Regeneron Pharmaceuticals Stock Price, News & Analysis

Regeneron Pharmaceuticals (NASDAQ: REGN) has secured its sixth consecutive position in the Dow Jones Sustainability World Index (DJSI World) and fifth consecutive inclusion in the DJSI North America Index. The company ranks in the top 1% of global biotechnology companies, being one of only six biotech firms globally in the DJSI World Index.

The company's success stems from significant achievements in Societal Healthcare, Human Capital Management, and Corporate Governance. Their responsibility strategy focuses on three key areas: improving lives of people with serious diseases, fostering integrity and excellence, and building sustainable communities. Regeneron is on track to meet its 2025 goals, which include developing ~40 investigational medicines, implementing responsible AI practices, ensuring global pay equity, and enhancing treatment access in lower-income countries.

Regeneron Pharmaceuticals (NASDAQ: REGN) presented new data for odronextamab at the ASH Annual Meeting, highlighting promising results across multiple B-cell lymphoma types. In the OLYMPIA-1 trial's safety lead-in, odronextamab achieved complete responses in all 12 evaluable previously untreated follicular lymphoma patients.

The ELM-1 trial's expansion cohort showed 48% objective response rate in diffuse large B-cell lymphoma patients who progressed after CAR-T therapy, with 32% achieving complete response. The ELM-2 trial demonstrated 77% complete response rate in relapsed/refractory marginal zone lymphoma patients.

Odronextamab is currently approved in the EU as Ordspono™ for certain lymphoma indications, with U.S. regulatory resubmission expected in first half of 2025.

Regeneron Pharmaceuticals announced positive Phase 3 data for their novel combination treatment pozelimab and cemdisiran (poze-cemdi) in treating paroxysmal nocturnal hemoglobinuria (PNH). The exploratory cohort of the ACCESS-1 trial showed superior results compared to standard-of-care ravulizumab.

Key findings showed that 96% of patients achieved adequate LDH control with poze-cemdi, compared to 80% with ravulizumab. Additionally, 93% achieved LDH normalization with poze-cemdi versus 65% with ravulizumab. The treatment demonstrated an 84% decrease in LDH from baseline at week 26.

The safety profile was comparable to approved C5 inhibitors, with treatment-emergent adverse events occurring in 84% of poze-cemdi patients versus 87% for ravulizumab. The combination therapy offers the advantage of four-week subcutaneous delivery with potential for self-administration.

Regeneron Pharmaceuticals will present new data from its hematology pipeline across 23 abstracts at the ASH 2024 Annual Meeting. Key highlights include head-to-head results comparing pozelimab plus cemdisiran versus ravulizumab in paroxysmal nocturnal hemoglobinuria, and initial results for odronextamab in first-line follicular lymphoma. The presentations showcase progress in treating 10 types of blood cancers and disorders through various therapeutic approaches, including CD3 bispecific antibodies, costimulatory bispecific antibodies, and a combination of monoclonal antibody and siRNA. Notable presentations include results from the Phase 3 OLYMPIA-1 trial, ELM-1 and ELM-2 trials in diffuse large B-cell lymphoma, and updates on linvoseltamab in multiple myeloma.

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.