TLDR
- Compass Pathways stock jumped +30.18% in pre-market trading, reaching $13.50
- Q1 adjusted EPS came in at -$0.30, beating the consensus estimate of -$0.43
- The FDA granted a rolling NDA submission and review for COMP360 psilocybin therapy
- A Commissioner’s National Priority Voucher was awarded, potentially shortening review timelines
- Multiple analysts raised price targets, with average rating across 11 analysts at “Strong Buy”
Compass Pathways had a busy weekend. The London-based biotech woke up Monday with a stack of catalysts that sent its stock up more than 30% before the opening bell, reaching $13.50 — well above its prior 52-week high of $11.28.
The move was driven by three things hitting at once: a solid earnings beat, a key FDA milestone, and a rare regulatory voucher.
On earnings, the company reported Q1 adjusted EPS of -$0.30, beating analyst expectations of -$0.43. That’s not a profit, but in clinical-stage biotech, beating by that margin matters.
The bigger news was on the regulatory front. The FDA granted Compass a rolling New Drug Application submission and review for COMP360, its synthetic psilocybin therapy targeting treatment-resistant depression. That process is already underway.
On top of that, the company received a Commissioner’s National Priority Voucher. That designation can cut FDA review timelines by one to two months — a meaningful acceleration when you’re this close to the finish line.
At least one of three NDA modules has already been submitted. The full submission is still targeted for Q4 2026, with launch readiness expected by year-end.
Analysts Back the Move
Wall Street responded quickly. TD Cowen reiterated a Buy rating. RBC Capital raised its price target to $22 from $21, keeping an Outperform rating and citing a favorable regulatory environment and a strong data package. Maxim made the biggest jump, lifting its target to $20 from $12. Morgan Stanley moved its target to $17 from $16, maintaining an Overweight rating.
Across 11 analysts, the average rating on CMPS sits at “Strong Buy.”
The backdrop also got a boost from a White House executive order directing the DEA to accelerate rescheduling reviews for psychedelics that have completed Phase 3 trials. Under current guidance, the DEA rescheduling review can run in parallel with FDA review.
Compass expects COMP360 to be initially reclassified as Schedule 2, with formal rescheduling potentially occurring days after FDA approval — a timeline that removes some of the legal uncertainty that has historically weighed on the sector.
What’s Next for COMP360
Part B data from the COMP006 Phase 3 trial are expected in early Q3 2026. That readout will be closely watched.
The company ended the quarter with $466 million in cash and equivalents, giving it a runway into 2028. That removes near-term financing concerns from the equation.
It’s worth noting the broader market wasn’t helping on Monday — the S&P 500 and Nasdaq were both down. The CMPS move was entirely stock-specific.
The company is also scheduled to appear at an upcoming investor conference, which may keep the name in front of institutional buyers in the weeks ahead.
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