«In the field of drug development, Compass Pathways announced on Tuesday the six-month data from its second, larger Phase 3 clinical trial of COMP360 psilocybin for treatment-resistant depression. These new data are the latest in a series of positive (though not spectacular) results from the company, which should be sufficient for approval.”.
Compass plans to submit its final New Drug Application (NDA) to the FDA in the fourth quarter of this year, with a potential launch in the first half of 2027. The company's stock remained stable throughout the week.
Other psychedelic drug developers also plan to file New Drug Applications (NDAs) in the coming months, as we previously reported. Among them are Usona Institute, which is also developing a psilocybin-based drug candidate, and Resilient Pharmaceuticals, the MDMA developer formerly known as Lykos Therapeutics. .
As we understand it, Resilient’s submission of its New Drug Application (NDA) is imminent, although it is unclear whether the company will announce this milestone. It is also unclear how quickly the agency will review the proposed product, which, according to our predictions, will be marketed under the name Rysanso. While reviews of existing applications may be faster than those for new ones, the program does not benefit from the Commissioner’s National Priority Bonus, and its rejection in 2024 was surrounded by controversy.
»In any case, all of this activity continues to reinforce our expectation that we will see multiple FDA approvals for psychedelic products in the coming quarters. Therefore, much of the work should focus on access—primarily on establishing and refining models for payment and healthcare delivery."
Josh Hardman
Founder and Editor of Pychedelic Alpha
