Shares of Fortress Biotech (FBIO -8.88%) were sinking 12.9% as of 12:20 p.m. EDT on Monday. The decline came after the company announced that it received a second Complete Response Letter (CRL) from the U.S. Food and Drug Administration for its regulatory submission seeking approval of intravenous tramadol in treating acute pain.
A thumbs-down from the FDA is never good news for a small biotech stock. It's especially concerning when the agency turns down a drug twice.
The first time the FDA refused to approve IV tramadol, the reason given was the drug wasn't safe for the intended patient group. It was a similar story this time around.
Fortress said the FDA thought that there wasn't enough information in the New Drug Application (NDA) supporting the safety of IV tramadol in combination with other pain relievers for the intended patient population. The agency also questioned the efficacy of the drug in combination with other analgesics as well as its clinical benefit as a monotherapy.
Fortress seems to think that the third time could be the charm. The company stated that it "intends to continue to pursue regulatory approval for IV tramadol."