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Spectrum Pharma withdraws license application for Rolontis after FDA seeks information on manufacturing [MarketWatch]

Spectrum Pharmaceuticals, Inc (SPPI)  More Company Research Source: MarketWatch
Last spectrum pharmaceuticals, inc earnings: 5/9 04:00 pm Check Earnings Report
US:NASDAQ Investor Relations: investor.sppirx.com/investor-relations
PDF Spectrum Pharma withdraws license application for Rolontis after FDA seeks information on manufacturing Spectrum Pharmaceuticals Inc. SPPI, -3.38% shares slid 7.6% in premarket trade Friday, after the company said it is withdrawing its Biologics License Application for Rolontis after the U.S. Food and Drug Administration asked for manufacturing-related information. The company said the decision was made because it needs more time to comply with the FDA request and that it will resubmit a BLA as soon as possible. "We are continuing to have productive discussions with the FDA and will deliver the additional information needed to support the application, " CEO Joe Turgeon said in a statement. Rolontis is a treatment for the management of chemotherapy-induced neutropenia in patients undergoing myelosuppressive chemotherapy. Neutropenia is a common side effect of myelosuppressive chemotherapy that increases the risk of infection and reduces patients' ability to fight infection. Spectrum [Read more]

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