Regeneron Pharmaceuticals Stock Price, News & Analysis

Regeneron Pharmaceuticals (REGN) announced promising results from a Phase 1 and pivotal Phase 2 trial of odronextamab, showing a 49% objective response rate (ORR) in CAR-T naive patients, with 31% achieving a complete response (CR). In patients post-CAR-T therapy, an ORR of 48% and 32% CR were noted. Data will support regulatory submissions planned for 2023. The ongoing trials include ELM-1 and ELM-2, focusing on treating relapsed/refractory diffuse large B-cell lymphoma (DLBCL). Adverse events were reported in 99% of patients, but no Grade 4 or 5 cytokine release syndrome cases were observed.

Regeneron Pharmaceuticals (REGN) announced key findings from its oncology pipeline at the ESMO IO Congress 2022 in Geneva. The results included initial data on the investigational combination of fianlimab and Libtayo in treating advanced non-small cell lung cancer (NSCLC). The Phase 1 trials indicated a 27% objective response rate in anti-PD-1/PD-L1-naïve patients and a 7% rate in experienced patients, demonstrating potential therapeutic benefits. Safety assessments showed adverse events but no treatment-related deaths. Additional presentations include analyses on melanoma and cervical cancer.

Regeneron Pharmaceuticals, Inc. (REGN) has announced that the FDA has accepted its supplemental Biologics License Application (sBLA) for Evkeeza® (evinacumab-dgnb) under Priority Review. This would establish Evkeeza as the first treatment for children aged 5 to 11 with homozygous familial hypercholesterolemia (HoFH). This condition affects 1,300 patients in the U.S. The trial indicated a significant average LDL-C reduction of 48% after 24 weeks of treatment. The FDA decision is expected by March 30, 2023.

Regeneron Pharmaceuticals announced the European Commission's approval of Libtayo (cemiplimab) for adult patients with recurrent or metastatic cervical cancer after platinum-based chemotherapy. This decision follows positive results from the Phase 3 EMPOWER-Cervical 1 trial, which demonstrated a 31% reduction in the risk of death compared to chemotherapy. Libtayo is now approved for four cancer types in the EU, marking a significant milestone in treatment options for advanced cervical cancer, which affects approximately 600,000 new cases globally each year.

Regeneron Pharmaceuticals and CytomX Therapeutics have entered a significant collaboration to develop next-generation bispecific immunotherapies. CytomX will receive an upfront payment of $30 million and could earn up to $2 billion in future milestones. The collaboration focuses on utilizing CytomX's Probody^® technology and Regeneron's Veloci-Bi^® platform to create therapies that activate specifically in tumor environments, potentially improving treatment efficacy and reducing side effects. The partnership aims to expand cancer treatment options significantly.

Regeneron Pharmaceuticals and Sanofi announced a positive opinion from the European Medicines Agency (EMA) recommending Dupixent (dupilumab) for treating adults with moderate-to-severe prurigo nodularis. If approved, Dupixent will be the first targeted medicine for this condition in the EU. Supported by two pivotal Phase 3 trials, the drug significantly improved itch, skin lesions, and health-related quality of life. Dupixent is already FDA-approved for the same indication in the U.S. The final decision from the European Commission is anticipated shortly.

Regeneron Pharmaceuticals, Inc. announced FDA approval for Libtayo (cemiplimab-rwlc) in combination with platinum-based chemotherapy as a first-line treatment for advanced non-small cell lung cancer (NSCLC). This approval extends treatment options to patients regardless of PD-L1 expression or tumor histology. The approval is based on the EMPOWER-Lung 3 trial, which showed a median overall survival of 22 months for the Libtayo combination versus 13 months for chemotherapy alone. This significant improvement supports Libtayo's role in managing NSCLC, aiming for broader patient access.

Regeneron Pharmaceuticals announced late-breaking results from pivotal trials of aflibercept 8 mg for treating diabetic macular edema (DME) and wet age-related macular degeneration (wAMD). The trials PHOTON and PULSAR demonstrated non-inferior vision gains compared to EYLEA at 48 weeks, with 93% and 83% of patients maintaining dosing intervals of 12 weeks or longer, respectively. Additional analyses showed sustained anatomical improvements in both dosing regimens. The safety profile of aflibercept 8 mg was similar to EYLEA, affirming its potential to reduce treatment burden significantly.