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Last week a team from Lykos Therapeutics led by new interim CEO, Michael Mullette, and new Chief Medical Officer, Dr. David Hough, had a productive meeting with the FDA regarding next steps in...
Amy Emerson, Lykos' founding leader, stepping down as CEO Pharma veteran and Lykos Chief Operating Officer Michael Mullette appointed as interim CEO Dr. David Hough named Chief Medical Officer SAN...
- Pharmaceutical industry veteran and former Janssen executive Dr. David Hough appointed senior medical advisor to oversee clinical and regulatory - Lykos to significantly reduce workforce,...
U.S. Food and Drug Administration requests additional Phase 3 study Issues raised in CRL echo those discussed in FDA Advisory Committee hearing The Company intends to pursue all available...
Company launching independent advisory board to inform key elements of a potential commercial launch, including therapy training, ethics and healthcare integration Company plans to work with...
Earlier today, the Institute for Clinical and Economic Review (ICER) shared its Final Evidence Report on Midomafetamine-Assisted Psychotherapy for Post-Traumatic Stress Disorder (PTSD).1 Lykos...
Dear Colleagues, As you know, Lykos is entering the final stages of a multi-year effort to study and apply for approval from the U.S. Food and Drug Administration (FDA) for midomafetamine (MDMA)...
Lykos Therapeutics ("Lykos"), a company dedicated to transforming mental healthcare, announced the outcome of the U.S. Food and Drug Administration's ("FDA") Psychopharmacologic Drugs Advisory...
Lykos Therapeutics ("Lykos"), a company dedicated to transforming mental healthcare, announced the appointment of finance veteran Scott Giacobello to the company's Board of Directors, effective...
Meeting to be held on June 4, 2024 First FDA Advisory Committee meeting for potential new PTSD treatment in 25 years SAN JOSE, Calif., May 6, 2024 /PRNewswire/ -- Lykos Therapeutics (formerly MAPS...
Allison Rosenthal appointed Chief Commercial Officer to lead the potential commercial launch of MDMA-assisted therapy if approved by the FDA Coy Stout joins as Vice President of Market Access SAN...
Study completion marks an important next step in the Company's Europe program SAN JOSE, Calif., April 24, 2024 /PRNewswire/ -- Lykos Therapeutics (formerly MAPS Public Benefit Corporation)...
PDUFA date is August 9, 2024 If approved, this would be the first MDMA-assisted therapy and psychedelic-assisted therapy SAN JOSE, Calif., Feb. 9, 2024 /PRNewswire/ -- Lykos Therapeutics (formerly...
Participants with severe PTSD who received MDMA-assisted therapy demonstrated significant improvements in self-experience Improvements in self-compassion associated with MDMA-assisted therapy were...
Funding comes from mission-aligned and institutional investors to support regulatory and pre-launch activities for investigational MDMA-assisted therapy for post-traumatic stress disorder ("PTSD")...
Codes provide avenue for qualified healthcare providers to seek reimbursement for delivering MDMA-assisted therapy if FDA approved SAN JOSE, Calif. , Jan. 2, 2024 /PRNewswire/ -- MAPS Public...
Filing marks first NDA submission for any psychedelic-assisted therapy Submission represents 30 plus years of clinical research into potential use of MDMA-assisted therapy for PTSD NDA includes...
Study met primary and secondary endpoints confirming first Phase 3 study findings MAPP2 population reflects PTSD demographic with approximately half of study participants identifying as racially...
Codes will provide qualified healthcare professionals a means to seek reimbursement for delivering MDMA-assisted therapy if it is approved by the U.S. Food and Drug Administration SAN JOSE, Calif....
Agreement underscores benefit of collaboration to accelerate review of new evidence-based treatment options for people with PTSD Submission of new drug application expected in the second half of 2023
COMPASS Pathways and MAPS PBC submitted joint application for new code to facilitate access to psychedelic therapy in the US, if approved London, UK and San Jose, US – May 2, 2023 COMPASS...
Interim results show improvements in PTSD symptom severity lasted at least six months after the last treatment session Findings are consistent with previously published Phase 2 data 1 on the...
Results demonstrate a biological correlation between reduction in PTSD severity and treatment with MDMA-assisted therapy in veterans and first responders Study sheds light on neurological...
Results met study pre-specified primary and key secondary endpoints and will support new drug application submission expected in third quarter of 2023 No serious adverse events observed in the...
Top-line data expected in the first quarter of 2023 Data to be part of new drug application submission expected in third quarter of 2023 SAN JOSE, Calif. , Nov. 17, 2022 /PRNewswire/ -- MAPS...