FX.co ★ MindMed Receives FDA Breakthrough Therapy Designation For MM120; Stock Up

On Thursday, Mind Medicine Inc., also known as MNMD, announced that its MM120 program, or the lysergide d-tartrate, had been given a breakthrough designation by the FDA for the treatment of generalized anxiety disorder. As a result, the company's stock surged by 45%.

Mind Medicine Inc. added that this breakthrough status from the FDA would hasten the advancement of their therapy, which had already demonstrated its primary objective during the Phase 2 trial. During the Phase 2b trial using a 100ug dose of MM120, it displayed a 65 percent clinical response rate and a 48 percent clinical remission rate maintained till the 12th week, compared to a placebo.

The company is scheduled to conduct an End-of-Phase 2 meeting with the FDA in the first half of 2024 and kick off a Phase 3 clinical program in the later half of the same year.

At present, MNMD's stock is being traded on the Nasdaq at $8.61, showing an increase of 45.02% or $2.67 per share.