Regeneron Pharmaceuticals Stock Price, News & Analysis

Regeneron Pharmaceuticals (NASDAQ: REGN) reported a 44% decline in Q2 2022 revenues to $2.86 billion, primarily due to the absence of REGEN-COV sales. Notably, EYLEA and Dupixent delivered record net sales of $1.62 billion and $2.09 billion, marking increases of 14% and 40%, respectively. The company’s GAAP diluted EPS fell to $7.47.

FDA approvals for Dupixent and progress in oncology research highlight Regeneron's strong pipeline, alongside updates to full-year guidance reflecting recent acquisitions.

Regeneron Pharmaceuticals announced initial data from a Phase 1/2 trial of REGN5678, a PSMAxCD28 costimulatory bispecific antibody, in combination with Libtayo for advanced mCRPC. Results indicate dose-dependent anti-tumor activity, particularly at higher dose levels, with some patients experiencing significant PSA reductions. Notably, immune-related adverse events correlated with anti-tumor response. This trial supports Regeneron's bispecific platform, potentially paving the way for more effective treatments against cancer types previously resistant to immunotherapy.

Regeneron Pharmaceuticals (NASDAQ: REGN) announced significant findings from the Regeneron Genetics Center regarding genetic mutations in the CIDEB gene, which are linked to a more than 50% reduction in the risk of nonalcoholic liver diseases.

The study, involving over 540,000 individuals, paves the way for potential therapeutics targeting these mutations via RNA interference technology, in collaboration with Alnylam Pharmaceuticals. The RGC's extensive human sequence database supports ongoing genetic discoveries, aiming to address the unmet needs in liver disease treatment.

Regeneron Pharmaceuticals (NASDAQ: REGN) has announced the winners of its 10th annual Regeneron Prize for Creative Innovation, awarding a total of $155,000 to eight finalists. Dr. Ryan Emenecker from Washington University won in the postdoctoral category, while Venkata Chaluvadi from the University of Pennsylvania won for graduate students. Honorable mention went to Meagan Esbin of UC Berkeley. The annual initiative highlights the creativity of early career scientists in biomedical research. Regeneron aims to foster innovation and support scientific breakthroughs through this competition.

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.