DRUG News & Events

In this week's "Psychedelic," The Fly's recurring series focused on psychedelic stock news, The Fly looks back on earnings, the signing of a term sheet and a research agreement .PSYCHEDELIC EARNINGS:On Friday, Enveric Biosciencesreported awhich compared to a loss per share of ($14.58) for the same period last year. As of May 15, the company's cash balance was approximately $10.3M. Enveric believes these funds will support the completion of preclinical development activities for EB-003, the planned filing of an IND application, and operations into 1Q27. "Our progress in the first quarter of 2026 reflects continued execution against our core mission of developing therapeutics capable of addressing the significant unmet need in mental health," said Joseph Tucker, CEO. "We remain laser focused on advancing EB-003, Enveric's lead drug candidate in development, toward an IND submission and first-in-human clinical trials…With IND-enabling activities underway and a strong intellectual property position, we believe Enveric is well positioned to generate meaningful value for stockholders as we transition toward the clinical phase of drug development."Additionally on Tuesday, Enveric announced results from preclinical in vitro experiments evaluating the risk for phototoxicity, which indicated no photoreactive potential for EB-003, further derisking its continued development for the chronic treatment of neuropsychiatric disorders. This represents another preclinical safety assessment milestone for Enveric's neuroplastogen EB-003, a compound designed to selectively engage both 5-HT2A and 5-HT1B receptors. EB-003 is intended to deliver fast-acting, durable antidepressant and anxiolytic effects with outpatient convenience. Phototoxicity testing is mandated by regulatory agencies like the FDA under the ICH S10 guideline and is performed to evaluate whether a novel pharmaceutical compound could become harmful when exposed to UV light.On Monday, NRx Pharmaceuticalsreportedwhich compares to a loss per share of (34c) for the same period last year. As of March 31, the company had approximately $6.7M in cash and cash equivalents. Management believes current cash resources, anticipated growth in clinic revenue, ongoing cost reduction initiatives, and continued availability under the company's active at-the-market offering will be sufficient to support operations through 2026. "The first quarter of 2026 was a pivotal one for NRx, as we advanced two lifesaving drugs towards FDA approval with the aim of initiating commercial pharmaceutical operations by the end of this year. We started the year debt-free, and made targeted investments in several critical strategic operating initiatives that drove substantial progress toward the approval of our first drug product, initiated commercial manufacture in anticipation of drug launch, advanced profitable clinic operations with an expanded footprint, burgeoned our overall intellectual property portfolio, augmented our development pipeline and attracted fundamental long-term investors who believe in our mission," said CEO Jonathan Javitt. "We are deeply grateful for the trust that has been afforded to us by our patients, their families, and our shareholders."On Thursday, Bright Minds Biosciencesreported awhich compared to a loss per share of (C$0.42) for the same period last year. At March 31, 2026, the company had working capital of C$308.5M including cash and cash equivalents of C$309.7M. The company's current and expected cash resources are sufficient to satisfy working capital requirements of running the operations for the following twelve months. Piper Sandler raised the firm's price target on Bright Minds to $220 from $190 and kept an Overweight rating on the shares. The firm caught up with Bright Minds following earnings, where management reflected confidence in the progress made across programs this past quarter. Piper remains bullish on Bright Minds and expects the stock will continue trading-up throughout the year, driving share-gains.PHARMALA, JUPITER SIGN TERM SHEET FOR ALA-002 U.S. RIGHTS:PharmAla Biotech Holdingsannounced Wednesday that it has entered into a term sheet under which PharmAla would grant Jupiter Neurosciencesexclusive,PharmAla's lead drug candidate and a next-generation, non-racemic MDMA novel chemical entity. The total potential value of the proposed transaction is in excess of $100M through a combination of upfront consideration, development milestone payments, and single-digit royalties on net sales. PharmAla would retain all rights to ALA-002 in territories outside of the U.S., including its existing commercial presence through its Cortexa joint venture in Australia. Pursuant to the term sheet, PharmAla would receive upfront consideration of $3.33M at closing of the definitive agreement, comprised of $1.50M in cash and $1.83M in shares of Jupiter common stock, with such shares subject to a 10-day lock-up period. The term sheet additionally provides that further development milestone payments and royalties will be paid to PharmAla as the product is developed, approved, and commercialized in the U.S. Closing of the definitive agreement is to occur no more than 90 days from the execution of the term sheet."This proposed transaction is a meaningful validation of the years of scientific, regulatory and manufacturing work PharmAla has invested in building ALA-002 into a credible, next-generation MDMA candidate," said Nicholas Kadysh, CEO. "Partnering with Jupiter Neurosciences gives ALA-002 a dedicated U.S. development and commercialization home, alongside a CNS-focused team and access to U.S. public capital markets, while PharmAla retains all rights to ALA-002 outside the United States and continues to expand our commercial footprint through Cortexa in Australia and our broader MDXX pipeline globally."CLEARMIND, YISSUM ENTER RESEARCH AGREEMENT:Clearmind Medicineannounced Monday the signing ofof the Hebrew University of Jerusalem. The agreement will fund a comprehensive preclinical study evaluating the metabolic efficacy of MEAI, both in combination with and as a maintenance therapy following tirzepatide treatment in diet-induced obese mice. The research will be conducted by Professor Joseph Tam and his team at the Obesity and Metabolism Laboratory at the Institute for Drug Research, School of Pharmacy, Hebrew University of Jerusalem.Building on results from its prior collaboration with Tam's laboratory, where MEAI demonstrated approximately 15–20% body weight reduction in DIO mice, primarily through increased energy expenditure and fat utilization while preserving lean mass and improving glucose homeostasis and hepatic steatosis, Clearmind is now advancing MEAI into combination and sequencing strategies with incretin therapy. The new 12-month study, titled "Assessing the Metabolic Efficacy of MEAI in Combination and Sequencing with Tirzepatide in Diet-Induced Obese Mice," will examine additive or synergistic effects when MEAI is administered concomitantly with tirzepatide and the potential of MEAI as a maintenance therapy to attenuate post-tirzepatide weight regain and preserve metabolic benefits across multiple doses."MEAI is designed to offer a differentiated mechanism that potentially complements incretin therapies," said Adi Zuloff-Shani, CEO.  "While those drugs excel at reducing food intake, our previous preclinical data show MEAI significantly enhances energy expenditure. We believe that this combination and maintenance approach has potential to deliver more robust, durable, and clinically meaningful outcomes for patients."Additionally on Tuesday, Clearmind announced that it will conduct a reverse share split of its issued and outstanding common shares, no par value, at a ratio of 1-for-10. The reverse split is being effected as part of the company's plan to regain compliance with the Nasdaq Minimum Bid Price Rule and will be effective commencing May 21.GH RESEARCH PRICE TARGET CHANGES:H.C. Wainwright lowered the firm's price target on GH Researchon the shares. The firm cited share count dilution from the company's April offering for the target cut.Cantor Fitzgerald raised the firm's price target on GH Research to $35 from $25 and kept an Overweight rating on the shares. GH Research is viewed as operating in a large and expanding psychedelic therapy market with significant unmet mental health need, where long-term peak sales across related treatments could reach roughly $50B, the firm said. This supports a constructive demand backdrop despite ongoing uncertainty around competitive dynamics in the space, the analyst said.Citizens lowered the firm's price target on GH Research to $39 from $42 and kept an Outperform rating on the shares. GH Research reported continued progress with its GH001 program, reaffirmed plans to begin a pivotal Phase 3 trial in late 2026 following ongoing discussions with the FDA and ended the quarter with approximately $267M in cash, the firm said. The cash balance appears sufficient to fund the global development program, the analyst said.COMPASS PRICE TARGET RAISE:Maxim raised the firm's price target on Compass Pathwaystoon the shares. Compass Pathways reported Q1 results with an operating loss of ($42.9M) and ended the period with $466M, the analyst said. Compass's Commissioner's National Priority Voucher award should accelerate the company's commercial timelines, driving the firm's price target increase, the firm added.OTHER PSYCHEDELIC STOCKS:Publicly-traded companies in the space include Grey Matters Health, AtaiBeckley, BetterLife, Definium Therapeutics, Filament Health, Helus Pharma, Incannex, MIRA Pharmaceuticals, Numinus Wellness, Pasithea Therapeutics, PharmaTher, Psyence Biomedical, Psyence Group, Revive Therapeutics, Silo Pharmaand Sibannac.

In this week's "Psychedelic," The Fly's recurring series focused on psychedelic stock news, The Fly looks back on a primary endpoint achievement, a grant program and analyst views.CLEARMIND'S CMND-100 MEETS PRIMARY ENDPOINT:Clearmind Medicineannounced Tuesday that CMND-100, the company's proprietary non-hallucinogenic MEAI-based oral drug candidate, for the treatment of Alcohol Use Disorder hasResults from the third cohort of the trial indicated a high safety profile for CMND-100, even at the higher dosage administered to date. The data demonstrated that the drug candidate was well tolerated, with no serious adverse events reported in the third cohort and continued favorable overall tolerability, consistent with the safety outcomes observed in prior cohorts. The Phase I/IIa clinical trial is a multinational, multicenter study designed to evaluate the safety, tolerability, pharmacokinetics, and preliminary efficacy of CMND-100 in patients with moderate to severe AUD. Meeting the primary safety and tolerability endpoint in this dose-escalation stage, including at the higher dosage in the third cohort, supports continued advancement of CMND-100 as a potential novel, non-hallucinogenic treatment option for AUD.Additionally on Wednesday, Clearmind announced that its independent Data and Safety Monitoring Board has completed its review and issued a positive recommendation to continue the ongoing FDA-approved Phase I/IIa clinical trial of CMND-100 for the treatment of Alcohol Use Disorder. The positive DSMB recommendation follows the completion of the third cohort and is based on encouraging top-line safety data demonstrating that CMND-100 was well tolerated with no serious adverse events reported. As a result, the company will now proceed to the fourth cohort of the trial and will increase the tested dose of its proprietary drug candidate CMND-100 to 160mg.COMPASS ANNOUNCES U.S. GRANT PROGRAM:Compass Pathwaysannounced Monday an invitation for U.S. based organizationsto deliver investigational COMP360 psilocybin treatment, if approved. Many high-quality training organizations already exist and have trained thousands of HCPs in core and psilocybin-specific psychedelic care. This grant program was established to support the development of high-quality training content, including a COMP360-specific module, with the aim of ensuring HCPs are well-prepared to care for patients receiving COMP360 following the expected commercial launch. Organizations who apply for these grants should have the capabilities to develop and deliver psychedelic treatment training content to ensure the highest standards of care delivery and consistent patient experience. Through the grant program, Compass expects to award up to three organizations grants to support the development of foundational psychedelic and COMP360-specific training. Applications will be accepted from April 14 through May 14."As we prepare for the potential commercial launch of COMP360 for treatment-resistant depression, our priority is ensuring that healthcare providers are trained, confident, and ready to deliver COMP360 treatment responsibly where eligible patients may receive care," said Dr. Steve Levine, Chief Patient Officer. "Through this grant program, we look forward to collaborating with credible and experienced training organizations to develop high quality content to ensure multidisciplinary teams of providers are ready to deliver psilocybin treatment at scale, if approved. This initiative represents an important step to making training for COMP360 broadly available and supporting operational readiness ahead of a U.S. launch."DEFINIUM PRICE TARGET RAISE:Canaccord raised the firm's price target on Definium Therapeuticstoon the shares. The firm believes the shares represent a significant opportunity heading into DT120 Phase 3 data for depression in late Q2. They believe shares of Definium could be up 50% or more on a solid Emerge result.Additionally, Piper Sandler initiated coverage of Definium with an Overweight rating and $49 price target. The firm said Definium's orally disintegrating tablet form of lysergide D-tartrate, DT120, represents a "best-in-class" opportunity in an emerging neuroplastogen space. Piper expects more differentiated antidepressant and anxiolytic options for populations that have been badly underserved by over a generation of therapeutic stagnation. It believes DT120's peak U.S. sales potential is well in excess of $3B, translating into a "compelling risk/reward profile" at current share levels.BRIGHT MINDS INITIATED WITH BUY:Jefferies initiated coverage of Bright MindswithThe firm said the company's oral BMB-101 is a potential best-in-class 5-HT2C agonist. BMB-101 has generated positive Phase II data in absence seizures and broad developmental and epileptic encephalopathy, two $1B+ epilepsy markets with minimal treatment options, the analyst said.HELUS PHARMA INITIATED WITH BUY:TD Cowen initiated coverage of Helus PharmawithThe firm believes the company's positive Phase 2 adjunct major depressive disorder data for HLP003 and precedent clinical data validating psilocybin-based therapies "de-risk" the company's Phase 3 program. The first Phase 3 two-dose HLP003 dataset is due in Q4, which could drive "major upside" in the shares, the analyst said. TD models a 2028 launch and peak U.S. sales of $1.3B.Meanwhile on Thursday, Helus Pharma announced the appointment of Ken Kramer as Senior Vice President, Medical Affairs. Most recently, he served as Vice President and Head of Medical Neuroscience at Bristol Myers Squibb."Strong medical leadership is vital to how we connect with and serve the scientific and clinical communities," said Michael Cola, CEO. "Dr. Kramer brings both deep experience and an execution mindset to help us scale medical capabilities and advance our pipeline. His leadership will be instrumental in translating strong science into meaningful engagement with patients, providers, and payors."NRX APPOINTS TYSON AS CCO:NRx Pharmaceuticalsannounced Monday the appointment of Glenn Tyson as theAs NRx looks forward to the anticipated approval of its Abbreviated New Drug Application for the preservative-free ketamine product, it looks to build its commercial capabilities and prepare for a successful launch. Most recently, Tyson has focused on the emerging sector of companies developing neuroplastic therapies for psychiatric conditions, including leadership level work with Transcend Therapeutics. As CCO, Tyson will be responsible for building world-class market-access, distribution, sales and marketing functions to support commercialization of this NDA, as well as future pipeline assets in psychiatry designed to address the tremendous unmet needs of people suffering with serious mental illnesses."We are excited for Glenn to join the NRx executive team. His passion for people suffering with serious mental illnesses, and his vast relevant experience in the industry successfully building and leading commercial functions gives us great confidence as we prepare for the anticipated launches of our portfolio of products," said Jonathan Javitt, CEO.Additionally on Thursday, NRx announced the incorporation of NRx Defense Systems, a Florida-based research and development subsidiary, charged with development of neuroplastic treatments that combine D-cycloserine with Transcranial Magnetic Stimulation under robotic-enabled neuro-navigation, using already developed technology. The company anticipates participating in future government and non-governmental research and development on a basis that is non-dilutive to current shareholders. NRx Defense Systems will be led by Dr. Dennis McBride, whose career spans the intersection of CNS disorders, neuroplastic therapy, and robotics. McBride will be supported by NRx's newly-appointed Chief Medical Innovation Officer, Professor Joshua Brown, who currently serves as Director of Transcranial Magnetic Stimulation Research at Harvard/McLean and is the Principal Investigator on projects related to TMS and neuroplastic therapy currently funded by the National Institutes of Health and DARPA. A key objective of the NRx Defense Systems initiative is to develop robotic and artificial intelligence-enabled solutions that can be forward-deployed within military organizations without relying on a new layer of skilled medical professionals. The prototype is being developed in partnership with Zeta Surgical. NRx and Zeta anticipate unveiling the prototype robotic-enabled TMS technology with neuroplastic therapy at the 14th Annual meeting of the Clinical TMS Society from June 4-6.OTHER PSYCHEDELIC STOCKS:Publicly-traded companies in the space include Algernon Health, AtaiBeckley, BetterLife, Enveric Biosciences, Filament Health, GH Research, Incannex, MIRA Pharmaceuticals, Numinus Wellness, Pasithea Therapeutics, PharmAla Biotech, PharmaTher, Psyence Biomedical, Psyence Group, Relmada Therapeutics, Revive Therapeuticsand Silo Pharma.