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Biotech Stocks Facing FDA Decision In September

Regeneron Pharmaceuticals
Regeneron Pharmaceuticals

The FDA is scheduled to announce its decision on two of Regeneron Pharmaceuticals Inc’s. (REGN) drugs, Libtayo and Dupixent, in September.

On September 19, the FDA will announce whether or not it approves the expanded use of Libtayo in combination with chemotherapy as first-line treatment in advanced non-small cell lung cancer.

Libtayo is already approved by the FDA for the treatment of squamous cell carcinoma, basal cell carcinoma, and non-small cell lung cancer. In the indication of non-small cell lung cancer, the drug is approved as first-line monotherapy treatment for adult patients with advanced NSCLC whose tumors have high PD-L1 expression, as determined by an FDA-approved test.

Regeneron acquired full rights to Libtayo from Sanofi in July of this year.

On September 30, the FDA will announce its decision on the expanded use of Dupixent as a treatment for adults with prurigo nodularis, a chronic inflammatory skin disease that causes extreme itch and skin lesions.

Dupixent is already approved for the treatment of atopic dermatitis, asthma, chronic rhinosinusitis with nasal polyposis, and eosinophilic esophagitis.

The drug is being jointly developed by Sanofi and Regeneron.

REGN closed Friday’s trading at $596.18, down 1.26%.