Últimas noticias sobre Pfizer (NYSE:PFE) Bolsa

PFIZER INC

Pfizer

Pfizer is one of the world's largest pharmaceutical firms, with annual sales close to $50 billion (excluding covid-19-related product sales). While it historically sold many types of healthcare products and chemicals, now prescription drugs and vaccines account for the majority of sales. Top sellers include pneumococcal vaccine Prevnar 13, cancer drug Ibrance, and cardiovascular treatment Eliquis. Pfizer sells these products globally, with international sales representing close to 50% of total sales. Within international sales, emerging markets are a major contributor.

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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.

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Merrill Lynch Pharmaceutical HOLDRs Trust

Trump quiere que las farmacéuticas vuelvan a EE. UU. ¿Cómo afectarán sus aranceles a las acciones del sector?

Trump presiona a farmacéuticas con aranceles para forzar regreso a EE. UU.

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Movers

Las acciones de Pfizer caen un 2,77 % después de que Trump anunciara nuevos aranceles a productos farmacéuticos fabricados fuera de EE.UU.

Acciones de Pfizer (PFE) caen tras anuncio de Trump sobre aranceles a productos farmacéuticos

Pfizer Inc

Innovator U.S. Equity Power Buffer ETF - February

PFEIFFER VACUUM TECH ORD by Pfeiffer Vacuum Technology AG

Pfeiffer Vacuum Technology AG

<ul>
<li>Five-year follow-up data from the Phase 3 ARCHES trial shows XTANDI (enzalutamide) plus androgen deprivation therapy (ADT) reduces risk of death by 30%</li>
<li>After a median follow-up of 61.4 months, treatment with XTANDI (enzalutamide)&nbsp;plus ADT was associated with a 66% probability of survival at five years compared to 53% probability of survival with placebo plus ADT</li>
<li>XTANDI (enzalutamide) is the first and only androgen receptor inhibitor to demonstrate an overall survival benefit at five years in men with metastatic hormone-sensitive prostate cancer</li>
<li>Data continue to show wide-ranging effect of treatment with XTANDI (enzalutamide) plus ADT across various patient subgroups, notably those with high-volume disease, no prior docetaxel use, and synchronous disease</li>
<li>Long-term data reinforce XTANDI (enzalutamide) plus ADT as a standard of care</li>
</ul>
TOKYO and NEW YORK, May 22, 2025 /PRNewswire/ -- Astellas Pharma Inc. (TSE: 4503, President and CEO: Naoki Okamura, "Astellas") and Pfizer Inc. (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/PFE#NYSE">PFE</a>) today announced longer-term follow-up results from an open-label extension of the Phase 3 ARCHES (<a href="https://c212.net/c/link/?t=0&amp;l=en&amp;o=4432875-1&amp;h=3659458001&amp;u=https%3A%2F%2Fclinicaltrials.gov%2Fstudy%2FNCT02677896%3Fterm%3DNCT02677896&amp;a=NCT02677896">NCT02677896</a>) study, reporting a five-year follow up of overall survival (OS) benefits and a 30% reduction in the risk of death in men with metastatic hormone-sensitive prostate cancer (mHSPC) treated with XTANDI&#x2122; (enzalutamide), an androgen receptor pathway inhibitor (ARPI), plus androgen deprivation therapy (ADT) compared to placebo plus ADT. These data will be presented during an oral presentation (Abstract #5005) at the American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago (Tuesday, June 3, 9:45 a.m.- 12:45 p.m. US CT).

Biotech

General

ALPMY

Astellas And Pfizer's XTANDI Shows Long-Term Overall Survival In Metastatic Hormone-Sensitive Prostate Cancer; 5-year Follow-up Data From The Phase 3 ARCHES Trial Shows XTANDI Plus Androgen Deprivation Therapy (Adt) Reduces Risk Of Death By 30%

<a href="https://endpts.com/fda-vaccine-advisors-update-covid-strain-guidance-following-new-framework/#:~:text=Committee%20members%20voted%20unanimously%20to,was%20the%20KP.2%20strain" title="https://endpts.com/fda-vaccine-advisors-update-covid-strain-guidance-following-new-framework/#:~:text=Committee%20members%20voted%20unanimously%20to,was%20the%20KP.2%20strain">https://endpts.com/fda-vaccine-advisors-update-covid-strain-guidance-following-new-framework/#:~:text=Committee%20members%20voted%20unanimously%20to,was%20the%20KP.2%20strain</a>.

BNTX

MRNA

NVAX

'All FDA Committee Members Voted Unanimously To Recommend A Monovalent JN.1-lineage Covid-19 Vaccine For The Upcoming Season, The Same Recommendation Made Last Year; The FDA Ultimately Told Vaccine Manufacturers That The Preferred Strain Within That Lineage Was The KP.2 Strain' - STAT News

During times of turbulence and uncertainty in the markets, many investors turn to dividend-yielding stocks. These are often companies that have high free cash flows and reward shareholders with a<a href="https://www.benzinga.com/yield-investments"> high dividend payout</a>.
Benzinga readers can review the latest analyst takes on their favorite stocks by visiting <a href="https://www.benzinga.com/analyst-stock-ratings">Analyst Stock Ratings</a> page. Traders can sort through Benzinga's extensive database of analyst ratings, including <a href="https://www.benzinga.com/analyst-ratings/analyst-color/22/09/28888638/exclusive-study-finds-benzinga-analyst-ratings-data-yields-market-beating-strategie">by analyst accuracy</a>.
Below are the ratings of the most accurate analysts for three high-yielding stocks in the health care sector.
<h3 class="wp-block-heading">Pfizer Inc. (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/PFE#NYSE">PFE</a>)</h3>
<ul class="wp-block-list">
<li>Dividend Yield: 7.47%</li>
<li>UBS analyst Trung Huynh maintained a Neutral rating and raised the price target from $24 to $25 on April 30, 2025. This analyst has an accuracy rate of 67%.</li>
<li>Guggenheim analyst Vamil Divan reiterated a Buy rating on March 18, 2025. This analyst has an accuracy rate of 72%.</li>
<li>Recent News: Pfizer announced Monday it has secured exclusive global rights, excluding China, to 3SBio Inc.'s bispecific antibody SSGJ-707 in a deal potentially worth up to $6 billion.</li>
<li>Benzinga Pro&#8217;s real-time newsfeed alerted to latest PFE <a href="https://www.benzinga.com/pro/register?utm_adType=bzprocontent&amp;utm_campaign=14daytrial&amp;utm_ad=0522">news</a>. </li>
</ul>
<figure class="wp-block-image size-full is-resized"><a href="https://www.benzinga.com/pro/register?utm_adType=bzprocontent&amp;utm_campaign=14daytrial&amp;utm_ad=0522"><img loading="lazy" decoding="async" width="891" height="832" src="https://editorial-assets.benzinga.com/wp-content/uploads/2025/05/22050725/image-280.png" alt="" class="wp-image-924044" style="width:531px;height:auto" srcset="https://editorial-assets.benzinga.com/wp-content/uploads/2025/05/22050725/image-280.png 891w,https://editorial-assets.benzinga.com/wp-content/uploads/2025/05/22050725/image-280-300x280.png 300w,https://editorial-assets.benzinga.com/wp-content/uploads/2025/05/22050725/image-280-768x717.png 768w" sizes="(max-width: 891px) 100vw, 891px" /></a></figure>
<h3 class="wp-block-heading">Merck &amp; Co., Inc. (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/MRK#NYSE">MRK</a>)</h3>
<ul class="wp-block-list">
<li>Dividend Yield: 4.21%</li>
<li>Citigroup analyst Andrew Baum downgraded the stock from Buy to Neutral and cut the price target from $115 to $84 on May 14, 2025. This analyst has an accuracy rate of 69%.</li>
<li>Guggenheim analyst Vamil Divan reiterated a Buy rating with a price target of $115 on April 17, 2025. This analyst has an accuracy rate of 72%.</li>
<li>Recent News: On May 19, Merck and Daiichi Sankyo started Phase 3 trial for Esophageal Cancer Drug.</li>
<li>Benzinga Pro's real-time newsfeed alerted to latest MRK <a href="https://www.benzinga.com/pro/register?utm_adType=bzprocontent&amp;utm_campaign=14daytrial&amp;utm_ad=0522">news </a></li>
</ul>
<figure class="wp-block-image size-full is-resized"><a href="https://www.benzinga.com/pro/register?utm_adType=bzprocontent&amp;utm_campaign=14daytrial&amp;utm_ad=0522"><img loading="lazy" decoding="async" width="900" height="827" src="https://editorial-assets.benzinga.com/wp-content/uploads/2025/05/22050803/image-281.png" alt="" class="wp-image-924046" style="width:545px;height:auto" srcset="https://editorial-assets.benzinga.com/wp-content/uploads/2025/05/22050803/image-281.png 900w,https://editorial-assets.benzinga.com/wp-content/uploads/2025/05/22050803/image-281-300x276.png 300w,https://editorial-assets.benzinga.com/wp-content/uploads/2025/05/22050803/image-281-768x706.png 768w" sizes="(max-width: 900px) 100vw, 900px" /></a></figure>
<h3 class="wp-block-heading">DENTSPLY SIRONA Inc. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/XRAY#NASDAQ">XRAY</a>)</h3>
<ul class="wp-block-list">
<li>Dividend Yield: 4.04%</li>
<li>UBS analyst Kevin Caliendo maintained a Buy rating and cut the price target from $27 to $25 on May 9, 2025. This analyst has an accuracy rate of 71%.</li>
<li>Mizuho analyst Steven Valiquette maintained a Neutral rating and slashed the price target from $21 to $18 on March 13, 2025. This analyst has an accuracy rate of 61%.</li>
<li>Recent News: On May 8, DENTSPLY SIRONA reported better-than-expected first-quarter financial results and raised its FY25 sales guidance above estimates.</li>
<li>Benzinga Pro&#8217;s real-time newsfeed alerted to latest <a href="https://www.benzinga.com/pro/register?utm_adType=bzprocontent&amp;utm_campaign=14daytrial&amp;utm_ad=0522">XRAY news</a> </li>
</ul>
<figure class="wp-block-image size-full is-resized"><a href="https://www.benzinga.com/pro/register?utm_adType=bzprocontent&amp;utm_campaign=14daytrial&amp;utm_ad=0522"><img loading="lazy" decoding="async" width="901" height="822" src="https://editorial-assets.benzinga.com/wp-content/uploads/2025/05/22050834/image-282.png" alt="" class="wp-image-924050" style="width:590px;height:auto" srcset="https://editorial-assets.benzinga.com/wp-content/uploads/2025/05/22050834/image-282.png 901w,https://editorial-assets.benzinga.com/wp-content/uploads/2025/05/22050834/image-282-300x274.png 300w,https://editorial-assets.benzinga.com/wp-content/uploads/2025/05/22050834/image-282-768x701.png 768w" sizes="(max-width: 901px) 100vw, 901px" /></a></figure>
<figure class="wp-block-embed is-type-video is-provider-youtube wp-block-embed-youtube wp-embed-aspect-16-9 wp-has-aspect-ratio"> 
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<iframe loading="lazy" title="How to Find Dividend Stocks: Scan, Analyze, and Capture with Benzinga Pro" width="500" height="281" src="https://www.youtube.com/embed/pVF0O2lsEH4?start=1&#038;feature=oembed" frameborder="0" allow="accelerometer; autoplay; clipboard-write; encrypted-media; gyroscope; picture-in-picture; web-share" referrerpolicy="strict-origin-when-cross-origin" allowfullscreen></iframe>
</div>
</figure>
Read More: 
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Photo via Shutterstock

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Analyst Ratings

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XRAY

Wall Street's Most Accurate Analysts Give Their Take On 3 Health Care Stocks Delivering High-Dividend Yields

<a href="https://www.bloomberg.com/news/articles/2025-05-21/pfizer-hits-fda-setback-in-effort-to-boost-prostate-cancer-drug?embedded-checkout=true">https://www.bloomberg.com/news/articles/2025-05-21/pfizer-hits-fda-setback-in-effort-to-boost-prostate-cancer-drug?embedded-checkout=true</a>

'Pfizer Hits FDA Setback in Effort to Boost Prostate Cancer Drug'- Bloomberg

<a href="https://www.wsj.com/politics/policy/rfk-jr-maha-commission-report-5c13696d">https://www.wsj.com/politics/policy/rfk-jr-maha-commission-report-5c13696d</a>

'What's Inside RFK Jr.'s MAHA Report'- Wall Street Journal

<a href="https://www.prnewswire.com/news-releases/sk-bioscience-wins-patent-lawsuit-against-pfizer-over-pneumococcal-vaccine-302461472.html" title="https://www.prnewswire.com/news-releases/sk-bioscience-wins-patent-lawsuit-against-pfizer-over-pneumococcal-vaccine-302461472.html">https://www.prnewswire.com/news-releases/sk-bioscience-wins-patent-lawsuit-against-pfizer-over-pneumococcal-vaccine-302461472.html</a>

Legal

Supreme Court Of Korea Rules In SK bioscience's Favor In Patent Infringement Lawsuit Filed Bt Pfizer

The U.S. Food and Drug Administration has announced significant changes to COVID-19 vaccine requirements, limiting annual booster approvals to older and high-risk Americans while implementing stricter clinical trial requirements for healthy adults.
What Happened: The FDA will now require new clinical trials for approval of annual COVID-19 boosters for healthy Americans under age 65, effectively restricting their availability to older adults and those at risk of severe illness, according to FDA Commissioner Marty Makary and top U.S. vaccines regulator Vinay Prasad in the New England Journal of Medicine, reported Reuters.
&#8220;At-risk Americans can be reassured that they will be covered by such approvals. At the same time, we want more evidence at the U.S. Food and Drug Administration,&#8221; Prasad told FDA scientists during a live-streamed presentation on Tuesday. &#8220;We want to know more about what these products are doing, especially as we enter the seventh, eighth and ninth dose.&#8221;
See Also: <a href="https://www.benzinga.com/markets/25/05/45537306/google-unveils-total-reimagining-of-search-with-chatbot-style-feature-to-compete-with-openai">Google Unveils &#8216;Total Reimagining Of Search&#8217; With Chatbot-Style Feature To Compete With OpenAI</a> Why It Matters: This policy shift represents a significant departure from previous U.S. vaccination strategy, with Makary and Prasad noting that America has been more aggressive than other high-income nations in recommending yearly shots for healthy adults.
The decision comes amid shifting political priorities at the FDA under Health Secretary Robert F. Kennedy Jr., who has been remaking the U.S. health system to align with President Donald Trump&#8216;s goal of dramatically <a href="https://www.benzinga.com/government/regulations/25/05/45488265/novavax-wins-limited-fda-nod-for-covid-shot-cleared-only-for-seniors-high-risk-groups-amid-safety-scrutiny">shrinking the federal government</a>. 
This follows a pattern of increased scrutiny of vaccines, as evidenced by the FDA&#8217;s recent limited approval of Novavax Inc.&#8217;s (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/NVAX#NASDAQ">NVAX</a>) COVID-19 vaccine only for <a href="https://www.benzinga.com/government/regulations/25/05/45488265/novavax-wins-limited-fda-nod-for-covid-shot-cleared-only-for-seniors-high-risk-groups-amid-safety-scrutiny">people 65 and older and those 12</a> and up with underlying health conditions.
Despite the policy change, investors appeared reassured that vaccine policies for older and high-risk Americans remain unchanged. Shares of COVID-19 vaccine makers rose following the announcement, with Moderna (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/MRNA#NASDAQ">MRNA</a>) up 6.06%, Pfizer (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/PFE#NYSE">PFE</a>) rising 2.22%, BioNTech&#8217;s (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/BNTX#NASDAQ">BNTX</a>) U.S. ADRs up 4.1%, and Novavax gaining 1.5%.
Image Via Shutterstock 
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<li><a href="https://www.benzinga.com/markets/equities/25/05/45537159/gary-black-compares-ubers-shift-to-driverless-cars-with-netflixs-2007-move-from-dvds-to-streaming-says-tesla-faithful-are-missing-the-bigger-picture">Gary Black Compares Uber&#8217;s Shift To Driverless Cars With Netflix&#8217;s 2007 Move From DVDs To Streaming, Says Tesla &#8216;Faithful&#8217; Are Missing The Bigger Picture</a></li>
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Disclaimer:&nbsp;This content was partially produced with the help of AI tools and was reviewed and published by Benzinga editors.

Regulations

FDA Limits Annual COVID-19 Boosters To High-Risk Americans, Demands New Trials For Healthy Adults In Policy Shift Under RFK Jr.

<a href="https://x.com/US_FDA/status/1924871996216951112">https://x.com/US_FDA/status/1924871996216951112</a>
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Macro Economic Events

Economics

PCVX

FDA's Vinayak Prasad Says No High-Quality Evidence For Benefit Of Vaccinating People Around Immunocompromised People With Covid Shots; I Don't Envision Randomized Trials Every Year For Covid Vaccines But Rather When There's Major Antigenic Shift

Looking into the current session, Pfizer Inc. (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/PFE#NYSE">PFE</a>) shares are trading at $23.35, after a 1.52% increase. Moreover, over the past month, the stock spiked by 3.64%, but in the past year, decreased by 21.11%. Shareholders might be interested in knowing whether the stock is undervalued, even if the company is performing up to par in the current session. 

<img src="https://www.benzinga.com/files/images/story/2025/1747760421_0.png" alt="Past Year Chart" />

<h3>Pfizer P/E Compared to Competitors</h3>
The P/E ratio measures the current share price to the company's EPS. It is used by long-term investors to analyze the company's current performance against it's past earnings, historical data and aggregate market data for the industry or the indices, such as S&amp;P 500. A higher P/E indicates that investors expect the company to perform better in the future, and the stock is probably overvalued, but not necessarily. It also could indicate that investors are willing to pay a higher share price currently, because they expect the company to perform better in the upcoming quarters. This leads investors to also remain optimistic about rising dividends in the future. 
Compared to the aggregate P/E ratio of the 25.27 in the Pharmaceuticals industry, Pfizer Inc. has a lower P/E ratio of 16.67. Shareholders might be inclined to think that the stock might perform worse than it's industry peers. It's also possible that the stock is undervalued. 

<img src="https://www.benzinga.com/files/images/story/2025/1747760421_1.png" alt="Guage" />

In conclusion, the price-to-earnings ratio is a useful metric for analyzing a company's market performance, but it has its limitations. While a lower P/E can indicate that a company is undervalued, it can also suggest that shareholders do not expect future growth. Additionally, the P/E ratio should not be used in isolation, as other factors such as industry trends and business cycles can also impact a company's stock price. Therefore, investors should use the P/E ratio in conjunction with other financial metrics and qualitative analysis to make informed investment decisions.

Intraday Update

P/E Ratio Insights for Pfizer

Pfizer Inc (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/PFE#NYSE">PFE</a>) shares are moving higher Tuesday following multiple developments. Here&#8217;s a look at <a href="https://www.benzinga.com/general/health-care/25/05/45510221/pfizer-secures-global-rights-to-chinas-3sbios-cancer-drug-in-6-billion-deal">what&#8217;s going on</a>.
What To Know: Pfizer shares are getting a boost after Reuters reported that FDA advisors are planning to discuss if they should recommend COVID-19 vaccines for 2025-26 targeting the LP.8.1 strain, which has started spreading at a faster rate than other variants.
The news comes after European regulators recommended that new vaccines should include protection against the LP.8.1 subvariant. 
The new strain has become the dominant subvariant in the U.S., where it has accounted for an estimated 70% of total cases in recent weeks, according to the Centers for Disease Control and Prevention.
Pfizer shares are also seeing some positive momentum after the company announced a licensing agreement with 3SBio for the development, manufacturing and commercialization of SSGJ-707.
SSGJ-707 is a bispecific antibody targeting PD-1 and VEGF that&#8217;s currently being evaluated in multiple clinical trials in China for non-small cell lung cancer, metastatic colorectal cancer and gynecological tumors.&nbsp;
Under the terms of the agreement, Pfizer will be granted an exclusive global license to develop, manufacture and commercialize SSGJ-707 across the world, excluding China.&nbsp;3SBio will receive an upfront payment of&nbsp;$1.25 billion&nbsp;and is eligible to receive milestone payments of up to&nbsp;$4.8 billion.
Pfizer will also make a $100 million equity investment in 3SBio upon closing of the deal. The transaction is expected to close in the third quarter.
PFE Price Action: Pfizer has a 52-week high of $31.54 and a 52-week low of $20.92. The stock is down about 12% year-to-date. <a href="http://benzinga.com/quote/pfe">Pfizer shares</a> were up 1.50% at $23.35 at the time of publication Tuesday, according to <a href="http://pro.benzinga.com">Benzinga Pro</a>.
Read Next:
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<li><a href="https://www.benzinga.com/insights/short-sellers/25/05/45523643/how-do-investors-really-feel-about-pfizer">How Do Investors Really Feel About Pfizer?</a></li>
</ul>
Photo: Shutterstock.

Contracts

Global

Pfizer Stock Is Trading Higher Tuesday: What's Going On?

Pfizer's (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/PFE#NYSE">PFE</a>) short percent of float has risen 6.84% since its last report. The company recently reported that it has 115.16 million shares sold short, which is 2.03% of all regular shares that are available for trading. Based on its trading volume, it would take traders 2.35 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>Pfizer Short Interest Graph (3 Months)</h3>
<img src="https://www.benzinga.com/files/images/story/2025/1747756832_0_0.png" alt="short_fig" />
As you can see from the chart above the percentage of shares that are sold short for Pfizer has grown since its last report. This does not mean that the stock is going to fall in the near-term but traders should be aware that more shares are being shorted.
<h3>Comparing Pfizer'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>, Pfizer's peer group average for short interest as a percentage of float is 3.60%, 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.

Short Sellers

Short Ideas

How Do Investors Really Feel About Pfizer?

WIIM

Shares of vaccine stocks are trading higher following a report indicating FDA advisers will consider if COVID-19 vaccines should target the LP.8.1 subvariant for 2025-2026.

<a href="https://www.reuters.com/business/healthcare-pharmaceuticals/us-fda-advisers-consider-if-new-covid-shots-should-target-lp81-subvariant-2025-05-20/" title="https://www.reuters.com/business/healthcare-pharmaceuticals/us-fda-advisers-consider-if-new-covid-shots-should-target-lp81-subvariant-2025-05-20/">https://www.reuters.com/business/healthcare-pharmaceuticals/us-fda-advisers-consider-if-new-covid-shots-should-target-lp81-subvariant-2025-05-20/</a>

'US FDA Advisers To Consider If New COVID Shots Should Target LP.8.1 Subvariant' - Reuters News

<a href="https://www.reuters.com/business/healthcare-pharmaceuticals/fda-sets-new-covid-booster-guidelines-requiring-trials-approvals-healthy-adults-2025-05-20/" title="https://www.reuters.com/business/healthcare-pharmaceuticals/fda-sets-new-covid-booster-guidelines-requiring-trials-approvals-healthy-adults-2025-05-20/">https://www.reuters.com/business/healthcare-pharmaceuticals/fda-sets-new-covid-booster-guidelines-requiring-trials-approvals-healthy-adults-2025-05-20/</a>

'FDA Sets New COVID Booster Guidelines Requiring Trials For Approvals For Healthy Adults' - Reuters News

Pfizer shares are trading higher after the company announced it secured the global rights to China's 3SBio cancer drug in a $6 billion deal.

Pfizer Inc. (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/PFE#NYSE">PFE</a>) announced Monday it has secured exclusive global rights, excluding China, to 3SBio Inc.&#8216;s bispecific antibody SSGJ-707 in a deal potentially worth up to $6 billion.
The agreement includes a $1.25 billion upfront payment to the Chinese biopharmaceutical company, with additional milestone payments of up to $4.8 billion. Pfizer will also make a $100 million equity investment in 3SBio upon closing, expected in the third quarter of 2025.
SSGJ-707, which targets PD-1 and VEGF pathways simultaneously, is currently in clinical trials for non-small cell lung cancer, metastatic colorectal cancer, and gynecological tumors in China. 3SBio plans to initiate Phase 3 trials there in 2025.
The transaction gives Pfizer manufacturing and commercialization rights globally except China, with an option for Chinese market rights. If approved, Pfizer will produce the drug substance in North Carolina and the drug product in Kansas, while paying 3SBio tiered double-digit royalties on sales.
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Disclaimer:&nbsp;This content was partially produced with the help of AI tools and was reviewed and published by Benzinga editors.
Photo courtesy: ShU studio/Shutterstock

Pfizer Secures Global Rights To China's 3SBio's Cancer Drug In $6 Billion Deal

Novavax Inc. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/NVAX#NASDAQ">NVAX</a>) has received limited approval from the U.S. Food and Drug Administration for its COVID-19 vaccine, Nuvaxovid, marking a regulatory milestone and unlocking a <a href="https://www.benzinga.com/pressreleases/25/05/n45489838/u-s-fda-approves-bla-for-novavaxs-covid-19-vaccine" target="_blank" rel="noreferrer noopener">$175 million milestone payment</a> from partner Sanofi SA (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/SNY#NASDAQ">SNY</a>).
The protein-based vaccine, distinct from mRNA options by Pfizer Inc. (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/PFE#NYSE">PFE</a>) and BioNTech SE (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/BNTX#NASDAQ">BNTX</a>), is now authorized for people aged 65 and older and for individuals 12 and up with underlying medical conditions that increase the risk of severe COVID-19. 
The approval came after a six-week delay as regulators sought additional data.
Related: <a href="https://www.benzinga.com/government/regulations/25/05/45488265/novavax-wins-limited-fda-nod-for-covid-shot-cleared-only-for-seniors-high-risk-groups-amid-safety-scrutiny" target="_blank" rel="noreferrer noopener">Novavax Wins Limited FDA Nod For COVID Shot—Cleared Only For Seniors, High-Risk Groups Amid Safety Scrutiny</a>         
Novavax CEO John C. Jacobs called the decision "a significant milestone" and emphasized the company's commitment to vulnerable populations. The CDC has noted that these groups will most likely seek seasonal COVID vaccinations.
The approval comes as CDC advisers weigh adjustments to annual COVID shot guidance, potentially narrowing recommendations to older adults and high-risk groups.
Novavax plans to begin commercial distribution of its 2025–2026 formula this fall, pending strain selection at the FDA advisory committee meeting on May 22. The company is also working with Sanofi to fund a Phase 4 study in adults 50–64 without high-risk conditions, as requested by the FDA.
Financially, Novavax reaffirmed its 2025 forecast for R&amp;D and SG&amp;A expenses between $475 million and $525 million. It plans to cut these to around $350 million in 2026 and $250 million by 2027, according to BZ Pro.
Related ETFs: iShares Biotechnology ETF (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/IBB#NASDAQ">IBB</a>), SPDR S&amp;P Biotech ETF (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/XBI#NYSE">XBI</a>)
Price Action: NVAX shares are trading higher by 19.0% at $8.01 premarket at the last check on Monday.&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;
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Image: Shutterstock

Novavax Scores Key FDA Win, Shares Jump 19% As Sanofi Unlocks Milestone Payment

Iterum Therapeutics plc (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/ITRM#NASDAQ">ITRM</a>) (the "Company" or "Iterum"), a company focused on delivering next generation oral and IV antibiotics to treat infections caused by multi-drug resistant pathogens in both community and hospital settings, today reported that Pfizer Inc. ("Pfizer") has agreed to extend the term for payment of the regulatory milestone payment of $20.0 million until October 25, 2029.
"We are very pleased to announce that Pfizer has agreed to extend the due date for payment of the regulatory milestone associated with ORLYNVAH&#x2122;'s approval by the FDA," said Corey Fishman, Iterum's Chief Executive Officer. "The $20.0 million promissory note was due October 2026 and is now due October 2029. As a result, any capital raised or earned in the near term from the sales of ORLYNVAH&#x2122;&nbsp;can be strategically invested to enable a successful launch of ORLYNVAH&#x2122;, including through the expansion into new territories or concentration of resources in high prescribing geographies."
Pursuant to the license agreement entered into on November 18, 2015, by and among the Company, Iterum Therapeutics International Limited ("ITIL") and Pfizer (the "Pfizer License Agreement"), ITIL agreed to make a regulatory milestone payment of $20.0 million to Pfizer (the "Milestone Payment") upon the approval of oral sulopenem for commercial sale in the United States by the U.S. Food and Drug Administration ("FDA"). The Company had the option to deliver notice of its election to defer such payment for up to two years from the date of approval and have a promissory note issued by ITIL in the amount of the Milestone Payment to Pfizer. After receiving FDA approval for ORLYNVAH&#x2122; on October, 25, 2024, the Company notified Pfizer on October 28, 2024, that it was electing to defer payment of the Milestone Payment for two years, or until October 25, 2026 (the "Deferral Period"), and a promissory note was issued to Pfizer by ITIL.

ITRM

Iterum Gets Pfizer to Extend $20M Milestone Payment for ORLYNVAH Approval to 2029

The U.S. Food and Drug Administration has granted limited approval to Novavax Inc.&#8217;s (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/NVAX#NASDAQ">NVAX</a>) COVID-19 vaccine, restricting its use to people 65 and older and those 12 and up with underlying health conditions that increase the risk of severe illness.
What Happened: The decision follows a six-week delay during which regulators sought additional data about the protein-based vaccine, which differs from the mRNA technology used by Pfizer Inc. (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/PFE#NYSE">PFE</a>) and BioNTech SE (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/BNTX#NASDAQ">BNTX</a>), <a href="https://edition.cnn.com/2025/05/17/health/novavax-covid-vaccine-approval">reported</a> CNN.
&#8220;This significant milestone demonstrates our commitment to these populations and is a significant step towards availability of our protein-based vaccine option,&#8221; Novavax President and CEO John Jacobs said in a statement Saturday.
The FDA is requiring Novavax to conduct postmarketing studies examining the risk of myocarditis and pericarditis—heart inflammation conditions rarely reported after COVID-19 vaccination. While a handful of cases were reported in trials, the CDC maintains that vaccination benefits outweigh these rare risks.
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Why It Matters: The approval comes amid shifting political winds at the FDA, where Commissioner Marty Makary previously characterized <a href="https://www.benzinga.com/general/health-care/25/04/45059756/trump-era-fda-appointees-request-new-trials-for-novavax-covid-vaccine-reportedly-delaying-approval-timeline?utm_source=chatgpt.com">updated COVID vaccines as &#8220;new products&#8221;</a> requiring fresh clinical trials. In April, Makary tweeted: &#8220;Under this administration, we are prioritizing the Gold Standard of Science—not what saves pharma.&#8221;
President Donald Trump administration appointees had directed a pause on Novavax&#8217;s application despite it being on track for approval by April 1, according to the Associated Press.
Earlier studies showed <a href="https://www.benzinga.com/general/biotech/25/04/44824383/novavax-covid-vaccine-shows-milder-side-effects-than-pfizer-biontechs-shot-study?utm_source=chatgpt.com">Novavax&#8217;s 2024-2025 formula </a>targeting the JN.1 strain produced fewer and less severe side effects compared to mRNA alternatives. In the SHIELD-Utah study, Novavax recipients experienced 1.7 symptoms on average versus 2.8 symptoms for Pfizer-BioNTech recipients.
The CDC&#8217;s vaccine advisers are currently considering changes to guidance for annual COVID-19 shots, potentially focusing recommendations on older adults, immunocompromised individuals, and those with higher exposure risks, the report noted.
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Disclaimer:&nbsp;This content was partially produced with the help of AI tools and was reviewed and published by Benzinga editors.
Image Via Shutterstock

Novavax Wins Limited FDA Nod For COVID Shot—Cleared Only For Seniors, High-Risk Groups Amid Safety Scrutiny

<a href="https://www.wsj.com/health/pharma/new-allegations-about-timing-of-pfizer-covid-vaccine-passed-to-house-panel-3451ec97?msockid=21c662101c496b42343370ae1de86aaa">https://www.wsj.com/health/pharma/new-allegations-about-timing-of-pfizer-covid-vaccine-passed-to-house-panel-3451ec97?msockid=21c662101c496b42343370ae1de86aaa</a>

'New Allegations About Timing of Pfizer Covid Vaccine Passed to House Panel'- WSJ

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Pfizer Provides Update on Oral GLP-1 Receptor Agonist Danuglipron

ACIP Votes to Expand Recommendation for Pfizer's RSV Vaccine ABRYSVO® to Include Adults Aged 50 to 59 at Increased Risk of Disease

Pfizer Advances Bold Vision for Future of Cancer Care at the ASCO 2025 Annual Meeting

Pfizer Declares Second-Quarter 2025 Dividend

Guardant Health Announces Strategic Collaboration With Pfizer to Support Development and Commercialization of New Cancer Therapies Using Guardant Infinity Smart Liquid Biopsy Platform

Pfizer's Sasanlimab Combination Significantly Improves Event-Free Survival in BCG-Naïve, High-Risk Non-Muscle Invasive Bladder Cancer

Pfizer Reports Solid First-Quarter 2025 Results And Reaffirms 2025 Guidance

Astellas Presents New Data that Explores Potential of its Cancer Therapies at 2025 ASCO Annual Meeting

Pfizer Enters into Exclusive Licensing Agreement with 3SBio

Astellas and Pfizer's XTANDI™ (enzalutamide) Shows Long-Term Overall Survival in Metastatic Hormone-Sensitive Prostate Cancer

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