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, Inc. (NASDAQ: REGN) regularly issues news on its medicines, clinical programs and corporate developments across multiple therapeutic areas. As a biotechnology company focused on serious diseases, Regeneron’s announcements often cover advances in eye care, allergic and inflammatory diseases, oncology, hematology, cardiovascular disease, infectious disease and rare conditions.
News about Regeneron frequently highlights regulatory milestones for its marketed products. Recent examples include approvals for Dupixent (dupilumab) in additional indications and age groups, such as chronic spontaneous urticaria in the European Union and bronchial asthma in children in Japan, as well as expanded indications and dosing flexibility for EYLEA HD (aflibercept) Injection 8 mg in retinal diseases. The company also reports on new approvals for Libtayo (cemiplimab), including adjuvant treatment of cutaneous squamous cell carcinoma at high risk of recurrence after surgery and radiation in the European Union.
Investors and healthcare professionals can expect updates on Regeneron’s oncology and hematology pipeline, including data from trials of Lynozyfic (linvoseltamab) in multiple myeloma and odronextamab in B‑cell non‑Hodgkin lymphomas, as well as programs in paroxysmal nocturnal hemoglobinuria and severe aplastic anemia. Regeneron often presents such data at major medical meetings, and issues press releases summarizing efficacy and safety results.
Corporate and R&D collaboration news is another recurring theme. The company has announced partnerships such as its global collaboration with Tessera Therapeutics on TSRA‑196, an investigational in vivo gene editing therapy for alpha‑1 antitrypsin deficiency, and provides updates on its factor XI antibody program for anticoagulation. Regeneron also communicates scheduling of quarterly and annual financial results webcasts and investor events, including its ‘Regeneron Roundtable’ series.
This news page aggregates these types of updates so readers can follow product approvals, late-stage trial readouts, scientific presentations, strategic collaborations and financial reporting dates related to REGN. For ongoing research and investment analysis, checking this feed regularly can provide timely insight into Regeneron’s progress across its broad portfolio.
Regeneron Pharmaceuticals (NASDAQ: REGN) presented promising Phase 1 data for two bispecific antibodies at the ESMO Congress 2022. The first is ubamatamab (REGN4018), targeting recurrent ovarian cancer, showcasing a 14% overall response rate in treated patients. The disease control rate stood at 57%. The second, REGN5093, aimed at MET-altered non-small cell lung cancer (NSCLC), reported a 17% partial response rate among the highest dose cohort. Both agents exhibited manageable safety profiles, prompting further clinical investigations.
Regeneron Pharmaceuticals (NASDAQ: REGN) will host a conference call and webcast on September 12, 2022, at 8:00 AM ET to discuss its oncology portfolio during the ESMO Annual Congress. Interested participants can join via telephone or watch the webcast on Regeneron's website. Registration in advance is required for phone participants. A replay of the webcast will be available for at least 30 days. Regeneron focuses on developing innovative medicines for serious diseases, with a strong emphasis on oncology, utilizing advanced technologies like VelociSuite®.
Regeneron Pharmaceuticals and Sanofi announced positive results from the second Phase 3 trial of Dupixent (dupilumab) for treating prurigo nodularis. At 24 weeks, 60% of patients on Dupixent reported significant itch reduction compared to 18% on placebo. Nearly three times as many Dupixent patients achieved clear skin (48% vs. 18% placebo). Submissions for regulatory approvals are underway in the U.S. and EU. Safety results aligned with established profiles, showing a lower rate of severe adverse events.
Regeneron Pharmaceuticals announced successful results from pivotal trials of aflibercept 8 mg for treating diabetic macular edema (DME) and wet age-related macular degeneration (wAMD). In the trials, 91% of DME patients and 79% of wAMD patients were maintained on 12- and 16-week dosing intervals without modifications through week 48. The efficacy was comparable to the standard EYLEA regimen. The safety profile was consistent with EYLEA, with no new safety signals. Data will be submitted to regulatory authorities globally.
Regeneron Pharmaceuticals and Sanofi announced positive results from the longest global Phase 3 trial of Dupixent (dupilumab) in children aged 6 to 11 with uncontrolled moderate-to-severe asthma. The trial showed sustained improvement in lung function and a low rate of severe asthma attacks over two years. Dupixent demonstrated an average of 0.118-0.124 severe asthma attacks per year compared to 2.16-2.56 at baseline. These findings were presented at the 2022 ERS International Congress, coinciding with over 500,000 patients treated with Dupixent worldwide.
Regeneron Pharmaceuticals (NASDAQ: REGN) will present new data on its oncology pipeline at the ESMO Congress 2022 from September 9-13 in Paris. Key highlights include Phase 1/2 trial results for investigational bispecific antibodies ubamatamab (REGN4018) in advanced ovarian cancer and REGN5093 in MET-altered non-small cell lung cancer (NSCLC). Additionally, updates on Libtayo's efficacy across various advanced cancers will be shared. An investor webcast is scheduled for September 12 to discuss these developments.
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Regeneron Pharmaceuticals (NASDAQ: REGN) reported a 44% decline in Q2 2022 revenues to $2.86 billion, primarily due to the absence of REGEN-COV sales. Notably, EYLEA and Dupixent delivered record net sales of $1.62 billion and $2.09 billion, marking increases of 14% and 40%, respectively. The company’s GAAP diluted EPS fell to $7.47.
FDA approvals for Dupixent and progress in oncology research highlight Regeneron's strong pipeline, alongside updates to full-year guidance reflecting recent acquisitions.
Regeneron Pharmaceuticals announced initial data from a Phase 1/2 trial of REGN5678, a PSMAxCD28 costimulatory bispecific antibody, in combination with Libtayo for advanced mCRPC. Results indicate dose-dependent anti-tumor activity, particularly at higher dose levels, with some patients experiencing significant PSA reductions. Notably, immune-related adverse events correlated with anti-tumor response. This trial supports Regeneron's bispecific platform, potentially paving the way for more effective treatments against cancer types previously resistant to immunotherapy.
Regeneron Pharmaceuticals (NASDAQ: REGN) announced significant findings from the Regeneron Genetics Center regarding genetic mutations in the CIDEB gene, which are linked to a more than 50% reduction in the risk of nonalcoholic liver diseases.
The study, involving over 540,000 individuals, paves the way for potential therapeutics targeting these mutations via RNA interference technology, in collaboration with Alnylam Pharmaceuticals. The RGC's extensive human sequence database supports ongoing genetic discoveries, aiming to address the unmet needs in liver disease treatment.