Últimas noticias sobre Sanofi (NASDAQ:SNY) Bolsa

Sanofi

NYSE

Sanofi develops and markets drugs with a concentration in vaccines, immunology, oncology, cardiovascular disease, diabetes, and over-the-counter treatments. However, the company's decision in late 2019 to pull back from the cardio-metabolic area will likely reduce the firm's footprint in this large therapeutic area. The company offers a diverse array of drugs with its highest revenue generator, Dupixent, representing about 30% of total sales, but profits are shared with Regeneron. Just over 40% of total revenue comes from the United States and 25% from Europe. Emerging markets represent the majority of the remainder of revenue.

Shanghai,,China,-,June,29,,2023:,Saic,Roewe,Feifan,F7

Tech

BPMC

CRDO

PSTV

SAIC

Aquí tienes cinco acciones estadounidenses que podrían llamar la atención de los inversores este lunes: CPB, SAIC, PSTV, BPMC y CRDO.

5 acciones en el foco este lunes: CPB, SAIC, PSTV, BPMC y CRDO

Equities

Large Cap

News

Buybacks

Movers

General

LRLCF

LRLCY

Sanofi adquiere 29,6 millones de acciones a L&#39;Oréal en una transacción de 3000M€. Descubre el impacto en la empresa y sus accionistas.

Sanofi recompra 2,3% de sus acciones a L&#39;Oréal por 3000M€

Health Care

Markets

IDNA

MRNA

NVAX

El brote de H5N9, la separación de la OMS y las audiencias de Kennedy generan incertidumbre en salud pública y mercados.

Acciones de Moderna (MRNA) y Pfizer (PFE) reaccionan al brote de H5N9 y la separación de los CDC de la OMS

Sanofi SA

Synthetify

SUNNYLIFE GLOBAL INC by Sunnylife Global, Inc.

Sunnylife Global Inc

Synergy CHC Corp

VITAL ENERGY INC (CDA) by Vital Energy, Inc.

Vital Energy Inc

SANY HEAVY EQUIP INTL HLD by Sany Heavy Equipment International Holdings Co.

Sany Heavy Equipment International Holdings Co Ltd

Sanofi's SAR446597 earns fast track designation in the US for geographic atrophy due to age-related macular degeneration
<ul>
<li>Designation earned for a one-time intravitreal gene therapy designed to inhibit two key complement cascade pathways</li>
<li>Geographic atrophy is an advanced form of dry age-related macular degeneration, that can lead to permanent vision loss</li>
</ul>

Sanofi's SAR446597 Gains US Fast Track For Dual-Targeting Gene Therapy Aiming To Replace Frequent Injections In Geographic Atrophy

On Monday, the U.S. Food and Drug Administration (FDA) agreed to review GSK plc&#8217;s (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/GSK#NYSE">GSK</a>) application to extend the indication of Arexvy (Respiratory Syncytial Virus Vaccine, Adjuvanted) to adults aged 18-49 <a href="https://www.benzinga.com/general/health-care" target="_blank" rel="noreferrer noopener">who are at increased risk</a>.
GSK's RSV vaccine is approved in the U.S. to prevent lower respiratory tract disease (LRTD) caused by RSV in adults aged 60 and older, as well as those aged 50-59 years at increased risk for LRTD caused by RSV.
RSV, a common contagious virus affecting the lungs and breathing passages, impacts an estimated 64 million people of all ages globally every year. More than 125 million adults in the U.S. are under 50. An estimated 21 million of these people have at least one diagnosed risk factor for severe RSV infection, such as chronic obstructive pulmonary disease, asthma, congestive heart failure, and coronary heart disease.
The regulatory submission is <a href="https://us.gsk.com/en-us/media/press-releases/fda-accepts-application-to-review-expanded-use-of-gsk-s-rsv-vaccine-arexvy/" target="_blank" rel="noreferrer noopener">supported</a> by a Phase 3b trial evaluating immune response and safety in adults aged 18-49 who are at increased risk compared to adults aged 60 and above.
The safety and reactogenicity data were consistent with those from the Phase 3 program, which supported the vaccine&#8217;s initial approval in the U.S.
A regulatory decision by the FDA on this submission is expected in the first half of 2026.
In June, the FDA expanded approval of Moderna Inc.'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 <a href="https://www.benzinga.com/news/health-care/25/06/45921359/fda-expands-modernas-rsv-vaccine-use-to-at-risk-adults-aged-18-59-amid-cdc-panel-shake-up" target="_blank" rel="noreferrer noopener">for disease</a>. That same month, the Centers for Disease Control and Prevention (CDC) Advisory Committee on Immunization Practices (ACIP) voted to recommend Merck &amp; Co Inc's (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/MRK#NYSE">MRK</a>) Enflonsia (clesrovimab-cfor) as an option for the prevention of respiratory syncytial virus (RSV) lower respiratory tract disease in infants younger than 8 months of age who are born during or entering their first RSV season.
With a <a target="_blank" href="https://www.cdc.gov/media/releases/2025/2025-cdcs-advisory-committee-on-immunization-concludes-meeting-with-joint-statement.html" rel="noreferrer noopener">five-to-two </a>majority, RFK Jr.'s newly constituted committee made its first ruling. This body was formed after RFK Jr. entirely replaced the previous 17-member panel <a target="_blank" href="https://www.benzinga.com/news/health-care/25/06/46136734/rfk-jrs-cdc-panel-recommends-mercks-rsv-shot-for-infants" rel="noreferrer noopener">with his selections</a>.
Also, in June, Sanofi SA (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/SNY#NASDAQ">SNY</a>) announced that it will begin shipping Beyfortus (nirsevimab) in early Q3 to ensure broad availability well ahead of the 2025-2026 respiratory syncytial virus (RSV) season, which typically starts in November and <a href="https://www.benzinga.com/news/health-care/25/06/45839621/beyfortus-output-tripled-as-sanofi-astrazeneca-scale-up-for-rsv-season" target="_blank" rel="noreferrer noopener">runs through March</a>.
In collaboration with its partner AstraZeneca plc (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/AZN#NASDAQ">AZN</a>), Sanofi has tripled production capacity and doubled the number of manufacturing sites since the launch of Beyfortus in 2023.
Last week, GSK announced it has started shipping doses of its trivalent seasonal influenza vaccines to U.S. healthcare providers and pharmacies in preparation for the 2025-26 flu season.
This immediately follows FDA licensing and approval of the lot release. FLULAVAL and FLUARIX will be available in a 0.5mL, single-dose, pre-filled syringe and are indicated for people <a href="https://www.benzinga.com/pressreleases/25/07/b46342250/gsk-begins-shipping-influenza-vaccine-doses-for-the-2025-26-flu-season" target="_blank" rel="noreferrer noopener">six months and older</a>.
Price Action: GSK stock is down 1.36% at $37.77 at the last check on Tuesday.
Read Next:
<ul class="wp-block-list">
<li><a href="https://www.benzinga.com/markets/tech/25/07/46410829/analyst-with-sell-rating-on-aapl-stock-warns-tim-cooks-company-is-unprepared-for-something-that-transformational" target="_blank" rel="noreferrer noopener">Analyst With Sell Rating On AAPL Stock Warns Tim Cook&#8217;s Company &#8216;Is Unprepared For Something That Transformational&#8217;</a></li>
</ul>
Photo: Shutterstock

GSK Seeks FDA Nod To Broaden RSV Vaccine For Younger At-Risk Adults

The Delaware Supreme Court has overturned a lower court&#8217;s decision that allowed expert testimony supporting plaintiffs&#8217; claims in a high-profile case alleging that Zantac, or its generic ranitidine, <a target="_blank" href="https://www.benzinga.com/general/biotech/24/05/38946928/gsk-concealed-risk-associated-with-discontinued-heart-burn-drug-zantac-whistleblower-lawsuit-clai" rel="noreferrer noopener">can cause cancer</a>.
The justices concluded that the trial court applied an incorrect legal standard when it ruled that the reliability of expert opinions should be determined by a jury rather than by the judge.
Initially marketed by a forerunner of&nbsp;GSK plc (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/GSK#NYSE">GSK</a>), Zantac, once a blockbuster heartburn drug, has been sold at different times by companies, including&nbsp;Pfizer Inc. (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/PFE#NYSE">PFE</a>), Boehringer Ingelheim, Sanofi SA (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/SNY#NASDAQ">SNY</a>), and <a target="_blank" href="https://www.benzinga.com/general/biotech/23/06/32917283/sanofi-stock-is-trading-higher-today-heres-why" rel="noreferrer noopener">several generic drugmakers</a>.
Also Read: <a target="_blank" href="https://www.benzinga.com/news/politics/25/07/46258994/trumps-big-beautiful-bill-hands-5-billion-win-to-big-pharma-report" rel="noreferrer noopener">Trump&#8217;s &#8216;Big, Beautiful Bill&#8217; Hands $5 Billion Win To Big Pharma: Report</a>
The case centers on nearly 75,000 plaintiffs who claim their cancer diagnoses were caused by exposure to ranitidine, the active ingredient in Zantac, which may degrade into the probable human carcinogen NDMA.
Plaintiffs submitted expert reports linking the drug to ten types of cancer, but the defendants challenged the validity of those reports, questioning the scientific methods used.
The Superior Court <a target="_blank" href="https://courts.delaware.gov/Opinions/Download.aspx?id=382080" rel="noreferrer noopener">denied</a> motions to exclude the expert opinions, citing Delaware&#8217;s &#8220;liberal thrust&#8221; toward admitting expert testimony. It found that any methodological disputes were issues for the jury.
The court also allowed the experts to base their causation claims on studies involving NDMA, rather than requiring a direct link to Zantac itself.
However, the Supreme Court found this reasoning flawed. In its opinion, the court emphasized that Delaware&#8217;s rules on expert evidence align with federal standards, which burden the proponent to prove that testimony is based on sufficient and reliable scientific methods.
The court also faulted the trial judge for improperly framing the central question of general causation. Rather than asking whether Zantac specifically could cause cancer, the lower court allowed experts to rely on data involving NDMA without demonstrating that Zantac exposure levels were comparable to those in the referenced studies.
The Supreme Court ruled that this failed to establish a scientifically valid connection between the product and the alleged harm.
In June, a federal judge ruled that key claims brought by plaintiffs against Patheon Manufacturing Services in the Zantac litigation may move forward, while one claim related to <a href="https://www.benzinga.com/general/biotech/22/12/29989120/relief-to-pfizer-sanofi-as-us-dismisses-several-lawsuits-associated-with-zantac" target="_blank" rel="noreferrer noopener">misrepresentation was dismissed</a>.
In its motion to dismiss, Patheon argued that the plaintiffs&#8217; claims failed on multiple fronts. The company said the plaintiffs did not identify a specific manufacturing defect, asserted that the design defect claim was preempted by federal law, and claimed that negligence was not pled with adequate specificity.
Additionally, Patheon <a href="https://business.cch.com/plsd/InreZantac6-16-25.pdf" target="_blank" rel="noreferrer noopener">contended</a> that no valid misrepresentation claim had been made. However, the court found that plaintiffs had adequately stated distinct claims for manufacturing and design defects.
The judge noted that plaintiffs alleged a flawed manufacturing process that caused ranitidine to form NDMA, a probable carcinogen, or that the manufacturing method contributed to the contamination. The court ruled that, at this stage of litigation, those allegations were sufficient to proceed.
On the negligence claim, the judge concluded that plaintiffs had met the specificity requirements under Rule 9(b), citing detailed allegations that Patheon exposed ranitidine to heat and humidity, leading to its degradation into NDMA.
The court emphasized that the claims were grounded in either violations of federal law or state law duties not solely governed by the FDA, meaning federal preemption did not apply at this stage.
Although the court, in June, agreed with Patheon that the plaintiffs had not asserted a misrepresentation claim, it allowed the remaining claims to proceed.
In May 2024, Pfizer settled 10,000 lawsuits alleging it concealed the cancer risks associated with its Zantac heartburn medication, marking the <a target="_blank" href="https://www.benzinga.com/general/biotech/24/05/38710835/pfizer-agrees-to-settle-over-10-000-lawsuits-about-cancer-risks-associated-with-discontinued-hear" rel="noreferrer noopener">largest resolution in the litigation</a>.&nbsp;
In October 2024, GSK reached agreements with ten plaintiff firms representing approximately 80,000 Zantac product liability&nbsp;cases in the <a target="_blank" href="https://www.benzinga.com/general/biotech/24/10/41295498/gsk-settles-majority-of-zantac-lawsuits-but-pipeline-doubts-remain" rel="noreferrer noopener">U.S. state courts</a>.
Price Action: PFE stock is down 0.43% at $25.67, and SNY stock is down 1.01% at $48.84 during the premarket session at last check Friday.
Read Next:
<ul class="wp-block-list">
<li><a href="https://www.benzinga.com/crypto/cryptocurrency/25/07/46363070/bitcoin-sets-all-time-high-at-118909-ethereum-xrp-surge-8-each" target="_blank" rel="noreferrer noopener">Bitcoin Sets All-Time High At $118,909, Ethereum, XRP Surge 8% Each</a></li>
</ul>
Image via Shutterstock

Biotech

Legal

Pfizer, Sanofi Find Relief As Delaware Top Court Rejects Zantac Expert Testimony

<a href="https://www.bloomberg.com/news/articles/2025-07-10/delaware-court-sides-with-zantac-makers-in-cancer-claims-suits" title="https://www.bloomberg.com/news/articles/2025-07-10/delaware-court-sides-with-zantac-makers-in-cancer-claims-suits">https://www.bloomberg.com/news/articles/2025-07-10/delaware-court-sides-with-zantac-makers-in-cancer-claims-suits</a>

'Delaware Court Sides With Zantac Makers In Cancer Claims' - Bloomberg News

On Monday, Cogent Biosciences, Inc. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/COGT#NASDAQ">COGT</a>) said bezuclastinib showed meaningful clinical benefit for patients with non-<a target="_blank" href="https://www.benzinga.com/general/health-care" rel="noreferrer noopener">advanced systemic mastocytosis</a>.
The company said that its experimental drug reduced the symptoms of a chronic immune disorder called non-advanced systemic mastocytosis.
The latest study demonstrated meaningful and highly statistically significant improvements across the primary and all key secondary endpoints, including patient-reported symptoms and <a target="_blank" href="https://www.benzinga.com/news/health-care/25/07/46273670/why-is-cogent-biosciences-stock-trading-higher-on-monday-2" rel="noreferrer noopener">objective measures of mast cell burden</a>.
Also Read: <a target="_blank" href="https://www.benzinga.com/news/health-care/25/07/46273670/why-is-cogent-biosciences-stock-trading-higher-on-monday-2" rel="noreferrer noopener">Why Is Cogent Biosciences Stock Trading Higher On Monday?</a>
The SUMMIT trial achieved its primary endpoint with a statistically significant difference in the mean change in total symptom score (TSS) at 24 weeks.
The bezuclastinib arm had a mean reduction of 24.3 points in TSS at 24 weeks, versus the placebo arm, which had a mean reduction of 15.4 points, resulting in a placebo-adjusted TSS improvement of 8.91 points.
Based on these data, Cogent is on track to submit its first new drug application (NDA) to the U.S. Food and Drug Administration (FDA) for bezuclastinib in NonAdvSM by the end of 2025.
Further underscoring the drug&#8217;s potential, JP Morgan views the asset as very strategically attractive. &#8220;We believe the SUMMIT Part 2 bezuclastinib results were near a best-case outcome on the emerging clinical profile in NonAdvSM, particularly on the safety side (removing a key overhang on the program),&#8221; wrote analyst Anupam Rama in an investor note on Monday.
Consequently, JP Morgan maintains its overweight rating on Cogent with a<a target="_blank" href="https://www.benzinga.com/quote/COGT/analyst-ratings" rel="noreferrer noopener"> price forecast of $25</a>. In fact, JPMorgan believes Cogent&#8217;s bezuclastinib for systemic mastocytosis (SM) has strong potential to become a blockbuster drug and could set a new standard for future treatments.
From a market perspective, Cogent estimates the U.S. market worth over $2 billion for non-advanced SM and $300 million for advanced SM.
To provide context, Blueprint previously suggested the overall SM market could reach around $4 billion in peak sales, with its own drug Ayvakit projected to generate about $2 billion by 2030. Overall, the SM market is considered large and full of opportunity.
The analyst says the strategic attractiveness of the systemic mastocytosis market was recently validated by Sanofi SA&#8217;s (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/SNY#NASDAQ">SNY</a>) acquisition of Blueprint Medicines Corporation (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/BPMC#NASDAQ">BPMC</a>) <a target="_blank" href="https://www.benzinga.com/news/health-care/25/06/45719179/sanofi-expands-rare-immunology-portfolio-with-blueprint-buyout" rel="noreferrer noopener">for over $9 billion</a>.
Beyond SM, JP Morgan also sees bezuclastinib&#8217;s potential in gastrointestinal stromal tumors (GIST) as underappreciated. The analyst adds, &#8220;We have been asked if a potential strategic interest in the asset would require positive data in GIST&#8230;and we do not believe so (SM is attractive on its own and GIST would be another lever of upside).
Looking ahead, Cogent remains on track to provide topline results from both PEAK, a Phase 3 trial of bezuclastinib in combination with sunitinib in patients with gastrointestinal stromal tumors, and APEX, a registration-directed trial of bezuclastinib in advanced systemic mastocytosis patients, during the second half of 2025.
Price Action: At the last check on Tuesday, COGT stock was up 6% at $9.911.
Read Next:
<ul class="wp-block-list">
<li><a href="https://www.benzinga.com/news/health-care/25/07/46300943/does-higher-dose-of-wegovy-result-in-more-weight-loss" target="_blank" rel="noreferrer noopener">Does Higher Dose Of Wegovy Result In More Weight Loss? Novo Nordisk Seeks European Approval</a></li>
</ul>
Photo by Gorodenkoff via Shutterstock

Analyst Color

Analyst Ratings

COGT

Cogent's Chronic Immune Disorder Drug Has Strong Potential To Become A Blockbuster: Analyst

The U.S. Food and Drug Administration (FDA) granted accelerated approval to Regeneron Pharmaceuticals, Inc.&#8217;s (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/REGN#NASDAQ">REGN</a>) Lynozyfic (linvoseltamab-gcpt) for adult patients with relapsed or refractory (R/R) multiple myeloma (MM) who have received at <a target="_blank" href="https://www.benzinga.com/general/health-care" rel="noreferrer noopener">least four prior lines of therapy</a>.
Lynozyfic was granted accelerated approval based on response rate and durability of response in the LINKER-MM1 trial. Continued approval for this indication may be contingent upon verification and description of clinical <a target="_blank" href="https://www.benzinga.com/pressreleases/25/07/g46223573/lynozyfic-linvoseltamab-gcpt-receives-fda-accelerated-approval-for-treatment-of-relapsed-or-refrac" rel="noreferrer noopener">benefit in a confirmatory trial</a>.
Lynozyfic is the first FDA-approved BCMAxCD3 bispecific antibody that can be dosed every two weeks starting at week 14, and every four weeks if a very good partial response (VGPR) or better is achieved following completion of at least 24 weeks of therapy.
Also Read: <a target="_blank" href="https://www.benzinga.com/news/health-care/25/06/45755748/johnson-johnson-highlights-multiple-blood-cancer-trial-data-at-asco-presentation" rel="noreferrer noopener">Johnson &amp; Johnson Highlights Multiple Blood Cancer Trial Data At ASCO Presentation</a>
The regimen includes hospitalization for safety during the step-up dosing period (one 24-hour period after the first step-up dose, and another 24 hours after the second step-up dose).
The FDA approval for linvoseltamab in R/R MM is based on the pivotal Phase 1/2 LINKER-MM1 trial. In this trial, patients (n=80) experienced a 70% objective response rate (ORR), with 45% achieving a complete response (CR) or better.
The median time to first response was 0.95 months. The median duration of response (DoR) was not reached. Among responders, the estimated DoR was 89% at 9 months and 72% at 12 months, with a median follow-up of 13 months.
The prescribing information for Lynozyfic includes a Boxed Warning for cytokine release syndrome and neurologic toxicity, including immune effector cell-associated neurotoxicity syndrome, in addition to warnings and precautions for infections, neutropenia, hepatotoxicity, and embryo-fetal toxicity.
In other news for the company, and highlighting their broader portfolio of approved treatments, in June, the FDA approved Regeneron and Sanofi SA&#8217;s (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/SNY#NASDAQ">SNY</a>) Dupixent (dupilumab) for adult patients with bullous pemphigoid (BP), a rare, chronic <a target="_blank" href="https://www.benzinga.com/news/fda/25/06/46028780/fda-approves-regeneronm-sanofi-treatment-for-rare-autoimmune-skin-disorder" rel="noreferrer noopener">autoimmune skin disorder</a>.
BP primarily affects elderly patients and is characterized by intense itch, painful blisters and lesions, and skin reddening. It can be chronic and relapsing with&nbsp;<a target="_blank" href="https://www.benzinga.com/pressreleases/25/06/g46019439/dupixent-dupilumab-approved-in-the-u-s-as-the-only-targeted-medicine-to-treat-patients-with-bullou" rel="noreferrer noopener">underlying type 2 inflammation</a>.
Price Action: REGN stock is trading higher by 0.24% to 549.06 at last check Thursday.
Read Next:
<ul class="wp-block-list">
<li><a href="https://www.benzinga.com/markets/equities/25/07/46242132/crwd-stock-could-soar-16-says-wedbushs-dan-ives-coming-in-very-strong-with-healthy-momentum" target="_blank" rel="noreferrer noopener">CRWD Stock Could Soar 16%, Says Wedbush&#8217;s Dan Ives: &#8216;Coming In Very Strong With Healthy Momentum&#8217;</a></li>
</ul>
Photo by Aunt Spray via Shutterstock

REGN

Regeneron's Lynozyfic Gains Accelerated FDA Approval For Heavily Pre-Treated Multiple Myeloma

Riliprubart granted orphan drug designation in Japan for chronic inflammatory demyelinating polyneuropathy
<ul>
<li>Two phase 3 studies are currently underway testing riliprubart in people with CIDP as a potential first-in-class treatment</li>
<li>Japanese Ministry of Health, Labour and Welfare decision adds to similar designations in the US and Europe, underscoring global regulatory recognition of the potential for riliprupart to address significant unmet medical needs for people living with this rare neurological condition</li>
</ul>

Sanofi's Riliprubart Granted Orphan Drug Designation In Japan For Chronic Inflammatory Demyelinating Polyneuropathy, Reinforcing Global Regulatory Momentum

Vor Biopharma Inc. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/VOR#NASDAQ">VOR</a>) saw its stock climb Thursday following a strategic licensing agreement and a major capital raise to support its <a href="https://www.benzinga.com/movers" target="_blank" rel="noreferrer noopener">push into autoimmune therapies</a>.
The developments mark a pivotal evolution for the Cambridge-based biotech, which was originally launched by PureTech Health plc (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/PRTC#NASDAQ">PRTC</a>).
Vor Bio signed an exclusive global licensing deal with RemeGen Co., Ltd., giving it rights outside Greater China to develop and commercialize telitacicept, a dual-action fusion protein already approved in <a href="https://www.benzinga.com/pressreleases/25/06/b46108474/puretech-founded-entity-vor-bio-announces-exclusive-global-license-agreement-with-remegen-for-late" target="_blank" rel="noreferrer noopener">China for multiple autoimmune disorders</a>.
Also Read: <a target="_blank" href="https://www.benzinga.com/trading-ideas/long-ideas/25/06/46113313/top-3-health-care-stocks-youll-regret-missing-this-quarter-2" rel="noreferrer noopener">Top 3 Health Care Stocks You&#8217;ll Regret Missing This Quarter</a>
Under the agreement, Vor will pay $125 million upfront, $45 million in cash, and $80 million in stock warrants, along with potential milestone payments exceeding $4 billion and tiered royalties.
Alongside the licensing news, Vor announced on Wednesday a private placement in public equity, which is expected to raise roughly <a target="_blank" href="https://www.benzinga.com/pressreleases/25/06/g46104566/vor-bio-announces-175-million-private-placement" rel="noreferrer noopener">$175 million in gross proceeds</a>.
The financing involves the issuance of 700 million pre-funded warrants at $0.25 each, with shares exercisable at $0.0001 upon shareholder approval. The transaction is anticipated to close on June 27, pending standard conditions.
On Thursday, Wedbush analyst David Nierengarten reiterated a Neutral rating on the company, and maintained <a target="_blank" href="https://www.benzinga.com/quote/VOR/analyst-ratings" rel="noreferrer noopener">a&nbsp;40 cents&nbsp;price forecast</a>.
Meanwhile, biotech veteran Jean-Paul Kress, M.D. has stepped in as CEO and Chairman of the company, replacing Dr. Robert Ang, who will stay on as a strategic advisor through October.
Kress brings decades of executive experience, including past roles at MorphoSys, Syntimmune, and current board service at Sanofi (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/SNY#NASDAQ">SNY</a>).
He expressed enthusiasm for leading Vor through its transition into a leading autoimmune innovator. As of May 8, PureTech held a 2.1% beneficial ownership stake in Vor Bio, reflecting its founding role in the company.
According to&nbsp;<a target="_blank" href="https://pro.benzinga.com/?gspk=YWRhbWVja2VydDUzMzY&amp;gsxid=zBMR4PKmcgBw" rel="noreferrer noopener">Benzinga Pro</a>, VOR stock has lost over 30% in the past year.
Price Action: VOR shares are trading higher by 112.8% to $1.18&nbsp;at last check Thursday.
Read Next:
<ul class="wp-block-list">
<li><a href="https://www.benzinga.com/news/25/06/46060176/donald-trump-jr-joins-mark-cuban-in-slamming-elizabeth-warren-on-healthcare-pricing" target="_blank" rel="noreferrer noopener">Donald Trump Jr. Joins Mark Cuban In Slamming Elizabeth Warren on Healthcare Pricing</a></li>
</ul>
Photo byv jittawit21 via Shutterstock

PRTC

Why This Biotech Stock Just Doubled In A Single Day

Nektar Therapeutics (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/NKTR#NASDAQ">NKTR</a>) released on Tuesday statistically significant data from the 16-week induction period of the ongoing Phase 2b REZOLVE-AD <a href="https://www.benzinga.com/news/health-care/25/06/46074205/nektar-therapeutics-shares-double-on-promising-eczema-drug-data" target="_blank" rel="noreferrer noopener">study of investigational rezpegaldesleukin</a>.
The trial met its primary endpoint of the <a href="https://www.benzinga.com/general/health-care" target="_blank" rel="noreferrer noopener">mean improvement in Eczema</a> Area and Severity Score (EASI) from baseline at week 16 for all three dose arms of rezpegaldesleukin versus placebo.
All three dose arms also achieved statistical significance at week 16 for the key secondary endpoints of EASI-75 (percent of patients who achieve ≥75% reduction in EASI from baseline), EASI-50 (percent of patients who achieve ≥50% reduction in EASI from baseline) and BSA (mean percent improvement in Body Surface Area score from baseline).
Also Read: <a href="https://www.benzinga.com/news/health-care/25/06/46074205/nektar-therapeutics-shares-double-on-promising-eczema-drug-data" target="_blank" rel="noreferrer noopener">Nektar Therapeutics Shares Double On Promising Eczema Drug Data</a>
After 16 weeks, patients had a 53% to 61% improvement in symptoms. This was compared to a 31% improvement for the placebo group.
William Blair writes, &#8220;We believe the efficacy parameters of rezpeg appear to be comparable to the OX40 drug class though numerically lower than Dupixent across the Phase IIb programs.&#8221;
Given the chronic nature of atopic dermatitis, analyst Andy Hsieh wrote that the high frequencies (high 30% to high 40% across a broader set of rezpeg safety data that includes the Phase 2b results) of injection site reactions versus Regeneron Pharmaceuticals Inc (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/REGN#NASDAQ">REGN</a>)/Sanofi SA&#8217;s (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/SNY#NASDAQ">SNY</a>) Dupixent (in the high-single- to mid-double-digit percent range) could be a commercial liability for rezpeg.
If rezpeg indeed demonstrates a remittive effect, it could mitigate injection site reactions, though investors will have to wait until the next update (Phase IIb REZOLVE-AD maintenance data) in early 2026 or 52-week off-treatment results in 2027.
The analyst adds, &#8220;Since we believe there is an absence of clear differentiation in the highly competitive atopic dermatitis field, we view today's stock reaction (up roughly 135%) as a valuation normalization event and not a reflection of investors ascribing value to a differentiated asset. Essentially, Nektar shares now trade around the company's current cash levels. We await further updates to gain appreciation of rezpeg&#8217;s potential remittive effect, which could elevate the asset against competitive offerings.&#8221;
NKTR Price Action: Nektar Therapeutics stock is up 26.83% at $31.01 at publication on Wednesday.
Read Next:
<ul class="wp-block-list">
<li><a href="https://www.benzinga.com/crypto/cryptocurrency/25/06/46097909/robinhood-ceo-highlights-retail-investor-interest-in-nvidia-tesla-despite-middle-east-tensions-barely-a-blip" target="_blank" rel="noreferrer noopener">Robinhood CEO Highlights Retail Investor Interest In Nvidia, Tesla Despite Middle East Tensions: &#8216;Barely A Blip&#8217;</a></li>
</ul>

Trading Ideas

NKTR

Why Is Nektar Therapeutics Stock Trading Higher On Wednesday?

Gilead Sciences, Inc. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/GILD#NASDAQ">GILD</a>) and Kymera Therapeutics, Inc. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/KYMR#NASDAQ">KYMR</a>) on Wednesday entered into an exclusive option and license agreement to accelerate the development and commercialization of a novel molecular glue degrader (MGD) program targeting cyclin-dependent kinase 2 (CDK2), with broad <a target="_blank" href="https://www.benzinga.com/general/health-care" rel="noreferrer noopener">oncology treatment potential</a>.
CDK2-directed MGDs are a new type of drug designed to remove CDK2, a key contributor to tumor growth, rather than just inhibiting its function.
Kymera can receive up to $750 million in total payments, including up to $85 million in upfront and potential <a target="_blank" href="https://www.benzinga.com/pressreleases/25/06/b46091245/gilead-sciences-and-kymera-therapeutics-enter-into-exclusive-option-and-license-agreement-to-devel" rel="noreferrer noopener">option exercise payments</a>.
Also Read: <a target="_blank" href="https://www.benzinga.com/news/health-care/25/06/45724030/kymera-therapeutics-says-atopic-dermatitis-potential-matches-sanofi-regenerons-blockbuster-dupixent-in-early-biomarker-response" rel="noreferrer noopener">Kymera Therapeutics Says Atopic Dermatitis Potential Matches Sanofi/Regeneron&#8217;s Blockbuster Dupixent In Early Biomarker Response</a>
In addition, Kymera may receive tiered royalties ranging from the high single-digits to the mid-teens on net product sales under the collaboration. Kymera will lead all research activities for the CDK2 program.
If Gilead exercises its option to exclusively license the program, Gilead will have global rights to develop, manufacture, and commercialize all products resulting from the collaboration.
The transaction with Kymera is expected to reduce Gilead&#8217;s GAAP and non-GAAP 2025 EPS by approximately $0.02-$0.03.
The core of this collaboration lies in the innovative approach of MGDs. Unlike traditional inhibitors that merely block the function of disease-driving proteins, MGDs work by selectively eliminating these proteins.
As Flavius Martin, MD, Executive Vice President, Research, Gilead Sciences, stated, this mechanism &#8220;aligns within our oncology scientific framework where we evaluate therapeutic agents that selectively target and kill cancer cells with minimal impact on healthy tissue.&#8221;
Nello Mainolfi, PhD, Founder, President and CEO, Kymera Therapeutics, highlighted that their &#8220;highly specific, orally active, CDK2 molecular glue degraders have demonstrated a compelling preclinical profile.&#8221;
Concurrently, Kymera Therapeutics announced an update on its IRAK4 partnership with Sanofi SA (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/SNY#NASDAQ">SNY</a>).
Sanofi has informed Kymera that KT-485/SAR447971, an oral, highly potent, and selective development candidate targeting IRAK4 for immuno-inflammatory diseases that Kymera has discovered and characterized through preclinical studies, has been selected to advance <a target="_blank" href="https://www.benzinga.com/pressreleases/25/06/g46091325/kymera-therapeutics-announces-sanofi-irak4-collaboration-update" rel="noreferrer noopener">into clinical studies</a>.
Following preclinical work supporting its development potential, KT-485 is being prioritized for development under the companies&#8217; existing IRAK4 collaboration and is expected to advance into Phase 1 testing next year.
Based on the planned development of KT-485, Sanofi <a target="_blank" href="https://www.benzinga.com/general/biotech/22/12/30076238/kymera-therapeutics-stock-jumps-after-positive-data-from-atopic-dermatitis-trial" rel="noreferrer noopener">will not advance KT-474</a>.
Sanofi was conducting Phase 2 trials for hidradenitis suppurativa and <a target="_blank" href="https://www.benzinga.com/pressreleases/24/07/g39675035/kymera-announces-expansion-of-kt-474-sar444656-hs-and-ad-phase-2-studies-following-interim-review-" rel="noreferrer noopener">atopic dermatitis indications</a>.
In conjunction with its plans to advance KT-485, Sanofi also communicated its decision to exercise its participation election right for the IRAK4 target under the companies&#8217; collaboration agreement terms.
Under the agreement, Kymera achieved a $20 million milestone in the second quarter of 2025 related to preclinical activities associated with KT-485.
Kymera can receive up to $975 million of potential clinical, regulatory, and commercial milestones related to KT-485, including an additional milestone upon the start of Phase 1 clinical testing.
Price Action: SNY stock is down 0.76% at $48.05, KYMR stock is down 4.54% at $45, and GILD stock is down 0.28% at $106.90 during the premarket session at last check Wednesday.
Read Next:
<ul class="wp-block-list">
<li><a href="https://www.benzinga.com/markets/tech/25/06/46093513/sam-altman-crushes-openai-microsoft-feud-rumors-hails-really-wonderfully-good-bond-with-satya-nadella" target="_blank" rel="noreferrer noopener">Sam Altman Crushes OpenAI-Microsoft Feud Rumors, Hails &#8216;Really Wonderfully Good&#8217; Bond With Satya Nadella</a></li>
</ul>
Photo by Aunt Spray via Shutterstock

GILD

KYMR

Gilead Bets On Kymera's CDK2 Molecular Glue Degrader For New Cancer Therapies

Riliprubart earns orphan drug designation in the US for antibody-mediated rejection in solid organ transplantation
<ul>
<li>Ongoing phase 2 study evaluating riliprubart for the potential prevention and treatment of active antibody-mediated rejection in kidney transplant recipients</li>
<li>Riliprubart was also designated orphan drug for the investigational use in chronic inflammatory demyelinating polyneuropathy in the US and EU</li>
</ul>

Sanofi's Riliprubart Granted Orphan Drug Status By FDA For Addressing Antibody-Mediated Rejection, A Major Unmet Need In Transplant Medicine

Cidara Therapeutics, Inc. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/CDTX#NASDAQ">CDTX</a>) stock is trading over 90% higher on Monday with a session volume of 3.2 million compared to the <a href="https://www.benzinga.com/pro/feature/newsfeed" target="_blank" rel="noreferrer noopener">average volume of 181.7K</a>.
On Monday, the company released topline results from its randomized, double-blind, placebo-controlled Phase 2b NAVIGATE trial evaluating CD388 for preventing seasonal influenza in healthy unvaccinated <a target="_blank" href="https://www.benzinga.com/general/health-care" rel="noreferrer noopener">adults aged 18 to 64</a>.
The study met its primary endpoint, demonstrating a statistically significant prevention efficacy (PE) for each of three dose groups in individuals who received a single dose of CD388 at the beginning of the flu season and were evaluated for laboratory and clinically confirmed <a target="_blank" href="https://www.benzinga.com/pressreleases/25/06/g46048318/cidara-therapeutics-announces-positive-topline-results-from-its-phase-2b-navigate-trial-evaluating" rel="noreferrer noopener">influenza over 24 weeks</a>.
The study also met all secondary endpoints, including efficacy at 37.8 and 37.2 degrees Celsius temperature thresholds and maintenance of PE for up to 28 weeks with statistical significance.
Over the same period, CD388 was well-tolerated at all doses, and no unexpected dose-limiting treatment-emergent adverse events were observed.
The highest dose group (450 mg) showed 76.1% prevention efficacy against laboratory and clinically confirmed influenza over 24 weeks, while the 300 mg and 150 mg doses demonstrated 61.3% and 57.7% efficacy, respectively.
All results were statistically significant compared to placebo.
Safety and tolerability data were similar in all arms ,but no safety signals were observed. No drug-related serious adverse events were observed, and treatment-emergent adverse events showed no dose-dependent pattern between CD388 and placebo groups.
Injection site reaction rates were similar across all CD388 dose groups and placebo.
Cidara expects to present additional results from the NAVIGATE trial at upcoming scientific conferences in 2025.
Cidara has submitted an end of Phase 2 meeting request to the FDA to review the Phase 2b results and further discuss the Phase 3 trial design and start time.
In June, Novavax Inc (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/NVAX#NASDAQ">NVAX</a>) announced the results of the initial cohort of its COVID-19-Influenza Combination (CIC) and standalone trivalent hemagglutinin nanoparticle&nbsp;seasonal <a target="_blank" href="https://www.benzinga.com/general/health-care" rel="noreferrer noopener">influenza (tNIV) Phase 3 trial</a>.
The study showed that the CIC and flu vaccine candidates induced immune responses similar to those of licensed comparators Nuvaxovid and Sanofi SA's (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/SNY#NASDAQ">SNY</a>) <a href="https://www.benzinga.com/news/health-care/25/06/45887132/novavaxs-experimental-covid-19-influenza-combo-shot-shows-immune-response-among-older-adults-in-phase-3-trial" target="_blank" rel="noreferrer noopener">Fluzone HD, respectively</a>.
Both standalone flu and CIC vaccine candidates induced robust immune responses to the vaccine strains (2.4-5.7-fold over baseline).
Price Action: CDTX stock is up 90.7% at $40.08 at last check on Monday.
Read Next:
<ul class="wp-block-list">
<li><a href="https://www.benzinga.com/general/biotech/24/09/40837263/gsk-reveals-positive-data-from-mid-stage-study-of-seasonal-influenza-mrna-vaccine" target="_blank" rel="noreferrer noopener">GSK Reveals &#8216;Positive&#8217; Data From Mid-Stage Study Of Seasonal Influenza mRNA Vaccine</a></li>
</ul>
Photo: Shutterstock

CDTX

Why Is Cidara Therapeutics Stock Trading Higher On Monday?

<a href="https://www.prnewswire.com/news-releases/libertas-bio-a-formation-bio-subsidiary-license-of-gusacitinib-a-dual-jaksyk-inhibitor-to-sanofi-302487403.html" title="https://www.prnewswire.com/news-releases/libertas-bio-a-formation-bio-subsidiary-license-of-gusacitinib-a-dual-jaksyk-inhibitor-to-sanofi-302487403.html">https://www.prnewswire.com/news-releases/libertas-bio-a-formation-bio-subsidiary-license-of-gusacitinib-a-dual-jaksyk-inhibitor-to-sanofi-302487403.html</a>

Libertas Bio Licenses Gusacitinib To Sanofi

<ul>
<li>Recommendation based on GMMG-HD7 phase 3 study demonstrating that Sarclisa with VRd induction treatment significantly improved MRD negativity benefit and prolonged PFS compared to VRd alone</li>
<li>If approved, it would represent the fourth indication in the EU and second in the front-line setting globally</li>
</ul>
 &nbsp;

Sanofi's Sarclisa Set To Expand Front-Line Multiple Myeloma Use In EU Following Positive CHMP Opinion Backed By MRD And PFS Gains

The U.S. Food and Drug Administration (FDA) on Friday approved Regeneron Pharmaceuticals Inc.&nbsp;(NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/REGN#NASDAQ">REGN</a>) and Sanofi SA&#8217;s (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/SNY#NASDAQ">SNY</a>) Dupixent&nbsp;(dupilumab) for adult patients with bullous pemphigoid (BP), a rare, chronic <a target="_blank" href="https://www.benzinga.com/general/health-care" rel="noreferrer noopener">autoimmune skin disorder</a>.
BP primarily affects elderly patients and is characterized by intense itch, painful blisters and lesions, and skin reddening. It can be chronic and relapsing with <a target="_blank" href="https://www.benzinga.com/pressreleases/25/06/g46019439/dupixent-dupilumab-approved-in-the-u-s-as-the-only-targeted-medicine-to-treat-patients-with-bullou" rel="noreferrer noopener">underlying type 2 inflammation</a>.
The blisters and rash can form over much of the body and cause the skin to bleed and break down, making patients more prone to infection.
Also Read: <a target="_blank" href="https://www.benzinga.com/trading-ideas/movers/25/05/45692578/regeneron-sanofi-stock-falls-after-uneven-smokers-lung-drug-data" rel="noreferrer noopener">Regeneron, Sanofi Stock Falls After Uneven Smoker&#8217;s Lung Drug Data</a>
The FDA approval is based on data from the pivotal ADEPT Phase 2/3 trial that evaluated the efficacy and safety of Dupixent compared to placebo in adults with moderate-to-severe BP.
Patients were randomized to receive Dupixent 300 mg (n=53) or placebo (n=53) added to standard-of-care oral corticosteroids (OCS).
During treatment, all patients underwent a protocol-defined OCS tapering regimen if control of disease activity was maintained.
The FDA-approved results at 36 weeks in the label for Dupixent compared to placebo are:
<ul class="wp-block-list">
<li>18.3% of patients experienced sustained disease remission compared to 6.1%, the primary endpoint.</li>
<li>38.3% of patients achieved clinically meaningful itch reduction compared to 10.5%.</li>
<li>The median cumulative OCS dose was 2.8 grams compared to 4.1 grams.</li>
</ul>
In this elderly population, the most common adverse events (≥2%) more frequently observed in patients on Dupixent compared to placebo were arthralgia, conjunctivitis, blurred vision, herpes viral infections, and keratitis.
Additionally, one acute generalized exanthematous pustulosis was reported in 1 patient treated with Dupixent and zero treated with placebo.
In April, the FDA approved Dupixent&nbsp;for adults and adolescents aged 12 years and older with chronic spontaneous urticaria (CSU) who remain symptomatic despite histamine-1 (H1) <a target="_blank" href="https://www.benzinga.com/general/biotech/25/04/44931246/regeneron-partners-with-japan-based-fujifilm-to-bolster-us-manufacturing-capacity-via-3-billion-d" rel="noreferrer noopener">antihistamine treatment</a>.
Price Action: REGN stock closed at $513.58 on Wednesday. SNY stock is up 1.45% at $48.31&nbsp;during the premarket session at the last check on Friday.
Read Next:
<ul class="wp-block-list">
<li><a href="https://www.benzinga.com/news/health-care/25/06/45724030/kymera-therapeutics-says-atopic-dermatitis-potential-matches-sanofi-regenerons-blockbuster-dupixent-in-early-biomarker-response" target="_blank" rel="noreferrer noopener">Kymera Therapeutics Says Atopic Dermatitis Potential Matches Sanofi/Regeneron&#8217;s Blockbuster Dupixent In Early Biomarker Response</a></li>
</ul>
Image: Shutterstock

FDA Approves Regeneron Sanofi Treatment For Rare Autoimmune Skin Disorder

<ul>
<li>New late-breaking data at EAACI showed Dupixent outperformed Xolair across all primary and secondary efficacy endpoints of CRSwNP and in all asthma-related endpoints</li>
<li>Dupixent also outperformed Xolair in improving such key signs and symptoms as nasal polyp size and sense of smell in CRSwNP, and lung function and disease control in asthma, with rapid improvements seen as early as 4 weeks</li>
<li>Results reinforce the efficacy of Dupixent in treating both upper and lower respiratory diseases by targeting IL-4 and IL-13, two key drivers of type 2 inflammation</li>
</ul>

Reported Earlier, Regeneron And Sanofi's Dupixent Demonstrates Statistically Superior Efficacy Over Xolair In Nasal Polyps And Lung Function In Patients With Coexisting Asthma

Novavax, Inc. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/NVAX#NASDAQ">NVAX</a>) announced results Wednesday of the initial cohort of its COVID-19-Influenza Combination (CIC) and standalone trivalent hemagglutinin nanoparticle seasonal <a href="https://www.benzinga.com/general/health-care" target="_blank" rel="noreferrer noopener">influenza (tNIV) Phase 3 trial</a>.
The study showed that the CIC and flu vaccine candidates induced immune responses similar to those of licensed comparators Nuvaxovid&nbsp;and Sanofi SA&#8217;s (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/SNY#NASDAQ">SNY</a>) <a target="_blank" href="https://www.benzinga.com/pressreleases/25/06/n45879363/novavaxs-covid-19-influenza-combination-and-stand-alone-influenza-vaccine-candidates-showed-robust" rel="noreferrer noopener">Fluzone HD, respectively</a>.
Both standalone flu and CIC vaccine candidates induced robust immune responses to the vaccine strains (2.4-5.7-fold over baseline).
Also Read: <a target="_blank" href="https://www.benzinga.com/25/05/45624037/robert-f-kennedy-jr-says-cdc-drops-covid-vaccine-for-healthy-pregnant-women-kids" rel="noreferrer noopener">Robert F. Kennedy Jr. Says CDC Drops COVID Vaccine For &#8216;Healthy&#8217; Pregnant Women, Children</a>
&#8220;Both our combination and standalone flu vaccine candidates induced robust immune responses and were well tolerated,&#8221; said Ruxandra Draghia-Akli, executive vice president and head of Research and Development at Novavax.
&#8220;This&nbsp;data set adds to&nbsp;findings from our Phase 2 trial and will help inform discussions with potential partners.&#8221;
Both vaccine candidates were well tolerated and saw reactogenicity comparable to authorized comparators.
Nearly all (&gt;98%) solicited adverse events were mild or moderate in severity.&nbsp;
The cohort was designed to provide descriptive data on three flu strains&nbsp;(H1N1, H3N2, B) and SARS-CoV-2 (COVID-19) to inform a future registrational Phase 3 program.
The descriptive trial evaluated the safety and immunogenicity of the CIC and standalone flu vaccine candidates&nbsp;compared to Nuvaxovid and Fluzone HD in approximately 2,000 adults&nbsp;aged 65 and older.
This trial was not adequately powered to demonstrate statistical significance.
In May 2023, Novavax unveiled data for its COVID-influenza combination vaccine and&nbsp;<a target="_blank" href="https://www.benzinga.com/general/biotech/23/05/32287464/novavax-eases-uncertainty-announces-job-cuts-encouraging-data-from-covidflu-combo-shot" rel="noreferrer noopener">two other shots</a>.
Data from a Phase 2 trial in adults aged 50-80 showed that the combination shot produced an immune response comparable to its protein-based COVID vaccine and already approved influenza shots.
The study found that all three of Novavax&#8217;s vaccine candidates—the COVID/flu combination shot, a standalone flu shot, and a higher dose of its COVID shot—were safe and well-tolerated.
In May, Novavax received limited approval from the U.S. Food and Drug Administration (FDA) for its COVID-19 vaccine, Nuvaxovid. This marked a regulatory milestone and unlocking a $175 million milestone payment <a href="https://www.benzinga.com/25/05/45496095/novavax-scores-key-fda-win-shares-jump-19-as-sanofi-milestone-unlock" target="_blank" rel="noreferrer noopener">from partner Sanofi</a>.
Earlier in June, the FDA approved&nbsp;Moderna, Inc.'s&nbsp;(NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/MRNA#NASDAQ">MRNA</a>) mNexspike&nbsp;(mRNA-1283), a new vaccine against COVID-19, for all adults 65 and older and individuals aged 12-64 years with at least one or more underlying risk factor as defined by the Centers for Disease&nbsp;<a target="_blank" href="https://www.benzinga.com/news/fda/25/06/45719840/modernas-new-covid-vaccine-secures-fda-clearance-for-seniors-at-risk-individuals" rel="noreferrer noopener">Control and Prevention (CDC)</a>.
Price Action: NVAX stock is up 0.56% at $7.24 at the last check on Wednesday.
Read Next:
<ul class="wp-block-list">
<li><a href="https://www.benzinga.com/news/health-care/25/06/45854247/american-pharmacists-association-withholds-endorsement-of-cdcs-revised-covid-19-vaccine-guidance" target="_blank" rel="noreferrer noopener">American Pharmacists Association Withholds Endorsement Of CDC&#8217;s Revised COVID-19 Vaccine Guidance</a></li>
</ul>
Photo: Shutterstock

Novavax's Experimental COVID-19-Influenza Combo Shot Shows Immune Response Among Older Adults In Phase 3 Trial

The American Pharmacists Association announced Monday it will withhold endorsement of the Centers for Disease Control and Prevention&#8217;s updated immunization schedule that removed COVID-19 vaccine recommendations for pregnant women and healthy children.
What Happened: The CDC modified its guidance last month, stating COVID-19 vaccines remain optional for healthy children when parents and physicians determine necessity, reported Reuters. Health Secretary Robert F. Kennedy Jr., who oversees the CDC, Food and Drug Administration and National Institutes of Health, announced the policy changes before official website updates.
&#8220;COVID-19 vaccination during pregnancy has been proven safe and effective. Additionally, this vaccine is not associated with any fertility issues in either women or men,&#8221; the pharmacists&#8217; association stated. The group emphasized that pregnancy represents a high-risk condition requiring COVID-19 vaccination recommendations.
Kennedy&#8217;s <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">announcement bypassed the traditional CDC Advisory Committee</a> for Immunization Practices review processes. The policy shift follows FDA changes<a href="https://www.benzinga.com/news/25/05/45661031/robert-f-kennedy-jr-says-cdc-drops-covid-vaccine-for-healthy-pregnant-women-children"> limiting annual boosters to Americans over 65</a> and high-risk populations while requiring new clinical trials for healthy adults under 65.
See Also: <a href="https://www.benzinga.com/crypto/cryptocurrency/25/06/45853504/circle-stock-has-popped-271-since-nyse-debut-now-a-kpmg-consultant-says-this-is-the-next-big-thing-after-stablecoins">Circle Stock Has Popped 271% Since NYSE Debut, Now A KPMG Consultant Says This Is The Next Big Thing After Stablecoins</a>
Why It Matters: The FDA recently advised vaccine manufacturers that fall 2025 formulations should target monovalent JN.1-lineage variants, preferentially using the LP.8.1 strain. Moderna Inc. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/MRNA#NASDAQ">MRNA</a>) submitted its Spikevax 2025-2026 formula application targeting the LP.8.1 variant Friday.
Novavax Inc. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/NVAX#NASDAQ">NVAX</a>) received limited FDA approval for its Nuvaxovid vaccine, authorized for individuals 65 and older and those 12 and up with underlying medical conditions. The approval triggered a $175 million milestone payment from partner Sanofi SA (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/SNY#NASDAQ">SNY</a>).
The policy changes create uncertainty for vaccine manufacturers and healthcare investors as the <a 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">administration implements stricter clinical trial</a> requirements. Previous guidance under the Biden administration recommended additional COVID-19 boosters for healthy children despite limited clinical data supporting repeat booster strategies in pediatric populations.
Read Next:
<ul class="wp-block-list">
<li><a href="https://www.benzinga.com/news/25/06/45853487/border-czar-tom-homan-says-no-intention-to-arrest-gavin-newsom-despite-trumps-remarks-they-havent-crossed-a-line-yet">Border Czar Tom Homan Says &#8216;No Intention&#8217; To Arrest Gavin Newsom Despite Trump&#8217;s Remarks: &#8216;They Haven&#8217;t Crossed A Line Yet&#8217;</a></li>
</ul>
Disclaimer:&nbsp;This content was partially produced with the help of AI tools and was reviewed and published by Benzinga editors.
Photo courtesy: JHVEPhoto / Shutterstock.com

American Pharmacists Association Withholds Endorsement Of CDC's Revised COVID-19 Vaccine Guidance

French drugmaker Sanofi SA (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/SNY#NASDAQ">SNY</a>) on Monday said it is shipping Beyfortus (nirsevimab) starting in early Q3 to ensure broad availability well ahead of the 2025-2026 respiratory syncytial virus (RSV) season, which typically starts in November and <a target="_blank" href="https://www.benzinga.com/general/health-care" rel="noreferrer noopener">runs through March</a>.
Sanofi, in collaboration with its partner AstraZeneca plc (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/AZN#NASDAQ">AZN</a>), has tripled production capacity and doubled the number of manufacturing sites since the launch of Beyfortus in 2023.
Immunizations <a target="_blank" href="https://www.sanofi.com/en/media-room/press-releases/2025/2025-06-09-05-00-00-3095598" rel="noreferrer noopener">begin</a> in early fall. The current supply for the upcoming season matches the total doses distributed last year, and production continues.
Also Read: <a target="_blank" href="https://www.benzinga.com/news/health-care/25/06/45726872/regeneron-experimental-weight-loss-drug-with-novo-nordisks-wegovy-helps-preserve-lean-mass-in-mid-stage-study" rel="noreferrer noopener">Regeneron&#8217;s Obesity Trial With Novo Nordisk&#8217;s Wegovy Hits Lean Target</a>
Sanofi said Beyfortus duration of protection was extended for six months in the EU. This year&#8217;s EU shipments are marked by an important change to the Beyfortus EU label, extending the duration of protection through six months so Beyfortus can continue to offer season-long protection for all infants, including older babies immunized just before the RSV season begins.
More than six million babies have been immunized worldwide, and millions more will be immunized this season in more than 40 countries to help protect them from the potentially devastating impact of RSV disease.
In another development, Regeneron Pharmaceuticals, Inc.&nbsp;(NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/REGN#NASDAQ">REGN</a>) and Sanofi on Saturday presented results from the DISCOVER Phase 4, single-arm, open-label trial assessing Dupixent&nbsp;(dupilumab) in adults and adolescents with moderate-to-severe atopic dermatitis <a target="_blank" href="https://www.benzinga.com/pressreleases/25/06/g45828306/dupixent-dupilumab-data-at-revolutionizing-atopic-dermatitis-rad-conference-reinforce-use-in-atopi" rel="noreferrer noopener">with skin of color</a>.
These are the first clinical trial results for Dupixent in a large population of patients with darker skin tones.
The results, along with the Dupixent Phase 3 trials, demonstrated patients taking Dupixent experienced improvements in signs and symptoms of atopic dermatitis from baseline across many skin tones.
The data were shared at the 2025 Revolutionizing Atopic Dermatitis (RAD) Conference. In the trial, 120 patients with atopic dermatitis and skin of color were treated with Dupixent every two weeks using a weight-based dosing regimen.
At 24 weeks:
<ul class="wp-block-list">
<li>76% achieved a ≥75% improvement in overall disease severity (EASI-75), the primary endpoint. Some patients saw improvements as early as two weeks.</li>
<li>53% achieved clinically meaningful improvement in itch (≥4-point reduction on the peak-pruritus numerical rating scale [PP-NRS]). Improvements were seen by some patients as early as two weeks.</li>
<li>Patients experienced a 53% reduction from baseline in post-inflammatory hyperpigmentation, dropping from 5.1 points (moderate/marked) to 2.4 points (mild).</li>
<li>Based on patient reporting, 18% were very or extremely bothered by dry skin, compared to 78% at baseline.</li>
<li>The safety results in the DISCOVER trial were generally consistent with the known safety profile of Dupixent in its approved dermatological indications.</li>
</ul>
Price Action: REGN stock was trading higher by 1.53% to $500.75, and SNY stock was down 0.99% at $49.97.
Read Next:
<ul class="wp-block-list">
<li><a href="https://www.benzinga.com/news/health-care/25/06/45817049/arcutis-unveils-long-term-efficacy-safety-for-zoryve-cream-in-pediatric-patients-with-atopic-dermatitis" target="_blank" rel="noreferrer noopener">Arcutis Unveils Long-Term Efficacy, Safety For Zoryve Cream In Pediatric Patients With Atopic Dermatitis</a></li>
</ul>
Photo by HJBC via Shutterstock

Beyfortus Output Tripled As Sanofi, AstraZeneca Scale Up For RSV Season

<ul>
<li>Atopic dermatitis is a chronic disease that disproportionately impacts communities of color</li>
<li>Dupixent achieved 75% or greater improvement in overall disease severity, the primary endpoint, in more than three-quarters of treated patients</li>
<li>Patients experienced substantial reductions in hyperpigmentation, dry skin and itch from baseline</li>
<li>Results support commitment to enhance clinical understanding of chronic diseases in communities of color</li>
</ul>

Reported Saturday, Sanofi And Regeneron Present New Dupixent Results Highlighting Disease Severity Reduction In Patients With Darker Skin Tones

Press Releases

INVESTOR ALERT: Pomerantz Law Firm Investigates Claims On Behalf of Investors of Sanofi - SNY

Financing

Adagene announces up to $25 million strategic investment from Sanofi

INVESTOR ALERT: Pomerantz Law Firm Investigates Claims  On Behalf of Investors of Sanofi - SNY

INVESTOR ALERT: Pomerantz Law Firm Investigates Claims on Behalf of Investors of Sanofi - SNY

VIGIL NEUROSCIENCE INVESTOR ALERT by the Former Attorney General of Louisiana: Kahn Swick & Foti, LLC Investigates Adequacy of Price and Process in Proposed Sale of Vigil Neuroscience, Inc. - VIGL

ADAG

VIGL

Amneal Pharmaceuticals, Inc. - Class A Common Stock

Amneal Pharmaceuticals

Axsome Therapeutics

AstraZeneca PLC - American Depositary Shares

AstraZeneca

Bristol-Myers Squibb Company Common Stock

Bristol-Myers Squibb

Corcept Therapeutics Incorporated - Common Stock

Corcept Therapeutics

Elanco Animal Health Incorporated Common Stock

Elanco Animal Health

GSK plc American Depositary Shares (Each representing two Ordinary Shares)

HUTCHMED (China) Limited - American Depositary Shares

HUTCHMED (China)

Haleon plc American Depositary Shares (Each representing two Ordinary Shares)

Haleon

Jazz Pharmaceuticals plc - Ordinary Shares

Jazz Pharmaceuticals

Johnson & Johnson

Eli Lilly

Merck & Co

Novo Nordisk

Novartis

Prestige Consumer Healthcare Inc. Common Stock

Prestige Consumer

Pfizer

Dr. Reddy's Laboratories Ltd Common Stock

Dr Reddy's Laboratories

Regencell Bioscience Holdings Limited - Ordinary Shares

Regencell Bioscience

Royalty Pharma plc - Class A Ordinary Shares

Royalty Pharma

Takeda Pharmaceutical Company Limited American Depositary Shares (each representing 1/2 of a share of Common Stock)

Takeda Pharmaceutical Co

Teva Pharmaceutical Industries Limited American Depositary Shares

Teva Pharmaceutical Indus

Verona Pharma plc - American Depositary Shares

Verona Pharma

Viatris

Zoetis

Goldman Sachs

Argus Research

Morgan Stanley

Screenshot 2025-03-12 at 4.47.01 PM

AMGN

BIIB

ELDN

TNXP

Tonix&#39;s TNX-1500 Shows Promise In Preventing Organ Transplant Rejections Of Either Human Or Pig Organs; Autoimmune Diseases Also A Target

Redington 2_29

BDRX

PowerShares Dynamic Financial Sector Portfolio

Comments

Sanofi

Noticias

Últimas noticias sobre Sanofi (NASDAQ:SNY) Bolsa

Noticias

SOCIO/CONTRIBUIDOR

BENZINGA GLOBAL