Welcome to our dedicated page for Regeneron Pharmaceuticals news (Ticker: REGN), a resource for investors and traders seeking the latest updates and insights on Regeneron Pharmaceuticals stock.
Regeneron Pharmaceuticals (NASDAQ: REGN) is a leading biotechnology innovator developing transformative treatments for serious diseases through advanced platforms like VelociSuite®. This page serves as the definitive source for official company announcements, research milestones, and therapeutic developments.
Investors and medical professionals will find curated updates including FDA approvals, clinical trial results, partnership announcements, and financial reports. Our aggregation ensures timely access to Regeneron's progress in oncology, immunology, rare diseases, and ophthalmic therapies.
All content is sourced directly from Regeneron's communications and verified financial disclosures. Bookmark this page to monitor the company's pipeline advancements, regulatory updates, and strategic collaborations that drive biopharmaceutical innovation.
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.
Regeneron Pharmaceuticals and Sanofi announced FDA approval of Dupixent® (dupilumab) for adolescents aged 12-17 with inadequately controlled chronic rhinosinusitis with nasal polyps (CRSwNP). This expands the 2019 approval for adults. The FDA granted Priority Review, recognizing potential significant improvements in treating this serious condition.
CRSwNP affects about 9,000 adolescents in the U.S., causing breathing difficulties and reduced quality of life. Dupixent, as an add-on maintenance treatment, offers an alternative to systemic steroids and surgery, which often result in symptom recurrence.
The approval is based on positive results from two pivotal trials in adults (SINUS-24 and SINUS-52), showing significant improvements in nasal congestion, polyp size, and smell. Safety profile in adolescents is consistent with that observed in adults.
Regeneron Pharmaceuticals (NASDAQ: REGN) announced new analyses of EYLEA HD® (aflibercept) Injection 8 mg and EYLEA® (aflibercept) Injection 2 mg to be presented at EURETINA 2024. The data reinforces EYLEA HD's long-term durability, sustained fluid control, and safety profile in wet age-related macular degeneration (wAMD) patients. Key highlights include:
1. Analysis of extended dosing intervals impact
2. Evaluation of sustained fluid control over two years
3. Safety analysis of intraocular pressure outcomes through week 96
4. Indirect comparison with faricimab across different Phase 3 trials
The presentations support EYLEA HD's efficacy, safety, and potential to become the new standard of care for retinal diseases. Additional data on diabetic macular edema and pooled safety analysis will also be shared.
Regeneron Pharmaceuticals and Sanofi announced positive results from a confirmatory Phase 3 trial (LIBERTY-CUPID Study C) of Dupixent for treating chronic spontaneous urticaria (CSU). The trial met primary and key secondary endpoints, showing:
- Nearly 50% reduction in itch and urticaria activity scores compared to placebo
- 30% of Dupixent-treated patients reported no urticaria vs 18% on placebo
- Safety results consistent with Dupixent's known profile
These results confirm findings from Study A. Regeneron plans to submit data to the FDA by year-end 2024 for potential U.S. approval. If approved, Dupixent would be the first targeted CSU therapy in a decade, potentially benefiting over 300,000 people in the U.S. with inadequately controlled CSU.
Regeneron Pharmaceuticals and Sanofi announced positive results from a pivotal trial of Dupixent (dupilumab) in adults with moderate-to-severe bullous pemphigoid (BP). The trial met its primary and all key secondary endpoints, with five times more Dupixent patients achieving sustained disease remission compared to placebo. Notably, 20% of Dupixent patients experienced sustained disease remission at 36 weeks versus 4% for placebo.
Dupixent showed significant improvements in disease severity, itch reduction, and decreased oral corticosteroid use. If approved, it would be the first targeted medicine for BP in the U.S. and EU. The drug's safety profile was consistent with previous studies. These results support upcoming regulatory submissions, starting with the U.S. later this year.
Regeneron Pharmaceuticals (NASDAQ: REGN) announced five-year results from the Phase 3 EMPOWER-Lung 1 trial, evaluating Libtayo (cemiplimab) monotherapy versus chemotherapy for advanced non-small cell lung cancer (NSCLC). Key findings include:
1. Libtayo nearly doubled median overall survival (26 vs 13 months) and reduced death risk by 41%.
2. Progression-free survival improved (8 vs 5 months) with a 50% risk reduction.
3. Objective response rate was higher (46.5% vs 21%) with longer duration (24 vs 6 months).
4. Patients with ≥90% PD-L1 expression showed the greatest benefit (39-month median overall survival).
5. No new safety signals were observed at five years.
Regeneron Pharmaceuticals (NASDAQ: REGN) announced data presentations from its oncology portfolio at the WCLC and ESMO conferences. Key highlights include:
1. Five-year survival data on Libtayo first-line monotherapy in advanced non-small cell lung cancer at WCLC.
2. Two-year results for investigational fianlimab plus Libtayo in advanced melanoma at ESMO, showing high clinical activity and deepening responses.
3. A total of 11 presentations across both conferences, demonstrating Regeneron's progress in treating difficult cancers.
4. New data on fianlimab and Libtayo combination in advanced melanoma, with promising complete response rates and objective response rates across different patient cohorts.
5. Safety profile of the combination generally consistent with Libtayo monotherapy, with some exceptions.
Regeneron will host a virtual investor event on September 16 to discuss these results and provide updates on its oncology portfolio.
Regeneron Pharmaceuticals (NASDAQ: REGN) has received European Commission approval for Ordspono™ (odronextamab) to treat adult patients with relapsed or refractory follicular lymphoma (FL) or diffuse large B-cell lymphoma (DLBCL) after two or more lines of systemic therapy. This marks Ordspono's first global regulatory approval and Regeneron's first approved bispecific antibody.
The approval is based on robust clinical trial results:
- In R/R FL: 80% objective response rate (ORR), 73% complete response (CR)
- In R/R DLBCL (CAR-T naive): 52% ORR, 31% CR
- In R/R DLBCL (post-CAR-T): 48% ORR, 32% CR
Ordspono offers an off-the-shelf, outpatient treatment option with potential for complete remission. Regeneron is advancing its OLYMPIA program to investigate Ordspono in earlier lines of therapy and expanding its bispecific antibody pipeline.
Regeneron Pharmaceuticals (NASDAQ: REGN) announced 20 abstracts on Dupixent® (dupilumab) and investigational therapy itepekimab to be presented at the European Respiratory Society (ERS) Congress 2024. The presentations focus on chronic obstructive pulmonary disease (COPD), asthma, and chronic rhinosinusitis with nasal polyps (CRSwNP).
Key highlights include:
- A pooled analysis of Phase 3 BOREAS and NOTUS trials showing Dupixent reduced COPD exacerbations by 31% over 52 weeks
- New data from the Phase 4 VESTIGE trial on Dupixent's effects on airway remodeling in asthma
- Results on itepekimab in former smokers with COPD
The presentations demonstrate Regeneron's commitment to advancing treatments for respiratory diseases by targeting type 2 inflammation and other pathways.
Regeneron Pharmaceuticals (NASDAQ: REGN) has received a Complete Response Letter (CRL) from the FDA for its Biologics License Application (BLA) for linvoseltamab, a treatment for relapsed/refractory multiple myeloma. The CRL was anticipated and relates to inspection findings at a third-party fill/finish manufacturer. The manufacturer believes the issues have been resolved and awaits FDA reinspection. Regeneron is committed to working with the manufacturer and FDA to bring linvoseltamab to market quickly. The European Medicines Agency (EMA) is still reviewing linvoseltamab for the same indication. This update is important as most multiple myeloma patients relapse and require additional therapies in late-line settings.
