Proactive Investors - MindMed (NASDAQ:MNMD, NEO:MMED) shares soared more than 26% higher before Thursday’s opening bell after the biopharmaceutical firm revealed that its drug candidate MM120 has been awarded breakthrough therapy status from the US Food and Drug Administration (FDA) for the treatment of generalized anxiety disorder (GAD).
MM120 is the tartrate sale form of lysergide (LSD) being developed by MindMed (NASDAQ:MNMD, NEO:MMED) for GAD and other potential applications in brain health disorders.
The company also said that its Phase 2b study of MM120 in GAD met its key secondary endpoint, and 12-week topline data demonstrated the drug’s clinically and statistically significant durability of activity through to Week 12.
It was earlier announced by the company that the trial had met its primary endpoint, being rapid, clinically meaningful and statistically significant improvements on the Hamilton Anxiety rating scale compared to placebo at Week 4.
“That MM120 exhibited rapid and robust efficacy, solidly sustained for 12 weeks after a single dose, is truly remarkable," MM120 study investigator Dr. David Feifel said.
“These results suggest the potential MM120 has in the treatment of anxiety, and those of us who struggle every day to alleviate anxiety in our patients look forward to seeing results from future Phase 3 trials."
MindMed CEO Robert Barrow added: “The FDA’s decision to designate MM120 as a breakthrough therapy for GAD and the durability data from our Phase 2b study provide further validation of the important potential role this treatment can play in addressing the huge unmet need among individuals living with GAD.”
MindMed plans to hold an End-of-Phase 2 meeting with the FDA during the first half of 2024 and initiate a Phase 3 clinical program in the second half of the year.
Meanwhile, the company also said on Thursday that it would be raising approximately $175 million through an underwritten offering of 16,666,667 shares and concurrent a private placement of 12,500,000 shares, both priced at $6.
Participating in the private placement are new investors including Deep Track Capital and Commodore Capital, with the underwritten offering including participation from new investors such as Ally Bridge Group and Driehaus Capital Management.
Subject to satisfying customary closing conditions, the underwritten offering and concurrent private placement are expected to close on or about March 11, 2024.
Shares of Mind Medicine had gained 26.2% at $7.50 premarket on Thursday.