Sanofi FR Stock Price, News & Analysis

Regeneron Pharmaceuticals and Sanofi have announced that the European Commission expanded the marketing authorization for Dupixent (dupilumab) to include children aged 6 to 11 with severe asthma characterized by type 2 inflammation. Supported by Phase 3 trial data, Dupixent significantly reduced severe asthma attacks by up to 65% compared to placebo, improved lung function, and quality of life. The treatment also reduced reliance on systemic corticosteroids by 66%. The approval highlights Dupixent's established safety profile and its commitment to addressing severe asthma in pediatric patients.

Regeneron and Sanofi announced positive results from the Phase 3 PRIME2 trial for Dupixent (dupilumab), showing significant effectiveness in treating prurigo nodularis. At 12 weeks, 37% of patients on Dupixent experienced meaningful itch reduction, compared to 22% on placebo. By 24 weeks, this increased to 58% vs 20%. Dupixent also improved skin clarity in 45% of patients. Regulatory filings for Dupixent's approval in prurigo nodularis are planned for 2022. Safety results were consistent with its existing profile, although some adverse events were reported.

Seagen and Sanofi have entered an exclusive collaboration to develop and commercialize antibody-drug conjugates (ADCs) for up to three cancer targets. This partnership combines Sanofi's monoclonal antibody technology with Seagen's ADC technology. Both companies will co-fund global development activities and share future profits. Sanofi will also provide undisclosed payments for the selected targets. The first target has already been designated, aligning with Seagen's strategy to advance cancer treatment options.

Regeneron and Sanofi announced positive Phase 3 trial results for Dupixent (dupilumab) 300 mg weekly in treating eosinophilic esophagitis (EoE), a chronic inflammatory disease. The trial showed a 64% reduction in disease symptoms after 24 weeks compared to placebo, with 59% of Dupixent patients achieving histological remission. The safety profile was consistent with previous studies. Regulatory filings are expected in 2022. EoE affects around 160,000 patients in the U.S., highlighting the potential market for Dupixent in this indication.

Sanofi announced a collaboration with Breast International Group (BIG), EORTC, and AFT to initiate the Phase 3 AMEERA-6 study, focusing on the oral selective estrogen receptor degrader (SERD) amcenestrant for estrogen receptor-positive breast cancer in patients unable to continue aromatase inhibitor therapy. The trial aims to evaluate amcenestrant's efficacy and safety against tamoxifen. Sanofi will sponsor the study, which is crucial for providing alternatives in adjuvant therapy to combat disease recurrence.

Sanofi and Merck have announced that Vaxelis, the first hexavalent combination vaccine in the U.S., is now available. This vaccine protects against six diseases: diphtheria, tetanus, pertussis, polio, Hib, and hepatitis B, administered in three doses to children aged 6 weeks to 4 years. The vaccine aims to reduce the number of shots children need, improving vaccination coverage. Vaxelis has been included in the CDC's immunization schedule and will be distributed through various channels. The collaboration reflects a commitment to enhancing pediatric health.

Sanofi has announced a three-year research collaboration with Stanford University School of Medicine, aiming to deepen the understanding of immunology and inflammation. The partnership will explore autoimmune diseases and inflammatory conditions, with funding for up to three joint programs annually. Initial projects will focus on type 2 inflammation, T cell mechanisms in autoimmunity, and immune-related adverse events. This collaboration strengthens Sanofi's commitment to research and innovation within immunoscience.

Sanofi has partnered with Moderna to manufacture up to 200 million doses of its COVID-19 vaccine, utilizing its Ridgefield, NJ facility starting September 2021. This represents Sanofi's third manufacturing commitment in response to the pandemic, having previously supported BioNTech and Johnson & Johnson. The company is also developing its COVID-19 vaccine candidates in collaboration with GSK and Translate Bio. Sanofi aims to enhance global vaccine supply while continuing its internal vaccine development efforts.