Lykos Therapeutics

The U.S. Food and Drug Administration (FDA) has offered positive feedback to CaaMTech, Inc. on its CT-4201 psilocin prodrug program, specifically endorsing the company's approach to addressing "functional unblinding" in its drug trials. This regulatory milestone not only clears the clinical...

The Department of Veterans Affairs (VA) is signaling potential support for another pivotal Phase III clinical trial of psychedelic therapy to treat post-traumatic stress disorder (PTSD). As Politico reported, Dr. Shereef Elnahal, the undersecretary for health at the VA, revealed that the agency is...

The U.S. Food and Drug Administration (FDA) has issued a complete response letter for MDMA-assisted psychotherapy (MDMA-AT) for treating post-traumatic stress disorder (PTSD) in which it calls for an additional phase 3 trial to further evaluate its safety and efficacy. As Psychiatric Times...

Amy Emerson, the CEO of Lykos Therapeutics, has stepped down from her role at the company, the WSJ reported. This announcement comes nearly a month after the Food and Drug Administration (FDA) rejected Lykos’s application for its ecstasy-based therapy intended to treat post-traumatic stress...

Lykos Therapeutics has announced a strategic reorganization in response to the recent FDA decision regarding its new drug application for MDMA capsules – also known as Ecstasy or Molly – intended for treating post-traumatic stress disorder (PTSD) in adults. New Senior Medical Advisor As...

In a significant development in the field of psychedelic medicine, the journal Psychopharmacology has retracted three research papers on MDMA-assisted therapy due to what it described as unethical conduct at one of the study sites. As New York Times reported, the retraction has cast a shadow over...

The Food and Drug Administration (FDA) this week declined to approve the use of MDMA — popularly known as Ecstasy or Molly — for MDMA-assisted therapy for treating PTSD, disappointing many Americans who suffer with intractable mental health conditions and had pinned their hopes on the treatment....

The U.S. Food and Drug Administration (FDA) is on the verge of making a historic decision regarding the approval of Lykos Therapeutics MDMA-assisted therapy as a mainstream medical treatment for post-traumatic stress disorder (PTSD). The decision, expected by August 11, could mark a turning point...

The potential of MDMA-assisted therapy (MDMA-AT) for treating post-traumatic stress disorder (PTSD) has garnered significant attention, including many scientific studies that indicate promising results. However, while the majority of the results suggest safety and efficacy, researchers emphasize...

MDMA, the drug commonly known as ecstasy and declared illegal by the DEA in 1985, is nearing a landmark moment in its journey toward becoming a legal and approved treatment for PTSD. Lykos Therapeutics Inc., a company that emerged from the nonprofit Multidisciplinary Association for Psychedelic...