Spectrum Pharma up as FDA to review its neutropenia drug candidate again

Spectrum Pharmaceuticals

11/04/2022 12:27

** Drug developer's shares  SPPI.O  up ~13% at $1.29
premarket
    ** Company says U.S. Food and Drug Administration (FDA)
accepted resubmitted marketing application for its neutropenia
drug eflapegrastim  urn:newsml:reuters.com:*:nBw6j6f08a
    ** SPPI says agency set to decide on approval by Sept. 9
    ** FDA had earlier declined to approve eflapegrastim, citing
deficiencies related to the drug's manufacturing  urn:newsml:reuters.com:*:nL4N2PD2UH
    ** SPPI seeking approval of eflapegrastim to treat
neutropenia, a side effect of treatment of cancer with
chemotherapy or radiation therapy
    ** Up to Friday's close, SPPI down ~28% YTD

 (Reporting by Bhanvi Satija in Bengaluru)
 ((Bhanvi.Satija@thomsonreuters.com; Outside U.S. +91
9873062788))