Regeneron Pharmaceuticals Stock Price, News & Analysis

On February 28, 2022, Intellia Therapeutics and Regeneron Pharmaceuticals announced promising interim results from a Phase 1 clinical trial of NTLA-2001 for treating transthyretin amyloidosis (ATTR). The study demonstrated a mean serum TTR reduction of 93% at the highest dose (1.0 mg/kg) by day 28, with durable reductions lasting between two to twelve months. The treatment was generally well tolerated, with mild adverse effects reported. The companies plan to advance the therapy into a dose-expansion cohort in Q1 2022, marking a significant step in CRISPR-based genomic medicine.

Regeneron and Sanofi announced positive Phase 3 trial results for Dupixent (dupilumab) 300 mg weekly in treating eosinophilic esophagitis (EoE), a chronic inflammatory disease. The trial showed a 64% reduction in disease symptoms after 24 weeks compared to placebo, with 59% of Dupixent patients achieving histological remission. The safety profile was consistent with previous studies. Regulatory filings are expected in 2022. EoE affects around 160,000 patients in the U.S., highlighting the potential market for Dupixent in this indication.

Regeneron Pharmaceuticals and Sanofi announced positive Phase 3 trial results for Dupixent (dupilumab) in treating chronic spontaneous urticaria (CSU) in biologic-naïve patients. The trial showed that Dupixent significantly reduced itch and urticaria activity scores at 24 weeks compared to standard antihistamine treatment. Key findings included a 63% reduction in itch severity and a 65% reduction in urticaria activity. The safety profile of Dupixent remained consistent, with adverse events rates comparable to placebo. Dupixent's potential for treating CSU is still under clinical evaluation.

Regeneron and Sanofi announced the termination of a Phase 3 trial for Dupixent in patients with chronic spontaneous urticaria (CSU) due to failure to achieve statistical significance despite observed improvements in key endpoints. The trial was halted based on an interim analysis indicating futility. However, a previous Phase 3 trial showed positive results in biologic-naïve patients, indicating Dupixent significantly reduced itch and hives. Both companies remain committed to developing Dupixent for CSU and are evaluating next steps following this setback.

Regeneron Pharmaceuticals (NASDAQ: REGN) announced positive outcomes from its Phase 2 trial of aflibercept 8 mg, showing enhanced visual acuity and drying effects compared to the standard 2 mg EYLEA dose. The trial met primary safety endpoints with no new safety signals observed through week 44. Key results include 40% of patients achieving dryness in the center subfield and average letter improvements of 7.9 in the aflibercept group. Phase 3 results for wet age-related macular degeneration and diabetic macular edema are anticipated in late 2022.

Regeneron Pharmaceuticals and Sanofi announced that the FDA has accepted for Priority Review the supplemental Biologics License Application for Dupixent (dupilumab) targeting children aged 6 months to 5 years with uncontrolled moderate-to-severe atopic dermatitis. This approval could make Dupixent the first biologic treatment for this age group, with a decision expected by June 9, 2022. The application is backed by successful Phase 3 trial results showing improved skin clearance and reduced disease severity compared to standard treatments, while safety results align with earlier data for older patients.

Regeneron Pharmaceuticals reported strong financial results for Q4 and FY 2021, with revenues soaring by 104% to $4.95 billion and 89% to $16.07 billion, respectively. Key drivers included $2.30 billion from REGEN-COV and significant growth in EYLEA and Dupixent sales. GAAP diluted EPS rose to $19.69 for Q4 and $71.97 for FY 2021. Despite success, the FDA's revision of REGEN-COV's Emergency Use Authorization raised concerns as it is not effective against the Omicron variant. The company aims to expand Dupixent's indications and develop next-generation antibodies.

Regeneron Pharmaceuticals (NASDAQ: REGN) and Sanofi announced promising Dupixent (dupilumab) data set to be presented at the AAAAI Annual Meeting from February 25 to 28, 2022. Highlights include significant disease improvements in eosinophilic esophagitis and chronic spontaneous urticaria, with 18 abstracts supporting Dupixent’s role in type 2 inflammation. The ongoing clinical investigations have not yet received regulatory approval. Dupixent is already approved for various indications, with over 350,000 patients treated globally.