Lykos will lay off approximately three-quarters of its staff amidst a reorganization aimed at helping the company complete a regulatory resubmission for its MDMA-assisted therapy.
Less than one week after failing to win approval for its MDMA-assisted therapy for post-traumatic stress disorder, Lykos Therapeutics announced it will lay off around 75% of its staff. Prior to the cuts, Lykos had about 100 employees, according to STAT News.
On Aug. 9, the FDA issued a Complete Response Letter for midomafetamine (MDMA) capsules, saying Lykos’ New Drug Application (NDA) could not be approved based on the data submitted to date. The decision followed a June advisory committee meeting in which the FDA’s Psychopharmacologic Drugs Advisory Committee voted 10-1 against recommending the treatment, saying that its benefits did not outweigh its risks.
Lykos was incorporated in January 2024, when MAPS PBC—the pharmaceutical arm of the nonprofit Multidisciplinary Association for Psychedelic Studies (MAPS)—closed a $100 million Series A funding round and changed its name. The rebranding reflected the company’s “new stage of focus—the integration of the potential first psychedelic-assisted therapy into the healthcare system if approved by FDA,” according to a press release issued at the time.
In addition to the layoffs, Rick Doblin, founder and president of MAPS, will relinquish his position on the Lykos board.
“After 38 plus years of work, I’m profoundly saddened by the FDA decision around this critically needed therapy, but am heartened that Lykos will still move forward continuing clinical research that addresses the FDA’s questions,” Doblin said in a prepared statement.
The reorganization is intended to “[streamline the] organization around clinical development and regulatory engagement,” as it prepares for a resubmission of its NDA for MDMA capsules, according to Thursday’s press release.
Former J&J executive David Hough, who helped spearhead the development of esketamine-based depression treatment Spravato, will lead these efforts.
“My hope is to build on the strong foundation Lykos has created and leverage my experience in the industry to ensure a productive ongoing dialogue with the FDA and oversee the clinical work that needs to be done to address the Agency’s questions which will allow us to serve patients safely and effectively,” Hough said in a statement.
In its CRL, the FDA requested that Lykos complete an additional Phase III study to glean more information on the safety and efficacy of the treatment—something CEO Amy Emerson said “would take several years.” In a press release issued Aug. 9, Lykos said it “believes that the data included in the NDA provide sufficient evidence of efficacy and durability in line with the relevant FDA guidance,” and vowed to “ask for reconsideration of the decision” and seek the FDA’s recommendations for a resubmission.
Lykos’ original NDA was backed by data from several studies, including the Phase III MAPP1 and MAPP2 trials. While both trials were successful, the development program came under fire from the Institute for Clinical and Economic Review (ICER), which flagged “substantial concerns” with the validity of Lykos’ data, pointing to the issue of functional unblinding “with nearly all patients who received MDMA correctly identifying that they were in the MDMA arm of the trials.” The advisory committee likewise spent a considerable amount of time on this issue.
The layoffs, which are expected to affect roles throughout the company, were first announced at an employee meeting on Thursday, according to reporting by Endpoints News, citing a person familiar with the discussion.
