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Sanofi

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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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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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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€

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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

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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.
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<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>
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Photo: Shutterstock

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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:
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<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

REGN

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.
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<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.
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Disclaimer:&nbsp;This content was partially produced with the help of AI tools and was reviewed and published by Benzinga editors.
Photo courtesy: 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.
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<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

Sanofi accelerates global shipping of Beyfortus to prepare healthcare providers months ahead of 2025-2026 RSV season

Sanofi And AstraZeneca Accelerate Global Rollout Of Beyfortus To Deliver Season-Long Respiratory Syncytial Virus Protection In Over 40 Countries

These ten mid-cap stocks were the best performers in the last week. Are they in your portfolio?
<ol class="wp-block-list">
<li>Applied Digital Corp (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/APLD#NASDAQ">APLD</a>) shares escalated 102.93% following the announcement of a long-term <a href="https://www.benzinga.com//node/45817409" target="_blank" rel="noreferrer noopener">infrastructure agreement with</a> AI hyperscaler CoreWeave Inc (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/CRWV#NASDAQ">CRWV</a>).</li>
<li>Kymera Therapeutics, Inc. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/KYMR#NASDAQ">KYMR</a>) stock jumped 60.66%. The company revealed clinical results from the Phase 1 healthy volunteer study of KT-621, its first-in-class <a href="https://www.benzinga.com//node/45724030" target="_blank" rel="noreferrer noopener">oral STAT6 degrader medicine</a>. Morgan Stanley and B. Riley Securities upgraded the stock to Overweight and Buy, respectively, and the company <a href="https://www.benzinga.com/quote/kymr/analyst-ratings" target="_blank" rel="noreferrer noopener">received several price forecast bumps</a>.</li>
<li>First Majestic Silver Corp. (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/AG#NYSE">AG</a>) stock increased 34.04% last week, when Silver rocketed past $35.60 an ounce Thursday, a level last seen in 2012. Gold bull Peter Schiff <a href="https://www.benzinga.com//node/45792880" target="_blank" rel="noreferrer noopener">says it's just warming up</a>.</li>
<li>AIFU Inc. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/AIFU#NASDAQ">AIFU</a>) shares rose 31.78%.</li>
<li>Recursion Pharmaceuticals, Inc. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/RXRX#NASDAQ">RXRX</a>) shares increased 31.34% after the company announced the launch of <a href="https://www.benzinga.com//node/45814396" target="_blank" rel="noreferrer noopener">Boltz-2 in partnership with MIT</a>.</li>
<li>Cleveland-Cliffs Inc.'s (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/CLF#NYSE">CLF</a>) stock grew 30.36% after U.S. President Donald Trump announced <a href="https://www.benzinga.com//node/45724684" target="_blank" rel="noreferrer noopener">plans to double steel tariffs</a>.</li>
<li>Zai Lab Limited (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/ZLAB#NASDAQ">ZLAB</a>) shares upped 26.44%. The company and NovoCure Limited (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/NVCR#NASDAQ">NVCR</a>) revealed additional data on Saturday from the Phase 3 PANOVA-3 trial of Tumor Treating Fields (TTFields) <a href="https://www.benzinga.com//node/45730717" target="_blank" rel="noreferrer noopener">therapy for pancreatic cancer</a>.</li>
<li>Blueprint Medicines Corporation (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/BPMC#NASDAQ">BPMC</a>) stock rose 26.15% after the company announced that Sanofi SA (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/SNY#NASDAQ">SNY</a>) <a href="https://www.benzinga.com//node/45719179" target="_blank" rel="noreferrer noopener">would acquire them for $9.5 billion</a>.</li>
<li>Sezzle Inc. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/SEZL#NASDAQ">SEZL</a>) stock escalated 23.78% last week.</li>
<li>Riot Platforms, Inc.'s (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/RIOT#NASDAQ">RIOT</a>) stock rose 22.06%. The company mined 514 bitcoin in May, up 11% month over month and <a href="https://www.benzinga.com//node/45752589" target="_blank" rel="noreferrer noopener">139% year over year</a>.</li>
</ol>
Photo by T. Schneider via Shutterstock

Mid Cap

AIFU

APLD

CRWV

KYMR

NVCR

RIOT

RXRX

SEZL

ZLAB

Applied Digital And Riot Platforms Are Among Top 10 Mid-Cap Gainers Last Week (Jun 2-Jun 6): Are The Others In Your Portfolio?

<h3 class="wp-block-heading">New On The Block</h3>
Byron Allen's Allen Media Group has hired Moelis &amp; Company to explore a sale of its TV stations across 21 markets. The company spent over $1 billion acquiring Big Four network affiliates (ABC, NBC, CBS, FOX) over the past six years. 
It is now looking to cash out and reduce debt. Deadline <a href="https://deadline.com/2025/06/allen-media-group-hires-investment-bank-to-sell-tv-stations-1236420381/">reported</a> that the TV stations have received multiple offers. 
Also for sale: 
<ul class="wp-block-list">
<li>Jefferies is shopping around PatientPoint, a health marketing and ad agency, according <a href="https://www.axios.com/pro/health-tech-deals/2025/06/04/patientpoint-jefferies-sale">to</a> Axios. L Catterton, Littlejohn &amp; Co. and Transformation Capital are on the sell side. </li>
<li>Just three years ago, private equity firm One Equity Partners <a href="https://www.oneequity.com/news/one-equity-partners-completes-investment-in-infucare-rx-a-leading-home-infusion-therapy-provider/">completed</a> a strategic investment in infusion provider InfuCare. Today? It&#8217;s looking to get rid of it. According to Axios, JPMorgan is <a href="https://www.axios.com/pro/health-tech-deals/2025/06/03/infucare-one-equity-jpmorgan-sale">looking</a> for a buyer. </li>
<li>Swiss biotech MoonLake Immunotherapeutics (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/MLTX#NASDAQ">MLTX</a>) received a <a href="https://www.benzinga.com/news/health-care/25/06/45743008/mercks-dealmaking-intensifies-with-moonlake-bid-as-keytruda-patent-cliff-nears-report">bid exceeding $3 billion</a> from Merck &amp; Co Inc (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/MRK#NYSE">MRK</a>). MoonLake turned down the initial offer, but talks are reportedly revived. The potential purchase signals renewed dealmaking activity as investor pressure has mounted on Merck to secure new assets, especially as its blockbuster <a href="https://www.benzinga.com/general/health-care" target="_blank" rel="noreferrer noopener">cancer drug Keytruda</a> faces patent expiration as early as 2028.</li>
</ul>
<h3 class="wp-block-heading">Updates From The Block</h3>
<ul class="wp-block-list">
<li>Post Holdings (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/POST#NYSE">POST</a>) is forking over $880 million—including assumed debt—to buy 8th Avenue Food &amp; Provisions. That means brands like Ronzoni pasta will go back into Post&#8217;s pantry. <a href="https://www.wsj.com/articles/post-holdings-to-buy-ronzoni-pasta-owner-8th-avenue-food-cf8f454c?mod=deals_news_article_pos2">Per</a> The Wall Street Journal, the private-label brands originally got spun off into 8th Avenue in 2018 with help from private equity firm THL. Post plans to wipe out 8th Avenue's net debt and pick up the tab for all equity interests, including $111 million in finance leases. All in, the transaction is expected to cook up $15 million in annual synergies by the end of fiscal 2026. If Post closes by July 1, it expects 2026 to be more profitable (on an adjusted basis) than initially expected.</li>
</ul>
<ul class="wp-block-list">
<li>Rosebank Industries (LON: ROSE) is once again in talks to buy Electrical Components International (ECI), a wire harnesses manufacturer, for about $1.9 billion, Reuters reported. Rosebank was in talks to buy ECI in February but dropped the plans in March.</li>
</ul>
<ul class="wp-block-list">
<li>Sanofi SA (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/SNY#NASDAQ">SNY</a>) 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. 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. Sanofi will pay&nbsp;$129&nbsp;per share in cash, representing an equity value <a href="https://www.benzinga.com/news/health-care/25/06/45719179/sanofi-expands-rare-immunology-portfolio-with-blueprint-buyout">of roughly&nbsp;$9.1 billion</a>.</li>
</ul>
<ul class="wp-block-list">
<li>Suzano S.A. (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/SUZ#NYSE">SUZ</a>) is acquiring a 51% stake in a new $3.4 billion tissue products joint venture with Kimberly-Clark (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/KMB#NASDAQ">KMB</a>), <a href="https://www.benzinga.com/m-a/25/06/45797473/tissue-titans-unite-suzano-kimberly-clark-form-3-4-billion-global-jv">paying $1.734 billion in cash</a>. Kimberly-Clark will retain a 49% stake. The Netherlands-based venture will produce and distribute toilet paper and facial tissues in 70 countries, with 22 factories across 14 countries, employing about 9,000 people. The facilities have an annual capacity of 1 million tonnes and generated $3.3 billion in net sales in 2024.</li>
</ul>
<h3 class="wp-block-heading">Off The Block</h3>
<ul class="wp-block-list">
<li>Robinhood (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/HOOD#NASDAQ">HOOD</a>) <a href="https://www.benzinga.com/crypto/cryptocurrency/25/06/45740112/robinhood-completes-200-million-bitstamp-deal-gains-access-to-500k-crypto-users-and-95-million-revenue-stream">completed its $200 million acquisition</a> of Bitstamp, a crypto exchange that had raised around $40 million from firms like Pantera Capital and Ripple.</li>
</ul>
<ul class="wp-block-list">
<li>Cactus Inc. (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/WHD#NYSE">WHD</a>) <a href="https://www.benzinga.com/m-a/25/06/45724879/cactus-takes-majority-stake-in-baker-hughes-spc-for-global-reach">formed a joint venture</a> with Baker Hughes Co. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/BKR#NASDAQ">BKR</a>), taking a 65% stake and operational control of Baker Hughes&#8217; Surface Pressure Control (SPC) business. Baker Hughes will retain a 35% stake. The new venture, separate from Cactus' current pressure control unit, will focus on international wellhead and production tree systems.</li>
</ul>
<ul class="wp-block-list">
<li>Guardian Pharmacy Services, Inc. (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/GRDN#NYSE">GRDN</a>) is <a href="https://www.benzinga.com/pressreleases/25/06/b45719054/guardian-pharmacy-services-expands-pacific-northwest-footprint-with-acquisition-of-washington-base" target="_blank" rel="noreferrer noopener">entering the Pacific Northwest market</a> via acquisition. Mercury Pharmacy Services, a provider of long-term care pharmacy solutions, agreed to a price, but <a href="https://www.benzinga.com/m-a/25/06/45723960/guardian-pharmacy-strengthens-us-footprint-with-new-seattle-area-acquisition">the amount remains undisclosed</a>.</li>
</ul>
<h3 class="wp-block-heading">Bankruptcy Block</h3>
<ul class="wp-block-list">
<li>AI startup Builder.ai has filed for Chapter 7 bankruptcy in Delaware after creditors seized most of its cash, citing overstated 2024 sales projections—by a staggering 300%. Once valued at $1.5 billion, Builder.ai is now the biggest AI collapse since the ChatGPT-driven investment boom began. According <a href="https://www.bloomberg.com/news/articles/2025-06-05/builder-ai-files-for-bankruptcy-after-creditors-seize-accounts?sref=TBDibEcD">to</a> Bloomberg, the fallout was fueled by revelations that Builder.ai allegedly faked business with Indian social media firm VerSe Innovation to inflate revenues. VerSe co-founder Umang Bedi denies any wrongdoing, calling the claims "baseless and false."</li>
</ul>
<ul class="wp-block-list">
<li>Hooters closed some 30 corporate-owned restaurants and explained that it has <a href="https://www.businesswire.com/news/home/20250331979797/en/Hooters-of-America-Takes-Strategic-Action-to-Continue-its-Iconic-Legacy-Under-Pure-Franchise-Business-Model" target="_blank" rel="noreferrer noopener">no plans </a>to shut down any other locations. The Atlanta, Georgia-based restaurant chain went <a href="https://www.benzinga.com/personal-finance/25/04/44647084/hooters-files-for-bankruptcy-says-brand-isnt-going-anywhere">bankrupt earlier this year</a>.</li>
</ul>
<ul class="wp-block-list">
<li>Alex Jones may see his personal assets — including guns, cars, and homes — sold by the end of the year, according to the Houston Chronicle, <a href="https://www.houstonchronicle.com/news/houston-texas/texas/article/alex-jones-personal-assets-sales-bankruptcy-20361565.php">citing</a> a bankruptcy trustee. The potential sale would mark the nearing end of his two-and-a-half-year bankruptcy process. Jones, who created the far-right conspiracy theory website Infowars, filed for bankruptcy in 2022 after being ordered to pay nearly $1.5 billion to families of Sandy Hook shooting victims for defamation.</li>
</ul>
<h3 class="wp-block-heading">Notes From The Block</h3>
A studio's IP portfolio and game development pipeline are critical for video game investors. A major acquirer in the sector is GDEV Inc (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/GDEV#NASDAQ">GDEV</a>). The Cyprus-based company has made three M&amp;A deals and spent $100 million on studio acquisitions since 2022. 
This week, Andrey Fadeev drafted <a href="https://www.benzinga.com/m-a/25/06/45722621/gdevs-founder-ceo-evaluates-m-a-deals-using-these-5-metrics">a listicle of key metrics</a> GDEV uses for M&amp;A evaluation.
<ol class="wp-block-list">
<li>LTV/CAC Ratio – Measures how efficiently a studio converts user acquisition spend into revenue. A ratio above 1.0 indicates profitable user growth.</li>
<li>Retention Rates (D1, D7, D30) – Track user engagement over time. High retention signals strong gameplay and monetization potential. Benchmarks vary by genre.</li>
<li>ARPU/ARPPU – Indicate monetization efficiency. ARPU includes all users; ARPPU focuses on paying users. Higher ARPU justifies higher CAC.</li>
<li>DAU/MAU Ratio – Shows user engagement depth. A ratio above 20% is considered strong.</li>
<li>EBITDA – Reflects core operational profitability and financial health. High EBITDA margins show sustainable growth and efficiency.</li>
</ol>
In 2024, video game M&amp;A activity reached $27.3 billion, underscoring the sector's immense growth and investment appeal. C-suite executives would be wise to consider these metrics when searching for their next target. 
<a href="https://www.benzinga.com/markets/asset-sales/25/05/45702349/deal-dispatch-beauty-brand-behavioral-health-firms-hit-auction-block">For last week&#8217;s edition of Deal Dispatch, click here</a>.
Now Read:
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<li><a href="https://www.benzinga.com/m-a/25/06/45816311/conagra-sells-seafood-brands-for-55m-as-it-sharpens-focus-on-core-business">Conagra Sells Seafood Brands For $55M As It Sharpens Focus On Core Business</a></li>
</ul>
Image created using a photo from Shutterstock.

Asset Sales

GDEV

GRDN

HOOD

KEYS

MLTX

POST

ROSE

SNOW

Deal Dispatch: TV Stations For Sale, This Buyer Wants Seconds On Pasta

U.S. Health Secretary Robert F. Kennedy Jr. has championed &#8220;medical freedom&#8221; while simultaneously limiting access to COVID-19 vaccines and restricting food stamp purchases, creating what public health experts call a dichotomy in his approach to healthcare policy.
What Happened: Kennedy announced last week that the Centers for Disease Control and Prevention would remove COVID-19 vaccines from <a href="https://www.benzinga.com/news/25/05/45661031/robert-f-kennedy-jr-says-cdc-drops-covid-vaccine-for-healthy-pregnant-women-children">recommended </a>immunization schedules for healthy children and pregnant women.
The decision bypassed traditional advisory committee processes and shifted coverage from routine recommendations to shared clinical decision-making between doctors and patients.
&#8220;Regarding the vaccines, HHS is restoring the doctor-patient relationship,&#8221; HHS spokesperson Andrew Nixon said in a <a href="https://abcnews.go.com/Health/rfk-jr-promoted-freedom-choice-limiting-vaccines-food/story?id=122526364">statement</a> to ABC News. &#8220;We are encouraging those groups to consult with their health care provider to help them make an informed decision.&#8221;
Kennedy has also pushed to ban Supplemental Nutrition Assistance Program recipients from purchasing candy and soda with food stamps. Ten state governors have submitted waivers to the Agriculture Department requesting permission for such restrictions, according to Kennedy&#8217;s statements at a Make America Healthy Again event in May.
The Food and Drug Administration began <a href="https://www.benzinga.com/government/regulations/25/05/45399804/robert-kennedy-jr-cheers-fda-plan-to-ban-fluoride-supplements-for-children-calls-move-long-overdue">removing fluoride supplements for children </a>from the market, earning Kennedy&#8217;s praise as &#8220;long overdue.&#8221; The agency cited a lack of FDA approval and evidence that these products alter gut microbiomes.
Kennedy&#8217;s broader MAHA initiative has influenced restaurant chains to eliminate seed oils. Biglari Holdings Inc. (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/BH#NYSE">BH</a>) subsidiary Steak &#8216;n Shake switched to beef tallow for French fries, while Sweetgreen Inc. (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/SG#NYSE">SG</a>), Bloomin&#8217; Brands Inc. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/BLMN#NASDAQ">BLMN</a>), and Restaurant Brands International Inc. (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/QSR#NYSE">QSR</a>) have initiated similar transitions.
See Also: <a href="https://www.benzinga.com/markets/equities/25/06/45809455/tesla-stock-climbed-nearly-5-in-friday-pre-market-whats-going-on">Tesla Stock Climbed Nearly 5% In Friday Pre-Market: What&#8217;s Going On?</a>
Why It Matters: Critics argue Kennedy&#8217;s policies contradict his &#8220;medical freedom&#8221; messaging by limiting choices. Removing COVID vaccines from CDC schedules restricts access while claiming to promote freedom.
&#8220;If you restrict access, you necessarily restrict choice,&#8221; Dr. Matthew Ferrari of Pennsylvania State University told ABC News. Public health experts warn Kennedy&#8217;s approach individualizes community health decisions. &#8220;We&#8217;re losing a lot of that underpinning, which has led to a lot of the gains in public health,&#8221; Dr. Craig Spencer of Brown University told ABC News.
Read Next:
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<li><a href="https://www.benzinga.com/markets/equities/25/06/45809443/larry-summers-identifies-3-key-reasons-for-rising-us-debt-but-doesnt-think-trumps-big-beautiful-bill-is-the-medicine-the-country-needs">Larry Summers Identifies 3 Key Reasons For Rising US Debt, But Doesn&#8217;t Think Trump&#8217;s &#8216;Big Beautiful Bill&#8217; Is The Medicine The Country Needs</a></li>
</ul>
Disclaimer:&nbsp;This content was partially produced with the help of AI tools and was reviewed and published by Benzinga editors.
Image Via Shutterstock

BLMN

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

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

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

Sanofi Launches 2025 Global Employee Stock Purchase Plan Offering Shares At €72.97 With 20% Discount And Matching Incentive

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

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

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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Photo via Shutterstock

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

Press Releases

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

Sanofi Appoints James Guy as Country Lead, Canada and General Manager, Specialty Care

Legal

SNY Investors Have Opportunity to Join Sanofi Fraud Investigation with the Schall Law Firm

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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AMGN

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