Privately-owned Lykos Therapeutics continues to reel from its devastating rejection by the Food and Drug Administration (FDA) for the company’s MDMA drug. The company announced that its Chief Executive Officer Amy Emerson is stepping down from her role and will transition into a senior advisor role through the end of the year. She will also serve as an observer on the Lykos Board.
Michael Mullette, who has served as chief operating officer since early 2022, will become the company’s interim CEO. According to the company’s statement, Mullette joined Lykos after more than two decades in the pharmaceutical industry, most recently heading North America for Moderna, where he oversaw commercialization of the company’s COVID-19 vaccine during the height of the pandemic.
“Mike is a highly experienced leader with the right background and skills to steer Lykos as we engage with the FDA and work to bring this pioneering treatment to patients in need,” said Jeff George, chairman of the Lykos board of directors. “Mike has been highly impactful in his role as COO and has a deep understanding of the path ahead. He brings a wealth of knowledge and an impressive track record from over two decades in pharmaceuticals and is well-equipped to lead Lykos as we look to the future.”
In addition to Mullette’s appointment, Dr. David Hough, who was recently announced as Lykos’ senior medical advisor, formally joins the company as chief medical officer. Dr. Hough will continue to oversee Lykos’ clinical development program and its regulatory engagement with the FDA regarding the resubmission of midomafetamine. Lykos told the marketplace that Dr. Hough previously spent 17 years with Johnson & Johnson, where he oversaw the Spravato (esketamine) Phase 3 development and approval in two indications across multiple markets.
Emerson had been the CEO at Lykos for nearly 10 years. She began work on the midomafetamine program in 2003 and was appointed to lead Lykos (then MAPS PBC) upon its formation in 2014.
“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. Mike has been an outstanding partner and is well-prepared to step in and lead our next steps. I know he will continue to pursue Lykos’ mission of helping patients with unwavering dedication and resolve.”
Last month, Green Market Report wrote that Lykos Therapeutics announced a reorganization plan in the wake of the federal government’s rejection of its application for its MDMA-based drug designed to treat post-traumatic stress disorder. However, the company promised stakeholders that it was not giving up. It cut its staff by roughly 75%, with those left focusing their time and resources on getting FDA approval for the MDMA capsules.
The final portion of the reorganization plan called for the departure of Dr. Rick Doblin, the founder of the Multidisciplinary Association for Psychedelic Studies (MAPS), from Lykos’ board of directors.
[[{“value”:”Lykos is continuing to place long-time pharmaceutical executives in top roles.
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