In a short statement Friday, Lykos Therapeutics expressed optimism about a recent meeting with the regulator to discuss next steps for the embattled program, following the FDA’s rejection in August 2024.
Nine weeks after the FDA rejected Lykos Therapeutics’ MDMA-assisted therapy for post-traumatic stress disorder, the company has taken its first steps forward, announcing a “productive” meeting with the agency.
In a statement released Friday, the psychedelic drug developer said the meeting—led by new interim CEO Michael Mullette and new Chief Medical Officer David Hough—“resulted in a path forward” that will include an additional Phase III trial and a potential third-party review of prior Phase III data.
The FDA in an Aug. 9 Complete Response Letter said Lykos’ application “could not be approved based on data submitted to date” and requested the company conduct an additional Phase III trial to glean more information on the safety and efficacy of MDMA.
At that time, Lykos stated its intention to request a meeting with the regulator to “ask for reconsideration of the decision” and to seek FDA’s recommendations for a resubmission.
Former CEO Amy Emerson said that an additional Phase III study “would take several years.” Emerson stepped down from her role in September after 10 years with the company. Along with naming Mullette as interim CEO, Lykos also introduced Hough as the company’s new CMO and said that he would spearhead the efforts to resubmit an FDA application for the MDMA therapy.
Less than a week after the FDA rejection, Lykos announced it would lay off around 75% of its staff “with the remaining team focused on its ongoing clinical development, medical affairs, and engagement with the FDA.”
On Friday, Lykos said it would “continue to work with the FDA on finalizing a plan” and continue to provide updates “as appropriate.”
