It's been a long road for Compass Pathways (CMPS 3.34%) to prove that its treatment using psilocybin therapy for treatment-resistant depression (TRD) can be successful. It was back in 2018 when the company received breakthrough therapy designation from the U.S. Food and Drug Administration (FDA) for its treatment.
Today, Compass updated investors on its drug trial progress, and the stock shot higher. Compass announced two Phase 3 trials that were statistically significant and positive, with plans to formally submit a New Drug Application (NDA) to the FDA for approval.
Shares initially rocketed more than 50% higher on the news. As of 11:30 a.m. ET, Compass stock was trading up by 42.3%
Image source: Getty Images.
Primary endpoint achieved
The second of two Phase 3 trials successfully met its primary endpoint in evaluating two fixed doses of COMP360. That's the company's proprietary formulation of psilocybin for TRD.
CEO Kabir Nath released the following statement:
Across three robust, well-designed and well-executed clinical trials involving more than 1,000 participants, we have now demonstrated consistent, highly statistically significant results at the primary endpoint and a clinically meaningful effect. This is a remarkable achievement for the field of psychiatry-especially in the TRD population, where proving benefit has historically been extraordinarily challenging.
There are currently limited treatment options for TRD patients. Compass has now requested a meeting with the FDA and plans to submit an NDA seeking full approval before the end of this year.
NASDAQ: CMPS
Key Data Points
That has investors jumping into this biotech stock today. Today's news is a meaningful step in the lengthy trial and approval process. The next step will be to hear from the FDA, and a positive response could keep the stock soaring.
