Why Fortress Biotech Stock Is Sinking Today
Shares of biopharmaceutical company Fortress Biotech (NASDAQ: FBIO) are dropping sharply on Tuesday after the company announced a regulatory update regarding one of its subsidiaries, Avenue Therapeutics (NASDAQ: ATXI). As of 2:49 p.m. EDT, shares of Fortress Biotech were down by 11.3%.
Avenue Therapeutics' New Drug Application (NDA) for IV tramadol, a medication intended for the management of acute pain in patients who require an opioid, has been in limbo for several months. In October, the U.S. Food and Drug Administration (FDA) issued a Complete Letter Response (CLR) to Avenue Therapeutics for this medicine.
After a productive meeting with the regulatory agency, Avenue Therapeutics planned on resubmitting an NDA for IV tramadol in February. The company did so, and it received an acknowledgment letter from the FDA stating that its NDA resubmission for IV tramadol was a complete, class 1 response to the agency's CLR.
Source Fool.com
