Spectrum Pharma drops as FDA declines to approve lung cancer drug

Spectrum Pharmaceuticals

25/11/2022 11:28

** Shares of Spectrum Pharmaceuticals Inc  SPPI.O  fall ~14%
to $0.37 premarket
    ** Co says U.S. FDA has declined to approve marketing
application for its experimental drug, poziotinib, for treating
a type of lung cancer 
    ** Will de-prioritize poziotinib program activities,
effective immediately, and in the process of reducing R&D
workforce by around 75% - SPPI
    ** Co to explore strategic alternatives for the drug 
program, including partnerships and business development
opportunities
    ** Co adds that based on FDA's complete response letter, it
would have to generate additional data including a randomized
controlled study prior to approval for the drug 
    ** FDA's decision in line with an advisory panel's
recommendation to not approve the drug
    ** As of last close, stock down ~66% YTD
 (Reporting by Raghav Mahobe)
 ((Raghav.Mahobe@thomsonreuters.com))