MindMed (NASDAQ:MNMD) stock is getting a boost on Monday following news from the U.S. Food and Drug Administration (FDA).
The news that has MNMD stock higher today is a Type C Meeting Responses from the FDA. This allows the company to finalize Project Lucy with Generalized Anxiety Disorder as its initial indication.
According to a news release from MindMed, the company is on target to submit its New Drug Application for Project Lucy to the FDA in the third quarter of 2021. This will open the way for it to start Phase 2b clinical trials in the fourth quarter of the year.
MindMed’s goal is to launch its Study MMED008, which will include 200 patients. The company says that it seeks to develop LSD as a treatment for Generalized Anxiety Disorder. This will measure anxiety symptoms in patients after a single treatment of LSD.
Rob Barrow, chief development officer of MindMed, said this about the news sending MNMD stock higher today.
“This approach both provides a clear regulatory pathway to advance LSD to possible approval and leverages the vast experience of Dr. Liechti and our UHB collaborators, including the Phase 2 clinical trial studying LSD in patients with anxiety.”
MindMed hopes that the results of the Phase 2b study will provide results that lead to a Phase 3 clinical trial. The company says that there’s great potential in using LSD to treat Generalized Anxiety Disorder. MNMD notes that the mental health disorder affects 6% of U.S. adults.
MNMD stock is seeing heavy trading on today’s news. As of this writing, more than 8 million shares of the stock have changed hands. For comparison, its daily average trading volume is closer to 6.1 million shares.
MNMD stock was up 2.8% as of Monday afternoon.
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On the date of publication, William White did not have (either directly or indirectly) any positions in the securities mentioned in this article. The opinions expressed in this article are those of the writer, subject to the InvestorPlace.com Publishing Guidelines.