Compass Pathways PLC（CMPS）资讯与事件CMPSCompass Pathways PLC

Compass Pathways Appoints Kelley Boucher as Chief People Officer

Compass Pathways announced the appointment of Kelley Boucher as Chief People Officer, effective September 30. This appointment strengthens the Compass executive team as the company continues to scale in support of its mission to bring the first classic psychedelic treatment to the field of psychiatry. In this role, Boucher will oversee the company's people strategy, with an initial focus on guiding its planned evolution towards the launch of COMP360 psilocybin, subject to FDA approval, in the first half of 2027. Prior to joining Compass, Kelley served as Chief People Officer at Apellis Pharmaceuticals.

Strata Mental Health Awarded Training Grant for COMP360

Strata Mental Health Solutions announced it has been awarded one of the five U.S. HCP training grants awarded by Compass Pathways to develop U.S. health care provider training programs for COMP360, Compass' investigational psilocybin treatment, if approved. Strata's founders worked with Compass on the development of the provider training program for COMP360 clinical trials. Their team is deeply experienced in training clinicians and providing direct care to patients receiving psychedelic treatments in regulated clinical settings. Compass has reported positive results from two Phase 3 trials of COMP360. Its NDA submission is expected to be complete in the fourth quarter of 2026 under a rolling submission and FDA review pathway, and commercial launch is expected in the first half of 2027. The training-partner grant program is intended to support the provider training of COMP360, if approved.

Optimi Health Plans to Initiate Phase 2 Trial in 2027

In this week's "Psychedelic," The Fly's recurring series focused on psychedelic stock news, The Fly looks back on study initiation plans, a Breakthrough Therapy designation and Phase 3 study data.OPTIMI TO INITIATE PHASE 2 TRIAL OF PSILOCYBIN-ASSISTED THERAPY:Optimi Healthannounced Thursday plansfor individuals with major depressive disorder. The trial is planned to be initiated in 1H27, with dosing expected to be complete by the end of 2027. The Phase 2 clinical trial is authorized to proceed by Health Canada and will enroll up to 200 participants across multiple sites in Canada, evaluating the safety and efficacy of a single supervised dose of natural psilocybin in the treatment of MDD. The primary efficacy endpoint is the change in Montgomery-Åsberg Depression Rating Scale total score from baseline, the most widely used clinician-rated measure of depressive symptom severity in trials of this kind."A 200-subject Phase 2 trial in major depressive disorder is the largest clinical commitment Optimi has made to date. We will supply our own naturally derived psilocybin, manufactured at our GMP facility, and we will have exclusive ownership of the trial results," said Dane Stevens, CEO "As we broaden our strategy to include clinical drug development, this Phase 2 trial is an initial step toward potential registration. Few companies in this sector are commercial today while also advancing their own clinical development. In Canada, we already hold a Drug Establishment Licence and supply psilocybin through Health Canada's Special Access Program. This trial builds directly on that foundation, and we can comfortably fund it with current cash on hand."DEFINIUM RECEIVES BREAKTHROUGH THERAPY DESIGNATION:Definium Therapeuticsannounced Tuesday that the U.S. Food and Drug Administration has grantedThe designation was supported by the significant unmet medical need in MDD and results from the company's Phase 3 Emerge study, in which a single 100 µg dose of DT120 ODT demonstrated a statistically significant 8.1-point placebo-adjusted improvement in MADRS total score at Week 6, with durable efficacy through Week 12. This milestone marks the second Breakthrough Therapy designation from the FDA for the DT120 development program, following its initial designation for the potential treatment of Generalized Anxiety Disorder."Securing our second Breakthrough Therapy designation, closely following the unprecedented results from our Phase 3 Emerge study, underscores the potential of DT120 to meaningfully transform the treatment landscape for people living with serious mental health disorders," said Rob Barrow, CEO. "This recognition of DT120's promise, first in GAD and now in MDD, reinforces the urgency to advance and deliver rapid, durable benefit across multiple indications. Our focus remains on developing innovative therapies that have the potential to expand treatment options and improve outcomes for the millions of people who continue to seek meaningful relief."COMPASS REPORTS DATA FROM PHASE 3 COMP005 TRIAL:Compass Pathwaysannounced Wednesday the toplinea synthetic, proprietary formulation of psilocybin, for treatment-resistant depression which further support COMP360's differentiated profile and potential for long lasting benefit. In the open-label Part C data, notable additional benefit was observed with an added reduction in MADRS score leading to an average 13-point reduction from baseline at Week 52 and extended out to one year for participants who were randomized to the 25 mg arm and received an additional dose in Part C. For participants in the Placebo arm who received their first dose of COMP360 25 mg in Part C, these findings further reinforce that a single dose of 25 mg has the potential to produce rapid onset, meaningful effect and durability. For all participants in Part C who received a 25 mg dose, strong response and remission rates were observed with 40%-45% responders and approximately 30% remitters across all timepoints in the six weeks post the Part C dose. The COMP360 safety profile in Part C is consistent with Parts A and B and continues to show a generally well-tolerated and safe profile with no new safety findings."COMP360 has now demonstrated rapid onset, substantial magnitude of effect and sustained durability through one year with just a few doses. This emerging clinical profile is unmatched in TRD and puts COMP360 in a league of its own," said Kabir Nath, CEO. "We are excited for what this means for TRD patients and for those who care for them and the potential to move beyond treatments that require daily or frequent administration. As we continue to advance COMP360 for patients, our rolling NDA submission and review are well underway, with final NDA submission expected in the fourth quarter and launch expected in the first half of next year, subject to FDA approval. With a robust clinical package, and growing patient and provider anticipation for COMP360 as a much-needed treatment for TRD, Compass is well-positioned and ready to deliver."Additionally on Thursday, Compass announced U.S. grant program recipients to create training programs for healthcare providers that will be involved in the delivery of psychedelic treatments, such as COMP360 psilocybin. These programs are intended to address both the need for foundational training in psychedelics, as well as ensuring HCPs are well-prepared to care for patients receiving treatment with COMP360 following its expected commercial launch, if approved. The recipients will remain independent training and education providers, retaining ownership and control of their training programs, content, faculty selection, and educational design, with Compass providing the grant program funding and recognizing them as grant awardees. In all, five organizations were awarded the grant, expanded from the originally three recipients due to the overall quality of applicants: CME Outfitters, Emory University, Fluence International, Integrative Psychiatry Institute and Strata Mental Health Solutions.CLEARMIND RECEIVES YALE IRB APPROVAL:Clearmind Medicineannounced Tuesday that thefor Parts B and C of its Phase I/II clinical trial evaluating CMND‑100. This approval advances the multicenter study, titled "A Phase I/II Single and Multiple Dose Tolerability, Safety and Pharmacokinetic Study of CMND‑100 in Healthy Volunteers and Subjects with Alcohol Use Disorder" and directly enables the company to accelerate enrollment at Yale School of Medicine's Department of Psychiatry. The Yale site now joins other centers already approved and actively recruiting patients for the trial, including Johns Hopkins University School of Medicine, Tel Aviv Sourasky Medical Center and Hadassah Medical Center. The trial at the Yale site is led by Anahita Bassir Nia, MD, a specialist in psychiatry and addiction medicine.Adi Zuloff-Shani, CEO, commented, "Yale IRB approval to proceed with Parts B and C is an important milestone for our CMND-100 clinical program. This clearance allows us to immediately expand and accelerate patient recruitment at another world‑class site, alongside Johns Hopkins and Israeli medical centers, as we continue evaluating our proprietary non-hallucinogenic, MEAI-based candidate for individuals with AUD."Additionally on Friday, Clearmind announced that it has entered into a definitive agreement to acquire a 51% stake in Charging Robotics, which develops dedicated intelligent wireless charging systems designed specifically for automated parking facilities, autonomous mobile platforms and robotaxi operations. Under the terms of the agreement, Clearmind will acquire the majority stake of Charging Robotics for an aggregate purchase price of $2.5M. In addition, in connection with and as a condition to the closing of the acquisition, the company shall extend a loan to Charging Robotics in the principal amount of $1.5M. The loan shall bear interest at a rate of 4% per annum. The closing of the acquisition is expected to occur during the week of September 7 subject to the satisfaction of certain closing conditions.FILAMENT COMPLETES DELIVERY OF PEX010 TO AUSTRALIA:Rhelion Life Sciencesannounced Tuesday that its wholly owned subsidiary, Filament Health, hasits patented, standardized, GMP manufactured botanical psilocybin drug candidate, from Canada to Australia in support of an investigator initiated clinical trial. The trial, known as PSI-PHY, investigates psilocybin-assisted physiotherapy in adults with refractory motor functional neurological disorder. It is sponsored by The University of Melbourne, conducted at Austin Health, a public tertiary teaching hospital in Melbourne, and funded by the Medical Research Future Fund of the Australian Government Department of Health and Aged Care. Filament supplies PEX010 as the investigational drug product."For a decade this field has been framed as a mental health story, but newer research is starting to show the potential of natural psychedelics to help patients go beyond that." said Todd Shapiro, CEO of Rhelion. "If a natural psychedelic can help the brain relearn how to move, we are talking about neurology, rehabilitation, and potentially even anti-aging, not only psychiatry. Functional neurological disorder is one of the most common conditions a neurologist sees, and there is no approved pharmacological treatment for it. That is the kind of gap this company exists to help close."OTHER PSYCHEDELIC STOCKS:Publicly-traded companies in the space include AtaiBeckley, Grey Matters Health, BetterLife, Bright Minds Biosciences, Enveric Biosciences, GH Research, Helus Pharma, Incannex, MIRA Pharmaceuticals, NRx Pharmaceuticals, Numinus Wellness, Pasithea Therapeutics, PharmAla Biotech, PharmaTher, Psyence Biomedical, Revive Therapeutics, Sibannacand Silo Pharma.