Regeneron Pharmaceuticals Stock Price, News & Analysis

Regeneron Pharmaceuticals (NASDAQ: REGN) announced positive results from a Phase 2 trial of REGN1908-1909, a novel antibody cocktail aimed at treating cat allergies in patients with mild asthma. The study demonstrated that a single dose effectively prevented early asthma reactions over three months, with significant improvements noted in lung function and allergen tolerance as early as week one. The trial enrolled 56 participants, and results were shared at the 2021 AAAAI Annual Meeting, highlighting promising new strategies for allergy management.

Regeneron Pharmaceuticals has received a positive opinion from the European Medicines Agency's CHMP for its COVID-19 antibody cocktail, REGEN-COV, which can treat high-risk patients without supplemental oxygen. The endorsement allows EU member states to use this opinion for national decisions prior to market authorization. Roche, Regeneron's collaboration partner, is responsible for distribution outside the U.S. and has started distribution in the EU. Data indicates a significant reduction in virus levels and fewer medical visits for treated patients. This therapy aims to support global COVID-19 management.

Regeneron Pharmaceuticals announced changes to its Phase 3 trial for REGEN-COV™ (casirivimab with imdevimab) in non-hospitalized COVID-19 patients. Following the Independent Data Monitoring Committee's recommendation, enrollment in the placebo group will be halted due to demonstrated clinical efficacy in reducing hospitalization and death rates with the 1,200 mg and 2,400 mg doses. Continued enrollment will focus on these treatment groups, with detailed results expected in March 2021. REGEN-COV is currently available in the U.S. under Emergency Use Authorization.

Regeneron and Sanofi announced FDA approval for Libtayo® (cemiplimab-rwlc) as a first-line treatment for advanced non-small cell lung cancer (NSCLC) with high PD-L1 expression. This approval, based on a pivotal trial with 710 patients, demonstrated that Libtayo improved overall survival (OS) by 32% over chemotherapy, with a median OS of 22 months versus 14 months. The trial also showed a notable crossover rate of over 70% to Libtayo post-chemotherapy. This is the third FDA approval for Libtayo, which is also effective in basal cell carcinoma and squamous cell carcinoma.

Regeneron Pharmaceuticals and Sanofi announced that Libtayo® (cemiplimab) demonstrated superior overall survival compared to chemotherapy in advanced non-small cell lung cancer (NSCLC) with ≥50% PD-L1 expression. The Lancet published these pivotal trial results, which support regulatory submissions in the U.S. and EU. The FDA has granted a Priority Review with a target action date of February 28, 2021. Libtayo reduced the risk of death by 32% overall and 43% in high PD-L1 expressers. Safety profiles were consistent, with higher immune-mediated adverse events in the Libtayo group.

Regeneron Pharmaceuticals (NASDAQ: REGN) announced that the U.S. Court of Appeals upheld a previous ruling invalidating Amgen's patent claims on PCSK9 antibodies, benefiting Regeneron's Praluent. This decision confirms that Amgen's patents were overly broad and validates Regeneron's proprietary technology in developing Praluent. This ruling follows a similar decision by the European Patent Office. Regeneron maintains exclusive rights to Praluent in the U.S., while Sanofi holds rights outside the U.S. Praluent is approved in over 60 countries to lower LDL cholesterol and reduce heart attack risks.

Regeneron Pharmaceuticals (NASDAQ: REGN) announced the FDA approval of Evkeeza (evinacumab-dgnb) for treating homozygous familial hypercholesterolemia (HoFH) in patients aged 12 and older. Evkeeza, the first ANGPTL3 inhibitor approved, reduced LDL-C levels by nearly 50% in a pivotal Phase 3 trial. The average annual cost is projected at $450,000. Regeneron also offers financial support through the myRARE™ program, aiming to ease access for eligible patients. This approval marks a significant milestone for patients suffering from this ultra-rare condition.

Regeneron and Sanofi announced FDA approvals for Libtayo® (cemiplimab-rwlc), the first immunotherapy for advanced basal cell carcinoma (BCC). The treatment received full approval for locally advanced BCC and accelerated approval for metastatic BCC. This marks a pivotal advancement for patients who progress on hedgehog pathway inhibitors. In clinical trials, Libtayo demonstrated a 21% overall response rate in metastatic BCC and 29% in locally advanced BCC. Adverse reactions were reported in 32% of patients, underscoring the need for monitoring during treatment.