Lykos CEO to depart after FDA rejection, layoffs

The CEO of Lykos Therapeutics will step down after the company’s efforts to win a milestone approval for MDMA as a therapy aid were rejected by the Food and Drug Administration last month.

Amy Emerson, who has led Lykos since its formation 10 years ago, will continue as an adviser and observer to the board of directors through the end of the year, the company said in a Wednesday statement. Michael Mullette, who joined Lykos as chief operating officer in 2022 after stints at Moderna and Sanofi, will serve as interim CEO until a full-time successor is found.

Lykos recently announced plans to cut 75% of its workforce and parted ways with founder Rick Doblin as part of a major reorganization following the FDA’s rejection. Lykos had sought to secure clearance of MDMA as a therapy aid for people with post-traumatic stress disorder, but the FDA wasn’t convinced by the company’s data and asked it to run another trial. Advisers to the agency had earlier flagged concerns over how Lykos collected and analyzed its data, as well as alleged ethics violations in testing.

“We founded Lykos with a deep belief in the need for innovation in mental health, and I am deeply grateful for the privilege of leading our efforts,” said Emerson. “While we are not at the finish line, the past decade of progress has been monumental.”

In addition to Emerson’s departure, Lykos also announced the promotion of David Hough, who it appointed as senior medical adviser last month, to chief medical officer. Hough previously worked at Johnson & Johnson, where he helped oversee the development of that company’s ketamine derivative Spravato for depression.

Lykos has said it plans to work toward resubmitting its application for approval of MDMA, but hasn’t specifically confirmed whether it will run the additional trial requested by the FDA. To experts in the field, the regulator’s rejection was a tone-setting verdict, although some saw the issues raised by the agency as specific to Lykos and its application.

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