NRXP 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 earnings, a treatment update and an analyst initiation.EARNINGS:On Thursday, GH Researchreportedwhich compared to analyst estimates of (26c). Cash, cash equivalents and marketable securities were $267.3M as of March 31. "The first quarter of 2026 marks progress as planned toward our global GH001 Phase 3 pivotal program," said Dr. Velichka Valcheva, CEO.On Wednesday, Compass Pathwaysreported awhich compared to analyst estimates of a loss per share of (31c). Cash and cash equivalents were $466M and debt was $50.5M as of March 31. The current cash position is expected to be sufficient to fund operating expenses and capital expenditure requirements into 2028. "With regulatory acceleration unfolding, we are working diligently towards our goal of completing the filing of a robust clinical package by Q4 and securing COMP360 approval," said Kabir Nath, CEO. "COMP360 represents a fundamentally different approach for patients with treatment resistant depression, unlike any other treatment approved today. Its transformative clinical profile has the potential to change what patients can expect in terms of both rapid and durable relief, and we are ready to deliver for those who have waited far too long for better options." Following the report, Morgan Stanley raised the firm's price target on Compass to $17 from $16 and kept an Overweight rating on the shares.On Tuesday, AtaiBeckleyreportedwhich compared to analyst consensus of (11c) and $90,910, respectively. As of March 31, the company had cash, cash equivalents and short-term securities of $209.9M. The company expects its cash, cash equivalents, short-term investments and other liquid assets to fund operations into 2029. Srinivas Rao, CEO, said, "Our $209.9M in cash is expected to provide a runway through our anticipated Phase 3 topline readouts for BPL-003, as we advance toward the late-stage execution phase. Our near-term priority is initiating the Phase 3 ReConnection program for BPL-003 this quarter, while VLS-01 continues to progress toward anticipated Phase 2 topline results later this year. The positive Phase 2a data for EMP-01 further demonstrated its potential in Social Anxiety Disorder. Collectively, our capital position, pipeline breadth, and multiple near- and mid-term clinical catalysts position us well as we seek to build sustained clinical and shareholder value."CLEARMIND REPORTS 20 PARTICPANTS TREATED IN CMND-100 TRIAL:Clearmind Medicineannounced Tuesday thatof its FDA-approved Phase I/IIa clinical trial evaluating CMND-100 for the treatment of moderate to severe Alcohol Use Disorder. This brings the total number of participants treated to date across all cohorts to 20. The two newly dosed patients in the fourth cohort were treated at Hadassah-University Medical Center in Jerusalem, Israel, one of the key active trial sites. The fourth cohort features a higher dose of CMND-100, following the Data and Safety Monitoring Board recommendation and completion of the third cohort in April. Building on safety and tolerability data from the first three cohorts, which included 18 participants and met the primary safety endpoint with no serious adverse events reported, the company continues to advance the dose-escalation phase of the trial."Reaching the 20- participants milestone and successfully initiating dosing in the fourth cohort at our Israeli site is an important step forward," said Dr. Adi Zuloff-Shani, CEO. "The consistent safety data observed so far across all cohorts reinforces our confidence in CMND-100 and brings us closer to potentially delivering a much-needed new therapeutic option for patients struggling with alcohol use disorder."DEFINIUM REPORTS FIRST PATIENT DOSED IN ASCEND:Definium Therapeutics, Inc.announced Tuesday that theits second Phase 3 study evaluating DT120 ODT for the treatment of major depressive disorder. The Ascend study will evaluate the efficacy and safety of DT120 ODT versus placebo and is expected to enroll 175 participants in the United States. The design of Ascend is aligned with Emerge, as well as the company's Phase 3 trials of DT120 ODT in generalized anxiety disorder, and is conducted in two parts: Part A, a 12-week, randomized, double-blind, placebo-controlled, parallel-group period; and Part B, a 40-week extension period during which participants will be eligible for open-label treatment with DT120 ODT based on symptom severity. The primary endpoint of Ascend is the change from baseline on the Montgomery-Asberg Depression Rating Scale at Week 6 between DT120 ODT 100 ug and placebo."DT120 ODT represents a potentially transformative treatment for people living with MDD, with our findings from our DT120 Phase 2b study showing strong effects on depression symptoms," said Daniel Karlin, CMO. "Too often, existing treatments for MDD fall short, leading many patients to be treated with multiple medications without lasting relief. We expect the Ascend study to continue to build on the clinical evidence that DT120 ODT can deliver a meaningfully differentiated option for one of psychiatry's most significant unmet needs and help alter the course of the growing mental health crisis. As we rapidly approach the anticipated topline readout from our first Phase 3 Study in MDD, Emerge, we believe Definium is entering a pivotal period that could enable meaningful advances in the treatment landscape for patients living with depression and anxiety."NRX INITIATED WITH A BUY:Lucid Capital initiated coverage of NRx PharmaceuticalswithThe company is about to enter the $1.5B North American ketamine market with a proprietary generic and a branded formulation, the analyst said. The firm said NRx has developed a preservative-free formulation of ketamine with a potential shelf-life of three years.ENVERIC GRANTED U.S. PATENT FOR EVM301 SERIES:Enveric Biosciencesannounced Wednesday that the United States Patent and Trademark Office issued to Enveric US Patent No. 12,605,361, titled,pertaining to the company's EVM301 Series of molecules being developed as potential treatments for mental health disorders. The '361 patent, which issued on April 21, is directed to method claims that cover the use of Enveric's previously patented pharmaceutical drug formulations claimed in U.S. Patent No. 11,752,130. The additional patent coverage broadens patent protection by covering use of the novel molecular structures for a family of carboxylated derivatives of tryptamine-based drug candidates."Our EVM301 Series continues to develop in strength and breadth with patent protection of potential small molecule therapies designed with the intent to enhance neuroplasticity while reducing or eliminating hallucinations associated with other psychedelic or psychedelic-inspired agents," said Joseph Tucker, CEO. "Enveric is focusing its resources on our lead candidate, EB003, to advance our unique molecular design that is intended to achieve a paradigm shift in the treatment of depression and anxiety. Our goal includes offering the opportunity for patients to benefit from psilocybin-derived medications while reducing or eliminating hallucinations otherwise associated with hallucinogenic agents. We anticipate that the potential for a safe and efficacious product that eliminates the requirement for observation by a healthcare professional during dosing will greatly enhance the acceptance and commercial value of EVM301 Series-based therapies and continues to drive Enveric innovation in the field."MIRA REPORTS PHASE 1 DATA FOR KETAMIR-2:MIRA Pharmaceuticalsannounced Thursdayevaluating Ketamir-2, the company's proprietary selective oral NMDA receptor modulator. The randomized, double-blind, placebo-controlled Phase 1 study evaluated the safety, tolerability, and pharmacokinetics of orally administered Ketamir-2 in healthy volunteers across single ascending dose and multiple ascending dose cohorts. A total of 57 healthy volunteers were enrolled across seven cohorts, including placebo. All participants completed the study with no withdrawals, and all subjects were fit for discharge following final administration. No serious adverse events or dose-limiting toxicities were reported during the study. Adverse events observed were predominantly mild in severity. The incidence of subjects reporting adverse events was higher in the placebo group than in the Ketamir-2-treated group.Pharmacokinetic analysis demonstrated rapid oral absorption and favorable systemic exposure, with dose-proportional Cmax observed across the evaluated dose range. No major differences were observed in pharmacokinetic parameters for Ketamir-2 or its active metabolite, nor-Ketamir-2, between Day 1 and Day 5 of administration, supporting pharmacokinetic consistency across repeated dosing. The half-life of Ketamir-2 ranged from approximately 2.5 to 7 hours, while the active metabolite nor-Ketamir-2 demonstrated a half-life of approximately 7 to 9 hours, supporting sustained pharmacologic exposure. Based on the observed pharmacokinetic profile of the parent compound and active metabolite, Ketamir-2 may support once-daily administration, subject to further clinical evaluation. Based on the completed Phase 1 data package, MIRA is advancing preparations for submission of its Phase 2a clinical protocol and supporting documentation to the FDA under its active Investigational New Drug application.Erez Aminov, CEO, stated: "Ketamir-2 was designed to retain the therapeutic potential of NMDA modulation while minimizing the dissociative effects associated with ketamine. We believe the Phase 1 findings observed to date support that objective and represent an important milestone as we advance toward Phase 2a development."PHARMALA EXECUTES DEAL TO FORM RESTORA:PharmAla Biotech Holdingsannounced Wednesday that it has executed awith Aluvaris and Diteba. The agreement establishes a jointly-owned special purpose vehicle called Restora Neurosciences to lead the clinical and regulatory development of APA-01, the company's patented novel MDXX molecule, with the explicit objective of filing a first IND application with the FDA. PharmAla retains ownership of the underlying intellectual property and a continuing economic interest in any product commercialized by the SPV through equity, license fee, royalty, and sublicense participation, while Restora's operating cash needs are met by capital raised by Aluvaris. Pursuant to the agreement, Diteba has been appointed as Restora's principal provider of bioanalytical and scientific project-management services for the duration of the IND development program. The agreement is structured to be highly capital-efficient for Restora, materially extending the development runway for each dollar of capital raised by the SPV."Closing the definitive agreement well ahead of our outside date reflects not only how this management team executes, but also how excited we are to partner with Diteba and Aluvaris to advance this transaction," said Nicholas Kadysh, Founding CEO. "Cortexa demonstrated that PharmAla can structure complex, multi-party partnerships that deliver product, generate revenue, and align long-term incentives around a clear clinical thesis. Restora Neurosciences applies that same discipline to a novel, U.S. & PCT patented molecule whose target indications align squarely with the priorities articulated in the recent Presidential Executive Order. This is precisely the kind of capital-efficient, partner-driven development model that Canadian capital markets have been asking biotech management teams to deliver."SIBANNAC ENTERS JV LOI WITH 1120 MANAGEMENT:Sibannacannounced Thursday the signing of awith 1120 Management, an Arizona-based licensed medical cannabis operator. The joint venture will develop and operate a dedicated, secure psilocybin research, cultivation, extraction, and analytical laboratory facility in Phoenix, Arizona. The facility will be fully segregated and designed to meet or exceed all federal DEA Schedule I researcher and manufacturer registration requirements, as well as Arizona state regulations. It will support advanced cultivation optimization, extraction processes, potency testing, preclinical studies, and potential clinical supply for serious mental health indications. Under the terms of the LOI, 1120 will contribute dedicated space within its existing +30,000-square-foot secured cannabis facility, substantial capital, in-house construction services, and full infrastructure support, including 3,000 Amps of 480V 3-phase power. Sibannac will provide scientific and operational staffing, deep expertise in psychedelic research protocols, clinical strategy, and regulatory navigation."This partnership represents a major step forward for Sibannac in building compliant, large-scale psychedelic research infrastructure in one of the most progressive states in the country," said David Mersky, CEO. "By combining 1120's exceptional facility, capital, and construction capabilities with our team's experience in the culture and service of plant medicines, we are well-positioned to accelerate research aligned with the April 18, 2026, Executive Order on Accelerating Medical Treatments for Serious Mental Illness."OTHER PSYCHEDELIC STOCKS:Publicly-traded companies in the space include Algernon Health, BetterLife, Bright Minds, Filament Health, Helus Pharma, Incannex, Numinus Wellness, Pasithea Therapeutics, PharmaTher, Psyence Biomedical, Psyence Group, Revive Therapeuticsand Silo Pharma.