Lucid News

01/23/2025

The decision in August by the FDA to reject Lykos Therapeutics’ application for M**A-assisted psychotherapy has engendered a wave of hand-wringing and finger-pointing, a surprising volta after half a decade of steady psychedelic hype. To best understand how a regulatory agency’s routine vote on whether to approve a novel psychiatric treatment could cause such consternation, we must return, in psychedelic parlance, to our set and setting. To read more link in bio.

08/17/2024

Lykos, MAPS Cut Staff As New Leadership Takes Charge of M**A-AT Research
After the rejection of its New Drug Application for M**A-assisted therapy to treat PTSD, Lykos Therapeutics announced a major reorganization on Thursday, cutting its workforce by 75% and appointing new leadership. The company, which reportedly laid off about 100 employees, will prioritize “clinical development and regulatory engagement,” towards the resubmission of its New Drug Application (NDA) for M**A-AT. The MAPS nonprofit organization, Lykos’s largest single shareholder, has also cut 33% of its workforce. Read more at the link in our bio.

08/11/2024

FDA Denies the Lykos Therapeutics Application for M**A-Assisted Therapy
The FDA has rejected Lykos Therapeutics’ New Drug Application (NDA) for M**A-assisted therapy for PTSD. The agency issued a Complete Response Letter to Lykos, stating that the data submitted were insufficient for approval and requested an additional Phase 3 study which could require years of research and significant funding.

The FDA’s decision was not unexpected after an FDA Psychopharmacologic Drugs Advisory Committee (AdComm) overwhelmingly voted against approving M**A-AT for PTSD in June, citing concerns about potential safety risks, study design, and research methods. These concerns were echoed in the Complete Response Letter (CRL), which is not publicly available, but was discussed by Lykos today in public comments.
Read more - link in bio👆

07/24/2024

(From Carmel) Dear Friends and people who love Ken and care for his family: we are floored by this generous outpouring of support during our time of great need. We are still in the middle of a major transition -- Kian and I are moving back into Ken's apartment, consolidating our lives. This amazing fundraiser is covering the costs of three households (in Brooklyn and Los Angeles) during this shift while our regular lives and our routine work have come to a standstill. While we are moving through the shock of Ken's passing, we feel held and loved by our greater community. I will write soon on the story of Ken's death when we have the final medical findings and when I am ready. For the moment, we are in the middle of clearing out Ken's apartment and saving the precious pieces of his life and memorable books. We couldn't have made any progress had it not been for your kind support! Thank you again from the bottom of our hearts. Please feel free to contact me if you want to make a personal, social connection.

07/23/2024

As the August 11 deadline nears for the FDA to issue a decision on Lykos Therapeutics’ New Drug Application for M**A-Assisted Therapy for PTSD, many observers are waiting to see if the drug company and the regulatory agency can reach agreement on the details of a Risk Evaluation and Mitigation Strategy (REMS) that would adequately address the cautions raised by advisors. 

In this first part of a two-part special report, Lucid News looks into the questions raised by the FDA’s Psychopharmacologic Drugs Advisory Committee (https://www.lucid.news/lykos-responds-fda-mdma-therapy/) (AdComm) and the Institute for Clinical and Economic Review (https://icer.org/assessment/ptsd-2024 ) (ICER), the history of these concerns, and efforts by researchers and clinicians to address safety considerations that could block FDA approval of M**A-AT. 

Read more in this latest business piece by Charles Lighthouse at the l*nk in our bio or at Lucid.News.

06/14/2024

On June 4, an advisory committee to the FDA voted to issue guidance that opposed the approval of M**A-assisted psychotherapy as a treatment for adults with PTSD. The recommendation is expected to influence the agency’s final decision on Lykos Therapeutics’s New Drug Application (NDA), which is expected on August 11.

For supporters of FDA approval for M**A-AT, the guidance was a sobering reminder about the complexities of securing FDA approval for psychedelic therapies. It is also a comedown for those hoping that FDA approval of M**A-AT would trigger the DEA to reconsider the drug’s status as a Schedule 1 substance with no accepted medical use. 

Read the article by Charles Lighthouse at the l*nk in bio.

06/14/2024

On June 4, an advisory committee to the U.S. Food and Drug Administration (FDA) voted to issue guidance that opposed the approval of M**A-assisted psychotherapy as a treatment for adults with PTSD. The recommendation, issued by the Psychopharmacologic Drugs Advisory Committee, is expected to influence the agency’s final decision on Lykos Therapeutics’s New Drug Application (NDA), which is expected on August 11.

For supporters of FDA approval for M**A-AT, the guidance was a sobering reminder about the complexities of securing FDA approval for psychedelic therapies. It is also a comedown for those hoping that FDA approval of M**A-AT would trigger the DEA to reconsider the drug’s status as a Schedule 1 substance with no accepted medical use.

Read more: https://www.lucid.news/lykos-responds-fda-mdma-therapy/

05/14/2024

The staff of Lucid News is deeply saddened by the death on Sunday of our friend and colleague Ken Jordan. In addition to being our Editorial Director and co-founder of Lucid News, Ken was a true pioneer and leader in the psychedelic movement and a dear friend to many of us.

Read the full statement at the link in our bio.

05/14/2024

The staff of Lucid News is deeply saddened by the death on Sunday of our friend and colleague Ken Jordan. In addition to being our Editorial Director and co-founder of Lucid News, Ken was a true pioneer and leader in the psychedelic movement and a dear friend to many of us.

Read the full statement here: https://bit.ly/3K0Ac3b

01/23/2024

APPA’s Stephen Xenakis Discusses the Future of Psychedelic Therapy.

The executive director of the American Psychedelic Practitioners Association (APPA) shares his vision for the professionalization of psychedelic-assisted therapy, as FDA approval seems likely this year.

Read the Lucid News interview: https://www.lucid.news/appas-stephen-xenakis-discusses-the-future-of-psychedelic-therapy/

01/22/2024

What could the technology industry learn from psychedelics, and what might the emerging psychedelics industry learn from the mistakes of Silicon Valley?"

Join authors Douglas Rushkoff (Survival of the Richest: Escape Fantasies of the Tech Billionaires), Paul D. Miller (aka DJ Spooky), Julie Holland (Good Chemistry), and moderator Ken Jordan (Lucid News Editorial Director) for a freewheeling discussion about the intersection of tech and psychedelics.

Wednesday, January 24, 7-9 PM
The Athenaeum, 222 East 46 Street, NYC

01/22/2024

01/22/2024

Dr. Bruce Damer suggests that humanity may be on the brink of a “fourth path for psychedelics,” to amp up our nerdiest states for creative breakthroughs in science, technology, design, and leadership. Damer writes, "To pursue this new path for psychedelic research and practice, a new organization has been formed: , an acronym for Multidisciplinary Investigations into Novel Discoveries and Solutions."

Read the article on Lucid News, l*nk in bio.

01/15/2024

How MAPS PBC Became Lykos Therapeutics and Raised $100M.

The MAPS nonprofit remains the largest shareholder, but gives up
controlling interest in MAPS PBC, as the for-profit company that seeks to commercialize M**A therapy successfully attracts investors.

Read the Lucid News article by Ann Harrison and Ken Jordan at bit.ly/48V3URO.