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Regeneron Pharmaceuticals and Sanofi announced that Dupixent (dupilumab) has been recommended for EU approval by the CHMP as an add-on maintenance treatment for adults with uncontrolled COPD marked by raised blood eosinophils. This recommendation is based on Phase 3 trials (BOREAS and NOTUS), where Dupixent showed a significant reduction in annualized moderate or severe acute COPD exacerbations by up to 34% compared to placebo and improved lung function and quality of life over 52 weeks. If approved, Dupixent would be the first targeted therapy for COPD in the EU and the first new treatment approach for COPD in over a decade. The European Commission's final decision is expected within months.
Regeneron Pharmaceuticals and Sanofi announced that the U.S. FDA has extended the target action date for the priority review of Dupixent (dupilumab) by three months to September 27, 2024. This extension follows the submission of additional efficacy analyses requested by the FDA for the BOREAS and NOTUS pivotal trials. The FDA has no concerns about the approvability of Dupixent for treating uncontrolled COPD with type 2 inflammation. The companies are optimistic that this supplemental Biologics License Application (sBLA) will be approved. Additionally, reviews are ongoing with regulatory authorities in the EU and China. The EMA has already recommended approval in the EU. However, the safety and efficacy of Dupixent in COPD have not been fully evaluated by any regulatory authority.
Biohaven has dosed its first patient in a Phase 1/2 study of BHV-1510, a Trop-2 directed antibody-drug conjugate (ADC) targeting advanced or metastatic epithelial tumors. BHV-1510 has shown promising preclinical results, including superior efficacy and a broader therapeutic margin compared to other Trop-2 ADCs. The study will evaluate the drug as a monotherapy and in combination with Regeneron's anti-PD-1 therapy, Libtayo®. Biohaven's proprietary ADC technology and partnership with Regeneron aim to advance treatment options in oncology, particularly for cancers with significant unmet medical needs.
The multicenter, open-label trial will have a dose-escalation phase followed by a multicohort expansion phase. Preclinical data suggests BHV-1510 could offer a better safety profile, including no lung toxicity, and improved clinical efficacy. The partnership with Regeneron will see Biohaven sponsor and fund the trial, while Regeneron supplies Libtayo. This initiative represents a key step in Biohaven's broader oncology strategy.
Regeneron Pharmaceuticals announced promising results from a Phase 1/2 trial of their bispecific antibody REGN7075 combined with Libtayo in advanced solid tumors, particularly microsatellite stable colorectal cancer (MSS CRC). The trial showed a 6% overall response rate (ORR) and 29% disease control rate (DCR) among 51 MSS CRC patients. Positive results were noted, especially in patients without liver metastases. The combination therapy displayed an acceptable safety profile, with no dose-limiting toxicities or treatment-related deaths. Results will be presented at the ASCO 2024 Annual Meeting.
Regeneron Pharmaceuticals and Sanofi have presented late-breaking data from the NOTUS Phase 3 trial, confirming positive results from the BOREAS trial. The data, presented at the 2024 American Thoracic Society International Conference and published in the New England Journal of Medicine, show Dupixent® (dupilumab) significantly reduced exacerbations by 34% and improved lung function in patients with uncontrolled chronic obstructive pulmonary disease (COPD) with type 2 inflammation. These results position Dupixent as a potential first-ever targeted therapy for COPD. Regulatory reviews are ongoing, with a U.S. FDA action date set for June 27, 2024.
Regeneron Pharmaceuticals and Society for Science awarded over $9 million to high school scientists at the 2024 Regeneron International Science and Engineering Fair (ISEF), the world's largest pre-college STEM competition.
Grace Sun won the top $75,000 award for her innovative organic electrochemical transistor. Michelle Wei and Krish Pai each received $50,000 for their respective projects in software efficiency and plastic biodegradation.
The competition, held in Tarrytown, NY and Washington, D.C., featured nearly 2,000 young scientists from 49 U.S. states and almost 70 countries. Other notable awards included $50,000 for a microplastics filtration system and $10,000 for a dementia multi-sensory therapy app.
Since 2020, Regeneron has provided STEM experiences to about 2.4 million students, aiming for 2.5 million by 2025. The fair emphasized the importance of fostering next-generation STEM leaders to tackle global challenges.
Regeneron Pharmaceuticals, Inc. and Sanofi's sBLA for Dupixent® (dupilumab) in adolescents with Chronic Rhinosinusitis with Nasal Polyposis has been accepted for FDA Priority Review. If approved, Dupixent would be the first treatment in the U.S. for this condition in adolescents aged 12-17 years. The target action date for the FDA decision is September 15, 2024. The sBLA is based on positive pivotal trials in adults that showed Dupixent improved nasal congestion, polyp size, sense of smell, and reduced the need for systemic corticosteroids or surgery.
Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) has announced positive preliminary data from the ongoing Phase 1/2 CHORD trial, showing significant hearing improvements in children with genetic deafness who received the investigational gene therapy DB-OTO. One child achieved normal hearing levels within 24 weeks, while another showed initial improvements at 6 weeks. The results were presented at the ASGCT conference, highlighting the potential of DB-OTO as a treatment for otoferlin-related deafness.
Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) will be participating in investor conferences including the RBC Capital Markets Global Healthcare Conference, Jefferies Global Healthcare Conference, and Goldman Sachs 45th Annual Global Healthcare Conference. The webcasts can be accessed on the company's website, with replays available for 30 days.
Regeneron reported first quarter 2024 financial results with revenues decreasing 1% to $3.15 billion; excluding Ronapreve, revenues increased 7%. Dupixent global net sales rose 24% to $3.08 billion, EYLEA U.S. net sales were $1.40 billion, and Libtayo global net sales increased 45% to $264 million. The company announced a $3.0 billion share repurchase program. Regeneron is progressing well in delivering medicines, advancing its pipeline, and pursuing cutting-edge science, particularly in retinal diseases, oncology, and potential regulatory approvals. Financially, GAAP net income decreased by 12% and non-GAAP diluted EPS decreased by 5%. The company is focusing on innovation and returned $298 million to shareholders through share repurchases.
