Regeneron Pharmaceuticals Stock Price, News & Analysis

Regeneron Pharmaceuticals and Sanofi announced the publication of significant Phase 3 trial results for Dupixent (dupilumab) in treating children aged 6 months to 5 years with uncontrolled atopic dermatitis. The study demonstrated that Dupixent, in combination with low-potency topical corticosteroids, improved skin clearance, reduced severity of disease, and lessened itch compared to placebo. Safety profiles were consistent with older children. The FDA approved Dupixent for this age group in June 2022, with further regulatory reviews ongoing in Europe.

Regeneron (REGN) and Alnylam (ALNY) announced positive preliminary data from a Phase 1 study of ALN-HSD, aimed at treating nonalcoholic steatohepatitis (NASH). Results show robust target knockdown and lower liver enzymes in patients receiving ALN-HSD compared to placebo, with a favorable safety profile. The companies plan to advance to a Phase 2 trial in late 2022. The study highlighted a significant unmet need in NASH, which affects 16 million people in the U.S. and is projected to be a leading cause of liver transplants.

Alnylam and Regeneron have released preliminary Phase 1 results for ALN-HSD, an RNAi therapeutic targeting HSD17B13, aimed at treating nonalcoholic steatohepatitis (NASH).

The study showed promising outcomes, with robust target knockdown and reduced liver enzymes over six months in 20 patients compared to 4 in the placebo group.

Following this success, a Phase 2 study is set to commence in late 2022. Safety data indicated mild injection site reactions, with no serious adverse events reported, further validating ALN-HSD's potential in addressing NASH's significant unmet medical needs.

Positive clinical data from a Phase 2 trial of Libtayo (cemiplimab) show a 63.3% combined pathologic response rate in patients with stage II to IV resectable cutaneous squamous cell carcinoma (CSCC). The trial involved 79 patients, with a 68% objective response rate. The findings were presented at the ESMO Congress 2022 and published in the New England Journal of Medicine. Adverse events were reported in 87% of patients; however, serious events were only 17%. Follow-up studies are ongoing, assessing potential impacts on disease-free survival.

Regeneron Pharmaceuticals (NASDAQ: REGN) presented positive clinical data for its investigational LAG-3 inhibitor fianlimab combined with PD-1 inhibitor Libtayo at the ESMO Congress 2022 in Paris. The results from a Phase 1 trial indicated an overall response rate (ORR) exceeding 60% in two independent cohorts of PD-1/PD-L1-naïve patients. The combination's safety profile was similar to Libtayo monotherapy, with a significant majority of patients experiencing adverse events. A Phase 3 trial is currently enrolling patients to further evaluate this promising combination in advanced melanoma.

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.