Lykos CEO to resign after FDA rejection of MDMA therapy, layoffs

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Lykos CEO to resign after FDA rejection of MDMA therapy, layoffs

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.

Read the full article on BioSpace.