Regeneron Pharmaceuticals Stock Price, News & Analysis

Regeneron Pharmaceuticals and Sanofi announced positive results from the second Phase 3 trial of Dupixent (dupilumab) for treating prurigo nodularis. At 24 weeks, 60% of patients on Dupixent reported significant itch reduction compared to 18% on placebo. Nearly three times as many Dupixent patients achieved clear skin (48% vs. 18% placebo). Submissions for regulatory approvals are underway in the U.S. and EU. Safety results aligned with established profiles, showing a lower rate of severe adverse events.

Regeneron Pharmaceuticals announced successful results from pivotal trials of aflibercept 8 mg for treating diabetic macular edema (DME) and wet age-related macular degeneration (wAMD). In the trials, 91% of DME patients and 79% of wAMD patients were maintained on 12- and 16-week dosing intervals without modifications through week 48. The efficacy was comparable to the standard EYLEA regimen. The safety profile was consistent with EYLEA, with no new safety signals. Data will be submitted to regulatory authorities globally.

Regeneron Pharmaceuticals and Sanofi announced positive results from the longest global Phase 3 trial of Dupixent (dupilumab) in children aged 6 to 11 with uncontrolled moderate-to-severe asthma. The trial showed sustained improvement in lung function and a low rate of severe asthma attacks over two years. Dupixent demonstrated an average of 0.118-0.124 severe asthma attacks per year compared to 2.16-2.56 at baseline. These findings were presented at the 2022 ERS International Congress, coinciding with over 500,000 patients treated with Dupixent worldwide.

Regeneron Pharmaceuticals (NASDAQ: REGN) will present new data on its oncology pipeline at the ESMO Congress 2022 from September 9-13 in Paris. Key highlights include Phase 1/2 trial results for investigational bispecific antibodies ubamatamab (REGN4018) in advanced ovarian cancer and REGN5093 in MET-altered non-small cell lung cancer (NSCLC). Additionally, updates on Libtayo's efficacy across various advanced cancers will be shared. An investor webcast is scheduled for September 12 to discuss these developments.

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.