Regeneron Pharmaceuticals Stock Price, News & Analysis

Regeneron Pharmaceuticals (NASDAQ: REGN) announced that the FDA has accepted for review its supplemental Biologics License Application (sBLA) for a 16-week dosing regimen of EYLEA (aflibercept) in treating diabetic retinopathy (DR). If approved by February 28, 2023, this regimen may enhance treatment flexibility for doctors and patients. EYLEA is already approved for various DR treatments using 4- and 8-week regimens. The submission is based on data from the PANORAMA and Protocol W trials, which demonstrated efficacy in improving DR severity scores.

Intellia Therapeutics and Regeneron Pharmaceuticals announced positive interim results from the Phase 1 study of NTLA-2001, a CRISPR-based therapy for ATTR amyloidosis. The study showed sustained serum transthyretin (TTR) reductions of 93% by day 28 at the 1.0 mg/kg dose, remaining durable through six months. Follow-up data from patients indicate a favorable safety profile, with the majority of adverse events being mild. The companies plan further development, aiming for an 80 mg fixed dose in the next study phase.

Dupixent has received FDA approval as the first biologic medicine for children aged 6 months to 5 years diagnosed with moderate-to-severe atopic dermatitis. A Phase 3 trial showed that children treated with Dupixent alongside topical corticosteroids achieved 28% clear skin, compared to 4% with corticosteroids alone. The treatment significantly reduced disease severity and itch. Long-term safety data reaffirmed Dupixent's established safety profile. Regeneron and Sanofi aim to address the significant unmet needs of young children suffering from this debilitating condition.

Regeneron Pharmaceuticals plans to acquire Sanofi's stake in Libtayo for an upfront payment of $900 million, including royalties and milestone payments. This acquisition grants Regeneron exclusive global rights to develop, commercialize, and manufacture Libtayo, which is currently approved in over two dozen countries for various cancers. The deal is expected to close in Q3 2022, contingent on regulatory approvals. Regeneron aims to enhance its oncology portfolio, as Libtayo recorded a 32% sales increase in 2021.

Regeneron Pharmaceuticals (NASDAQ: REGN) has acquired Checkmate Pharmaceuticals to enhance its immuno-oncology portfolio. This strategic acquisition focuses on Checkmate's lead candidate, vidutolimod, which shows promise in treating PD-1 refractory melanoma. The tender offer concluded with 83.8% of Checkmate's shares validly tendered at $10.50 each. Regeneron anticipates accounting for this transaction as an asset acquisition, with no immediate change to its 2022 financial guidance. The acquisition aims to diversify Regeneron's cancer treatment approaches, emphasizing combination therapies.

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.