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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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The U.S. Food and Drug Administration (FDA) expanded approval of Moderna Inc.&#8217;s (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/MRNA#NASDAQ">MRNA</a>) respiratory syncytial virus vaccine to adults aged 18-59 at increased risk for disease.
What Happened: The FDA on Thursday approved broader use of Moderna&#8217;s mRESVIA vaccine for younger at-risk adults based on late-stage trial results, reported Reuters.
The mRNA-based shot showed significant immune responses in adults with underlying health conditions and maintained a favorable safety profile. The vaccine was previously limited to adults 60 and older, where it demonstrated 79% efficacy against RSV symptoms.
Health Secretary Robert F. Kennedy Jr. simultaneously <a href="https://www.benzinga.com/news/health-care/25/06/45898417/rfk-jr-appoints-vaccine-critics-to-cdc-vaccine-panel-after-firing-entire-advisory-committee-report">appointed eight new members to the CDC&#8217;s Advisory Committee</a> on Immunization Practices, including prominent mRNA vaccine critics Robert Malone and Retsef Levi.
The health secretary fired all 17 existing panel members, claiming the need to <a href="https://www.benzinga.com/news/health-care/25/06/45853393/robert-kennedy-jr-axes-entire-cdc-vaccine-panel-to-restore-public-trust-pfizer-moderna-other-biotech-stocks-drop-in-after-hours-trading">&#8220;re-establish public confidence in vaccine science.&#8221;</a> The committee provides crucial guidance on vaccine recommendations that influence insurance coverage and policy.
The CDC currently recommends RSV vaccines for adults 75 and older, plus those 60-74 at increased risk. The final CDC recommendation remains pending for the expanded age group before availability.
See Also: <a href="https://www.benzinga.com/markets/economic-data/25/06/45919422/trumps-one-big-beautiful-bill-is-the-largest-redistribution-from-poor-to-rich-in-american-history-says-economist-justin-wolfers-amid-tax-cuts-spending-s">Trump&#8217;s &#8216;One Big, Beautiful Bill&#8217; Is &#8216;The Largest Redistribution From Poor To Rich In American History,&#8217; Says Economist Justin Wolfers Amid Tax Cuts, Spending Slashes And Tariffs</a>
Why It Matters: William Blair analysts noted the <a href="https://www.benzinga.com/news/fda/25/06/45719840/modernas-new-covid-vaccine-secures-fda-clearance-for-seniors-at-risk-individuals">approval represents</a> &#8220;an incremental win for Moderna, especially considering HHS Secretary Robert F. Kennedy Jr.&#8217;s negative public opinion on mRNA COVID-19 vaccines.&#8221; However, they cautioned that approval alone won&#8217;t massively boost COVID vaccine sales, which depend primarily on overall vaccination market sentiment.
The advisory panel restructuring creates regulatory uncertainty for vaccine manufacturers. Kennedy&#8217;s broader policy changes include removing COVID vaccines from <a href="https://www.benzinga.com/government/regulations/25/05/45688464/rfk-jr-drops-covid-vaccine-recommendation-for-healthy-kids-but-experts-warn-of-major-risks">recommended schedules for healthy children and pregnant women</a>, plus terminating Moderna&#8217;s $600 million bird flu vaccine contract.
RSV hospitalizes 15,000-20,000 U.S. adults aged 50-59 annually. Competing vaccines from Pfizer Inc. (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/PFE#NYSE">PFE</a>) and GSK plc (LSE: GSK) also target similar demographics, intensifying market competition amid shifting federal oversight. Read Next:
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Disclaimer: This content was partially produced with the help of AI tools and was reviewed and published by Benzinga editors.
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MRNA

FDA Expands Moderna's RSV Vaccine Use To At-Risk Adults Aged 18–59 Amid CDC Panel Shake-Up

Health Secretary Robert F. Kennedy Jr. named eight new members to the CDC&#8217;s Advisory Committee on Immunization Practices on Wednesday, including several anti-vaccine proponents, after <a href="https://www.benzinga.com/news/health-care/25/06/45853393/robert-kennedy-jr-axes-entire-cdc-vaccine-panel-to-restore-public-trust-pfizer-moderna-other-biotech-stocks-drop-in-after-hours-trading">dismissing all 17 existing advisers</a>.
What Happened: The reconstituted panel includes Robert Malone, a prominent mRNA vaccine opponent aligned with Kennedy&#8217;s Make America Healthy Again movement, and Retsef Levi, who has called for the immediate withdrawal of mRNA vaccines, citing serious harm risks, according to a Reuters report.
The committee advises the CDC on immunization schedules after FDA approval, directly influencing insurance coverage and vaccine policy.
Kennedy justified the overhaul to &#8220;re-establish public confidence in vaccine science,&#8221; claiming prior Biden-appointed members had conflicts of interest without providing specific evidence. The new eight-member committee represents the minimum allowed under ACIP&#8217;s founding charter. See Also:<a href="https://www.benzinga.com/markets/equities/25/06/45897549/jim-cramer-says-america-wont-be-truly-liberated-until-it-strikes-rare-earth-deals-with-other-countries-us-doesnt-have-the-cards"> Jim Cramer Says America Won&#8217;t Be &#8216;Truly Liberated&#8217; Until It Strikes Rare-Earth Deals With Other Countries: US Doesn&#8217;t &#8216;Have The Cards&#8217;</a>
Why It Matters: Kennedy previously fired the entire 17-member panel Monday through a Wall Street Journal op-ed, arguing it had become a &#8220;rubber stamp for any vaccine.&#8221;
The Trump administration simultaneously terminated a $600 million Moderna Inc. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/MRNA#NASDAQ">MRNA</a>) contract for mRNA bird flu vaccine development and removed COVID-19 vaccines from recommended schedules for <a href="https://www.benzinga.com/news/health-care/25/06/45810364/rfk-jr-champions-medical-freedom-while-curtailing-access-say-public-health-experts">healthy pregnant women and children</a>. Kennedy&#8217;s broader <a href="https://www.benzinga.com/government/regulations/25/03/44519638/us-department-of-health-and-human-services-aligns-with-trumps-executive-order-to-cut-10k-jobs-save-18-billion">healthcare restructuring eliminated</a> 10,000 HHS positions to save $1.8 billion annually.
Market reaction was mixed, with Moderna Inc. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/MRNA#NASDAQ">MRNA</a>) and Pfizer Inc. (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/PFE#NYSE">PFE</a>) shares declining marginally while Novavax Inc. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/NVAX#NASDAQ">NVAX</a>) rose in after-hours trading. Earlier this year, <a href="https://www.benzinga.com/markets/25/03/44550801/rfk-jr-spreading-misinformation-and-lies-fdas-top-vaccine-official-walks-out-sparking-debate-on-safety-and-public-trust">FDA&#8217;s top vaccine official</a>, Peter Marks, resigned after condemning Kennedy&#8217;s &#8220;misinformation and lies.&#8221;
The new panel will attend the June 25 ACIP meeting, originally scheduled to deliberate flu shots and 2025-26 COVID-19 booster recommendations. Critics argue Kennedy&#8217;s &#8220;medical freedom&#8221; messaging contradicts policies that restrict vaccine access. Read Next:
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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: lev radin / Shutterstock.com

NVAX

RFK Jr. Appoints Vaccine Critics To CDC Vaccine Panel After Firing Entire Advisory Committee: Report

On Monday, the U.S. Secretary of Health and Human Services, Robert F. Kennedy Jr., decided to fire all 17 members of the Advisory Committee on Immunization Practices, a panel that plays a key role in shaping U.S. vaccine policy.
What Happened: In an <a href="https://www.wsj.com/opinion/rfk-jr-hhs-moves-to-restore-public-trust-in-vaccines-45495112">op-ed</a> published in the Wall Street Journal, Kennedy said that this clean sweep was necessary in order to &#8220;re-establish public confidence in vaccine science.&#8221; He argued that the current panel had become a &#8220;rubber stamp for any vaccine&#8221; and was compromised by &#8220;persistent conflicts of interest.&#8221;
See Also: <a href="https://www.benzinga.com/crypto/cryptocurrency/25/06/45852346/elon-musk-recently-said-yes-to-impeaching-trump-and-the-odds-of-that-happening-in-2025-rose-on-this-crypto-betting-market">Elon Musk Recently Said &#8216;Yes&#8217; To Impeaching Trump And The Odds Of That Happening In 2025 Rose On This Crypto Betting Market</a>
Kennedy, who has been a vocal anti-vaccine activist even before becoming the country&#8217;s top health official, hasn&#8217;t mentioned who will be appointed to the panel, but has said that the panel would convene within two weeks in Atlanta, according to a <a href="https://apnews.com/article/kennedy-cdc-acip-vaccines-3790c89f45b6314c5c7b686db0e3a8f9">report</a> from the Associated Press.
The ACIP advises the CDC on immunization schedules and insurance coverage guidance, and its recommendations thus carry immense sway on pharma and biotech stocks, especially those with a sizable vaccine portfolio.
Since the announcement was made, most stocks in the sector are in the red in after-hours trade,
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<td class="has-text-align-center" data-align="center">Stock / ETF</td>
<td class="has-text-align-center" data-align="center">1 Day</td>
<td class="has-text-align-center" data-align="center">After Hours</td>
<td class="has-text-align-center" data-align="center">Year-To-Date</td>
</tr>
<tr>
<td class="has-text-align-center" data-align="center">Pfizer Inc. (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/PFE#NYSE">PFE</a>)</td>
<td class="has-text-align-center" data-align="center">+2.66%</td>
<td class="has-text-align-center" data-align="center">-0.29%</td>
<td class="has-text-align-center" data-align="center">-9.92%</td>
</tr>
<tr>
<td class="has-text-align-center" data-align="center">Eli Lilly And Co. (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/LLY#NYSE">LLY</a>)</td>
<td class="has-text-align-center" data-align="center">+0.50%</td>
<td class="has-text-align-center" data-align="center">+0.15%</td>
<td class="has-text-align-center" data-align="center">-0.56%</td>
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<td class="has-text-align-center" data-align="center">Moderna Inc. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/MRNA#NASDAQ">MRNA</a>) </td>
<td class="has-text-align-center" data-align="center">+2.48%</td>
<td class="has-text-align-center" data-align="center">-0.85%</td>
<td class="has-text-align-center" data-align="center">-33.00%</td>
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<td class="has-text-align-center" data-align="center">BioNTech SE ADR (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/BNTX#NASDAQ">BNTX</a>)</td>
<td class="has-text-align-center" data-align="center">+0.44%</td>
<td class="has-text-align-center" data-align="center">-0.26%</td>
<td class="has-text-align-center" data-align="center">-5.49%</td>
</tr>
<tr>
<td class="has-text-align-center" data-align="center">iShares US Pharmaceuticals ETF (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/IHE#NYSE">IHE</a>)</td>
<td class="has-text-align-center" data-align="center">+0.24%</td>
<td class="has-text-align-center" data-align="center">-2.47%</td>
<td class="has-text-align-center" data-align="center">+1.26%</td>
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Why It Matters: Kennedy has taken several steps against vaccination mandates in recent weeks, starting with the <a href="https://www.benzinga.com/25/05/45624037/robert-f-kennedy-jr-says-cdc-drops-covid-vaccine-for-healthy-pregnant-women-kids">removal of COVID vaccines</a> from the recommended immunization schedule for healthy pregnant women and children.
Around the same time, the Trump administration <a href="https://www.benzinga.com/government/regulations/25/05/45663794/hhs-cancels-590m-moderna-bird-flu-vaccine-deal-casting-uncertainty-over-pandemic-preparedness-effort">terminated a $600 million contract</a> with Moderna for developing an mRNA-based bird flu vaccine, which was part of former President Joe Biden&#8217;s pandemic preparedness efforts. 
Dr. Matthew Ferrari of the Pennsylvania State University <a href="https://www.benzinga.com/news/health-care/25/06/45810364/rfk-jr-champions-medical-freedom-while-curtailing-access-say-public-health-experts">criticized the health secretary</a>, saying that &#8220;If you restrict access, you necessarily restrict choice,&#8221; referring to the removal of COVID vaccines from the CDC schedule.
Price Action: The iShares U.S. Pharmaceuticals ETF tracks several of the heavyweights across pharma and biotech. On Monday, the fund was up 0.24%, trading at $66.45 per share, but is now down 2.47% after hours.
<figure class="wp-block-image size-large"><a href="https://www.benzinga.com/premium/ideas/benzinga-edge-2#:~:text=Turn%20Market%20Chaos,when%20markets%20rebound"><img loading="lazy" decoding="async" width="1024" height="191" src="https://editorial-assets.benzinga.com/wp-content/uploads/2025/06/10010026/Screenshot-2025-06-10-at-10.30.08-AM-1024x191.png" alt="" class="wp-image-944102" srcset="https://editorial-assets.benzinga.com/wp-content/uploads/2025/06/10010026/Screenshot-2025-06-10-at-10.30.08-AM-1024x191.png 1024w,https://editorial-assets.benzinga.com/wp-content/uploads/2025/06/10010026/Screenshot-2025-06-10-at-10.30.08-AM-300x56.png 300w,https://editorial-assets.benzinga.com/wp-content/uploads/2025/06/10010026/Screenshot-2025-06-10-at-10.30.08-AM-768x143.png 768w,https://editorial-assets.benzinga.com/wp-content/uploads/2025/06/10010026/Screenshot-2025-06-10-at-10.30.08-AM.png 1178w" sizes="(max-width: 1024px) 100vw, 1024px" /></a></figure>
The ETF is ranked in the 45th percentile according to Benzinga&#8217;s Edge Stock Rankings, and has a favorable price trend in the short term, but not so much in the medium and long term. Click <a href="https://www.benzinga.com/premium/ideas/benzinga-edge-2#:~:text=Turn%20Market%20Chaos,when%20markets%20rebound">here</a> for deeper insights into the stock, as well as its alternatives. 
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BNTX

Robert Kennedy Jr Axes Entire CDC Vaccine Panel To 'Restore Public Trust' — Pfizer, Moderna, Other Biotech Stocks Drop In After-Hours Trading

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: 7.37%</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 70%.</li>
<li>Guggenheim analyst Vamil Divan reiterated a Buy rating on March 18, 2025. This analyst has an accuracy rate of 74%.</li>
<li>Recent News: Arvinas, Inc. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/ARVN#NASDAQ">ARVN</a>) on Friday announced in a press release the submission of a New Drug Application to the U.S. Food and Drug Administration (FDA) with its partner Pfizer.</li>
<li>Benzinga Pro&#8217;s real-time newsfeed alerted to <a href="https://www.benzinga.com/pro/register?utm_adType=bzprocontent&amp;utm_campaign=14daytrial&amp;utm_ad=0609">latest PFE 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=0609"><img loading="lazy" decoding="async" width="882" height="842" src="https://editorial-assets.benzinga.com/wp-content/uploads/2025/06/09091603/image-114.png" alt="" class="wp-image-943187" style="width:620px;height:auto" srcset="https://editorial-assets.benzinga.com/wp-content/uploads/2025/06/09091603/image-114.png 882w,https://editorial-assets.benzinga.com/wp-content/uploads/2025/06/09091603/image-114-300x286.png 300w,https://editorial-assets.benzinga.com/wp-content/uploads/2025/06/09091603/image-114-768x733.png 768w" sizes="(max-width: 882px) 100vw, 882px" /></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: 4.10%</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 74%.</li>
<li>Recent News: On Monday, Merck reported positive topline results from the first two Phase 3 CORALreef trials evaluating enlicitide decanoate for the treatment of adults with hyperlipidemia.</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=0609">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=0609"><img loading="lazy" decoding="async" width="857" height="832" src="https://editorial-assets.benzinga.com/wp-content/uploads/2025/06/09091645/image-115.png" alt="" class="wp-image-943188" style="width:582px;height:auto" srcset="https://editorial-assets.benzinga.com/wp-content/uploads/2025/06/09091645/image-115.png 857w,https://editorial-assets.benzinga.com/wp-content/uploads/2025/06/09091645/image-115-300x291.png 300w,https://editorial-assets.benzinga.com/wp-content/uploads/2025/06/09091645/image-115-768x746.png 768w" sizes="(max-width: 857px) 100vw, 857px" /></a></figure>
<h3 class="wp-block-heading">GSK plc (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/GSK#NYSE">GSK</a>)</h3>
<ul class="wp-block-list">
<li>Dividend Yield: 3.88%</li>
<li>Oppenheimer analyst Rupesh Parikh maintained an Outperform rating and raised the price target from $87 to $93 on Feb. 13, 2025. This analyst has an accuracy rate of 72%.</li>
<li>Canaccord Genuity analyst Susan Anderson maintained a Buy rating and increased the price target from $93 to $100 on Feb. 7, 2025. This analyst has an accuracy rate of 67%.</li>
<li>Recent News: GSK and Spero Therapeutics Inc (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/SPRO#NASDAQ">SPRO</a>), on May 28, announced that the pivotal phase 3 PIVOT-PO trial evaluating tebipenem HBr for complicated urinary tract infections (cUTIs) will stop early for efficacy.</li>
<li>Benzinga Pro&#8217;s real-time newsfeed alerted to latest GSK <a href="https://www.benzinga.com/pro/register?utm_adType=bzprocontent&amp;utm_campaign=14daytrial&amp;utm_ad=0609">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=0609"><img loading="lazy" decoding="async" width="863" height="838" src="https://editorial-assets.benzinga.com/wp-content/uploads/2025/06/09091720/image-116.png" alt="" class="wp-image-943189" style="width:552px;height:auto" srcset="https://editorial-assets.benzinga.com/wp-content/uploads/2025/06/09091720/image-116.png 863w,https://editorial-assets.benzinga.com/wp-content/uploads/2025/06/09091720/image-116-300x291.png 300w,https://editorial-assets.benzinga.com/wp-content/uploads/2025/06/09091720/image-116-768x746.png 768w" sizes="(max-width: 863px) 100vw, 863px" /></a></figure>
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ARVN

SPRO

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

Arvinas, Inc. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/ARVN#NASDAQ">ARVN</a>) on Friday announced in a press release the submission of a New Drug Application to the U.S. Food and Drug Administration (FDA) <a href="https://www.benzinga.com/pressreleases/25/06/g45810251/arvinas-announces-submission-of-new-drug-application-to-u-s-fda-for-vepdegestrant-for-patients-wit" target="_blank" rel="noreferrer noopener">with its partner</a> Pfizer Inc. (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/PFE#NYSE">PFE</a>).
The application covers vepdegestrant for patients with ER-positive (ER+)/human epidermal growth factor receptor 2 (HER2)-negative (ER+/HER2-) ESR1-mutated advanced or metastatic breast cancer previously treated with <a target="_blank" href="https://www.benzinga.com/general/health-care" rel="noreferrer noopener">endocrine-based therapy</a>.
This submission is based on Phase 3 VERITAC-2 trial results evaluating vepdegestrant versus fulvestrant.
Also Read: <a target="_blank" href="https://www.benzinga.com/25/04/44651990/arvinas-touts-positive-data-from-potential-parkinsons-candidate-in-human-study-with-healthy-volunteers" rel="noreferrer noopener">Arvinas Potential Parkinson&#8217;s Treatment Shows Positive Data In Human Study</a>
At the American Society of Clinical Oncology, the companies shared detailed results from the Phase 3 VERITAC-2 trial.
These detailed results follow the March 2025 announcement of the <a target="_blank" href="https://www.benzinga.com/general/biotech/25/03/44255339/arvinas-pfizer-breast-cancer-drug-fails-to-show-progression-free-survival-benefit-in-trial" rel="noreferrer noopener">topline results from VERITAC-2</a>.
In the trial, vepdegestrant demonstrated a statistically significant and clinically meaningful improvement in progression-free survival (PFS) among patients with an estrogen receptor 1 (ESR1) mutation, reducing the risk of disease progression or death by 43% compared to fulvestrant.
The median PFS was 5 months with vepdegestrant <a href="https://www.benzinga.com/pressreleases/25/05/g45709824/arvinas-and-pfizers-vepdegestrant-significantly-improves-progression-free-survival-for-patients-wi" target="_blank" rel="noreferrer noopener">versus 2.1 months with fulvestrant</a>.
The trial did not reach statistical significance in improvement in PFS in the intent-to-treat (ITT) population, with a median PFS of 3.7 months for vepdegestrant versus 3.6 for fulvestrant.
Vepdegestrant was generally well tolerated in the trial, with a safety profile consistent with that observed in previous studies, and mostly low-grade treatment-emergent adverse events (TEAEs).
Overall survival (OS), the key secondary endpoint in VERITAC-2, was immature at the time of the analysis, with less than a quarter of the required number of events having occurred.
Additional secondary endpoints include clinical benefit rate (CBR), objective response rate (ORR), and duration of response.
In patients with an ESR1 mutation, CBR was 42.1% with vepdegestrant versus 20.2% with fulvestrant, and ORR was 18.6% with vepdegestrant versus 4.0% with fulvestrant.
The median duration of response was not reached.
ARVN, PFE Price Action: ARVN stock is up 4.91% at $7.26, and Pfizer stock is up 1.79% at $23.25 at publication on Friday.
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Photo: jittawit21 via Shutterstock

Biotech

General

Pfizer, Arvinas Partnered Breast Cancer Drug Cuts Progression Risk By 43% In Trial, Seeks FDA Approval

– This submission is supported by the pivotal Phase 3 VERITAC-2 clinical trial, results of which were recently presented at the 2025 American Society for Clinical Oncology Annual Meeting and published in The New England Journal of Medicine –
– VERITAC-2 data support vepdegestrant as a potential treatment option in patients with ESR1m ER+/HER2- advanced or metastatic breast cancer –
NEW HAVEN, Conn., June 06, 2025 (GLOBE NEWSWIRE) -- Arvinas, Inc. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/ARVN#NASDAQ">ARVN</a>), today announced the submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) with its partner Pfizer Inc. (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/PFE#NYSE">PFE</a>), for vepdegestrant for the treatment of patients with ER-positive (ER+)/human epidermal growth factor receptor 2 (HER2)-negative (ER+/HER2-) ESR1-mutated advanced or metastatic breast cancer previously treated with endocrine-based therapy. This submission is based on results from VERITAC-2 (NCT05654623), a global, randomized Phase 3 trial evaluating vepdegestrant versus fulvestrant.

Arvinas Submits NDA To FDA With Partner Pfizer For Vepdegestrant For Treatment Of Patients With ER+/HER2- ESR1-Mutated Advanced Or Metastatic Breast Cancer Previously Treated With Endocrine-Based Therapy

U.S. Health Secretary Robert F. Kennedy Jr. has championed &#8220;medical freedom&#8221; while simultaneously limiting access to COVID-19 vaccines and restricting food stamp purchases, creating what public health experts call a dichotomy in his approach to healthcare policy.
What Happened: Kennedy announced last week that the Centers for Disease Control and Prevention would remove COVID-19 vaccines from <a href="https://www.benzinga.com/news/25/05/45661031/robert-f-kennedy-jr-says-cdc-drops-covid-vaccine-for-healthy-pregnant-women-children">recommended </a>immunization schedules for healthy children and pregnant women.
The decision bypassed traditional advisory committee processes and shifted coverage from routine recommendations to shared clinical decision-making between doctors and patients.
&#8220;Regarding the vaccines, HHS is restoring the doctor-patient relationship,&#8221; HHS spokesperson Andrew Nixon said in a <a href="https://abcnews.go.com/Health/rfk-jr-promoted-freedom-choice-limiting-vaccines-food/story?id=122526364">statement</a> to ABC News. &#8220;We are encouraging those groups to consult with their health care provider to help them make an informed decision.&#8221;
Kennedy has also pushed to ban Supplemental Nutrition Assistance Program recipients from purchasing candy and soda with food stamps. Ten state governors have submitted waivers to the Agriculture Department requesting permission for such restrictions, according to Kennedy&#8217;s statements at a Make America Healthy Again event in May.
The Food and Drug Administration began <a href="https://www.benzinga.com/government/regulations/25/05/45399804/robert-kennedy-jr-cheers-fda-plan-to-ban-fluoride-supplements-for-children-calls-move-long-overdue">removing fluoride supplements for children </a>from the market, earning Kennedy&#8217;s praise as &#8220;long overdue.&#8221; The agency cited a lack of FDA approval and evidence that these products alter gut microbiomes.
Kennedy&#8217;s broader MAHA initiative has influenced restaurant chains to eliminate seed oils. Biglari Holdings Inc. (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/BH#NYSE">BH</a>) subsidiary Steak &#8216;n Shake switched to beef tallow for French fries, while Sweetgreen Inc. (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/SG#NYSE">SG</a>), Bloomin&#8217; Brands Inc. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/BLMN#NASDAQ">BLMN</a>), and Restaurant Brands International Inc. (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/QSR#NYSE">QSR</a>) have initiated similar transitions.
See Also: <a href="https://www.benzinga.com/markets/equities/25/06/45809455/tesla-stock-climbed-nearly-5-in-friday-pre-market-whats-going-on">Tesla Stock Climbed Nearly 5% In Friday Pre-Market: What&#8217;s Going On?</a>
Why It Matters: Critics argue Kennedy&#8217;s policies contradict his &#8220;medical freedom&#8221; messaging by limiting choices. Removing COVID vaccines from CDC schedules restricts access while claiming to promote freedom.
&#8220;If you restrict access, you necessarily restrict choice,&#8221; Dr. Matthew Ferrari of Pennsylvania State University told ABC News. Public health experts warn Kennedy&#8217;s approach individualizes community health decisions. &#8220;We&#8217;re losing a lot of that underpinning, which has led to a lot of the gains in public health,&#8221; Dr. Craig Spencer of Brown University told ABC News.
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</ul>
Disclaimer:&nbsp;This content was partially produced with the help of AI tools and was reviewed and published by Benzinga editors.
Image Via Shutterstock

BLMN

RFK Jr. Champions 'Medical Freedom' While Curtailing Access, Say Public Health Experts

<a href="https://www.statnews.com/2025/06/05/glp-1-drugs-low-but-elevated-risk-of-age-related-macular-degeneration/?utm_campaign=rss" title="https://www.statnews.com/2025/06/05/glp-1-drugs-low-but-elevated-risk-of-age-related-macular-degeneration/?utm_campaign=rss">https://www.statnews.com/2025/06/05/glp-1-drugs-low-but-elevated-risk-of-age-related-macular-degeneration/?utm_campaign=rss</a>

'GLP-1 Drugs May Be Linked To Elevated Risk Of Serious Eye Disease, Study Finds' - STAT News

<a href="https://x.com/seckennedy/status/1930012848056365294?s=46&amp;t=dtUiyC3dUs5yGRgT9qYHWg">https://x.com/seckennedy/status/1930012848056365294?s=46&amp;t=dtUiyC3dUs5yGRgT9qYHWg</a>

US Health Secretary Kennedy Posts On X "I want to address those of you who have anxieties about @US_FDA's limited approval of a new mRNA COVID vaccine for high-risk populations. Moderna has agreed to a true placebo-controlled trial of the new vaccine....."

Nearly 80% of S&amp;P 500 companies exceeded earnings forecasts in the first quarter of 2025, helping the index post a 13.3% profit surge — its second straight quarter <a href="https://www.benzinga.com/earnings">of double-digit growth.</a>
According to the latest Earnings Insight report from FactSet, authored by vice president and senior earnings analyst John Butters, only 18% fell short of analyst forecasts.
About 98% of S&amp;P 500 companies now have reported first-quarter results. And up to 78% beat earnings-per-share (EPS) expectations—a figure that outpaces both the 5-year average of 77% and the 10-year average of 75%. 
&#8220;In aggregate, companies are reporting earnings that are 8.2% above expectations. This surprise percentage is above the 1-year average (+6.1%), below the 5-year average (+8.8%), and above the 10-year average (+6.9%),&#8221; Butters wrote. 
The "Magnificent Seven" — Apple Inc (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/AAPL#NASDAQ">AAPL</a>), Microsoft Corp (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/MSFT#NYSE">MSFT</a>), Amazon.com Inc (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/AMZN#NASDAQ">AMZN</a>), Meta Platforms Inc (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/META#NASDAQ">META</a>), Alphabet Inc (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/GOOGL#NASDAQ">GOOGL</a>), Tesla Inc. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/TSLA#NASDAQ">TSLA</a>), and Nvidia Corp (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/NVDA#NASDAQ">NVDA</a>) — outperformed the broader index.
Six of the seven companies beat EPS estimates (86%), with an average earnings surprise of 14.9%, nearly twice the S&amp;P 500 average.
See Also: <a href="https://www.benzinga.com/25/05/45517783/magnificent-7-stun-the-street-with-the-best-earnings-beat-since-2021">Magnificent 7 Stun The Street With Best Earnings Beat Since 2021</a>
<h3 class="wp-block-heading">Which Sectors Led The Upside?</h3>
Health Care topped the leaderboard with 92% of its constituents beating estimates, followed by Communication Services (87%) and Information Technology (86%). 
At the opposite end, Utilities and Energy sectors posted the weakest beat rates at 61% and 64%, respectively.
Communication Services delivered the strongest upside surprises, boasting an average earnings surprise of +23.8%. 
Meta Platforms Inc. beat by over $1 per share ($6.43 vs. $5.23), while Alphabet Inc. posted EPS of $2.81 against estimates of $2.02. 
Other strong performers included Electronic Arts Inc. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/EA#NASDAQ">EA</a>), Interpublic Group of Companies Inc. (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/IPG#NYSE">IPG</a>), News Corp. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/NWSA#NASDAQ">NWSA</a>), and Walt Disney Co. (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/DIS#NYSE">DIS</a>).
Consumer Discretionary followed with a 9.4% surprise rate. Booking Holdings Inc. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/BKNG#NASDAQ">BKNG</a>) surged past expectations with $24.81 in EPS vs. $17.37 forecast, while NIKE Inc. (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/NKE#NYSE">NKE</a>) posted $0.54 vs. $0.30.
Health Care delivered an 8.6% surprise, with Pfizer Inc. (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/PFE#NYSE">PFE</a>) earning $0.92 per share vs. $0.67 estimate, and CVS Health Corp. (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/CVS#NYSE">CVS</a>) reporting $2.25 vs. $1.70. The sector also had the highest beat rate, with 92% of companies exceeding EPS forecasts.
<h3 class="wp-block-heading">Market Response: Positive Earnings Are Paying Off</h3>
Investors rewarded strong results. Companies that beat expectations saw their stock prices rise by an average of 1.9% from two days before to two days after earnings — the highest average gain since the third quarter of 2022. 
Conversely, companies that missed expectations saw a more muted decline of -1.9%, smaller than the 5-year average drop of -2.3%.
<h3 class="wp-block-heading">Valuations Are Getting Stretched</h3>
The forward 12-month price-to-earnings (P/E) ratio for the S&amp;P 500 rose to 21.3, above the 5-year average of 19.9 and the 10-year average of 18.4. 
That increase reflects a 5.4% rise in the index since March 31, while forward EPS estimates have slipped less than 0.1%.
By sector, Consumer Discretionary (28.1) and Information Technology (27.2) have the richest valuations, while Energy (14.6) trades at the lowest. 
The trailing 12-month P/E ratio also moved higher to 25.9, above the historical 5- and 10-year norms.
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Image: Shutterstock

S&P 500 Q1 Earnings Stun Wall Street Again With Broad-Based Beats, Double-Digit Growth

<a href="https://www.dailymail.co.uk/health/article-14773791/ozempic-weight-loss-drugs-kidney-cancer-risk-study.html" title="https://www.dailymail.co.uk/health/article-14773791/ozempic-weight-loss-drugs-kidney-cancer-risk-study.html">https://www.dailymail.co.uk/health/article-14773791/ozempic-weight-loss-drugs-kidney-cancer-risk-study.html</a>

"Exclusive: Ozempic Linked To 'Silent Cancer' That Is Rising In Young People As Doctors Issue Shock Warning" - DailyMail+

<ul>
<li>Pivotal Phase 3 VERITAC-2 clinical trial results presented at ASCO demonstrate 2.9-month improvement in median progression-free survival when compared to fulvestrant in second line-plus patients with an estrogen receptor 1 mutation</li>
<li>Vepdegestrant was generally well tolerated, with few discontinuations and low rates of gastrointestinal-related adverse events</li>
<li>Vepdegestrant is the first and only PROteolysis TArgeting Chimera (PROTAC) evaluated in a Phase 3 clinical trial and the first to show benefit in patients with breast cancer</li>
<li>Data to be featured in a late-breaking oral presentation at ASCO and simultaneously published in the New England Journal of Medicine</li>
</ul>

Reported Saturday, Arvinas and Pfizer's Vepdegestrant Demonstrates Statistically Significant 2.9-Month PFS Benefit Over Fulvestrant In ESR1-Mutant Second-Line Advanced Breast Cancer

Pfizer Inc. (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/PFE#NYSE">PFE</a>) on Friday released data from Phase 3 BREAKWATER trial evaluating BRAFTOVI&nbsp;(encorafenib) in combination with cetuximab (marketed as ERBITUX) and mFOLFOX6 (fluorouracil, leucovorin, and oxaliplatin) for metastatic colorectal cancer (mCRC) with <a target="_blank" href="https://www.benzinga.com/general/health-care" rel="noreferrer noopener">a&nbsp;</a><a target="_blank" href="https://www.benzinga.com/general/health-care" rel="noreferrer noopener">BRAF V600E</a><a target="_blank" href="https://www.benzinga.com/general/health-care" rel="noreferrer noopener"> mutation</a>.
The study showed statistically significant and clinically meaningful <a target="_blank" href="https://www.benzinga.com/pressreleases/25/05/b45691850/pfizers-braftovi-combination-regimen-cuts-the-risk-of-death-in-half-for-patients-with-braf-v600e-m" rel="noreferrer noopener">survival results</a>.
The data will be presented at the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting and published in the&nbsp;New England Journal of Medicine.
Also Read: <a target="_blank" href="https://www.benzinga.com/general/biotech/25/04/45073128/pfizers-covid-windfall-shrinks-expands-cost-cutting-efforts" rel="noreferrer noopener">Pfizer&#8217;s Covid Windfall Shrinks, Expands Cost-Cutting Efforts</a>
In a second interim analysis of overall survival (OS), a key secondary endpoint, the BRAFTOVI combination regimen reduced the risk of death by 51% compared to standard-of-care chemotherapy with or without bevacizumab (Hazard Ratio [HR] 0.49).
Median OS was 30.3 months with BRAFTOVI&nbsp;in combination with cetuximab and mFOLFOX6 compared to 15.1 months with chemotherapy with or without bevacizumab.
In the primary analysis of progression-free survival (PFS), the BRAFTOVI combination regimen reduced the risk of disease progression or death by 47% compared to standard-of-care chemotherapy with or without bevacizumab (HR 0.53) as assessed by blinded independent central review (BICR).
Median PFS was 12.8 months with the BRAFTOVI combination regimen compared to 7.1 months.
The updated objective response rate (ORR) by BICR confirmed the improvement previously observed with the BRAFTOVI combination regimen compared to patients receiving chemotherapy with or without bevacizumab.
The prior primary analysis also maintained the estimated median duration of response and median time to response.
The BRAFTOVI combination regimen received accelerated approval by the U.S. Food and Drug Administration (FDA) in December 2024 for patients with&nbsp;BRAF V600E -mutant mCRC based on a clinically meaningful and statistically significant improvement in confirmed ORR in treatment-naïve patients, the study&#8217;s other dual primary endpoint.
Continued approval for this indication is contingent upon verification of clinical benefit.
The BREAKWATER survival data are being discussed with the U.S. FDA to support potential conversion to full approval in 2025.
Price Action: PFE stock is up 0.51% at $23.57 at the last check on Friday.
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Photo via Shutterstock

Pfizer Reports Survival Gains In Colorectal Cancer Study, Combo Therapy Cuts Death Risk By Over 50%

<a href="https://www.washingtonpost.com/health/2025/05/30/covid-vaccines-children-pregnant-women/" title="https://www.washingtonpost.com/health/2025/05/30/covid-vaccines-children-pregnant-women/">https://www.washingtonpost.com/health/2025/05/30/covid-vaccines-children-pregnant-women/</a>

'Contradicting RFK Jr., CDC keeps recommending covid vaccine for kids' - Washington Post

Pfizer Announces Survival Results From Phase 3 BREAKWATER Showing 51% Risk Reduction In Death Compared To Standard-Of-Care Treatment In BRAF V600E-Mutant Metastatic Colorectal Cancer

<ul>
<li>Global pharmaceutical company Pfizer Inc. is facing a multidistrict litigation (MDL No.3140) in the USA, currently comprising approximately 400 lawsuits against the company.</li>
<li>This MDL follows a study by EPI-PHARE (Roland et al.) published in March 2024 in the <a href="https://cts.businesswire.com/ct/CT?id=smartlink&amp;url=https%3A%2F%2Fwww.bmj.com%2Fcontent%2F384%2Fbmj-2023-078078&amp;esheet=54259861&amp;newsitemid=20250526151184&amp;lan=en-US&amp;anchor=British+Medical+Journal&amp;index=1&amp;md5=bb6a0f0bb07641328232d8090edcc479">British Medical Journal</a>, which found that women who had used the Pfizer contraceptive injection Depo-Provera1 for more than one year were 5.6 times more likely to develop an intracranial meningioma, a type of brain tumor.</li>
<li>An estimated 74 million women globally receive Depo-Provera injections according to a 2019 UN study2.</li>
</ul>
A Case Management Conference (CMC) in the Depo-Provera legal action against Pfizer Inc. (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/PFE#NYSE">PFE</a>) will take place on Friday, 30 May at 9:00am CT in the United States Courthouse is Pensacola, Florida. The litigation is being brought on behalf of women in the USA who developed meningiomas after receiving at least 4 consecutive injections of Pfizer's Depo-Provera (DMPA). One of the law firms appointed to the Plaintiff's Executive Committee responsible for overseeing the MDL is Levin Papantonio, which has helped to secure more than $80 billion in jury verdicts and settlements against some of the world's largest corporations, including Johnson &amp; Johnson, BP, Dupont, 3M, Merck and big tobacco. The law firm is currently acting for plaintiffs in the Talcum Powder Litigation against Johnson &amp; Johnson and the Preterm Infant Nutrition Products Liability Litigation against Abbott Laboratories and Mead Johnson, owned by Reckitt Benckiser.
The lawsuits allege that Pfizer and other generic producers of Depo-Provera were aware of the link between these birth control injections and brain tumors and that they failed to adequately warn of the risk and promote safer alternatives. Pfizer has acknowledged its awareness of the risks linked to long-term use of the drug and added warning labels in Canada in 2015, and in the UK and Europe in October 2024 following the Roland study published in the British Medical Journal. On 25 February 2025, Pfizer issued a note to healthcare professionals in South Africa warning that DMPA can cause meningiomas and should not be used by patients with a history of the condition. However, Pfizer has never provided an equivalent warning to women in the United States, highlighting inconsistent global safety standards.

Legal

Pfizer Faces Legal Battle In U.S. Multidistrict Litigation Over Alleged Link Between Depo-Provera Contraceptive Injections And Brain Tumors, With Over 400 Lawsuits Citing Study Showing 5.6x Increased Risk Of Meningioma

<a href="https://nypost.com/2025/05/27/us-news/new-covid-19-strain-from-china-that-saw-massive-hospitalizations-spike-spreads-to-us/" title="https://nypost.com/2025/05/27/us-news/new-covid-19-strain-from-china-that-saw-massive-hospitalizations-spike-spreads-to-us/">https://nypost.com/2025/05/27/us-news/new-covid-19-strain-from-china-that-saw-massive-hospitalizations-spike-spreads-to-us/</a>

Global

'New COVID strain from China that led to massive spike in hospitalizations has spread to the US — including NYC' - NY Post

The U.S. Health and Human Services Secretary Robert F. Kennedy Jr. announced Tuesday that the COVID-19 vaccine will no longer be among the recommended vaccines for pregnant women and healthy children on the US Centers for Disease Control and Prevention&#8217;s <a href="https://www.benzinga.com/general/health-care" target="_blank" rel="noreferrer noopener">immunization schedule</a>.
Kennedy announced the change in a&nbsp;video&nbsp;<a target="_blank" href="https://x.com/seckennedy/status/1927368440811008138?s=46&amp;t=dtUiyC3dUs5yGRgT9qYHWg" rel="noreferrer noopener">posted</a> to the social media platform X.
&#8220;As of today, the Covid vaccine for healthy children and healthy pregnant women has been removed from the CDC recommended immunization schedule,&#8221; Kennedy said. &#8220;Last year, the Biden administration urged healthy children to get yet another COVID shot, despite the lack of any clinical data to support the repeat booster strategy in children.&#8221;
Also Read: <a target="_blank" href="https://www.benzinga.com/general/biotech/25/05/45254051/vinay-prasads-appointment-to-fdas-cber-triggers-questions-over-future-of-cell-and-gene-therapy-regulation" rel="noreferrer noopener">Vinay Prasad&#8217;s Appointment To FDA&#8217;s CBER Triggers Questions Over Future Of Cell And Gene Therapy Regulation</a>
He was joined by the U.S. Food and Drug Administration Commissioner Dr. Marty Makary and National Institutes of Health Director Dr. Jay Bhattacharya.
As of Tuesday morning, the immunization schedule posted online had not yet been changed.
In 2021, Kennedy <a target="_blank" href="https://www.regulationsa.gov/document/FDA-2021-P-0460-0001" rel="noreferrer noopener">filed</a> a citizen petition&nbsp;requesting the FDA to revoke Emergency Use Authorizations for existing COVID-19 vaccines and refrain from approving and licensing them.
The update follows the FDA&#8217;s changes to COVID-19 vaccine requirements, limiting annual booster approvals to older and high-risk Americans while implementing stricter clinical trial <a target="_blank" href="https://www.benzinga.com/government/regulations/25/05/45537919/fda-limits-annual-covid-19-boosters-to-high-risk-americans-demands-new-trials-for-healthy-adults-in-policy-shift-under-rfk-jr" rel="noreferrer noopener">requirements for healthy adults</a>.
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&nbsp;Marty Makary&nbsp;and top U.S. vaccines regulator&nbsp;Vinay Prasad&nbsp;in the New England Journal of Medicine, reported Reuters.
Last week, the FDA&#8217;s Vaccines and Related Biological Products Advisory Committee (VRBPAC) <a target="_blank" href="https://www.fda.gov/vaccines-blood-biologics/industry-biologics/covid-19-vaccines-2025-2026-formula-use-united-states-beginning-fall-2025" rel="noreferrer noopener">voted</a> to recommend a monovalent JN.1-lineage vaccine composition.
Based on the totality of the evidence, the FDA has advised the manufacturers of the approved COVID-19 vaccines that to more closely match currently circulating SARS-CoV-2 viruses, the COVID-19 vaccines for use in the United States beginning in fall 2025 should be monovalent JN.1-lineage-based COVID-19 vaccines (2025-2026 Formula), preferentially using the LP.8.1 strain.&nbsp;
On Friday, Moderna Inc.&nbsp;(NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/MRNA#NASDAQ">MRNA</a>) submitted an application to the FDA to review its Spikevax 2025-2026 formula, targeting the SARS-<a target="_blank" href="https://www.benzinga.com/pressreleases/25/05/ac45595488/moderna-files-fda-application-for-the-lp-8-1-targeting-covid-19-vaccine" rel="noreferrer noopener">CoV-2 variant LP.8.1</a>.
Also, Novavax Inc.&nbsp;(NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/NVAX#NASDAQ">NVAX</a>) received limited FDA approval for its COVID-19 vaccine, Nuvaxovid, marking a regulatory milestone and unlocking a&nbsp;$175 million milestone payment&nbsp;from partner&nbsp;Sanofi SA&nbsp;(NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/SNY#NASDAQ">SNY</a>)
The approval came after a six-week delay as regulators <a target="_blank" href="https://www.benzinga.com/25/05/45295534/novavax-reports-q1-profit-as-revenue-surges-to-over-600-million-and-lower-costs-raises-2025-forecasts" rel="noreferrer noopener">sought additional data</a>.
The vaccine is now authorized for people aged 65 and older and for individuals 12 and up with underlying medical conditions that increase the <a target="_blank" href="https://www.benzinga.com/25/05/45496095/novavax-scores-key-fda-win-shares-jump-19-as-sanofi-milestone-unlock" rel="noreferrer noopener">risk of severe COVID-19</a>.
Price Action: MRNA stock is down 2.86% at $27.01 at the last check Tuesday.
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Robert F. Kennedy Jr. Says CDC Drops COVID Vaccine For 'Healthy' Pregnant Women, Children

<a href="https://x.com/seckennedy/status/1927368440811008138?s=46&amp;t=dtUiyC3dUs5yGRgT9qYHWg">https://x.com/seckennedy/status/1927368440811008138?s=46&amp;t=dtUiyC3dUs5yGRgT9qYHWg</a>

US Health Secretary Kennedy Posts On X "Today, the COVID vaccine for healthy children and healthy pregnant women has been removed from @CDCgov recommended immunization schedule. Bottom line: it's common sense and it's good science. We are now one step closer to realizing @POTUS's promise to Make America Healthy Again."

<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).

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%

Press Releases

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

Hearing Against Pfizer Set For 30 May In Contraceptive 'Depo-Provera' Multidistrict Litigation Overseen By Levin Papantonio

Pfizer's BRAFTOVI® Combination Regimen Cuts the Risk of Death in Half for Patients with BRAF V600E-Mutant Metastatic Colorectal Cancer

Arvinas and Pfizer's Vepdegestrant Significantly Improves Progression-Free Survival for Patients with ESR1-Mutant, ER+/HER2- Advanced Breast Cancer

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Arvinas Announces Submission of New Drug Application to U.S. FDA for Vepdegestrant for Patients with ESR1-Mutated ER+/HER2- Advanced or Metastatic Breast Cancer

AM Best Affirms Credit Ratings of Blue Whale Re Ltd.

Global Billion Dollar Oncology Industry Experiencing Substantial Growth Driven by Increasing Cancer Incidences

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