#NYSE">JNJ</a>), Merck &amp; Co Inc (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/MRK#NYSE">MRK</a>), Novartis AG (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/NVS#NYSE">NVS</a>), Pfizer Inc (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/PFE#NYSE">PFE</a>), Roche Holdings AG (OTC:<a class="ticker" href="https://www.benzinga.com/stock/RHHBY#OTC">RHHBY</a>), Sanofi SA (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/SNY#NASDAQ">SNY</a>), Takeda Pharmaceutical Co Ltd (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/TAK#NYSE">TAK</a>) and UCB SA (OTC:<a class="ticker" href="https://www.benzinga.com/stock/UCBJY#OTC">UCBJY</a>) (OTC:<a class="ticker" href="https://www.benzinga.com/stock/UCBJF#OTC">UCBJF</a>) point to the challenges to investing in the U.K.
The pharmaceutical sector <a target="_blank" href="https://www.abpi.org.uk/media/news/2025/march/medicine-levy-makes-the-uk-un-investable-say-pharma-leaders/" rel="noreferrer noopener">contributes</a> over 17.6 billion pounds ($22.76 billion) directly to the U.K. economy, with an additional 45 billion generated through research and development spillovers.
However, companies argue that growth is being stifled due to escalating mandatory payments. Under the current system, firms must pay between 23.5% and 35.6% of their branded medicine sales revenue to the NHS. This is significantly higher than other European nations, where comparable rates range from 5.7% to 9%, ABPI writes.
The ABPI report highlights that while the UK once led in medicine availability, it has slipped to ninth place in Europe over the past decade. One year after launch, medicine usage in England is only 52% of the average of comparable nations, rising to 62% after five years.
Additionally, the UK has dropped from fourth to tenth in global rankings for phase 3 clinical trials, lagging behind Spain, Germany and Italy.
Investment in UK pharmaceutical research has also declined, with the country&#8217;s share of global R&amp;D investment falling from 7.3% to 5.7% in just three years.
This marks the fastest decline of any European G7 nation. Meanwhile, NHS funding has grown by 33% in real terms over the past decade, but spending on branded medicines has been capped at annual growth rates between 1.1% and 2%, declining by 11% when adjusted for inflation.
The industry and government have long collaborated on agreements to ensure NHS access to medicines.
The latest, the Voluntary Scheme for Branded Medicines, Pricing, Access, and Growth (VPAG), was intended to realign UK payment rates with international standards. While rates for newer medicines briefly dropped to 15.1% in 2024, they surged again in 2025 to 23.5% for newer medicines, with companies still paying 10.6%-35.6% for older products.
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Photo: Shutterstock

Eurozone

BIIB

DSNKY

Pharmaceutical Firms Say UK Investment Is 'Unlikely' Unless Payment Levy Is Adressed

Syneron Bio, a cutting-edge oral macrocyclic peptide drug biotech company, announced today a strategic collaboration with the global biopharmaceutical leader&nbsp;AstraZeneca&nbsp;to develop potential first-in-class macrocyclic peptides for the treatment of chronic diseases.&nbsp;Under this collaboration,&nbsp;AstraZeneca will gain access to&nbsp;Syneron Bio's innovative Synova&#x2122; platform, an intelligent&nbsp;and high-throughput macrocyclic peptide drug research and development platform, designed to support the advancements of research programmes exploring possible future treatments of chronic diseases,&nbsp;including rare, autoimmune,&nbsp;and metabolic disease.
Under the terms of the agreements, AstraZeneca will provide upfront payments and potential near-term milestone payments totaling $75 million and up to $3.4 billion in additional development and commercial milestones. In addition, tiered royalties will be paid based on global sales. AstraZeneca will also make an equity investment .&nbsp;As a result of this collaboration, Syneron Bio plans to expand its Beijing R&amp;D center.

Contracts

Global

Syneron Bio Announces Strategic Collaboration With AstraZeneca To Develop Potential First-In-Class Macrocyclic Peptides For The Treatment Of Chronic Diseases; AstraZeneca Will Provide Upfront Payments And Potential Near-Term Milestone Payments Totaling $75M And Up To $3.4B In Additional Development And Commercial Milestones

AstraZeneca Announced Global Collaboration With Harbour BioMed To Develop Next-Gen Therapeutic Antibodies, Including $105M Equity Investment, $175M Upfront, Up To $4.4B In Milestones, And Acquisition Of 9.15% Newly Issued Shares Of Harbour BioMed

AstraZeneca today announced an investment of $2.5 billion in Beijing to establish its sixth global strategic R&amp;D centre together with major research and manufacturing agreements that will further advance life sciences in China. This investment over the next five years is part of a strategic partnership with the Beijing Municipal Government and the Beijing Economic-Technological Development Area Administrative Office and includes agreements with three biotechs; Harbour BioMed, Syneron Bio, and BioKangtai, and follows the recent Fibrogen announcement. AstraZeneca expects its Beijing workforce to grow to 1,700 employees.

AstraZeneca Announced $2.5B Investment In Beijing To Establish Sixth Global R&D Centre, Sign Major Research And Manufacturing Agreements To Advance Life Sciences In China

<figure class="wp-block-image size-full is-resized"><img loading="lazy" decoding="async" width="900" height="600" src="https://contributor-assets.benzinga.com/wp-content/uploads/2025/03/20063705/TYKW.png" alt="" class="wp-image-8354" style="width:920px;height:auto" srcset="https://contributor-assets.benzinga.com/wp-content/uploads/2025/03/20063705/TYKW.png 900w,https://contributor-assets.benzinga.com/wp-content/uploads/2025/03/20063705/TYKW-300x200.png 300w,https://contributor-assets.benzinga.com/wp-content/uploads/2025/03/20063705/TYKW-768x512.png 768w" sizes="(max-width: 900px) 100vw, 900px" /></figure>
The medicines company released scanty but promising results for an experimental drug just as its shares were joining the Hong Kong Stock Connect scheme
<h4 class="wp-block-heading">Key Takeaways:</h4>
<ul>
<li>The drug being developed by TYK Medicines targets lung cancer that has spread to the brain, where market competition is already fierce</li>
<li>The market leader in lung cancer drugs, AstraZeneca, declined to comment without seeing more detailed clinical data about the Chinese product</li>
</ul>
A victory in head-to-head clinical trials has the power to shake up the pharmaceutical industry, where companies are competing to deliver the next game-changing drug.
Which is why China's&nbsp;TYK Medicines Inc.&nbsp;(2410.HK) grabbed the sector spotlight this month when it announced that a drug under development had outperformed the world's leading lung cancer treatment in early trials. Investors wondered if they were witnessing the arrival of a new disruptor in the market for cancer therapies.
But the news left many questions still to be answered.
TYK released a short&nbsp;<a href="https://www1.hkexnews.hk/listedco/listconews/sehk/2025/0309/2025030900033.pdf">statement</a>&nbsp;on March 9 saying that its candidate drug TY-9591 had, by one measure, demonstrated greater effectiveness against brain metastases from a type of lung cancer than the best-in-class treatment, osimertinib, developed by the pharma giant&nbsp;AstraZeneca&nbsp;(AZN.US).
However, it was worth reading the fine print about the comparison between the two drugs. The evaluation was made using a limited sample in a Phase Two trial and focused on a specific metric for effects on the brain. On that basis, the drug achieved "notably improved statistical and clinical significance over osimertinib", TYK said.
In a head-to-head trial, a new drug is tested under standardized trial conditions against a proven benchmark treatment. TYK's experimental drug is a tyrosine kinase inhibitor targeting cancers with a genetic mutation known as EGFR. The TYK version deviates from the osimertinib formula by replacing hydrogen atoms with deuterium, with the aim of allowing larger doses to be dispensed safely. The company said that it planned to file a new drug application for its product with Chinese regulators in due course.
EGFR, which stands for epidermal growth factor receptor, is a common mutation seen in lung cancer patients and is therefore a frequent therapy target. AstraZeneca's drug is a third-generation inhibitor in this field, used to treat the most common type of cancer affecting the lungs, non-small cell lung cancer. Osimertinib sales rose16% to $6.58 billion in 2024, confirming the drug's status as the leading weapon against lung cancer.
Investors were excited about a potential challenger. Shares in the Chinese drug developer surged as much as 50% on the first trading day after the announcement, before closing with a gain of 16.18%. Interestingly, TYK shares made their debut that same day in the Hong Kong Stock Connect system, which allows mainland Chinese investors to participate in the market. Trading turnover spiked to 3.39 million shares after languishing at a daily average of 200,000, but the euphoria quickly cooled. The price corrected over three days, falling more than 21% to sink below the pre-announcement level.
What could explain the volatility over four trading days?
<h4 class="wp-block-heading">Clinical findings under scrutiny</h4>
In its statement to the Hong Kong Stock Exchange about the trial results, the company did not reveal detailed data, saying that more comprehensive information would be shared at clinical conferences in China or overseas. Asked for its response, AstraZeneca said it could not comment on the limited data available so far.
The methodology also deserves a closer look. The industry-standard endpoints, or targeted outcomes, in cancer drug trials are overall survival, progression-free survival or disease-free survival. In this case, TYK chose to focus on the intracranial objective response rate, or iORR, which tracks lesions in the brain. Moreover, the study was small in scope with 244 test subjects, leaving a question mark over whether the drug can continue to outperform when it moves into a much larger Phase Three trial.
The competitive picture should also be factored in. Other drugs have beaten TY-9591 to market for treating secondary brain cancer that originated in the lungs. &nbsp;Zorifertinib, jointly developed by Jiangsu Chentai Pharmaceutical Technology and AstraZeneca, launched last November as the world's first EGFR-TKI product specifically aimed at brain tumors triggered by lung cancer.
Novel drug developer TYK was founded in 2017 and went public in Hong Kong in August last year. The IPO prospectus showed that, aside from TY-9591, its 10 other candidate drugs are all at the pre-clinical research stage. With no products yet to sell, the company is far from the breakeven point. It made annual losses of 312 million yuan ($43 million) in 2022 and 383 million yuan the following year, before landing 108 million yuan in the red in the first quarter of 2024. Its pre-IPO financial profile raised other concerns, with net debt of 934 million yuan at the end of last March and a cash reserve of 77.21 million yuan.
The EGFR-TKI marketplace includes at least six products, with more advanced drugs lining up in the Phase Three stage of clinical testing. &nbsp;Companies such as&nbsp;Betta Pharmaceuticals&nbsp;(300558.SZ),&nbsp;Chia Tai Tianqing Pharmaceutical,&nbsp;Shanghai Junshi Biosciences&nbsp;(1877.HK) and&nbsp;Qilu Pharmaceutical&nbsp;have all launched clinical trials for the latest iterations in this product category.
With fierce competition in a fast-evolving market for specialist drugs, it remains to be seen whether TYK Medicines can deliver a standout product.

Equities

A Potential Challenger For AstraZeneca's Blockbuster Lung Cancer Drug?

On Monday, AstraZeneca Plc (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/AZN#NASDAQ">AZN</a>) released high-level results from the CALYPSO Phase 3 trial designed to evaluate the efficacy and safety of eneboparatide in adults with chronic hypoparathyroidism.
The study showed that eneboparatide (AZP-3601), an investigational parathyroid hormone (PTH) receptor 1 agonist, met its primary endpoint with statistical significance at 24 weeks in adults with chronic hypoparathyroidism (HypoPT) compared to placebo.
The primary <a target="_blank" href="https://www.astrazeneca.com/media-centre/press-releases/2025/eneboparatide-phase-iii-trial-met-primary-endpoint.html" rel="noreferrer noopener">endpoint</a> is a composite of normalization of albumin-adjusted serum calcium levels and independence from active vitamin D and oral calcium therapy.
Also Read: <a target="_blank" href="https://www.benzinga.com/general/biotech/25/03/44188407/astrazenecas-imfinzi-based-regimen-shows-improved-event-free-survival-in-early-stage-gastric-cancer-patients" rel="noreferrer noopener">AstraZeneca&#8217;s Imfinzi-Based Regimen Shows Improved Event-Free Survival In Early-Stage Gastric Cancer Patients</a>
HypoPT is a rare endocrine disease caused by a deficiency of PTH and is characterized by impaired regulation of calcium and phosphate levels in the blood. Eneboparatide was well tolerated.
After the 24-week randomized treatment period, all patients receive eneboparatide in the ongoing long-term extension until 52 weeks. Full efficacy and safety data will be analyzed at 52 weeks.
Concurrently, AstraZeneca and Alteogen <a target="_blank" href="https://www.astrazeneca.com/media-centre/press-releases/2025/astrazeneca-enters-license-agreement-with-alteogen-for-subcutaneous-formulations-of-multiple-oncology-assets.html" rel="noreferrer noopener">entered</a> into an exclusive license agreement for ALT-B4, a hyaluronidase utilizing Hybrozyme platform technology.
Under the terms of the agreement, AstraZeneca will acquire worldwide rights to use ALT-B4 to develop and commercialize subcutaneous formulations of several oncology assets.
Alteogen will be responsible for the clinical and commercial supply of ALT-B4 to AstraZeneca.
AstraZeneca will pay Alteogen an upfront payment and additional payments upon achieving specific development, regulatory, and sales-related milestones. Additionally, Alteogen will receive royalties on the sales of the commercialized products.
On Monday, the European Union approved AstraZeneca&#8217;s Imfinzi (durvalumab)&nbsp;as monotherapy for adults with limited-stage small cell lung cancer whose disease has not progressed following platinum-based chemoradiation therapy.
The <a target="_blank" href="https://www.astrazeneca.com/media-centre/press-releases/2025/imfinzi-approved-in-eu-for-limited-stage-sclc.html" rel="noreferrer noopener">approval</a> is based on results from the&nbsp;ADRIATIC&nbsp;Phase 3 trial.
The trial showed&nbsp;that Imfinzi&nbsp;reduced the risk of death by 27% compared to placebo.
The estimated median overall survival was 55.9 months for&nbsp;Imfinzi&nbsp;versus 33.4 months for placebo. An estimated 57% of patients treated with&nbsp;Imfinzi&nbsp;were alive at three years compared to 48% for placebo.
Imfinzi&nbsp;also reduced the risk of disease progression or death by 24% versus placebo.
The median progression-free survival (PFS) was 16.6 months for&nbsp;Imfinzi&nbsp;versus 9.2 months for placebo. An estimated 46% of patients treated with&nbsp;Imfinzi&nbsp;had not experienced disease progression at two years compared to 34% for placebo.
Earlier on Monday, AstraZeneca agreed to acquire cell therapy focused-EsoBiotec SA for <a target="_blank" href="https://www.benzinga.com/markets/equities/25/03/44352234/astrazeneca-seals-deal-for-esobiotec-to-advance-cell-therapy-details" rel="noreferrer noopener">up to $1 billion</a>.
Price Action: At the last check on Monday, AZN stock was down 1.04% to $76.78 during the premarket session.
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Image by Robert Way via Shutterstock

Eventful Monday For AstraZeneca - What's Going On?

EsoBiotec SA, a biotechnology company specializing in in vivo cell therapies, has announced a <a target="_blank" href="https://www.benzinga.com/pressreleases/25/03/g44350232/esobiotec-to-be-acquired-by-astrazeneca-to-advance-cell-therapy-ambition" rel="noreferrer noopener">definitive agreement to be acquired</a> by AstraZeneca PLC (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/AZN#NYSE">AZN</a>).
The agreement represents a major step forward for EsoBiotec, which has demonstrated encouraging early clinical results with its Engineered NanoBody Lentiviral (ENaBL) platform.
AstraZeneca is acquiring all of EsoBiotec&#8217;s outstanding equity for a total of up to $1 billion. The deal includes an initial $425 million payment at closing, with up to an additional $575 million in contingent consideration based on development and regulatory milestones.
The transaction is expected to be finalized in the second quarter of 2025. EsoBiotec will continue operations in Belgium as a wholly owned subsidiary of AstraZeneca.
&#8220;We believe it has the potential to transform cell therapy and will enable us to scale these innovative treatments so that many more patients around the world can access them. EsoBiotec will accelerate and expand the impact of our recent investments and marks a major step forward in realising our ambition to harness the full potential of cell therapy,&#8221; said AstraZeneca Executive Vice President, Oncology Haematology R&amp;D, Susan Galbraith.
Also Read: <a target="_blank" href="https://www.benzinga.com/general/biotech/25/03/44313315/perspective-therapeutics-cancer-focused-radiotherapy-portfolio-has-upside-potentional-says-analyst" rel="noreferrer noopener">Perspective Therapeutics&#8217; Cancer-Focused Radiotherapy Portfolio Has Upside Potentional, Says Analyst</a>
EsoBiotec&#8217;s&nbsp;ENaBL platform utilizes highly targeted lentiviruses to deliver genetic instructions directly to immune cells like T cells. The technology programs these cells to recognize and destroy cancerous cells or autoreactive cells related to immune-mediated diseases.
In contrast to conventional treatments that require extracting cells from patients, modifying them externally, and enduring prolonged manufacturing periods, ENaBL works by enhancing the immune system within the patient&#8217;s body itself, by administering therapies through a simple intravenous (IV) injection.
AstraZeneca held $5.6 billion in <a target="_blank" href="https://www.sec.gov/Archives/edgar/data/901832/000165495425001189/a1107w.htm" rel="noreferrer noopener">cash </a>and equivalents as of December 31.
Price Action: AZN shares traded lower by 0.66% at $77.08 in premarket at last check Monday.
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AstraZeneca Seals Deal For EsoBiotec To Advance Cell Therapy: Details

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