Spectrum Pharma Stock Craters As FDA Slaps Response Letter For Its Neutropenia Candidate
- Spectrum Pharmaceuticals Inc (NASDAQ: SPPI) has received an FDA Complete Response Letter (CRL) regarding its marketing application for Rolontis (eflapegrastim) for neutropenia (low count of a type of white blood cell) in patients receiving myelosuppressive anti-cancer drugs.
- The CRL cited deficiencies related to manufacturing and indicated that a reinspection would be necessary.
- The company is seeking further clarification and plans to meet with the agency as soon as possible.
- "We are disappointed with this outcome and look forward to fully understanding the remediation timelines for the program," said Joe Turgeon, President and CEO of Spectrum Pharmaceuticals.
- Rolontis is long-acting granulocyte colony-stimulating factor (G-CSF).
- Price Action: SPPI shares are down 25% at $2.44 during the market session on the last check Friday.
- Related content: Benzinga's Full FDA Calendar.
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