Regeneron Pharmaceuticals Inc - REGN STOCK NEWS

Regeneron and Sanofi announced positive results from a Phase 3 trial of Dupixent (dupilumab) in children aged 1-11 with eosinophilic esophagitis (EoE), making it the first treatment for this age group. The trial met its primary endpoint, with 68% of higher dose and 58% of lower dose Dupixent patients achieving histological remission at 16 weeks. Approximately 21,000 U.S. children are treated for EoE, with many not responding to existing therapies. The safety profile aligns with previous studies, and further discussions with regulatory authorities are planned.

Ultima Genomics has entered a collaborative agreement with Regeneron Pharmaceuticals (REGN) to enhance Ultima's sequencing architecture. This partnership aims to develop Ultima's second-generation sequencing platform, building on the UG100^™, set to launch in 2023. Regeneron will also invest in Ultima and participate in the UG100^™'s early access program. The collaboration focuses on providing affordable high-throughput sequencing to accelerate genomic research, addressing the high costs that currently limit data production in the life sciences sector.

Regeneron Pharmaceuticals, based in Tarrytown, NY, will announce its second quarter 2022 financial results on August 3, 2022, prior to market opening. A conference call is scheduled for 8:30 AM ET the same day, available via webcast on the company's website. Founded nearly 35 years ago, Regeneron focuses on developing innovative treatments for serious conditions, utilizing proprietary technologies such as VelociSuite®. The company has multiple FDA-approved products and a robust pipeline.

Regeneron Pharmaceuticals (NASDAQ: REGN) has completed the acquisition of Sanofi's stake in Libtayo (cemiplimab), granting it exclusive worldwide rights to develop, commercialize, and manufacture the drug. Initially announced on June 2, 2022, this transaction allows Regeneron to record 100% of global net sales and expenses from Libtayo. The company expects to report an acquired in-process research and development charge of approximately $195 million from the recent acquisition of Checkmate Pharmaceuticals, negatively impacting earnings per share by about $1.70 for Q2 2022.

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.