Sanofi FR - SNY STOCK NEWS

Regeneron Pharmaceuticals and Sanofi announced that a Phase 3 trial of Dupixent (dupilumab) 300 mg weekly for treating eosinophilic esophagitis (EoE) showed significant improvements in patient histology and symptoms compared to placebo. Improvements were sustained for up to one year in patients aged 12 and older. Dupixent is the first U.S. approved targeted treatment for EoE. The FDA approved Dupixent in May 2022, and the EMA has given a positive opinion for its use in Europe. Safety results matched Dupixent's known profile, suggesting a favorable risk-benefit ratio.

Innate Pharma (Euronext: IPH; Nasdaq: IPHA) has expanded its collaboration with Sanofi (NASDAQ: SNY) by granting an exclusive license for its B7H3 ANKET^TM program. Sanofi will be accountable for all development and commercialization activities. Innate will receive an upfront payment of €25 million and up to €1.35 billion in potential milestones, along with royalties from net sales. This partnership continues the 2016 collaboration focused on NK cell engagers, enhancing Innate's cancer treatment portfolio and Sanofi's oncology strategy.

Regeneron Pharmaceuticals and Sanofi announced that the European Medicines Agency's Committee has recommended Dupixent for approval to treat adolescents and adults aged 12 and over with eosinophilic esophagitis (EoE). This would make Dupixent the first targeted treatment for EoE in the EU, following its U.S. approval in May 2022. The positive recommendation is based on pivotal trial data showing significant improvements in patients' ability to swallow and histological remission. The European Commission will make a final decision soon.

Regeneron Pharmaceuticals and Sanofi announced that the European Commission approved Dupixent (dupilumab) for treating adults with moderate-to-severe prurigo nodularis, marking it the first targeted medicine for this condition in Europe. Clinical trials showed that 60% of Dupixent patients experienced significant itch reduction at 24 weeks, compared to 18% for placebo. The drug also improved skin lesions and overall quality of life. Approximately 70,000 adults in Europe are affected by this chronic skin disease, underscoring the need for effective treatment options.

Regeneron Pharmaceuticals and Sanofi announced a positive opinion from the European Medicines Agency (EMA) recommending Dupixent (dupilumab) for treating adults with moderate-to-severe prurigo nodularis. If approved, Dupixent will be the first targeted medicine for this condition in the EU. Supported by two pivotal Phase 3 trials, the drug significantly improved itch, skin lesions, and health-related quality of life. Dupixent is already FDA-approved for the same indication in the U.S. The final decision from the European Commission is anticipated shortly.

Regeneron Pharmaceuticals and Sanofi reported positive results from a Phase 3 trial of Dupixent (dupilumab) for treating eosinophilic esophagitis (EoE) in children aged 1 to 11 years. At week 16, up to 68% of children on a higher dose achieved significant disease remission, exceeding the 3% in the placebo group (p<0.0001). The trial suggests Dupixent can improve esophageal damage and promote healthy weight gain in this vulnerable population. Safety data indicated similar adverse event rates compared to placebo, with common issues being mild and manageable. The data has been submitted to global regulatory authorities.

Sanofi US has entered a co-promotion agreement with Provention Bio for the commercialization of teplizumab, an investigational therapy aimed at delaying type 1 diabetes (T1D). Pending FDA approval expected on November 17, 2022, Sanofi will utilize its established diabetes care teams to promote the therapy. Provention Bio retains rights and responsibilities for R&D, while Sanofi will make an upfront payment of $20 million and commit to a potential equity investment of $35 million following FDA approval.

Regeneron Pharmaceuticals and Sanofi announced the FDA's approval of Dupixent (dupilumab) for treating prurigo nodularis in adults, marking it as the first approved therapy for this chronic skin condition. This decision impacts about 75,000 adults in the U.S. affected by prurigo nodularis, a disease characterized by severe itching and skin lesions. The approval followed positive outcomes from pivotal Phase 3 trials, where Dupixent demonstrated significant reductions in itch and skin lesions compared to placebo. Safety data were consistent with known profiles, with common adverse events including nasopharyngitis and conjunctivitis.

Regeneron Pharmaceuticals and Sanofi announced the publication of significant Phase 3 trial results for Dupixent (dupilumab) in treating children aged 6 months to 5 years with uncontrolled atopic dermatitis. The study demonstrated that Dupixent, in combination with low-potency topical corticosteroids, improved skin clearance, reduced severity of disease, and lessened itch compared to placebo. Safety profiles were consistent with older children. The FDA approved Dupixent for this age group in June 2022, with further regulatory reviews ongoing in Europe.