CMPS Stock Is Breaking Out Again — Retail Traders Think A Major FDA Catalyst Is Brewing

• Michael Davis was appointed as the acting head of the FDA’s Center for Drug Evaluation and Research.
• Davis previously served as chief medical officer at Usona Institute, where he helped advance psilocybin-based therapies.
• Compass Pathways was recently granted an FDA a Commissioner’s National Priority Voucher for its synthetic psilocybin treatment, COMP360.

Shares of Compass Pathways (CMPS) soared 16% in pre-market trading on Monday as psychedelic therapy momentum returned to focus. In April, President Donald Trump’s executive order aimed at fast-tracking medical research and treatment access in the sector last month. Investors are also watching regulatory developments closely after a former Usona executive was named acting head of the FDA’s drug division.

If the pre-market levels hold after the opening bell, CMPS shares would hit their highest levels in more than two years.

FDA Leadership Shakeup Puts CMPS In Focus

A leadership shake-up at the U.S. Food and Drug Administration’s (FDA) drug division is drawing attention from investors closely watching the psychedelic medicine space. Tracy Beth Hoeg, the acting head of the FDA’s Center for Drug Evaluation and Research (CDER), was removed from the role and replaced by deputy director Michael Davis on Friday.

Davis previously served as chief medical officer at Usona Institute, where he helped advance psilocybin-based therapies for major depressive disorder and PTSD. The development comes as enthusiasm around psychedelic drugmakers continues to build.

COMP360 Approval Hopes Remain Key Catalyst

Compass Pathways has emerged as one of the leading publicly traded psychedelic therapy companies in the U.S., with investors closely tracking COMP360, its synthetic psilocybin treatment for treatment-resistant depression.

Last month, Compass Pathways said the FDA granted its synthetic psilocybin treatment, COMP360, a Commissioner’s National Priority Voucher for treatment-resistant depression, providing enhanced regulatory access and a significantly faster review timeline.

What Is Retail Saying About CMPS?

Retail sentiment on Stocktwits has remained ‘bullish’ over the past 24 hours. CMPS was among the top trending tickers on the platform at the time of writing.

One user said “it's happening,” linking two notes on Davis’ appointment and Jefferies’ forecast of COMP360 approval.

Earlier this month, Jefferies said it is 75%-85% confident that the FDA will approve COMP360 in FY26, according to The Fly.

Another user expects a strong rally if the stock breaks its $16 resistance level.

The stock has gained 56% so far in 2026, with most of that gain coming after Trump’s executive order on April 18.

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