Acceleration of Launch Plans
COMPASS Pathways announced a 9- to 12-month acceleration of their launch plans for COMP360, highlighting excellent progress.
Successful Phase III Trial Results
The first Phase III trial, COMP005, demonstrated a highly statistically significant result for the primary endpoint, marking an important derisking event for the company.
Completion of Enrollment for Second Phase III Trial
COMPASS completed enrollment for the COMP006 trial, which will inform dosing for labeling and clarify timing for data disclosures.
Positive Interaction with FDA
The company had a positive and collaborative interaction with the FDA, supporting the acceleration of the planned NDA filing for COMP360 in TRD, including the potential for a rolling submission.
Strong Cash Position
As of the end of September, COMPASS had $186 million in cash and cash equivalents, with a cash runway into 2027.
Launch Readiness Advancements
Significant progress in commercial preparations, including strategic collaborations and understanding of the commercial landscape, was highlighted.