Regeneron gets FDA nod for squamous cell carcinoma therapy

Published 1 month ago Negative
Regeneron gets FDA nod for squamous cell carcinoma therapy
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[Cancer cells]

* Regeneron Pharmaceuticals (NASDAQ:REGN [https://seekingalpha.com/symbol/REGN]) has received approval from the U.S. FDA for its monoclonal antibody, Libtayo (cemiplimab), as an additional treatment for patients with cutaneous squamous cell carcinoma.
* The company has also submitted a regulatory application in the European Union for Libtayo, with a decision anticipated by mid-2026.
* The FDA's approval [https://seekingalpha.com/pr/20259597-libtayo-cemiplimab-rwlc-approved-in-the-u-s-as-first-and-only-immunotherapy-for-adjuvant]is supported by data from the phase 3 C-POST trial, which indicated that Libtayo can reduce the risk of cancer recurrence or death by 68% compared to a placebo.

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