Lykos Therapeutics CEO and founder Amy Emerson is stepping down, with Chief Operating Officer Michael Mullette taking over the top spot on an interim basis.
Emerson has been with the MDMA treatment-focused biotech since its inception in 2014 and will transition into a senior adviser role until the end of the year, according to a Sept. 5 company release. In her place steps Mulette, who has served as Lykos’ COO since 2022 and has past leadership experience at Sanofi and Moderna.
Meanwhile, David Hough, M.D., who was just appointed Lykos’ senior medical adviser in August, will officially join Lykos as chief medical officer.
Emerson’s departure and the C-suite shake-up follow a major restructuring that sent 75% of the company’s workforce packing. The massive reorganization came in the aftermath of the FDA’s rejection of Lykos’ MDMA candidate for post-traumatic stress disorder, plus the retraction of three research papers on the treatment due to protocol violations at a clinical trial site.
The hits kept coming, though. In late August, The Wall Street Journal reported that the FDA was investigating certain studies sponsored by the company. Investigators specifically asked whether side effects went unreported in the studies, according to a report from the newspaper.
Now, the company—which rebranded from MAPS PBC this January—has lost its long-time leader.
“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,” Emerson said in a Sept. 5 release. “While we are not at the finish line, the past decade of progress has been monumental. Mike has been an outstanding partner and is well prepared to step in and lead our next steps.”
Mulette will lead Lykos’ interactions with the FDA in continued efforts to bring the investigational treatment to market.
Aug. 9, the federal agency denied approval for Lykos’ MDMA treatment—to be used in conjunction with psychological intervention—asking that the biotech run another phase 3 trial to further weigh the efficacy and safety of MDMA-assisted therapy, according to a release from Lykos.