TLDR
- CMPS jumps as COMP360 Phase 3 data hits endpoint with rapid TRD relief
- COMP360 posts strong MADRS drop and supports next-day onset through Week 6
- Compass plans FDA meeting and targets NDA submission in Q4 after Phase 3 win
- COMP005 hints at durability to Week 26 after one or two 25 mg doses
- Safety stays consistent as Compass moves COMP360 toward approval pathway.
Compass Pathways (CMPS) shares jumped to $8.06, up nearly 39% intraday, after fresh Phase 3 data. The company reported another positive pivotal trial for COMP360 in treatment-resistant depression. As a result, Compass moved closer to an NDA submission timeline and an FDA review path.
COMPASS Pathways plc, CMPS
The company met the primary endpoint in the Phase 3 COMP006 study. It compared two 25 mg doses against a 1 mg control dose at Week 6. Compass reported a -3.8 point mean MADRS difference and a p-value below 0.001.
Compass also referenced earlier Phase 3 COMP005 results that supported a consistent signal. Together, the two Phase 3 trials reinforced rapid symptom improvement and sustained benefit in responders. The update expanded the evidence base after multiple large trials in the same population.
Phase 3 COMP006 Delivers Clear Signal on Symptoms and Onset
COMP006 tested two fixed doses administered three weeks apart. The study measured depression severity changes using the MADRS scale. Compass reported a statistically significant symptom reduction at the week 6 endpoint.
The company also reported a rapid onset that started the day after dosing. It then maintained that effect across measured timepoints through Week 6 in the 25 mg arm. This pattern supported both fast response and short-term durability.
Compass also highlighted response rates based on a MADRS reduction threshold. It reported that 39% of participants in the 25 mg arm achieved at least a 25% reduction. That result reinforced a clinically meaningful benefit alongside the statistical outcome.
COMP005 Adds Durability Data and Supports Repeat Dosing Framework
COMP005 previously compared a single 25 mg dose against placebo. The trial showed a statistically significant treatment difference at Week 6. Compass used that result as the first pivotal support for the program.
The company also reported durability in participants who responded by Week 6. It said those participants maintained benefit at least through Week 26 after one or two doses. This longer follow-up strengthened the narrative around sustained relief.
Compass also described how Part B supported a second dose option for certain participants. It reported that some participants moved into remission after the second dose. This structure supported a practical approach for patients who need additional response.
Safety Profile Holds While Regulatory Timeline Accelerates
Compass said COMP360 showed a generally well-tolerated safety profile across Phase 3 trials. It reported most treatment-emergent events as mild or moderate and typically short-lived. It also said most events resolved within 24 hours of dosing days.
The company listed common events that included headache, nausea, anxiety, and visual hallucinations. It reported low rates of serious adverse events across trials and very low rates tied to suicidality. It also reported no unexpected safety findings across the Phase 3 dataset.
Compass requested an FDA meeting to discuss a rolling submission and review. It expects to complete an NDA submission in Q4 based on the Phase 3 package. Management also scheduled a public webinar for February 17 at 8:00 a.m. ET.
Background: Why TRD Data Matters and Where COMP360 Fits
Treatment-resistant depression describes patients who fail multiple standard therapies. This group often cycles through options with limited relief and high relapse risk. As a result, new mechanisms with durable benefits remain a priority in psychiatry.
Compass develops COMP360 as a synthetic psilocybin formulation under supervision protocols. The program targets rapid and durable effects rather than daily chronic dosing. That design aligns with the trial structure that uses one or two high-dose sessions.
Compass also holds regulatory designations that support development speed. It has Breakthrough Therapy designation in the United States for TRD. It also has a UK ILAP designation linked to the same indication.
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