(Bloomberg) -- Lykos Therapeutics Inc. Chief Executive Officer Amy Emerson stepped down weeks after US regulators rejected the company’s psychedelic drug MDMA for treatment of post-traumatic stress disorder.
Emerson, who has led Lykos since its founding in 2014, will serve as a senior adviser through the end of the year and will serve as an observer on the company’s board, according to a statement on Thursday. Michael Mullette, who has been been chief operating officer since 2022, will become interim CEO.
The Food and Drug Administration’s Aug. 9 rejection of MDMA followed an outside panel’s vote against approval where advisers said Lykos hadn’t proved the drug was effective. Patients in the company’s trial could likely tell if they were getting MDMA instead of a placebo, distorting the result of the trial, panel members said. They also cited limited information regarding adverse events and potential clinical trial misconduct.
The drugmaker said in August that it would cut three-quarters of its workforce, leaving a small team focused on reversing the FDA’s decision. The company previously said the FDA asked it to conduct another final-stage trial of the drug. Such studies normally take years to complete.
Lykos said last month that it planned to resubmit MDMA for approval. It didn’t offer an estimate for how long that will take.
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