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Benzinga
Benzinga
Technology
Vandana Singh

Regeneron, Sanofi Withdraw FDA Application For Libtayo's Expanded Use

Regeneron Pharmaceuticals Inc (NASDAQ:REGN) and its partner Sanofi SA (NASDAQ:SNY) have voluntarily withdrawn their application with the FDA for the expanded use of Libtayo in patients with advanced cervical cancer.

  • The application for the monoclonal antibody as the second-line of treatment in the patients was withdrawn "after the companies and the FDA were not able to align on certain post-marketing studies."
  • The FDA had accepted the supplemental application for priority review in September, with the target action date for the decision on January 30, 2022.
  • Related: Sanofi, Regeneron, Share Competitive Libtayo Survival Data in 1L NSCLC.
  • Regeneron and Sanofi are still discussing marketing applications with regulatory authorities outside the U.S, the companies said.
  • Related content: Benzinga's Full FDA Calendar.
  • The drug is already approved for some types of skin and lung cancer.
  • Price Action: REGN stock is down 0.43% at $606.09, and SNY is lower by 0.93% at $52.37 on the last check Friday.
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