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. (symbol: REGN) is a prominent American biotechnology company headquartered in Westchester County, New York, since its founding in 1988. The core mission of Regeneron is to discover, develop, and commercialize innovative products targeting a range of serious medical conditions. With a diverse portfolio, Regeneron focuses on therapies for eye diseases, cardiovascular conditions, cancer, and inflammatory disorders.
Among its marketed products, Eylea stands out as a treatment for wet age-related macular degeneration and other eye diseases. Praluent is designed to lower LDL cholesterol levels, while Dupixent addresses multiple immunological conditions. In the oncology sector, Libtayo is a key therapy, and Kevzara targets rheumatoid arthritis.
The company is also heavily invested in the development of monoclonal and bispecific antibodies, often in collaboration with Sanofi and other partners. These initiatives include cutting-edge technologies such as RNA interference (RNAi) with Alnylam and CRISPR-based gene editing with Intellia.
Regeneron's recent progress includes significant advancements in its clinical-stage pipeline, which comprises over 35 product candidates. The company's financial health remains robust, supported by strong revenue streams from collaboration with Sanofi and a strategic $3.0 billion share repurchase program authorized by the board.
Latest updates highlight the company's ongoing efforts in gene therapy, particularly in treating genetic deafness and solid tumors. Regeneron's commitment to pioneering genetic medicine and leveraging data insights from the Regeneron Genetics Center® positions it as a leader in the biopharmaceutical industry.
For more information, visit Regeneron Pharmaceuticals.
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.
Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) has announced upcoming investor events for September 2024. These include presentations at two major healthcare conferences: the Morgan Stanley 22nd Annual Global Healthcare Conference on September 4 and the 2024 Wells Fargo Healthcare Conference on September 5. Additionally, Regeneron will host an oncology-focused webcast on September 16, coinciding with the European Society for Medical Oncology (ESMO) 2024 conference. This webcast will provide updates on the company's oncology portfolio. All events will be accessible via Regeneron's investor relations website, with replays and transcripts available for at least 30 days after each event.
Regeneron Pharmaceuticals reported strong Q2 2024 financial results, with total revenue up 12% to $3.55 billion. EYLEA HD and EYLEA U.S. net sales increased 2% to $1.53 billion, including $304 million from EYLEA HD. Dupixent global net sales grew 27% to $3.56 billion, while Libtayo global net sales rose 42% to $297 million. GAAP diluted EPS increased 46% to $12.41, and non-GAAP diluted EPS rose 13% to $11.56. The European Commission approved Dupixent for uncontrolled COPD, marking its first regulatory approval for this indication. Regeneron's pipeline progress includes advancing over 35 product candidates, with key developments in oncology and other therapeutic areas.
Regeneron Pharmaceuticals (NASDAQ: REGN) has announced the winners of its 12th annual Regeneron Prize for Creative Innovation. Christopher Giuliano and Julian Roessler, both Ph.D. candidates at MIT's Whitehead Institute for Biomedical Research, were awarded $50,000 each, plus a $10,000 grant for their institution. Six other finalists received $5,000 awards.
The Regeneron Prize recognizes outstanding early-career scientists in biomedical research. Nominees from leading U.S. research universities propose 'dream projects' evaluated on scientific merit, creativity, and originality. Since 2013, the program has supported early-career scientists with over $1.7 million in awards.
Regeneron's commitment to fostering the next generation of scientific innovators is evident in its broader STEM initiatives, which have supported over 2.4 million students since 2020 through various programs and competitions.
Regeneron Pharmaceuticals and Sanofi announced that the European Commission has approved Dupixent (dupilumab) as the first targeted therapy for adults with uncontrolled chronic obstructive pulmonary disease (COPD) with raised blood eosinophils. This approval is based on two Phase 3 trials, BOREAS and NOTUS, which showed significant reductions in COPD exacerbations and improvements in lung function and quality of life. The trials demonstrated a 30% and 34% reduction in annual exacerbation rates and notable lung function improvements.
This marks the first new treatment for COPD in over a decade, offering a novel option for approximately 220,000 adults in the EU. Dupixent's approval also represents its sixth indication in the EU and seventh globally. Further regulatory submissions are under review in other countries, including the U.S., China, and Japan.
The efficacy results showed improvements in FEV1 by 160 mL and 139 mL at 12 weeks, compared to placebo improvements of 77 mL and 57 mL. Safety results were consistent with known profiles, with common side effects including injection site reactions and conjunctivitis.
Regeneron Pharmaceuticals announced that the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has recommended conditional marketing authorization for odronextamab to treat relapsed/refractory follicular lymphoma (FL) and diffuse large B-cell lymphoma (DLBCL). The recommendation is based on data from Phase 1 and Phase 2 trials showing robust and durable response rates. The European Commission is expected to make a final decision in the coming months. FL and DLBCL are common subtypes of B-cell non-Hodgkin lymphoma, with significant relapse rates after initial treatments. In Europe, approximately 15,000 FL and 31,000 DLBCL cases are diagnosed annually. The most common serious adverse reactions reported were cytokine release syndrome, pneumonia, COVID-19, and pyrexia. Odronextamab has not yet been approved by any regulatory authority and is still under clinical development.
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