Psychedelic: FDA awards Compass Pathways priority review voucher

In this week’s “Psychedelic,” The Fly’s recurring series focused on psychedelic stock news, The Fly looks back on a BTD evaluation, granting of a priority review voucher and a collaboration for veterans.

CLEARMIND EVALUATES CMND-100 FOR BTD: Clearmind Medicine (CMND) announced Monday that it is evaluating its lead candidate, CMND-100, for eligibility for the U.S. Food and Drug Administration’s Breakthrough Therapy Designation. The BTD is granted to drugs intended to treat serious or life-threatening conditions where preliminary clinical evidence indicates the potential for substantial improvement over existing therapies on at least one clinically significant endpoints. Alcohol Use Disorder represents a life-threating with a significant unmet medical need, affecting millions worldwide with limited effective treatment options.

“We are encouraged by the recognition and positive developments in the space and are evaluating the suitability for potential Breakthrough Therapy Designation for CMND-100 based on the positive results demonstrated to date throughout our ongoing FDA-approved Phase I/IIa clinical trial for Alcohol Use Disorder,” said Adi Zuloff-Shani, CEO. “These data, combined with the recent Executive Order signed by President Trump, which accelerates FDA review processes for certain psychedelic and neuroplastogen therapies designated as breakthrough treatments, further support our belief that CMND-100 may meet the rigorous criteria for this important designation.”

COMPASS ANNOUNCES GRANT OF NDA ROLLING REVIEW REQUEST: Compass Pathways (CMPS) announced Friday that the FDA granted its New Drug Application rolling review request and selected COMP360, the company’s proprietary formulation of synthetic psilocybin, for the Commissioner’s National Priority Voucher program for treatment-resistant depression. Companies selected for the voucher program will be entitled to benefits including enhanced communications and a shortened one-to-two-month review time following filing of an NDA.

“We are honored and grateful to be selected for the CNPV which is a clear validation of both the urgent unmet need facing millions of people living with treatment resistant depression and the innovative science of COMP360,” said Kabir Nath, CEO. “As the most advanced company in the classic psychedelics field, Compass has generated positive data from two large, well controlled Phase 3 clinical trials. Based on the strength of our data, the FDA granted us a rolling NDA submission and review. Importantly, while the CNPV may provide process efficiencies and accelerated review timelines, an NDA submission must still meet FDA’s established standards of clinical evidence, scientific rigor, and regulatory compliance. We are confident we meet these standards. Patients with TRD often endure years of persistent suffering with limited options, and the need for meaningful innovation for these patients has never been more urgent. We are well advanced in our commercial preparations and the CNPV could further accelerate momentum toward bringing our transformative treatment, if approved, to patients who have been waiting far too long.”

B. Riley initiated coverage of Compass Pathways with a Buy rating and $17 price target. The company is on track to develop the first FDA-approved oral psychedelic drug for treatment-resistant depression, but the stock trades in the bottom percentile of its psychedelic peers, the analyst said. The firm views the COMP006 Part B 26-week durability readout in early Q3 as the most important near-term catalyst for the shares. A “clean print” and subsequent successful new drug application submission in Q4 may drive over 50% upside in the stock, contended Riley.

Meanwhile, Oppenheimer said it views the FDA granting a CNPV with agreement on the NDA rolling review as reinforcing the firm’s conviction considering the earlier launch timeline for COMP360 in treatment-resistant depression. Compass Pathways previously expected NDA submission in Q4 following the Phase 3 COMP006 26-week readout in Q3, informing Oppenheimer’s prior expectation for launch in mid-2027. The firm now believes launch could occur by year-end 2026 assuming the NDA rolling submission still includes the durability data, while CNPV enables the shortened one-to-two-month review timeline. Compass Pathways already planned for launch readiness by year-end 2026, and Oppenheimer anticipates management will execute a successful launch according to the updated timelines. The firm has an Outperform rating on the shares with a price target of $20.

HELUS PARTNERS WITH TARA MIND: Helus Pharma (HELP) announced Tuesday a collaboration with TARA Mind, which works with Veterans Exploring Treatment Solutions to support clinical trial recruitment for its PARADIGM HLP003 Phase 3 program for Major Depressive Disorder, while expanding mental health awareness and access within the veteran community. This partnership directly aligns with President Trump’s Executive Order, “Accelerating Medical Treatments for Serious Mental Illness,” which emphasizes expanding clinical research participation and advancing innovative treatment approaches for populations, including veterans, who face disproportionately high rates of depression, Post-Traumatic Stress Disorder, and suicide. TARA Mind and VETS will leverage their deep networks to facilitate veteran engagement and support recruitment for the ongoing PARADIGM HLP003 Phase 3 program.

“Veterans face significant mental health challenges, and expanding awareness and access to clinical research opportunities is an important step toward improving outcomes,” said Eric So, Interim CEO. “TARA Mind and VETS bring deep experience working with veteran communities. These collaborations will support recruitment efforts for our FDA Breakthrough Therapy-designated HLP003 program while aligning with the broader priorities highlighted in the recent Executive Order to expand research participation and advance innovative treatments for serious mental illness.”

PHARMALA EXECUTES LOI WITH ALUVARIS: PharmAla Biotech Holdings (MDXXF) announced Monday that it has executed a binding letter of intent with a strategic partner, Aluvaris, for the formation and operation of a special purpose vehicle for the clinical and regulatory development of APA-01, the company’s patented novel MDXX molecule. APA-01 is a novel molecule protected by United States Patent No. 12,042,478, with potential therapeutic applications in the treatment of psychological trauma and neurological conditions, including Traumatic Brain Injury and Stroke. APA-01 is part of PharmAla’s broader portfolio of novel MDXX class molecules being developed alongside its lead drug candidate, ALA-002, via its Phenesafe.AI drug discovery platform.

Under the terms of the binding LOI, PharmAla and Aluvaris have agreed to form an SPV for the purpose of advancing APA-01 through clinical and regulatory development. The key terms of the arrangement are as follows: PharmAla will seed the SPV with a global exclusive license to its APA-01 intellectual property portfolio, including all patents, patent applications worldwide, research data, and related know-how. The license will be granted on a conditional basis and will become final and irrevocable upon the SPV’s strategic partner meeting the funding threshold. Aluvaris has committed to securing seed capital for the SPV. Upon the SPV completing a financing event that satisfies the funding threshold, the SPV will pay to PharmAla a one-time fee in consideration for the PharmAla IP license. The license fee is payable within thirty days of the closing of the funding threshold. In addition to the license fee, the SPV and any future assignees of the PharmAla IP will pay to PharmAla a perpetual royalty of three percent on net sales of any product incorporating or derived from APA-01. The SPV has retained a contract research organization, Diteba, to manage the advancement of APA-01 through the clinical and regulatory stages of development. The parties have agreed to complete due diligence and execute a definitive agreement by June 8, subject to extension by mutual written agreement.

“This binding LOI represents a significant milestone in PharmAla’s strategy of creating value from our intellectual property portfolio beyond LaNeo MDMA and ALA-002,” said Nicholas Kadysh, CEO. “APA-01 is a molecule with compelling therapeutic potential, and significant regulatory upside noted in the Executive Order signed by President Donald Trump on April 18th. By partnering with a strategic counterparty that brings capital to the SPV, PharmAla can advance APA-01 while allowing us to devote our resources to our core business assets. The retainer of Diteba by the SPV facilitates the clinical development of APA-01 without diverting PharmAla management and science resources from the development of the balance of its intellectual property portfolio. The terms and structure of the SPV ensure that PharmAla and its shareholders can participate meaningfully in the upside of APA-01’s development, while allowing us to maintain our focus and resources on our core LaNeo™ MDMA business and ALA-002 clinical program.”

SILO PHARMA ADVANCING PTSD PROGRAM: Silo Pharma (SILO) announced Thursday that it “commends” a wave of coordinated U.S. federal actions that are rapidly advancing the development of psychedelic-based therapeutics for mental health and substance use disorders. Building on last weekend’s executive initiative to fast-track these treatments, multiple agencies have taken steps this week to accelerate research, clinical progress, and regulatory clarity across the sector. The Advanced Research Projects Agency for Health announced initial awardees under its EVIDENT program, including leading institutions such as Johns Hopkins University and other innovators focused on psychedelic science. Silo believes this funding validates its position on the growing importance of data-driven approaches to treating complex neurological and psychiatric conditions. In parallel, the FDA granted investigational new drug clearance to DemeRx NB for its noribogaine candidate targeting alcohol use disorder, highlighting continued expansion of clinical-stage programs in the mental health space.

“We are witnessing a coordinated and accelerating shift at the federal level,” said Silo CEO Eric Weisblum. “From funding and clinical advancement to regulatory prioritization, in our opinion the foundation is being laid for a new generation of therapies that could transform how we treat PTSD and related disorders.”

OTHER PSYCHEDELIC STOCKS: Publicly-traded companies in the space include Algernon Health (AGNPF), AtaiBeckley (ATAI), BetterLife (BETRF), Bright Minds (DRUG), Definium Therapeutics (DFTX), Enveric Biosciences (ENVB), Filament Health (FLHLF), GH Research (GHRS), Incannex (IXHL), MIRA Pharmaceuticals (MIRA), NRx Pharma (NRXP), Numinus Wellness (NUMIF), Pasithea Therapeutics (KTTA), PharmaTher (PHRRF), Psyence Biomedical (PBM), Psyence Group (PSYGF), Relmada Therapeutics (RLMD) and Revive Therapeutics (RVVTF).