SPPI - Spectrum shares slide 24% after FDA declines to approve ROLONTIS

The U.S. FDA has declined to approve Spectrum Pharmaceuticals' (NASDAQ:SPPI) ROLONTIS (eflapegrastim) for the treatment of neutropenia in patients receiving myelosuppressive anti-cancer drugs. Shares down more than 24% premarket. The FDA's complete response letter cited deficiencies related to manufacturing and indicated that a reinspection will be necessary. The company is seeking further clarification from the FDA and plans to meet with the agency as soon as possible. "We continue to believe in ROLONTIS and plan to diligently complete the regulatory process to bring ROLONTIS to market," CEO Joe Turgeon said.

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Spectrum shares slide 24% after FDA declines to approve ROLONTIS