Regeneron Pharmaceuticals Stock Price, News & Analysis

Regeneron Pharmaceuticals (NASDAQ: REGN) presented promising Phase 1 data for two bispecific antibodies at the ESMO Congress 2022. The first is ubamatamab (REGN4018), targeting recurrent ovarian cancer, showcasing a 14% overall response rate in treated patients. The disease control rate stood at 57%. The second, REGN5093, aimed at MET-altered non-small cell lung cancer (NSCLC), reported a 17% partial response rate among the highest dose cohort. Both agents exhibited manageable safety profiles, prompting further clinical investigations.

Regeneron Pharmaceuticals (NASDAQ: REGN) will host a conference call and webcast on September 12, 2022, at 8:00 AM ET to discuss its oncology portfolio during the ESMO Annual Congress. Interested participants can join via telephone or watch the webcast on Regeneron's website. Registration in advance is required for phone participants. A replay of the webcast will be available for at least 30 days. Regeneron focuses on developing innovative medicines for serious diseases, with a strong emphasis on oncology, utilizing advanced technologies like VelociSuite®.

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.