By Mary de Wet
Mind Medicine's shares rose 19% after the biopharmaceutical company received breakthrough designation from the Food and Drug Administration for MM120 to treat generalized anxiety disorder.
The stock recently traded at $7.06 and was up about 87% for the past 52 weeks as of Wednesday's close.
MindMed said its Phase 2b study met its key secondary endpoint to determine the dose-response relationship of four doses of MM120 versus placebo. The company said the FDA granted the breakthrough designation because of the medical need for treatment of generalized anxiety disorder, especially in patients who don't respond to or tolerate currently available medications.
The FDA's breakthrough-therapy designation aims to expedite the development and review of a drug for serious conditions when preliminary clinical evidence shows the drug may show substantial improvement over available therapies.
MindMed plans to hold an end of Phase 2 meeting with the FDA about MM120 in the first half of this year and begin a Phase 3 clinical program in the second half.
Write to Mary de Wet at mary.dewet@dowjones.com
(END) Dow Jones Newswires
March 07, 2024 08:18 ET (13:18 GMT)
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