FDA sends small biotech and its reformulated pain med packing, triggering a collapse in the share price
A small-cap biotech founded by Fortress has run into a brick wall at the FDA.
Avenue Therapeutics $ATXI says the agency has hit it with a complete response letter for its pitch on IV tramadol to treat post-operative pain. According to the biotech, regulators said that the IV approach wasn’t safe, as any additional need for quick pain relief would likely lead to “opioid stacking.”
The drug hasn’t received much attention from analysts, but investors clearly thought that the reformulation was a shoo-in. Ahead of the bell this morning, its shares were routed, plunging 57%.
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