Psychedelic: Jefferies initiates Compass Pathways with a Buy rating

In this week’s “Psychedelic,” The Fly’s recurring series focused on psychedelic stock news, The Fly looks back on an analyst initiation, patent filings and commercial manufacturing.

COMPASS PATHWAYS INITIATED WITH BUY: Jefferies initiated coverage of Compass Pathways (CMPS) with a Buy rating and $18 price target. The firm is 75%-85% confident the Food and Drug Administration will approve COMP360, the company’s oral psilocybin for treatment-resistant depression, in FY26, the analyst said. Additionally, Jefferies believes COMP360’s launch prospects are favorable, noting its potential as the first-to-market will drive public awareness and its differentiation from Johnson & Johnson’s (JNJ) Spravato.

CLEARMIND FILES EUROPEAN PATENT APPLICATION: Clearmind Medicine (CMND) announced Tuesday the filing of a European patent application for psychedelic compounds targeting the treatment of Post-Traumatic Stress Disorder and other mental health disorders. The European patent application forms part of the company’s exclusive worldwide licensing agreement with Yissum Research Development Company of the Hebrew University of Jerusalem. Under the terms of the licensing agreement, Clearmind holds exclusive global rights to develop, manufacture, and commercialize novel compounds developed at Yissum. The company is responsible for advancing the development program in accordance with regulatory requirements.

NRX INITIATES COMMERCIAL MANUFACTURING FOR KETAMINE: NRx Pharmaceuticals (NRXP) announced Tuesday the initiation of a first commercial manufacturing order of its preservative free ketamine product in anticipation of approval under the Generic Drug User Fee Act in Summer. The order is based on stability observed in more than three manufactured registration batches and the company’s third-party audit of the manufacturing facility. The company expects that the initial manufacturing pace will be sufficient to support initial substantial yearly revenues and notes the ability to rapidly scale manufacturing as demand grows.

“NRx thanks its manufacturing partner for the care and support that has been invested in this project and looks forward to being able to serve Americans with a safe and convenient US-made ketamine product. We hope to alleviate the supply shortages that have frequently been reported in association with sterile ketamine,” said Dr. Jonathan Javitt, CEO.

Additionally on Thursday, NRx announced receipt of clearance from the FDA to initiate a clinical trial of NRX-101 vs. placebo in patients with depression and suicidality who are being treated with either Robotic-assisted Transcranial Magnetic Stimulation or sham TMS. The placebo-controlled phase 2/3 trial is identified as “A Randomized, Double-Blind, Three-Arm Study of NRX-101 as Adjunctive Therapy to Active or Sham Transcranial Magnetic Stimulation in Adults with Treatment Resistant Major Depressive Disorder.” The trial will be conducted by NRx Defense Systems. The randomized portion of the clinical trial will enroll 240 participants at a leading U.S. academic teaching hospital and three planned study sites maintained by HOPE Therapeutics. An additional group of participants is planned to be enrolled at two United States Military Treatment Facilities. Study sites will be announced following approval by Institutional Review Boards. The Principal Investigator of the MIND1 trial, Prof. Josh Brown, PhD, served as the Principal Investigator of predecessor Phase 1 and Phase 2 studies funded by the US Defense Advanced Research Projects Agency.

SILO FILES PATENT APPLICATION FOR IBOGAINE-BASED THERAPEUTIC: Silo Pharma (SILO) announced Thursday a strategic initiative to explore ibogaine-based therapeutics for the treatment of traumatic brain injury and associated neuropsychiatric conditions. Silo has filed a provisional patent application with the United States Patent and Trademark Office titled “Compositions and Methods for Treating Traumatic Brain Injuries and/or Disorders Associated therewith with Ibogaine.” The invention applies to the use of ibogaine and related compounds for the treatment of TBI, PTSD and associated conditions. Silo’s newest drug discovery initiative is in line with recently published clinical and neuroimaging findings demonstrating substantial improvements in patients with TBI following treatment with ibogaine-based protocols. Reported outcomes include significant reductions in depression and anxiety symptoms, as well as measurable structural brain changes, including increased cortical thickness, subcortical volume expansion, and reductions in predicted brain age following a single treatment.

“Promising clinical findings on ibogaine signify a potential paradigm shift in how we think about treating traumatic brain injury and related central nervous system (CNS) disorders,” said Eric Weisblum, CEO. “While many drugs are used off label to manage TBI symptoms like cognitive dysfunction or depression, no pharmaceutical agent has ever received FDA approval for the direct treatment of TBI. The possibility of not only addressing symptoms but also driving measurable structural brain improvements opens a compelling new frontier in neurotherapeutics.”

ENVERIC HIGHLIGHTS EB-003 RESULTS IN PTSD MODEL: On Tuesday Enveric Biosciences (ENVB) highlighted preclinical data for its lead candidate, EB-003, a dual 5-HT2A and 5-HT1B modulator, in which a single dose of EB-003 significantly reduced context-induced freezing behavior one hour post-dose. These results indicate a rapid reduction in conditioned fear response in a validated preclinical model of PTSD.

Joseph Tucker, CEO, stated, “We believe Enveric’s portfolio of neuroplastogenic compounds, such as EB-003, is well positioned to meet the challenges recognized by regulators and provide therapeutic solutions that fit within existing patient treatment approaches while avoiding real-world limitations of delivering traditional hallucinogenic psychedelic therapies, which may require specialized clinical infrastructure. Enveric’s EB-003 findings in a model of PTSD highlight the potential importance of targeting both neuroplasticity and mood signaling pathways. We believe EB-003’s combined activity at 5-HT2A and 5-HT1B receptors may offer a differentiated approach to promoting neuroplasticity while restoring key signaling pathways involved in emotional regulation and stress response.”

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