Regeneron Pharmaceuticals Stock Price, News & Analysis

The FDA has accepted Dupixent (dupilumab) for Priority Review to treat prurigo nodularis, a chronic skin disease. If approved, Dupixent will be the first medicine specifically indicated for this condition in the U.S. The target decision date is September 30, 2022. This application is backed by two Phase 3 trials demonstrating significant improvements in symptoms compared to placebo. The most commonly observed adverse event was conjunctivitis. Approximately 75,000 U.S. patients struggle with this disease, highlighting the potential market need for Dupixent.

Regeneron Pharmaceuticals (NASDAQ: REGN) announced promising results from a Phase 3 trial of Evkeeza^® (evinacumab) in children aged 5-11 with homozygous familial hypercholesterolemia (HoFH). The trial showed a significant average LDL-C reduction of 48% after 24 weeks, with 79% of participants achieving at least a 50% decrease. The FDA submission is scheduled for late 2022. Evkeeza, previously approved for older patients, has displayed potential as a breakthrough therapy for managing HoFH in younger patients.

The FDA has approved Dupixent (dupilumab) 300 mg weekly as the first and only treatment for eosinophilic esophagitis (EoE) in the U.S., benefiting approximately 160,000 patients. In a Phase 3 trial, Dupixent demonstrated a 69% and 64% reduction in symptoms compared to placebo, with a significant histological remission rate of 60% and 59% versus 5% and 6%. This approval marks Dupixent's fourth indication and supports its role in addressing type 2 inflammation-related conditions. Regulatory filings in Europe and other regions are planned in 2022.

Vyriad, a clinical-stage biotechnology firm focused on oncological virus therapies, secured $29.5M in funding led by Harry Stine of Stine Seed Farms. This investment increases Vyriad's total funding since 2015 to over $100M. The company aims to develop safe, effective oncolytic viruses to treat cancer, leveraging high-throughput screening methods. Dr. James Hampton, a genetics expert, joins Vyriad's Board as part of this funding round. Vyriad has an ongoing collaboration with Regeneron (NASDAQ: REGN) to explore new oncolytic treatments.

Robert Sansone, a 17-year-old from Fort Pierce, FL, won the $75,000 top award at the 2022 Regeneron International Science and Engineering Fair for his innovative project on electric motor efficiency, highlighting the potential for sustainable vehicle manufacturing. The event recognized over 1,750 finalists from 49 states and 63 countries, awarding nearly $8 million in prizes. Other notable winners included projects in energy storage and AI-based drug production, emphasizing the competition's commitment to promoting STEM education.

Regeneron Pharmaceuticals announced the winners of the 2022 Regeneron International Science and Engineering Fair, awarding a total of nearly $8 million to innovative projects. The top award of $75,000 was won by Robert Sansone for his project on improving electric motor efficiency. Other awards included $50,000 Regeneron Young Scientist Awards and various honors in multiple categories, showcasing the next generation of STEM talent from students across the globe.

Regeneron Pharmaceuticals reported Q1 2022 revenues of $2.97 billion, marking a 17% increase from Q1 2021. Excluding REGEN-COV, revenues grew by 25%. EYLEA U.S. net sales rose 13% to $1.52 billion, while Dupixent global sales surged 43% to $1.81 billion. GAAP diluted EPS was $8.61, down 15% year-over-year. The company announced significant progress in its pipeline, including regulatory approvals for Dupixent for children and advances in other therapies. Additionally, Regeneron entered a merger agreement to acquire Checkmate Pharmaceuticals for approximately $250 million.

Regeneron Pharmaceuticals has announced an all-cash acquisition of Checkmate Pharmaceuticals for approximately $250 million, valuing Checkmate at $10.50 per share. This acquisition aims to enhance Regeneron's immuno-oncology portfolio, particularly through Checkmate's lead candidate, vidutolimod, a promising TLR9 agonist demonstrating clinical response in PD-1 refractory melanoma. The acquisition is expected to close in mid-2022, pending certain conditions.