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

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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

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Large Cap

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Buybacks

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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

<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>

Biotech

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

ASCO: new Sarclisa data support subcutaneous administration with on-body injector
<ul>
<li>New data from two clinical studies demonstrated that Sarclisa administered subcutaneously via an investigational on-body injector shortened treatment time to minutes with similar efficacy and safety compared to intravenous infusion</li>
<li>Studies used Enable Injections' enFuse&#xAE; on-body injector, an automated hands-free injector</li>
<li>Data will form the basis of global regulatory submissions across all currently approved lines of treatment &nbsp;</li>
</ul>
Paris, June 3, 2025. New data from two clinical studies of the investigational use of Sarclisa administered subcutaneously (SC) via an on-body injector (OBI) (also referred to as an on-body delivery system) in relapsed or refractory multiple myeloma (R/R MM) support the potential use of this innovative delivery method to advance patient care, while upholding Sarclisa's efficacy and safety profile. The results were presented at the American Society of Clinical Oncology (ASCO) Annual Meeting and include full data from the <a href="https://www.sanofi.com/en/media-room/press-releases/2025/2025-01-09-06-00-00-3006798">IRAKLIA phase 3 study</a>, the first to incorporate the use of an OBI in the treatment of MM, and demonstrate non-inferior efficacy and pharmacokinetics compared to Sarclisa intravenous (IV) infusion.

Sanofi Announces New Data Shows Subcutaneous Sarclisa Delivered Via On-Body Injector Cuts Treatment Time To Minutes While Maintaining Efficacy And Safety, At ASCO 2025

Rilzabrutinib granted orphan drug designation in the US for sickle cell disease
<ul>
<li>Fourth orphan drug designation for rilzabrutinib in rare diseases</li>
<li>Under regulatory review in the US, the EU, and China in immune thrombocytopenia</li>
</ul>

Sanofi's Rilzabrutinib Receives Fourth Orphan Drug Designation In The US, Targeting Vaso-Occlusive Crises In Sickle Cell Disease

Kymera Therapeutics, Inc. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/KYMR#NASDAQ">KYMR</a>) on Monday revealed clinical results from the Phase 1 healthy volunteer study of KT-621, its first-in-class, oral <a target="_blank" href="https://www.benzinga.com/general/health-care" rel="noreferrer noopener">STAT6 degrader medicine</a>.
The findings significantly surpassed the company&#8217;s expectations, demonstrating robust STAT6 degradation and a favorable safety profile, thereby derisking the program, the company said in a press release.
Pharmacokinetics (PK):
KT-621 demonstrated a favorable <a target="_blank" href="https://www.benzinga.com/pressreleases/25/06/g45717730/kymera-therapeutics-announces-positive-first-in-human-results-from-phase-1-healthy-volunteer-clini" rel="noreferrer noopener">plasma PK profile</a> after single and multiple doses. Rapid absorption was demonstrated with a median tmax&nbsp;of 2-4 hours and a mean half-life of 9-36 hours. There was a dose-proportional increase in exposure after multi-dosing, and a steady state was achieved by Day 4.
Also Read: <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">Moderna&#8217;s New COVID Vaccine Secures FDA-Clearance For Seniors, At-Risk Individuals</a>
Pharmacodynamics (PD):
KT-621 demonstrated rapid, deep, and prolonged STAT6 degradation in blood after single doses of KT-621 and in blood and skin after multiple doses of KT-621.
STAT6 levels in blood and skin were measured. Complete degradation within a cohort is defined as either a mean reduction of ≥95% or, when most subjects&#8217; STAT6 levels are reduced below the Lower Limit of Quantification (LLOQ), or both.
In SAD, maximal degradation was achieved in blood as quickly as the first collected timepoint of 4 hours after a single dose, with mean STAT6 degradation reaching &gt;90% across all SAD doses starting at 6.25 mg.
All SAD cohorts at 75 mg or greater doses achieved &gt;95% mean STAT6 degradation with STAT6 levels below LLOQ in multiple subjects.
In MAD, STAT6 degradation was observed in blood at the first timepoint measured (8 hours) for doses above 1.5 mg.
Steady-state, complete degradation, associated with STAT6 reductions below the LLOQ in the majority of subjects, was achieved at doses ≥50 mg, with recovery starting as early as 4 days after the last dose.
In MAD, robust STAT6 degradation was observed in the skin at the first timepoint measured (Day 7) for doses above 1.5 mg.
Steady-state, complete degradation, associated with ≥95% mean STAT6 degradation with STAT6 levels below LLOQ in multiple subjects, was achieved at doses ≥50 mg.
Th2 Biomarkers:
TARC reduction was observed for all KT-621 dose groups, with a median reduction of up to 37% at Day 14.
The company says the results are comparable or superior to what was seen in the Sanofi SA (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/SNY#NASDAQ">SNY</a>)/Regeneron Pharmaceuticals Inc&#8217;s (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/REGN#NASDAQ">REGN</a>) Dupixent (dupilumab) healthy volunteer study.
The safety profile of KT-621 was undifferentiated from that of the placebo.
The company&#8217;s KT-621 BroADen Phase 1b trial in moderate to severe atopic dermatitis patients is ongoing, with data expected to be reported in the fourth quarter of 2025. 
Two parallel Phase 2b trials in atopic dermatitis and asthma will start in 4Q25 and 1Q26, respectively.
Price Action: KYMR stock was trading higher by 30.2% to $38.58 at last check Monday.
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</ul>
Photo via Shutterstock

KYMR

REGN

Kymera Therapeutics Says Atopic Dermatitis Potential Matches Sanofi/Regeneron's Blockbuster Dupixent In Early Biomarker Response

The U.S. Food and Drug Administration (FDA) on Saturday approved Moderna, Inc.&#8217;s (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 <a target="_blank" href="https://www.benzinga.com/general/health-care" rel="noreferrer noopener">Control and Prevention (CDC)</a>.
&#8220;The FDA approval of our third product, mNEXSPIKE&#8230;,&#8221; said Stéphane Bancel, Chief <a target="_blank" href="https://www.benzinga.com/pressreleases/25/05/ac45708511/moderna-receives-u-s-fda-approval-for-covid-19-vaccine-mnexspike" rel="noreferrer noopener">Executive Officer of Moderna</a>.
The FDA&#8217;s approval of mNEXSPIKE is based on results from a randomized, observer-blind, active-controlled Phase 3 trial, which enrolled approximately 11,400 participants aged 12 years and older.
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>
The primary efficacy objective was to demonstrate the non-inferior vaccine efficacy against COVID-19 starting 14 days after mNexspike compared to that after the comparator vaccine, mRNA-1273 (Spikevax), Moderna&#8217;s original COVID-19 vaccine.
Participants received either a 10 μg dose of mRNA-1283 or a 50 μg dose of mRNA-1273.
mRNA-1283 showed a 9.3% higher relative vaccine efficacy (rVE) compared to mRNA-1273 in individuals aged 12 years and older, and in a descriptive sub-group analysis, a 13.5% higher rVE in adults aged 65 and older.
In the Phase 3 trial, mRNA-1283 was found to have a similar safety profile to mRNA-1273, with fewer local reactions and comparable systemic reactions.
The most commonly solicited side effects were injection site pain, fatigue, headache and myalgia.
Moderna expects to have mNexspike available for eligible populations in the U.S. for the 2025-2026 respiratory virus season, alongside Spikevax and mRESVIA, the company&#8217;s approved respiratory syncytial virus (RSV) vaccine.
William Blair writes, &#8220;Approval of mRNA-1283 is an incremental win for Moderna, especially considering HHS Secretary Robert F. Kennedy Jr.&#8217;s negative public opinion on mRNA COVID-19 vaccines, and we continue to see autonomy and data-driven decisions at the FDA.&#8221;
&#8220;We do not see approval of mRNA-1283 as a massive boost to Moderna&#8217;s COVID-19 vaccine sales, which we believe are primarily driven by sentiment surrounding the vaccination market in general, but this is a critical step in the regulatory path for the combo flu/COVID vaccine product, mRNA-1083, which uses mRNA-1283 as the COVID-19 component of its formulation,&#8221; analyst Myles Minter writes.
Analyst Minter says Moderna is still facing challenges from new government policies, including <a target="_blank" href="https://www.benzinga.com/government/regulations/25/05/45663794/hhs-cancels-590m-moderna-bird-flu-vaccine-deal-casting-uncertainty-over-pandemic-preparedness-effort" rel="noreferrer noopener">losing about $700 million</a> in funding from the Department of Health and Human Services for its bird flu vaccine project.
In addition, William Blair writes that the company&#8217;s goal to break even by 2028 is overly optimistic since it would need to more than double its revenue—based on cash costs—to reach that target.
In May, the FDA approved Novavax, Inc.&#8217;s (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/NVAX#NASDAQ">NVAX</a>) Nuvaxovid for active immunization to prevent coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in adults 65 years and older and individuals 12 through 64 years who have at least one underlying condition that puts them at high risk for severe outcomes from COVID-19 (e.g. asthma, cancer, <a target="_blank" href="https://www.benzinga.com/pressreleases/25/05/n45489838/u-s-fda-approves-bla-for-novavaxs-covid-19-vaccine" rel="noreferrer noopener">diabetes, obesity, smoking)</a>.
Achievement of the U.S. license approval has triggered a&nbsp;$175 million&nbsp;milestone payment from Sanofi SA (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/SNY#NASDAQ">SNY</a>).
Price Action: MRNA stock is up 4.82% at $27.84 during the premarket session at the last check on Monday.
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</ul>
Photo by Wolfilser via Shutterstock

Trading Ideas

Moderna's New COVID Vaccine Secures FDA-Clearance For Seniors, At-Risk Individuals

Sanofi SA (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/SNY#NASDAQ">SNY</a>) on Monday agreed to acquire Blueprint Medicines Corporation (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/BPMC#NASDAQ">BPMC</a>).
The acquisition includes a rare immunology disease medicine, Ayvakit/Ayvakyt (avapritinib), approved in the U.S. and the EU, and a promising advanced and <a target="_blank" href="https://www.benzinga.com/general/health-care" rel="noreferrer noopener">early-stage immunology pipeline</a>.
Ayvakit/Ayvakyt is the only approved medicine for advanced and indolent systemic mastocytosis (ASM &amp; ISM), a rare immunology disease, which is characterized by the accumulation and activation of aberrant mast cells in bone marrow, skin, the gastrointestinal tract, and other organs.
The acquisition will also include elenestinib, a next-generation medicine for SM, and BLU-808, a highly selective and potent oral wild-type KIT inhibitor with the potential for immunology diseases.
Also Read: <a target="_blank" href="https://www.benzinga.com/24/11/41987123/blood-cancer-focused-blueprint-medicines-could-be-attractive-target-for-partnerships-analyst-initiates-with-around-30-upside" rel="noreferrer noopener">Blood Cancer-Focused Blueprint Medicines Could Be &#8216;Attractive Target For Partnerships&#8217;: Analyst</a>
Sanofi will pay&nbsp;$129.00&nbsp;per share in cash, representing an equity value of <a target="_blank" href="https://www.benzinga.com/pressreleases/25/06/n45714358/sanofi-to-acquire-blueprint-medicines-expanding-portfolio-in-rare-immunological-disease-and-adding" rel="noreferrer noopener">approximately&nbsp;$9.1 billion</a>.
Blueprint shareholders will also receive one contingent value right (CVR), which entitles the holder to two potential milestone payments of&nbsp;$2&nbsp;and&nbsp;$4&nbsp;per CVR to achieve future development and regulatory milestones for BLU-808.
The total equity value of the transaction, including potential CVR payments, represents approximately&nbsp;$9.5 billion&nbsp;on a fully diluted basis.
Paul Hudson, CEO of Sanofi, said, &#8220;The proposed acquisition of Blueprint Medicines represents a strategic step forward in our rare and immunology portfolios&#8230;It complements recent acquisitions of early-stage medicines that remain our main field of interest. Sanofi still retains a sizeable capacity for further acquisitions.&#8221;&nbsp;
Ayvakit achieved net revenues of&nbsp;$479 million&nbsp;in 2024 and nearly&nbsp;$150 million&nbsp;in Q1 2025, representing year-on-year growth of more than 60% over Q1 2024.
Sanofi currently expects to complete the acquisition in the third quarter of 2025. The acquisition will not significantly impact Sanofi&#8217;s financial guidance for 2025. It is immediately accretive to gross margin and accretive to business operating income and EPS after 2026.
In another development, Sanofi exercised its option to exclusively license Nurix Therapeutics, Inc.&#8217;s (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/NRIX#NASDAQ">NRIX</a>) STAT6 program on Monday, including the drug development candidate NX-3911, an oral, highly selective STAT6 degrader.
STAT6 (signal transducer and activator of transcription 6) plays a central role in type 2 inflammation, which drives diseases such as atopic dermatitis and asthma.
Under its 2019 collaboration agreement, Nurix will receive a $15 million license extension fee from Sanofi, bringing the total amount received under this <a target="_blank" href="https://www.benzinga.com/pressreleases/25/06/g45717764/sanofi-exercises-license-extension-option-to-nurixs-stat6-program" rel="noreferrer noopener">collaboration to $127 million</a>.
Nurix is eligible for an additional $465 million in development, regulatory, and commercial milestones associated with the STAT6 program and potential future royalties and retains an option to co-develop and co-promote in the U.S.
Price Action: SNY stock is trading lower by 0.73% to $49.01, BPMC stock is trading higher by 26.8% to $128.50, and NRIX stock is trading lower by 0.28% to $10.60 during the premarket session at last check Monday.
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</ul>
Photo by HJBC via Shutterstock

Contracts

NRIX

Sanofi Expands Rare Immunology Portfolio With Blueprint Buyout

Shares of Blueprint Medicines Corporation (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/BPMC#NASDAQ">BPMC</a>) rose sharply in <a href="https://www.benzinga.com/quote/BPMC/news">today's pre-market trading</a>.
Sanofi SA (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/SNY#NASDAQ">SNY</a>) announced plans to acquire Blueprint Medicines for $9.5 billion.
Blueprint Medicines shares jumped 26.9% to $128.62 in the pre-market trading session.
Here are some other stocks moving in pre-market trading.
<h3 class="wp-block-heading">Gainers</h3>
<ul class="wp-block-list">
<li>Lyra Therapeutics, Inc. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/LYRA#NASDAQ">LYRA</a>) shares jumped 199% to $14.74 in pre-market trading after the company reported positive results from the ENLIGHTEN 2 Phase 3 trial of LYR-210 achieving statistically significant results for primary and key secondary endpoints in the treatment of Chronic Rhinosinusitis (CRS).</li>
<li>InMed Pharmaceuticals Inc. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/INM#NASDAQ">INM</a>) rose 93.2% to $4.81 in pre-market trading.</li>
<li>Vera Therapeutics, Inc. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/VERA#NASDAQ">VERA</a>) surged 69% to $32.02 in pre-market trading after the company said Atacicept ORIGIN Phase 3 trial met primary endpoint of reduction in UPCR for IgAN treatment.</li>
<li>Brand Engagement Network, Inc. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/BNAI#NASDAQ">BNAI</a>) jumped 68.5% to $0.47 in pre-market trading after gaining 13% on Friday.</li>
<li>Basel Medical Group Ltd (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/BMGL#NASDAQ">BMGL</a>) surged 51.4% to $9.20 in pre-market trading after jumping 485% on Friday.</li>
<li>Black Spade Acquisition II Co (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/BSII#NASDAQ">BSII</a>) gained 37.3% to $13.29 in pre-market trading after falling 5% on Friday.</li>
<li>DigiAsia Corp. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/FAAS#NASDAQ">FAAS</a>) climbed 27.7% to $1.6990 in pre-market trading after jumping 24% on Friday.</li>
<li>Cleveland-Cliffs Inc. (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/CLF#NYSE">CLF</a>) rose 25.6% to $7.32 in pre-market trading.</li>
<li>BioNTech SE (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/BNTX#NASDAQ">BNTX</a>) gained 14.1% to $109.32 in pre-market trading. BioNTech and Bristol Myers Squibb announced a global strategic partnership to co-develop and co-commercialize next-generation bispecific antibody candidate BNT327 broadly for multiple solid tumor types</li>
</ul>
<h3 class="wp-block-heading">Losers</h3>
<ul class="wp-block-list">
<li>ReShape Lifesciences Inc. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/RSLS#NASDAQ">RSLS</a>) shares dipped 23.2% to $3.77 in pre-market trading. ReShape Lifesciences entered into equity distribution agreement relating to sale of up to $9.7 million of shares of common stock.</li>
<li>China Liberal Education Holdings Limited (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/CLEU#NASDAQ">CLEU</a>) shares fell 22.6% to $0.7500 in pre-market trading after the company announced suspension of Nasdaq trading.</li>
<li>Silexion Therapeutics Corp (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/SLXN#NASDAQ">SLXN</a>) fell 20.2% to $0.8300 in pre-market trading after gaining 8% on Friday.</li>
<li>SharpLink Gaming, Inc. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/SBET#NASDAQ">SBET</a>) declined 18.4% to $62.60 in pre-market trading after the company filed for mixed shelf offering.</li>
<li>ContextLogic Inc. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/LOGC#NASDAQ">LOGC</a>) shares tumbled 18.3% to $6.70 in pre-market trading. ContextLogic will commence trading on the OTC Markets and delist from the Nasdaq.</li>
<li>Xilio Therapeutics, Inc. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/XLO#NASDAQ">XLO</a>) fell 17.9% to $0.8788 in pre-market trading after the company announced a proposed public offering.</li>
<li>Super League Enterprise, Inc. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/SLE#NASDAQ">SLE</a>) fell 16.4% to $0.1629 in today's pre-market trading. Super League Enterprise, on Friday, announced a registered direct offering.</li>
<li>Tian Ruixiang Holdings Ltd (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/TIRX#NASDAQ">TIRX</a>) dipped 16% to $1.68 in pre-market trading. TIAN RUIXIANG shares gained 8% on Friday after the company announced plans to buy Ucare for $150 million in an all-stock deal.</li>
<li>Lucid Diagnostics Inc. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/LUCD#NASDAQ">LUCD</a>) shares fell 15.1% to $1.18 in pre-market trading. Lucid Diagnostics may offer sell shares of common stock of up to $25 MILLION.</li>
<li>Algoma Steel Group Inc. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/ASTL#NASDAQ">ASTL</a>) fell 9.2% to $4.78 in pre-market trading.</li>
</ul>
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Photo via Shutterstock

ASTL

BMGL

BNAI

BNTX

BSII

CLEU

FAAS

LOGC

LUCD

LYRA

RSLS

SBET

SLXN

TIRX

VERA

Why Blueprint Medicines Shares Are Trading Higher By 27%; Here Are 20 Stocks Moving Premarket

<ul>
<li>STAT6 is a key transcription factor within the IL4/IL13 signaling pathways which act as drivers of inflammation in allergic conditions</li>
<li>Nurix to receive a $15 million license extension fee from Sanofi under its 2019 collaboration agreement, bringing the total amount received by Nurix under this collaboration to date to $127 million</li>
<li>Nurix is eligible for an additional $465 million in development, regulatory and commercial milestones associated with the STAT6 program as well as potential future royalties and retains an option to co-develop and co-promote in the U.S.</li>
</ul>

Sanofi Has Exercised Its Option To Exclusively License Nurix Therapeutics' STAT6 Program, Including The Drug Development Candidate NX-3911, Nurix To Receive A $15M License Extension Fee From Sanofi Under Its 2019 Collaboration Agreement

U.S. stock futures fell on Monday after a mixed close on Friday. Futures of major benchmark indices were trading lower in premarket.
After the Federal appeals court temporarily reinstated Donald Trump&#8216;s tariffs, he accused <a href="https://www.benzinga.com/news/legal/25/05/45683326/trump-tariffs-temporarily-preserved-as-appeals-court-pauses-lower-ruling">China of violating an agreement</a> with the U.S. to ease tariffs in his Truth Social <a href="https://truthsocial.com/@realDonaldTrump/posts/114596705340367716">post</a>. 
However, Trump did not specify the details of this violation. Treasury Secretary Scott Bessent on Sunday clarified that China was withholding critical minerals it agreed to release in a trade deal the country signed with U.S. negotiators last month in Geneva.
Meanwhile, the 10-year Treasury bond yielded 4.44% and the two-year bond was at 3.92%. The CME Group's FedWatch <a href="https://www.cmegroup.com/markets/interest-rates/cme-fedwatch-tool.html">tool</a>&#8216;s projections show markets pricing a 98.7% likelihood of the Federal Reserve keeping the current interest rates unchanged in its June meeting.
<figure class="wp-block-table is-style-stripes"> 
<table class="has-fixed-layout">
<tbody>
<tr>
<td>Futures</td>
<td>Change (+/-)</td>
</tr>
<tr>
<td>Dow Jones</td>
<td>-0.48%</td>
</tr>
<tr>
<td>S&amp;P 500</td>
<td>-0.53%</td>
</tr>
<tr>
<td>Nasdaq 100</td>
<td>-0.68%</td>
</tr>
<tr>
<td>Russell 2000</td>
<td>-0.58%</td>
</tr>
</tbody>
</table>
</figure>
The SPDR S&amp;P 500 ETF Trust (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/SPY#NYSE">SPY</a>) and Invesco QQQ Trust ETF (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/QQQ#NASDAQ">QQQ</a>), which track the S&amp;P 500 index and Nasdaq 100 index, respectively, fell in premarket on Monday. The SPY was down 0.53% at $586.24, while the QQQ declined 0.63% to $515.83, according to <a href="https://pro.benzinga.com/dashboard">Benzinga Pro</a> data.
Cues From Last Session:
Sectoral moves led the U.S. stocks to a mixed close on Friday, with energy, consumer discretionary, and information technology stocks posting the largest declines, while consumer staples and utilities ended higher.
Wall Street ended May on a strong note, with the S&amp;P 500 up 6.2% and the Nasdaq soaring 9.6%, marking their best months since November 2023. The Dow gained 3.9% for the month.
Weekly gains showed the S&amp;P 500 advancing, the Dow up 1.6%, and the tech-heavy Nasdaq rising 2%.
Dell Technologies Inc. (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/DELL#NYSE">DELL</a>) shares dropped over 2% after mixed first-quarter results, while Ulta Beauty Inc. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/ULTA#NASDAQ">ULTA</a>) surged about 12% on better-than-expected Q1 earnings and raised guidance.
Economic data revealed the University of Michigan consumer sentiment revised up to 52.2 in May from a preliminary 50.8, while the Chicago PMI fell to 40.5 from 44.6 in the prior month.
The Dow Jones index ended 54 points or 0.13% higher at 42,270.07, whereas the S&amp;P 500 index fell 0.0081% to 5,911.69. Nasdaq Composite declined 0.28% to 19,113.77, and the small-cap gauge, Russell 2000, tumbled 0.41% to 2,066.29.
<figure class="wp-block-table is-style-stripes"> 
<table class="has-fixed-layout">
<tbody>
<tr>
<td>Index</td>
<td>Performance (+/-)</td>
<td>Value</td>
</tr>
<tr>
<td>Nasdaq Composite</td>
<td>-0.28%</td>
<td>19,113.77</td>
</tr>
<tr>
<td>S&amp;P 500</td>
<td>-0.0081%</td>
<td>5,911.69</td>
</tr>
<tr>
<td>Dow Jones</td>
<td>0.13%</td>
<td>42,270.07</td>
</tr>
<tr>
<td>Russell 2000</td>
<td>-0.41%</td>
<td>2,066.29</td>
</tr>
</tbody>
</table>
</figure>
Insights From Analysts:
According to Bob Elliott, the CIO of Unlimited Funds, there was a "consensus" among the market participants that TACO trade or Trump Always Chickens Out' trade is priced in, meaning investors anticipate Trump's tariff retreats, especially now that he is embroiled in the legal battle over the validation of his levied tariffs.
He implied that TACO could pave the way for a "Run It Hot" economic environment, characterized by growth-oriented policies and sustained stimulus, further fueling market optimism.
Elliott's post signaled a widespread belief that Trump&#8217;s possible tariff rollbacks or extensions are not only predictable but also conducive to a pro-growth economic stance.
<figure class="wp-block-embed is-type-rich is-provider-twitter wp-block-embed-twitter"> 
<div class="wp-block-embed__wrapper">
<blockquote class="twitter-tweet" data-width="500" data-dnt="true">TACO and Run It Hot are consensus at this point.
&mdash; Bob Elliott (@BobEUnlimited) <a href="https://twitter.com/BobEUnlimited/status/1929147958139744440?ref_src=twsrc%5Etfw">June 1, 2025</a></blockquote>
<script async src="https://platform.twitter.com/widgets.js" charset="utf-8"></script></div>
</figure>
Meanwhile, head of research at Fundstrat Global Advisors, Tom Lee, stated that a "<a href="https://www.benzinga.com/analyst-stock-ratings/analyst-color/25/06/45715677/tom-lee-bets-on-a-new-bull-market-as-trumps-tariff-retreat-fuels-taco-trade-a">new bull market</a>" has emerged following the spike in the volatility gauge in April. &#8211;
"I think we had what was a miniature bear market, but has essentially rebirthed the new bull market," he <a href="https://www.cnbc.com/2025/05/30/tom-lee-says-the-april-selloff-rebirthed-a-new-bull-market-.html?__source=twitter%7Cpro&amp;taid=6839dcb51dc732000173796f&amp;utm_campaign=trueanthem&amp;utm_content=pro&amp;utm_medium=social&amp;utm_source=twitter">told</a> CNBC as he expects "pretty shallow" dips from here, advising investors to consider small-cap stocks other than the Magnificent 7
"As I look at the second half, I think the small caps really have a strong case to be made, because as long as we move towards a tariff resolution, or the markets feel that way, then I think investors can actually start putting flows back into stocks other than the Mag Seven,&#8221; Lee said.
See Also: <a href="https://www.benzinga.com/money/how-to-trade-futures">How to Trade Futures</a>
Upcoming Economic Data
Here&#8217;s what investors will keep an eye on this week:
<ul class="wp-block-list">
<li>On Monday, May&#8217;s S&amp;P final U.S. manufacturing PMI will be released by 9:45 a.m. ET.</li>
<li>ISM manufacturing data for May and construction spending data for April will be out by 10:00 a.m. ET.</li>
<li>Dallas Fed President Lorie Logan will speak at 10:15 a.m., Chicago Fed President Austan Goolsbee will speak at 12:45 p.m., and Federal Reserve Chair Jerome Powell will speak at 1:00 p.m. ET.</li>
<li>Auto sales data will also be released on Monday.</li>
<li>On Tuesday, April&#8217;s factory orders and job openings data will be out by 10:00 a.m. ET.</li>
<li>Chicago Fed President Austan Goolsbee will speak at 12:45 p.m., Federal Reserve Governor Lisa Cook will speak at 1:00 p.m., and Dallas Fed President Lorie Logan will speak at 3:30 p.m. ET.</li>
<li>On Wednesday, May&#8217;s ADP employment data will be out by 8:15 a.m. ET.</li>
<li>May&#8217;s S&amp;P final U.S. services PMI will be released at 9:45 a.m., and ISM services data will be out by 10:00 a.m. ET.</li>
<li>Atlanta Fed President Raphael Bostic and Federal Reserve Governor Lisa Cook will speak at the Fed listens event at 10:15 a.m. ET.</li>
<li>Fed Beige Book will be out by 2:00 p.m. ET.</li>
<li>On Thursday, the initial jobless claims data for the week ended May 31, April U.S. trade deficit, and first quarter&#8217;s U.S. productivity data will be out by 8:30 a.m. ET.</li>
<li>Federal Reserve Governor Adriana Kugler will speak at noon, and Philadelphia Fed President Patrick Harker will speak at 1:30 p.m. ET.</li>
<li>On Friday, May&#8217;s U.S. employment report, unemployment rate, and hourly wages data will be released by 8:30 a.m. ET.</li>
<li>April&#8217;s consumer credit data will be announced at 3:00 p.m. ET.</li>
</ul>
Stocks In Focus:
<ul class="wp-block-list">
<li>Campbell&#8217;s Co. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/CPB#NASDAQ">CPB</a>) rose 2.32% in premarket on Monday as analysts expect it to report quarterly earnings of 66 cents per share on revenue of $2.43 billion, before the opening bell.</li>
<li>Science Applications International Corp. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/SAIC#NASDAQ">SAIC</a>) was up 0.29% ahead of its earnings, which are supposed to be released before the opening bell. Analysts expect earnings of $2.13 per share on revenue of $1.87 billion.</li>
<li>Credo Technology Group Holding Ltd. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/CRDO#NASDAQ">CRDO</a>) declined 1.03% as analysts expect it to report quarterly earnings of 28 cents per share on revenue of $160.16 million, after the closing bell.</li>
<li>Sanofi SA (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/SNY#NASDAQ">SNY</a>) advanced 0.32% after it announced plans to acquire Blueprint Medicines Corp. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/BPMC#NASDAQ">BPMC</a>), which jumped 26.78%, for $9.5 billion.</li>
<li>Brand Engagement Network Inc. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/BNAI#NASDAQ">BNAI</a>) surged 63.73% after its plans to acquire Cataneo GmbH for $19.5 million were extended, with $550,000 paid so far.</li>
<li>Plus Therapeutics Inc. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/PSTV#NASDAQ">PSTV</a>) gained 37.05% after its cancer drug REYOBIQ extended patient survival to 17 months.</li>
<li>Ryvyl Inc. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/RVYL#NASDAQ">RVYL</a>) climbed 26.19% after it received an extension from Nasdaq to regain compliance with listing requirements after failing to meet minimum stockholders&#8217; equity criteria last week.</li>
</ul>
Commodities, Gold, And Global Equity Markets:
Crude oil futures were trading higher in the early New York session by 3.55% to hover around $62.95 per barrel.
Gold Spot US Dollar rose 1.78% to hover around $3,348.94 per ounce. Its last record high stood at $3,500.33 per ounce. The U.S. Dollar Index spot was lower by 0.64% at the 98.6940 level.
Asian markets closed lower on Friday except South Korea's Kospi index. Australia's ASX 200, China&#8217;s CSI 300, India's S&amp;P BSE Sensex, Japan's Nikkei 225, and Hong Kong's Hang Seng indices declined. European markets were lower in early trade.
Read Next:
<ul class="wp-block-list">
<li><a href="https://www.benzinga.com/analyst-stock-ratings/analyst-color/25/06/45715677/tom-lee-bets-on-a-new-bull-market-as-trumps-tariff-retreat-fuels-taco-trade-amid-run-it-hot-optimism">Tom Lee Bets On &#8216;A New Bull Market,&#8217; As Trump&#8217;s Tariff Retreat Fuels &#8216;TACO&#8217; Trade Amid &#8216;Run It Hot&#8217; Optimism </a></li>
</ul>
Photo courtesy: godongphoto / Shutterstock.com

Pre-Market Outlook

DELL

RVYL

ULTA

US Stocks Likely To Open Lower After A Solid May: 'TACO' Trade And 'Run It Hot' Optimism 'Are Consensus At This Point,' Says Expert

With U.S. stock futures trading lower this morning on Monday, some of the stocks that may grab investor focus today are as follows:
<ul class="wp-block-list">
<li>Wall Street expects Campbell&#8217;s Co. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/CPB#NASDAQ">CPB</a>) to report quarterly earnings at 66 cents per share on revenue of $2.43 billion before the opening bell, according to data from <a href="https://pro.benzinga.com/dashboard">Benzinga Pro</a>. Campbell&#8217;s shares gained 0.6% to $34.24 in after-hours trading.</li>
<li>Analysts expect Science Applications International Corp. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/SAIC#NASDAQ">SAIC</a>) to post quarterly earnings at $2.13 per share on revenue of $1.87 billion. The company will release earnings before the markets open. SAIC shares rose 0.2% to $115.71 in after-hours trading.</li>
<li>Plus Therapeutics Inc. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/PSTV#NASDAQ">PSTV</a>) posted a net loss of $17.4 million, or $1.19 per share, for the first quarter, versus a year-ago net loss of $3.3 million, or 75 cents per share. Plus Therapeutics shares jumped 34.2% to $0.3851 in the after-hours trading session.</li>
</ul>
Check out our <a href="https://www.benzinga.com/premarket/">premarket coverage here</a>
<ul class="wp-block-list">
<li>Sanofi SA (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/SNY#NASDAQ">SNY</a>) announced plans to acquire Blueprint Medicines Corp. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/BPMC#NASDAQ">BPMC</a>) for $9.5 billion. Blueprint Medicines shares fell 1.7% to close at $101.35 on Friday.</li>
<li>Analysts expect Credo Technology Group Holding Ltd. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/CRDO#NASDAQ">CRDO</a>) to post quarterly earnings at 28 cents per share on revenue of $160.16 million after the closing bell. Credo Technology shares gained 0.6% to $61.30 in after-hours trading.</li>
</ul>
Check This Out:
<ul class="wp-block-list">
<li><a href="https://www.benzinga.com/cannabis/25/05/45692676/wall-streets-most-accurate-analysts-spotlight-on-3-utilities-stocks-delivering-high-dividend-yields-8"> Wall Street&#8217;s Most Accurate Analysts Spotlight On 3 Utilities Stocks Delivering High-Dividend Yields</a></li>
</ul>
Photo via Shutterstock

Campbell's, SAIC And 3 Stocks To Watch Heading Into Monday

Sanofi to acquire Blueprint Medicines, expanding portfolio in rare immunological disease and adding early-stage pipeline in immunology
<ul>
<li>Adds fast-growing and only approved medicine for advanced and indolent systemic mastocytosis to the Sanofi portfolio &nbsp;</li>
</ul>

Sanofi To Acquire Blueprint Medicines For $9.5B, Paying $129/Share To Expand Rare Immunology Portfolio With Ayvakit And KIT Pipeline

Benzinga examined the prospects for <a href="http://www.benzinga.com/trading-ideas" target="_blank" rel="noreferrer noopener">many investors' favorite stocks</a> over the last week — here's a look at some of our top stories.
In May, U.S. stocks recorded their strongest monthly rally since November 2023, driven by easing trade tensions and robust tech earnings. The S&amp;P 500 rose 6.2%, and the Nasdaq Composite surged 9.6%, returning both indices to positive territory for the year. The "Magnificent Seven" tech giants led the charge, with Nvidia (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/NVDA#NASDAQ">NVDA</a>) stock climbing 24% after reporting a 70% year-over-year revenue increase.
Despite the tech sector's dominance, investors anticipate a broader market rally, citing improving earnings in sectors like industrials, consumer staples, and financials. Analysts expect the earnings growth gap between the Magnificent Seven and the rest of the S&amp;P 500 to narrow in 2025.
However, uncertainties remain. A U.S. court ruling declared President Donald Trump's recent tariffs illegal, though the decision was promptly appealed. Analysts warn that renewed tariffs, particularly on chips and pharmaceuticals, could threaten the sustainability of recent market gains.
Benzinga provides daily reports on the stocks most popular with investors. Here are a few of this past week's most bullish and bearish posts that are worth another look.

The Bulls
<a href="https://www.benzinga.com/analyst-ratings/analyst-color/25/05/45655507/tech-analyst-expects-palantir-stock-to-rise-above-400-as-ai-revolution-kicks-into-gear">"Tech analyst expects Palantir stock to rise above $400 as AI revolution kicks into gear"</a>, by Adam Eckert, reports that Wedbush analyst Dan Ives predicts Palantir Technologies Inc. (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/PLTR#NYSE">PLTR</a>) will surpass $400 per share and reach a $1 trillion market cap within a few years, citing its leadership in AI and calling it the "Messi of AI."
<a href="https://www.benzinga.com/analyst-ratings/analyst-color/25/05/45675006/nvidia-stock-has-significant-upside-as-ai-godfather-jensen-huang-delivers-another-robust-quarter">"Nvidia stock has ‘significant upside' as AI ‘godfather' Jensen Huang delivers another ‘robust quarter'"</a>, by Chris Katje, reports that Nvidia Corp. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/NVDA#NASDAQ">NVDA</a>) shares rose after the company beat Q1 estimates and analysts projected a market cap of up to $5 trillion, citing surging demand for its Blackwell AI chips and growth in AI infrastructure despite China export restrictions.
<a href="https://www.benzinga.com/news/earnings/25/05/45682895/ulta-beauty-stock-climbs-after-better-than-expected-q1-report-raised-fiscal-2025-outlook">"Ulta Beauty stock climbs after better-than-expected Q1 report, raised fiscal 2025 outlook"</a>, by Erica Kollmann, reports that Ulta Beauty Inc. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/ULTA#NASDAQ">ULTA</a>) shares surged over 11% after the company exceeded Q1 earnings and revenue expectations, posting $6.70 EPS and $2.85 billion in sales, and raised its fiscal 2025 guidance amid strong demand for skincare and fragrance products.
For additional bullish calls of the past week, check out the following:
<a href="https://www.benzinga.com/news/earnings/25/05/45683235/uipath-stock-surges-on-q1-earnings-beat-raised-guidance-this-was-a-milestone-quarter">UiPath Stock Surges On Q1 Earnings Beat, Raised Guidance: ‘This Was A Milestone Quarter'</a>
<a href="https://www.benzinga.com/government/regulations/25/05/45650179/uranium-stocks-hit-17-year-highs-as-mays-rally-marks-best-month-on-record">Uranium Stocks Hit 17-Year Highs As May's Rally Marks Best Month On Record</a>
<a href="https://www.benzinga.com/general/biotech/25/05/45648350/why-is-gsk-partner-spero-therapeutics-stock-skyrocketing-on-wednesday">Why Is GSK Partner Spero Therapeutics Stock Skyrocketing On Wednesday?</a>

The Bears
<a href="https://www.benzinga.com/news/earnings/25/05/45681892/marvell-technology-stock-slips-after-q1-results-details">"Marvell Technology stock slips after Q1 results: Details"</a>, by Erica Kollmann, reports that Marvell Technology Inc. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/MRVL#NASDAQ">MRVL</a>) shares fell over 3% after the company posted Q1 adjusted earnings of 62 cents per share on $1.9 billion in revenue—both slightly above analyst estimates—but investors showed muted enthusiasm despite strong AI-driven data center demand and a raised Q2 revenue forecast of $2 billion.
<a href="https://www.benzinga.com/trading-ideas/movers/25/05/45692578/regeneron-sanofi-stock-falls-after-uneven-smokers-lung-drug-data">"Regeneron, Sanofi stock falls after uneven smoker's lung drug data"</a>, by Vandana Singh, reports that Regeneron Pharmaceuticals Inc. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/REGN#NASDAQ">REGN</a>) and Sanofi SA (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/SNY#NASDAQ">SNY</a>) shares declined after their experimental COPD drug, itepekimab, showed a 27% reduction in exacerbations in one Phase 3 trial but failed to meet the primary endpoint in a second trial, raising concerns about its efficacy.
<a href="https://www.benzinga.com/economics/macro-economic-events/25/05/45645056/gold-etf-bleeds-money-at-fastest-pace-in-3-years-is-the-safe-haven-trade-over">"Gold ETF bleeds money at fastest pace in 3 years — is the safe-haven trade over?"</a>, by Piero Cingari, reports that the SPDR Gold Shares ETF (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/GLD#NYSE">GLD</a>) experienced $2.1 billion in outflows in May — its worst since July 2022 — as easing U.S.-China tensions and a surging S&amp;P 500 shifted investor appetite toward riskier assets, though Goldman Sachs still forecasts gold reaching $3,700 per ounce by year-end, driven by central bank demand and long-term macro risks.
For more bearish takes, be sure to see these posts:
<a href="https://www.benzinga.com/news/stock-split/25/05/45679654/mullen-automotive-stock-is-tumbling-thursday-whats-driving-the-action">Mullen Automotive Stock Is Tumbling Thursday: What's Driving The Action?</a>
<a href="https://www.benzinga.com/general/biotech/25/05/45655674/rocket-pharmas-gene-therapy-future-clouded-by-regulatory-uncertainty">Rocket Pharma's Gene Therapy Future Clouded By Regulatory Uncertainty</a>
<a href="https://www.benzinga.com/general/biotech/25/05/45624650/why-is-neuropace-stock-falling-after-epilepsy-treatment-study-data">Why Is NeuroPace Stock Falling After Epilepsy Treatment Study Data?</a>
Keep up with all the latest breaking news and trading ideas by following <a href="https://twitter.com/Benzinga" target="_blank" rel="noreferrer noopener">Benzinga</a><a href="http://twitter.com/Benzinga" target="_blank" rel="noreferrer noopener"> on X</a>.
Image created using artificial intelligence via Midjourney.

MRVL

MULN

NPCE

NVDA

PATH

PLTR

RCKT

SPRO

Benzinga Bulls And Bears: Nvidia, Palantir, Marvell Technology — And Markets Rallied In May

Regeneron Pharmaceuticals, Inc. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/REGN#NASDAQ">REGN</a>) and Sanofi SA (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/SNY#NASDAQ">SNY</a>) on Friday announced results from two Phase 3 trials of itepekimab in <a href="https://www.benzinga.com/general/health-care">chronic obstructive pulmonary disease (COPD) patients</a>.
Phase 3 AERIFY-1 trial evaluating itepekimab in adults who were former smokers with inadequately controlled COPD met the primary endpoint of significantly reducing moderate or severe acute exacerbations by 27% compared to placebo at week 52, <a href="https://www.benzinga.com/pressreleases/25/05/g45687030/itepekimab-met-primary-endpoint-in-one-of-two-chronic-obstructive-pulmonary-disease-copd-phase-3-t">a clinically meaningful benefit</a>.
A second Phase 3 trial, AERIFY-2, did not meet the same primary endpoint. Despite showing some benefit earlier in the trial (at week 24), itepekimab did not achieve a statistically significant reduction in moderate or severe exacerbations at week 52 in the second trial.
Also Read: <a href="https://www.benzinga.com/general/biotech/25/03/44121869/gsks-once-daily-inhalers-for-smokers-lung-has-potential-benefits-independent-organization-report" target="_blank" rel="noreferrer noopener">GSK&#8217;s Once-Daily Inhalers For Smoker&#8217;s Lung Has Potential Benefits: Independent Organization Report</a>
In the trials, patients were randomized to receive itepekimab every two weeks (AERIFY-1: n=375; AERIFY-2: n=326), every four weeks (AERIFY-1: n=377; AERIFY-2: n=303), or placebo (AERIFY-1: n=375; AERIFY-2: n=324), which was added to inhaled triple or double standard-of-care therapy.
The primary endpoint for AERIFY-1 and AERIFY-2 was the reduction in the annualized rate of acute moderate or severe COPD exacerbations with itepekimab treatment.
The total number of exacerbations was lower than prospectively anticipated, decreasing the power of both trials. Enrollment largely occurred during the global COVID-19 pandemic, which could have contributed to the lower overall exacerbation rates.
The safety profile of itepekimab was consistent across dosing regimens, and adverse events (AEs) were generally comparable between treatment and placebo groups.
Regeneron and Sanofi will review the data and discuss it with regulatory authorities to evaluate the next steps.
Itepekimab is also being evaluated in other respiratory conditions, including chronic rhinosinusitis without nasal polyps, chronic rhinosinusitis with nasal polyps, and non-cystic fibrosis bronchiectasis.
In November 2024, Regeneron and Sanofi&#8217;s Dupixent gained FDA approval for COPD, marking its sixth U.S. indication since its first use for atopic dermatitis&nbsp;<a target="_blank" href="https://www.benzinga.com/general/biotech/24/11/41945225/regeneron-sanofis-dupixent-approval-signals-major-treatment-breakthrough-for-smokers-lung-disease" rel="noreferrer noopener">seven years ago</a>.
This expansion positions Dupixent as the first targeted therapy for COPD, a significant leap in treating this progressive lung condition that impedes breathing due to obstructed airflow.
Last Thursday, the U.S. Food and Drug Administration (FDA) approved GSK Plc&#8217;s (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/GSK#NYSE">GSK</a>) Nucala (mepolizumab) as an add-on maintenance treatment for adult patients with inadequately controlled COPD and <a href="https://www.gsk.com/en-gb/media/press-releases/nucala-mepolizumab-approved-by-us-fda/">an</a> eosinophilic phenotype.
Last June, the FDA approved&nbsp;Verona Pharma plc's&nbsp;(NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/VRNA#NASDAQ">VRNA</a>) Ohtuvayre (ensifentrine) for the maintenance treatment of chronic obstructive pulmonary disease (COPD)&nbsp;<a target="_blank" href="https://www.benzinga.com/general/biotech/24/06/39526177/first-inhaled-copd-therapy-in-over-2-decades-fda-approves-verona-pharmas-first-commercial-product" rel="noreferrer noopener">in adult patients</a>.
Ohtuvayre is the first inhaled product with a novel mechanism of action available for the maintenance treatment of COPD in more than 20 years.
In May, Sanofi announced it will invest at least $20 billion in the U.S. <a href="https://www.benzinga.com/general/health-care" target="_blank" rel="noreferrer noopener">through 2030</a>. Research and development, plus U.S. manufacturing, will receive the <a href="https://www.benzinga.com/25/05/45419235/sanofi-joins-other-big-pharma-to-navigate-potential-tariff-impact-with-at-least-20-billion-in-investments-through-2030" target="_blank" rel="noreferrer noopener">bulk of the spending</a>.
The company also expects higher job creation within the communities where Sanofi and its partners are located, which will help&nbsp;enhance the U.S. supply chain.
Earlier in May, Regeneron secured the winning bid in the bankruptcy auction for key assets of&nbsp;23andMe Holding Co.&nbsp;in a&nbsp;$256 million deal&nbsp;to boost its genetics-based <a target="_blank" href="https://www.benzinga.com/general/biotech/25/05/45504107/genetic-data-from-23andme-ends-up-with-this-company-in-256-million-deal" rel="noreferrer noopener">drug discovery efforts</a>.
Price Action: REGN stock is down 9.98% at $545, and SNY stock is down 4.57% at $49.96 during the premarket session at last check Friday.
Read Next:
<ul class="wp-block-list">
<li><a href="https://www.benzinga.com/25/05/45487788/trumps-drug-price-order-hits-pbms-hardest-cvs-cigna-unh-in-focus-as-experts-highlight-racket-and-pricing-distortion">Trump&#8217;s Drug Price Order Hits PBMs Hardest: CVS, Cigna, UNH In Focus As Experts Highlight &#8216;Racket,&#8217; Pricing Distortion</a></li>
</ul>
Photo by Marianne Campolongo via Shutterstock

VRNA

Regeneron, Sanofi Stock Falls After Uneven Smoker's Lung Drug Data

WIIM

Sanofi shares are trading lower after the company and Regeneron said the AERIFY-1 study met its primary endpoint but the AERIFY-2 study didd not.

<ul>
<li>AERIFY-1 study met its primary endpoint of a statistically significant reduction in moderate or severe exacerbations in former smokers regardless of eosinophilic phenotype and provided a clinically meaningful benefit</li>
<li>AERIFY-2 study, a second Phase 3 study, did not meet the primary endpoint despite a benefit seen earlier in the study</li>
<li>Itepekimab was generally well tolerated in both AERIFY-1 and AERIFY-2</li>
<li>Sanofi and Regeneron are assessing the data and will discuss with regulatory authorities to evaluate next steps</li>
</ul>

Sanofi And Regeneron To Consult Regulators After Mixed Phase 3 COPD Results For Itepekimab, As AERIFY-1 Meets Primary Endpoint And AERIFY-2 Falls Short

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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Photo: Shutterstock

Robert F. Kennedy Jr. Says CDC Drops COVID Vaccine For 'Healthy' Pregnant Women, Children

- Sanofi today announces the formal opening of the company's new flagship US offices, unveiling a state-of-the-art modern workplace fostering collaboration and innovation with the ultimate goal of bringing medicines and vaccines to patients faster.

Sanofi Opens New $130M Offices In Morristown, NJ

Vigil Neuroscience, Inc. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/VIGL#NASDAQ">VIGL</a>) on Wednesday disclosed that it entered a deal to be acquired by Sanofi (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/SNY#NASDAQ">SNY</a>) for&nbsp;an equity value of approximately <a target="_blank" href="https://www.benzinga.com/pressreleases/25/05/g45555759/vigil-neuroscience-enters-into-definitive-merger-agreement-to-be-acquired-by-sanofi" rel="noreferrer noopener">$470 million (on a fully diluted basis)</a>.
Per the terms, Sanofi will pay $8.00 per share in cash to acquire Vigil. In addition, shareholders will be granted a non-tradeable contingent value right (CVR), which could provide an extra $2.00 per share in cash if VG-3927 achieves its first commercial sale <a target="_blank" href="https://www.benzinga.com/pressreleases/25/05/g45555705/press-release-sanofi-to-acquire-vigil-neuroscience-inc-adding-a-new-investigational-medicine-to-tr" rel="noreferrer noopener">within a designated timeframe</a>.
The total equity value of the transaction, including the potential CVR payment, represents approximately $600 million on a fully diluted basis.
Also Read: <a target="_blank" href="https://www.benzinga.com/25/01/43167375/vigil-neurosciences-alzheimers-candidate-shows-encouraging-safety-profile-plans-to-start-mid-stage-study-in-q3" rel="noreferrer noopener">Vigil Neuroscience&#8217;s Alzheimer&#8217;s Candidate Shows Encouraging Safety Profile, Plans To Start Mid-Stage Study In Q3</a>
This acquisition, expected to close in the third quarter of 2025, strengthens Sanofi&#8217;s neurology pipeline with VG-3927, an oral TREM2 agonist for Alzheimer&#8217;s disease, addressing a critical unmet need in treatment.
Ivana Magovčević-Liebisch, Ph.D., J.D., President and CEO of Vigil, said, &#8220;Sanofi&#8217;s development capabilities, therapeutic expertise, global footprint, and financial strength provide the greatest opportunity to further the development of VG-3927 for the potential treatment of Alzheimer&#8217;s disease and potentially bring this important and differentiated therapy to those struggling with the immense burden of this disease.&#8221;
Houman Ashrafian, M.D., Ph.D., Head of Research and Development of Sanofi, added, &#8220;TREM2 represents a compelling target at the intersection of immune dysregulation and neurodegeneration, particularly in people living with Alzheimer&#8217;s because they face devastating cognitive decline with limited treatment options.&#8221;
In April 2025, Vigil Neuroscience presented new data from its oral small molecule program, featuring its lead candidate, VG-3927, through two oral presentations at the AD/PD 2025 <a target="_blank" href="https://www.benzinga.com/pressreleases/25/04/g44603290/vigil-neuroscience-presents-data-on-its-small-molecule-trem2-agonist-vg-3927-in-two-oral-presentat" rel="noreferrer noopener">International Conference in Austria</a>.
At that time, Ivana Magovčević-Liebisch said the two presentations highlight the strong potential of VG-3927. This oral, brain-penetrant TREM2 agonist showed positive results in Phase 1, with good safety, tolerability, and drug activity.
She further explained that VG-3927 could offer a new way to treat Alzheimer&#8217;s disease by targeting more than just amyloid buildup.
Vigil plans to begin Phase 2 trials of VG-3927, the only once-daily oral TREM2 agonist currently in clinical development, later this year.
Vigil&#8217;s monoclonal antibody program, Iluzanebart (VGL101), is excluded from the acquisition by Sanofi. Before the transaction is finalized, the exclusive license agreement with Amgen for VGL101 will be terminated, and the rights to the program will be returned to Amgen, its original licensor.
Price Action: SNY shares were trading lower by 0.36% to $52.71 premarket at last check Thursday, and VIGL shares traded higher by 245.9% at $7.99.
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</ul>
Image by HJBC via Shutterstock

VIGL

Sanofi Boosts Alzheimer's Pipeline With Vigil Neuroscience Acquisition

Financial considerations Under the terms of the merger agreement, Sanofi and Vigil have agreed to the following:
<ul>
<li>Sanofi will acquire all outstanding common shares of Vigil for $8 per share in cash at closing, representing an equity value of approximately $470 million (on a fully diluted basis)</li>
<li>In addition, Vigil's shareholders will receive a non-transferrable contingent value right (CVR) per Vigil share, which will entitle its holder to receive a deferred cash payment of $2, conditioned upon the first commercial sale of VG-3927.</li>
</ul>
To demonstrate their commitment to the transaction, Bruce Booth, Atlas Ventures, and CEO Ivana Magovčević-Liebisch have signed voting and support agreements in favor of the deal. The shares subject to these agreements represent a total of approximately 16.2% of Vigil's total common shares outstanding.

Reported Earlier, Sanofi To Acquire Vigil Neuroscience In $470M Deal, Boosting Neurology Pipeline With Investigational Alzheimer's Medicine

In the current session, the stock is trading at $53.16, after a 0.51% spike. Over the past month, Sanofi Inc. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/SNY#NASDAQ">SNY</a>) stock increased by 0.04%, and in the past year, by 8.24%. With performance like this, long-term shareholders are optimistic but others are more likely to look into the price-to-earnings ratio to see if the stock might be overvalued.

<img src="https://www.benzinga.com/files/images/story/2025/1747836025_0_0.png" alt="Past Year Chart" />

<h3>Sanofi P/E Compared to Competitors</h3>
The P/E ratio measures the current share price to the company's EPS. It is used by long-term investors to analyze the company's current performance against it's past earnings, historical data and aggregate market data for the industry or the indices, such as S&amp;P 500. A higher P/E indicates that investors expect the company to perform better in the future, and the stock is probably overvalued, but not necessarily. It also could indicate that investors are willing to pay a higher share price currently, because they expect the company to perform better in the upcoming quarters. This leads investors to also remain optimistic about rising dividends in the future. 
Compared to the aggregate P/E ratio of the 28.58 in the Pharmaceuticals industry, Sanofi Inc. has a lower P/E ratio of 18.95. Shareholders might be inclined to think that the stock might perform worse than it's industry peers. It's also possible that the stock is undervalued. 

<img src="https://www.benzinga.com/files/images/story/2025/1747836026_1.png" alt="Guage" />

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

Intraday Update

Price Over Earnings Overview: Sanofi

Press Releases

Deep Track Capital Files Definitive Proxy Statement and Sends Letter to Fellow Shareholders

Sanofi to invest at least $20 billion in the US through 2030, growing investments in science and expanding domestic manufacturing

Viz.ai Announces Collaboration With Sanofi and Regeneron to Improve Management and Care of Chronic Obstructive Pulmonary Disease (COPD)

Vigil Neuroscience Enters into Definitive Merger Agreement to be Acquired by Sanofi

Sanofi opens new, $130 million NJ offices in Morristown, showcasing innovative, modern design and strengthening US presence

Navitas (NASDAQ: NVTS) Surges on NVIDIA Deal – SNYR, VIGL, XAGE Lead $2 Stock Watch Now, More Inside

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

Sanofi to acquire Blueprint Medicines, expanding portfolio in rare immunological disease and adding early-stage pipeline in immunology

Legal

Johnson Fistel Investigates Fairness of Proposed Sale of Blueprint Medicines

BLUEPRINT MEDICINES INVESTOR ALERT by the Former Attorney General of Louisiana: Kahn Swick & Foti, LLC Investigates Adequacy of Price and Process in Proposed Sale of Blueprint Medicines Corporation - BPMC

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