Biotech Calendar: Key FDA Action Dates
These can be make-or-break events for drug and biotech companies, so naturally, FDA decisions often move stocks significantly.
The following calendar covers most of the expected drug approval decisions by the FDA through the end of the year. To be included in this FDA calendar, a drug must already be submitted and under review by the agency.
I put the calendar together using company reports and the BioMedTracker service from Sagient Research -- a handy, subscription-based tool for keeping track of biotech and drug catalysts.Let's start with updates on upcoming FDA approval decisions: Hemispherx Biopharma (HEB)
Drug/indication: Ampligen for chronic fatigue syndrome
FDA decision date: May 25 Hemispherx announced May 26 that the FDA requested a "brief delay" of one to two weeks to take action on the Ampligen application. But on a July 22 conference call, the company said it may get a response from the FDA in the fall. NeurogesX (NGSX)
Drug/indication: Qutenza for neuropathic pain
FDA decision date: Aug. 16 Qutenza is a skin patch that delivers a form of capsaicin through the skin to alleviate nerve pain. The patch/drug recently received approval in Europe. Cell Therapeutics (CTIC)
Drug/indication: pixantrone for non-Hodgkin's lymphoma
FDA acceptance date: Aug. 24
Tentative FDA approval decision date: Dec. 24 The FDA will inform Cell Therapeutics on Aug. 24 whether it has accepted pixantrone for review under a priority, six-month review clock. If pixantrone is granted priority review, the FDA approval decision date would be Dec. 24.
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