Regeneron Pharmaceuticals Inc - REGN STOCK NEWS

Regeneron Pharmaceuticals (NASDAQ: REGN) announced it will release its first quarter 2023 financial results on May 4, 2023, before U.S. markets open. The company will hold a conference call and webcast at 8:30 AM ET to discuss these results. Participants can access the call via the ‘Investors and Media’ section on Regeneron's website. Registration is required for telephone participation, where attendees will receive a confirmation email with access details. Regeneron is renowned for its biotechnology innovations and has developed multiple FDA-approved treatments for severe diseases.

Regeneron Pharmaceuticals announced that the European Commission approved Libtayo (cemiplimab) in combination with chemotherapy for first-line treatment of adults with advanced non-small cell lung cancer (NSCLC) showing ≥1% PD-L1 expression. This marks Libtayo's second first-line indication and fifth overall approval in the EU. The decision is based on the successful Phase 3 EMPOWER-Lung 3 trial, which demonstrated significant survival benefits, including a 45% reduction in the risk of death compared to chemotherapy alone. Patients receiving Libtayo had a median overall survival of 22 months versus 13 months for those on chemotherapy alone.

Regeneron Pharmaceuticals (NASDAQ: REGN) has entered a collaboration with Sonoma Biotherapeutics to develop novel regulatory T cell (T_reg) therapies for autoimmune diseases. The agreement includes an upfront payment of $75 million, consisting of $45 million in cash and a $30 million equity investment, as well as a potential development milestone payment of $45 million. Both companies will jointly research therapies targeting conditions such as ulcerative colitis and Crohn's disease, sharing R&D costs and profits. Regeneron retains the option to lead late-stage development globally, while Sonoma will co-promote products in the U.S.

Regeneron Pharmaceuticals and Sanofi announced positive results from a Phase 3 trial of Dupixent for chronic obstructive pulmonary disease (COPD). The trial demonstrated a 30% reduction in exacerbations compared to placebo, alongside a significant improvement in lung function (160 mL in FEV1) and quality of life. This makes Dupixent the first biologic to achieve these results in COPD patients with type 2 inflammation. COPD, the third leading cause of death globally, has seen no new treatment approaches in over a decade, highlighting the importance of these findings. The study included 939 participants and met all primary and secondary endpoints.

Regeneron Pharmaceuticals announced FDA approval to extend Evkeeza to treat children aged 5 to 11 with homozygous familial hypercholesterolemia (HoFH). This is the first therapy targeting this condition for young children, addressing high levels of low-density lipoprotein cholesterol (LDL-C). In a pivotal trial, Evkeeza demonstrated a 48% reduction in LDL-C levels at week 24. The therapy is now set to improve treatment options for the 1,300 affected individuals in the U.S. Regeneron is committed to facilitating access for patients through its myRARE™ support program.

Regeneron Pharmaceuticals announced that Dupixent (dupilumab) received European Commission approval for treating severe atopic dermatitis in children aged 6 months to 5 years. This makes Dupixent the first targeted therapy for this age group in Europe. The approval follows a Phase 3 trial showing significant improvements: 46% of children treated with Dupixent achieved a 75% reduction in disease severity, and 14% experienced clear or almost clear skin at 16 weeks. The treatment is noted for rapid itch reduction and sustained efficacy over one year. Dupixent is already used by over 600,000 patients globally.

Regeneron Pharmaceuticals (NASDAQ: REGN) and Sanofi have shared promising results from a clinical trial of Dupixent (dupilumab) for adults and adolescents with uncontrolled moderate-to-severe atopic hand and foot dermatitis. The trial, the first focusing on this hard-to-treat condition, achieved both primary and secondary endpoints. Key findings include that 40% of patients on Dupixent achieved clear or almost clear skin at 16 weeks compared to 17% on placebo. Additionally, 52% reported significant itch reduction versus 14% with placebo. Overall safety data mirrored Dupixent's established profile, indicating solid efficacy and safety outcomes for patients.

Regeneron Pharmaceuticals (NASDAQ: REGN) awarded Neel Moudgal, 17, from Saline, Mich., the $250,000 top award in the 2023 Regeneron Science Talent Search, the nation’s most prestigious science competition for high school seniors. Moudgal's project focused on developing a computer model for RNA structure prediction, facilitating disease diagnosis and treatment. The competition, in its 82nd year, awarded a total of $1.8 million to 40 finalists who excelled in scientific rigor and innovation. Regeneron aims to inspire future generations in STEM, with a commitment to promoting science education.

Regeneron Pharmaceuticals and Sanofi announced that the FDA has accepted their supplemental Biologics License Application (sBLA) for Dupixent (dupilumab) aimed at treating adults and adolescents with chronic spontaneous urticaria (CSU) inadequately controlled by antihistamines. The FDA's target action date is October 22, 2023. CSU affects over 300,000 people in the U.S., with up to 50% remaining uncontrolled by standard treatment. The sBLA is based on data from two Phase 3 trials, LIBERTY-CUPID A and B, further confirming Dupixent's efficacy in this indication, currently under clinical development.