Amy Emerson is stepping down on the heels of the FDA last month rejecting Lykos Therapeutics’ MDMA-based therapy for post-traumatic stress disorder and the company laying off three-quarters of its staff.
Reeling from a major regulatory setback, Lykos Therapeutics announced on Thursday that CEO Amy Emerson will step down from her post, handing the reins over to the biotech’s current COO Michael Mullette on an interim basis.
Emerson will stay on with the company as a senior advisor through the end of 2024 and will act as an observer on the biotech’s board. Emerson has been with Lykos since its founding in 2014 and has been working on the biotech’s midomafetamine program since 2003.
Jeff George, chairman of Lykos’ board of directors, in a statement said that Emerson’s contributions to the biotech and to the mental health field more broadly “cannot be overstated,” noting that her work “has helped pioneer the pathway” for the company’s MDMA therapy. “We are deeply grateful for her leadership and service.”
Mullette, who has been with Lykos since March 2022 after holding leadership roles at Sanofi and Moderna, will serve as interim CEO. George in a statement called Mullette a “highly experienced leader” possessing “the right background and skills to steer Lykos” as it works with the FDA to chart the path forward for its MDMA therapy.
Lykos on Thursday also named senior medical advisor David Hough as its CMO. In this expanded engagement, Hough will continue to take charge of Lykos’ clinical development program and the company’s efforts to resubmit an FDA application for its MDMA therapy.
Thurdsay’s C-suite shuffle comes as Lykos recovers from a big regulatory setback for its lead program. Last month, the FDA rejected its MDMA-assisted therapy for post-traumatic stress disorder. Lykos was proposing its psychedelic therapy as an add-on to other supportive mental health services, such as psychotherapy.
In its Complete Response Letter, the regulator noted that Lykos’ investigational therapy “could not be approved based on data submitted to date,” adding that the biotech needs to run an additional late-stage trial to better elucidate the safety and efficacy of MDMA in the proposed indication. At the time, Lykos said that it intended to request for a reconsideration and seek guidance regarding a resubmission.
Lykos’ psychedelic therapy has been mired in controversy, with the FDA’s internal reviewers flagging the “functional unblinding” of the biotech’s Phase III studies, as well as the risk of scientific misconduct. The regulator’s Psychopharmacologic Drugs Advisory Committee cited similar concerns in a panel meeting in June 2024, ultimately voting against the candidate’s approval.
After failing to win the FDA’s approval last month for its MDMA-assisted therapy for PTSD, Lykos announced it would lay off around 75% of its workforce.
