Brief: Spectrum Pharmaceuticals Receives Complete Response Letter From U.S. Food And Drug Administration For Poziotinib

Spectrum Pharmaceuticals

25/11/2022 11:02

Nov 25 (Reuters) - Spectrum Pharmaceuticals Inc
 SPPI.O :
    * SPECTRUM PHARMACEUTICALS RECEIVES COMPLETE RESPONSE LETTER
FROM
U.S. FOOD AND DRUG ADMINISTRATION FOR POZIOTINIB; REAFFIRMS
FOCUS ON THE COMMERCIALIZATION OF ROLVEDON™ (EFLAPEGRASTIM-XNST)
INJECTION
    * SPECTRUM PHARMACEUTICALS INC - TO EXPLORE STRATEGIC
ALTERNATIVES
FOR POZIOTINIB PROGRAM, INCLUDING PARTNERSHIPS AND BUSINESS
DEVELOPMENT OPPORTUNITIES
    * SPECTRUM PHARMACEUTICALS-IMMEDIATELY DE-PRIORITIZES
POZIOTINIB
PROGRAM, ACCELERATES COST REDUCTIONS, INCLUDING 75% REDUCTION IN
RESEARCH AND DEVELOPMENT RELATED WORKFORCE
    * SPECTRUM PHARMACEUTICALS INC - FDA ISSUED A CRL INDICATING
POZIOTINIB APPLICATION CANNOT BE APPROVED IN ITS PRESENT FORM
    * SPECTRUM PHARMACEUTICALS INC - BASED ON CRL, CO WOULD HAVE
TO
GENERATE ADDITIONAL DATA INCLUDING A RANDOMIZED CONTROLLED STUDY
PRIOR TO APPROVAL
    * SPECTRUM PHARMACEUTICALS INC - WILL FOCUS EFFORTS ON
DRIVING
GROWTH FOR RECENTLY LAUNCHED COMMERCIAL DRUG, ROLVEDON
    * SPECTRUM PHARMACEUTICALS INC - BELIEVES IT WILL BE ABLE TO
GENERATE WORKING CAPITAL REQUIRED TO SUPPORT ITS STRATEGIC
REFOCUSING THROUGH 2024

Source text for Eikon:  ID:nBw6572Ska 
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