08:38 AM EDT, 08/12/2024 (MT Newswires) -- Numinus Wellness ( NUMIF ) , a player in mental health care, on Monday said the U.S. Food and Drug Administration (FDA) decision on a new drug application related to MDMA-assisted therapy for PTSD was "a blow", but added it is not dependent on new therapies to achieve profitability.

NUMI noted the FDA decided to not approve Lykos Therapeutics' new drug application for MDMA (midomafetamine capsules) used in combination with psychological intervention for individuals with post-traumatic stress disorder (PTSD). Lykos' new drug application for MDMA was knocked back by the FDA on August 9. The agency requested that an additional Phase 3 study be conducted to study the safety and efficacy of MDMA further.

"While this is a blow to all the incredibly positive and encouraging work that has been done to advance safe access to psychedelic therapy, which MAPS and Lykos have led the charge for, we remain unwavering and committed to doing all we can to make these important therapies available for all those suffering who need it most," said Payton Nyquvest, Numinus Founder and CEO in a statement. "We're confident that further study will continue to show the efficacy of MDMA, and with many psychedelic compounds at the late stages of research, the pipeline of treatments to address severe conditions remains strong."

Nyquvest added Numinus will continue to execute on its previously announced plan to achieve profitability with existing operations, "which were and continue not to be dependent on the commercialization of new therapies."

Meanwhile, Numinus also confirmed the termination of its letter of intent to acquire Medbright AI Investments ( MBAIF ) . Medbright had made a similar announcement last week.