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

Published on November 25, 2022 03:02 AM PST

Nov 25 (Reuters) - Spectrum Pharmaceuticals Inc :

* 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: Further company coverage:

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