Spectrum Pharma Stock Craters As FDA Slaps Response Letter For Its Neutropenia Candidate

Spectrum Pharmaceuticals Inc 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.