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Lykos calls ICER’s final report ‘subjective’

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Psychedelic drug company Lykos Therapeutics wasn’t too happy with the Final Evidence Report issued by the Institute for Clinical and Economic Review (ICER) on its Midomafetamine (MDMA) Assisted Psychotherapy for Post-Traumatic Stress Disorder (PTSD). Lykos Therapeutics said it was disappointed in the contents and the overall findings of the report, while still asserting that it was encouraged that ICER found MDMA could be a cost-effective treatment for PTSD.

Lykos said in a statement, “However, like the interim report before it, the final report unfortunately goes beyond ICER’s traditional scope. It cites trial design concerns that, while important, have been and are being extensively discussed with FDA through the course of Lykos’ development program and New Drug Application (NDA) review. Further, it draws on select anonymous reports, without adequate and proper documentation, and uses these to cast unfair doubt on the integrity of Lykos, dozens of dedicated clinicians and researchers, and data from hundreds of clinical trial participants.”

ICER report

Green Market Report previously covered the ICER draft report that concluded that the current publicly available evidence is insufficient to assess the overall net benefit of MDMA-AP, which gave the company an “I” rating. ICER also stated that it would not provide Health Benefit Price Benchmarks for MDMA-AP based on that incomplete rating.

The final report came to the same conclusion and continued the I rating. It clearly stated that it had substantial concerns about the validity of the Lykos test results.

The report had three recommendations:

  1. Improve the identification of people living with PTSD across diverse communities to reduce health inequities
  2. For any approved therapy using a psychedelic agent, the FDA should establish an expansive Risk Evaluation and Mitigation Strategies (REMS) program with components including tracking of adverse outcomes, which requires rigorous certification of all healthcare providers involved in treatment.
  3. Clinical researchers and life science companies in this space should attend to the research needed to help all stakeholders understand the appropriate place of psychedelic therapies in the care of people living with PTSD.

Lykos pushback

Lykos seemed to fall back on the ‘it’s not us, it’s you’ response. It accused ICER of not regarding the need for new PTSD treatments and that developing these treatments was complex.

The company also reiterated its study findings and complained that ICER diminished those findings. Lykos also believed that ICER focused too much on what it called a “deeply unfortunate case of therapist sexual misconduct stemming from a 2015 Phase 2 clinical trial.” Lykos said it reported the incident promptly to the appropriate authorities and banned the therapists from working with Lykos in any capacity.

Ultimately, this final report relies on subjective analysis in a manner that seems misaligned to the data-driven approach ICER is meant to provide, and in doing so creates a concerning precedent that could negatively impact innovative treatments. The company has requested time to discuss its concerns with ICER and looks forward to a constructive dialogue.

Public Comments

While Lykos seemed to suggest that there was only one incident of sexual boundaries being crossed in its study, a read through of the public comments attached to the ICER report told another story. There was more than one person publicly speaking about the study and how therapists crossed the line in the physical treatment of patients.

There was one response that favored the Lykos treatment and suggested that current study methods, specifically the blinding nature of studies, weren’t appropriate for psychedelic drugs. The comment also noted that the MDMA had helped many suffering patients.

Lykos is still hoping for FDA approval, but the negative vote with the Advisory Council is beginning to make that approval look less likely. However, if it did get the approval in August, the negative ICER report would make the battle for patients to get reimbursed for treatments more difficult.

 



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Nebraska medical cannabis regulations stall in legislative committee

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A Nebraska legislative committee voted 5-3 against advancing a bill designed to implement and regulate the state’s medical cannabis program, leaving legislators and advocates searching for alternative paths forward, according to the Nebraska Examiner.

The General Affairs Committee rejected Legislative Bill 677, sponsored by State Sen. Ben Hansen of Blair, during a Thursday vote where committee members declined to offer amendments to the legislation, the publication reported.

“I don’t want to shut all the doors right now, but some doors are closing, and they’re closing fast, and so we have to act,” Hansen told reporters after the vote, according to the Examiner.

Nebraska voters approved medical cannabis in November 2024, with residents legally permitted to possess up to 5 ounces with a healthcare practitioner’s recommendation since mid-December. However, the regulatory commission created by the ballot initiative lacks effective power and funding to regulate the industry.

Hansen described his legislation as “a must” for 2025 to prevent a “Wild West” scenario in the state’s cannabis market. The bill would have expanded regulatory structure through the Nebraska Medical Cannabis Commission and extended deadlines for regulations and licensing to allow more time for implementation, the Examiner noted.

Committee disagreements centered on proposed restrictions. A committee amendment would have prohibited smoking cannabis and the sale of flower or bud products while limiting qualified healthcare practitioners to physicians, osteopathic physicians, physician assistants or nurse practitioners who had treated patients for at least six months.

The amendment also would have limited qualifying conditions to 15 specific ailments including cancer, epilepsy, HIV/AIDS, and chronic pain lasting longer than six months.

State Sen. Bob Andersen of Sarpy County opposed allowing vaping due to concerns about youth drug use, while committee chair Rick Holdcroft suggested selling cannabis flower would be “a gateway toward recreational marijuana,” a claim Hansen “heavily disputed,” according to the Examiner.

Hansen now faces a difficult path forward, requiring at least 25 votes to pull the bill from committee and then needing 33 senators to advance it across three rounds of debate, regardless of filibuster attempts.

Crista Eggers, executive director of Nebraskans for Medical Marijuana, remained optimistic despite the setback.

“This will not be the end,” Eggers said, according to the outlet. “Giving up has never been an option. Being silenced has never been an option. It’s not over. It’s not done.”

The legislative impasse is further complicated by ongoing litigation. Former state senator John Kuehn has filed two lawsuits challenging the voter-approved provisions, with one appeal pending before the Nebraska Supreme Court. The state’s Attorney General is also trying to do something about the hemp question, akin to other states across the country.



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One of Las Vegas’ cannabis lounges closes its doors

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Nevada’s cannabis lounge experiment faces some expected growing pains, with one of just two state-licensed venues closing its doors after barely a year in business, according to the Las Vegas Weekly.

“The regulatory framework, compliance costs and product limitations just don’t support a sustainable business model,” said Thrive Cannabis managing partner Mitch Britten, who plans to convert the space into an event venue until regulations loosen up.

The closure leaves Planet 13’s Dazed Consumption Lounge as the only operational state-regulated cannabis lounge in Nevada. Dazed manager Blake Anderson estimates the venue attracts around 250 customers daily, primarily tourists. One other establishment, Sky High Lounge, has operated since 2019 on sovereign Las Vegas Paiute Tribe land exempt from state regulations.

Even with Nevada regulators conditionally approving 21 more lounge licenses, potential owners are struggling to meet the $200,000 liquid assets requirement – particularly social equity applicants from communities hit hardest by prohibition.

Recreational marijuana has been legal statewide since 2017, but public consumption remains prohibited. That’s created an obvious disconnect for the millions of tourists who visit Las Vegas annually but have nowhere legal to use the products they purchase. The state recorded roughly $829 million in taxable sales during the 2024 fiscal year.

“It always comes down to money, and it’s difficult to get a space if you can’t afford to buy a building. On top of that, getting insurance and finding a landowner who’s willing to lease to a cannabis business is a challenge in and of itself,” said Christopher LaPorte, whose consulting firm Reset Las Vegas helped launch Smoke and Mirrors, told Las Vegas Weekly.

Many think the key to future success lies in legislative changes that would allow lounges to integrate with food service and entertainment – playing to Las Vegas’s strengths as a hospitality innovator. In the meantime, the industry will continue to adapt and push forward.

“Things take time,” LaPorte said. “There’s a culture that we have to continue to embrace and a lot of education that we still have to do. But at the end of the day, tourists need a place to smoke, and that’s what these places are.”



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Psyence Group consolidates its shares

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Psyence Group Inc. (CSE: PSYG) told investors that it will be consolidating all of its issued and outstanding share capital on the basis of every 15 existing common shares into one new common share effective April 23, 2025 with a record date of April 23, 2025. As a result of the consolidation, the issued and outstanding shares will be reduced to approximately 9,387,695 on the effective date.

This is the second time a Psyence company has consolidated shares recently. In November, its Nasdaq-listed associate, Psyence Biomedical Ltd. (Nasdaq: PBM), implemented a 1-for-75 share consolidation as the psychedelics company worked to maintain its Nasdaq listing.

Psyence Group reported earnings in February when the company delivered a net loss of C$3 million and was reporting as a going concern. At the end of 2024, the company said it had not yet achieved profitable operations, has accumulated losses of C$48,982,320 since its inception.

Total assets at the end of 2024 were C$11,944,478 and comprised predominantly of: cash and cash equivalents of C$10,611,113, other receivables of C$159,808, investment in PsyLabs of C$1,071,981 and prepaids of C$68,243.

Still, the company is pushing ahead. Psyence told investors that it has historically secured financing through share issuances and convertible debentures, and it continues to explore funding opportunities to support its operations and strategic initiatives. “Based on these actions and
management’s expectations regarding future funding and operational developments, the company believes it will have sufficient resources to meet its obligations as they become due for at least the next twelve months,” it said in its last financial filing.

The company said it believes that the consolidation will position it with greater flexibility for the development of its business and the growth of the company.

 



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