Regeneron Pharmaceuticals Inc - REGN STOCK NEWS

Regeneron Pharmaceuticals (NASDAQ: REGN) has announced its upcoming participation in two major investor conferences. The company will present at the Jefferies London Healthcare Conference on November 19, 2024, at 11:00 a.m. BST (6:00 a.m. ET), and at the Piper Sandler 36th Annual Healthcare Conference on December 5, 2024, at 9:30 a.m. ET.

Both presentations will be accessible via webcast through Regeneron's investor relations website. Recordings and transcripts will remain available for a minimum of 30 days after the events.

Regeneron Pharmaceuticals and Sanofi announced European Commission approval of Dupixent (dupilumab) for treating eosinophilic esophagitis (EoE) in children aged 1 to 11 years weighing at least 15 kg. The approval is based on Phase 3 trial results showing 68% of children achieved histological disease remission at 16 weeks compared to 3% on placebo. The treatment demonstrated an 86% reduction in peak esophageal intraepithelial eosinophil count from baseline. This makes Dupixent the first and only medicine approved in the EU for treating EoE in young children who are inadequately controlled by conventional therapy.

Regeneron (REGN) reported strong Q3 2024 financial results with an 11% revenue increase to $3.72 billion. Key highlights include Dupixent global sales growth of 23% to $3.82 billion, EYLEA HD and EYLEA U.S. sales up 3% to $1.54 billion, and Libtayo global sales increase of 24% to $289 million. GAAP diluted EPS rose 30% to $11.54, while non-GAAP diluted EPS grew 8% to $12.46. The FDA approved Dupixent as the first biologic therapy for COPD treatment. The company maintains a robust pipeline with approximately 40 product candidates in clinical development.

Regeneron Pharmaceuticals and Sanofi presented positive Phase 3 data for Dupixent in treating chronic spontaneous urticaria (CSU). The LIBERTY-CUPID Study C showed significant improvements in patients receiving Dupixent with antihistamines compared to placebo. Key results at 24 weeks included a 8.64-point reduction in itch severity score and 41% of patients achieving well-controlled disease status. The study involved 151 biologic-naïve patients, with 74 receiving Dupixent and 77 receiving placebo. Safety results aligned with Dupixent's known profile, with 53% experiencing treatment emergent adverse events in both groups. The companies plan to submit for U.S. regulatory approval by year-end.

Regeneron Pharmaceuticals announced positive three-year data for EYLEA HD® (aflibercept) Injection 8 mg from an extension study of the Phase 3 PHOTON trial in patients with diabetic macular edema (DME). Key findings include:

- 88% of EYLEA HD patients maintained ≥12-week dosing intervals at week 156
- 48% achieved ≥20-week dosing intervals
- Sustained visual gains and anatomic improvements from year two
- Patients switched from EYLEA® 2 mg to EYLEA HD experienced slower fluid reaccumulation
- 83% of switched patients maintained ≥12-week dosing intervals

The safety profile remained consistent with known EYLEA HD and EYLEA profiles. These results support EYLEA HD's longer duration of action and potential for reduced treatment burden in DME patients.

Regeneron Pharmaceuticals and Sanofi announced that the FDA has approved Dupixent® (dupilumab) as the first-ever biologic medicine for adults with inadequately controlled chronic obstructive pulmonary disease (COPD) and an eosinophilic phenotype. This approval follows recent approvals in the EU and China.

The approval is based on two Phase 3 trials (BOREAS and NOTUS) that showed Dupixent significantly reduced exacerbations, improved lung function, and enhanced health-related quality of life compared to placebo. Key results include:

• 30-34% reduction in moderate or severe COPD exacerbations
• 68-74mL improvements in post-bronchodilator FEV1
• 51% response in health-related quality of life measure

Dupixent is now indicated for approximately 300,000 adults in the U.S. with this specific COPD phenotype. The FDA evaluated Dupixent under Priority Review, recognizing its potential significant improvements in efficacy or safety for treating serious conditions.

Regeneron Pharmaceuticals and Sanofi announced that China's National Medical Products Administration (NMPA) has approved Dupixent® (dupilumab) for adults with uncontrolled chronic obstructive pulmonary disease (COPD) characterized by raised blood eosinophils. The approval is based on two Phase 3 trials, BOREAS and NOTUS, which showed Dupixent significantly reduced COPD exacerbations by 30% and 34% respectively, improved lung function, and enhanced quality of life compared to placebo.

COPD is the most prevalent chronic respiratory disease in China, affecting one in four people with COPD worldwide. The approval of Dupixent fills a gap in targeted therapy for COPD patients who remain inadequately controlled even after triple therapy. Dupixent is now approved in four indications across respiratory and dermatological diseases in China, and in more than 30 countries worldwide for COPD treatment.

Regeneron Pharmaceuticals (NASDAQ: REGN) has announced it will report its third quarter 2024 financial and operating results on Thursday, October 31, 2024, before the U.S. financial markets open. The company will host a conference call and simultaneous webcast at 8:30 AM Eastern Time on the same day.

Participants can access the conference call via webcast on Regeneron's website or by telephone after registering in advance. A replay and transcript of the call will be archived on the company's website for at least 30 days.

Regeneron Pharmaceuticals and Sanofi announced that the European Medicines Agency's CHMP has recommended the expanded approval of Dupixent® (dupilumab) in the EU for eosinophilic esophagitis (EoE) in children aged 1 to 11 years. The recommendation is based on a Phase 3 trial showing significantly greater histological remission in children treated with Dupixent compared to placebo. If approved, Dupixent would be the first and only medicine in the EU indicated for EoE in this age group.

The trial demonstrated sustained results for up to one year, with caregivers observing improvements in EoE signs and symptoms. The safety profile was consistent with that observed in adolescents and adults. The European Commission is expected to make a final decision in the coming months.