NRXP News & Events

In this week's "Psychedelic," The Fly's recurring series focused on psychedelic stock news, The Fly looks back on earnings, publications of study results and MDMA commercialization.COMPASS PATHWAYS REPORTS Q4 EARNINGS:On Tuesday, Compass Pathwaysreported awhich compared to a loss per share of (63c) for the same period last year. Cash and cash equivalents were $149.6M as of December 31. The cash position at March 24 is expected to be sufficient to fund operating expenses and capital expenditure requirements into 2028."COMP360 is shaping the future of mental healthcare, and we are moving the field of psychiatric medicine forward for the millions of people urgently needing better options. As the potential first classic psychedelic approved by the FDA, COMP360 is redefining rapidity and durability with response as early as the day after dosing and lasting through at least 6 months with just one or two doses – an unmatched clinical profile and important advancement for those living with TRD," said Kabir Nath, CEO. "We look forward to our upcoming FDA meeting to confirm our NDA submission strategy, and we continue to advance our commercial readiness to be launch-ready by the end of this year. We are also initiating our late-stage PTSD study, reinforcing our commitment to advancing innovative, science driven treatments for people facing the most challenging mental health conditions."Following the report, Morgan Stanley lowered the firm's price target on Compass to $16 from $18 and keept an Overweight rating on the shares. 26-week Part B data from the COMP006 study is expected in early Q3 and management anticipates NDA submission in Q4, the analyst noted.Stifel raised the firm's price target on Compass to $14 from $11 and kept a Buy rating on the shares. The firm reiterated its Buy view following Q4 earnings, where completion of the rolling NDA is on track for 4Q26. With recent positive topline from Part-A of the '006 Phase 3 study, plus encouraging 26-week durability from Part B of the '005 study, Compass plans to meet with the FDA to confirm alignment on the rolling submission and the path to approval, the analyst said.Additionally, Canaccord lowered the firm's price target on Compass to $18 from $20 and kept a Buy rating on the shares.NRX REPORTS FY25 RESULTS:On Tuesday, NRx Pharmaceuticalsreported awhich compared to a net loss of ($18.5M) and no revenue for the same period last year.  As of December 31, the company had approximately $7.8M in cash and cash equivalents. Management believes that current available cash resources in concert with anticipated growth in total clinic revenue, ongoing cost reduction initiatives, and current availability and trends in connection with the company's active at-the-market offering will be sufficient to support ongoing operations through the end of 2026."2025 was a pivotal year for NRx and HOPE Therapeutics as we have advanced two lifesaving drugs towards FDA approval with the aim of initiating commercial pharmaceutical operations by the end of this year. We ended the year debt-free and attracted fundamental long-term investors who believe in our mission," said Jonathan Javitt, CEO. "We have opened our first HOPE Therapeutics Clinics and are witnessing firsthand the impact that properly coordinated neuroplastic care can have on patients and their families who suffer from depression, PTSD, and suicidality. Clinical response rates approaching 90% have been reported in the medical literature for the combination of neuroplastic drugs, Transcranial Magnetic Stimulation, and Hyperbaric Oxygen Therapy. We look forward to a world in which physician-led neuroplastic care replaces a world of older antidepressants and electroshock therapy. We are deeply grateful to the trust that has been afforded us by our patients, their families, and our shareholders."GH RESEARCH REPORTS PUBLICATION OF PHASE 2B GH001 RESULTS:GH Researchannounced Wednesdayin treatment-resistant depression: the primary trial results in JAMA Psychiatry, and a new analysis demonstrating that efficacy is independent of the number of prior lifetime treatment failures in a forthcoming issue of Psychopharmacology Bulletin. The peer-reviewed article, titled "GH001 vs Placebo in Patients with Treatment-Resistant Depression" has been published in JAMA Psychiatry. The publication includes the complete results from the randomized, double-blind, placebo-controlled Phase 2b trial of mebufotenin in patients with TRD, including all primary and secondary efficacy endpoints, safety and tolerability data, and initial results from the 6-month open-label extension. These results were previously reported in topline form.A supporting peer-reviewed article, titled "GH001 Efficacy is Independent of Prior Antidepressant Treatment Failures in Treatment-Resistant Depression: A Post Hoc Analysis of a Phase 2b Randomized Controlled Trial," will be published in a forthcoming issue of Psychopharmacology Bulletin. In TRD, a well-established finding across multiple treatment modalities is that remission rates decline significantly with each successive antidepressant treatment failure. This pattern, first quantified in the landmark STAR*D trial, represents a fundamental challenge in treating patients with extensive treatment histories. The new analysis of Phase 2b data demonstrates that GH001 does not follow this pattern. Day 8 remission rates ranged from 53.9% to 63.6% across patients with 2 to greater than or equal to 5 prior lifetime antidepressant failures, with no decline at higher failure counts. End of trial/Month 6 remission rates ranged from 61.5% to 85.7% across the same subgroups. No meaningful correlation was observed between the number of prior lifetime treatment failures and Montgomery-Asberg Depression Rating Scale improvement at Day 8 or among those who completed the 6-month OLE."One interesting, unanticipated finding from this trial is that the benefit of GH001 appeared to be independent of the number of prior lifetime antidepressant failures. Remission rates were consistently high across subgroups – in contrast to the decline seen with each successive treatment that we observed in the STAR*D trial. This suggests patients who have not responded to three or more prior courses of antidepressant therapy might benefit from this novel therapy," said Michael Thase, Professor of Psychiatry, Perelman School of Medicine at the University of Pennsylvania.CORTEXA ADVANCES COMMERCIALIZATION OF MDMA SUPPLY:Cortexa, a 50/50 joint venture between PharmAla Biotechand Vitura Health, announced Monday that, following completion of theearlier this year, the company has secured supply arrangements with authorized providers nationally to support clinical programs and patient treatment under Australia's regulated prescribing pathways. Through Cortexa market activities, the majority of the initial batch has now been committed. The Cortexa sales value for these activities will exceed A$1M. To support current and future requirements, PharmAla has initiated the production of a second GMP batch of a new 20mg dosage form, which is expected to be available to Cortexa's customers in Q2. Cortexa's products are manufactured to support local clinical research and patient treatments by Authorised Psychiatrists under the Therapeutic Goods Administration's Authorised Prescriber Scheme.The company also confirmed that the previously contracted three-year license arrangement with PharmAla, which involved annual license payments of $250,000 for manufacturing and intellectual property rights, concludes during the current financial year. The completion of this arrangement continues to allow ongoing access to the relevant manufacturing processes and associated intellectual property exclusively provided for the Cortexa joint venture structure. Cortexa will continue to benefit from PharmAla's product development activity, as the Joint Venture has right of first refusal on any new innovations developed by PharmAla for the Australian market. PharmAla will continue to benefit from the Joint Venture Agreement's royalty provisions."This week, PharmAla's management team is meeting with Cortexa's customers and partners across Australia," said Nick Kadysh, PharmAla CEO. "We're incredibly excited to hear firsthand about the growth in the Australian market, and are exceptionally focused on bringing new innovation to Australia to support its continued rapid growth. Cortexa provides PharmAla with a dedicated sales organization and local expertise in the most exciting market for commercial MDMA-assisted therapies, and we're excited to share the fruits of our development to expand this market even further in the coming months – starting with our 20mg GMP capsule, and moving on to even more exciting opportunities with our customers."ATAIBECKLEY JOINS S&P, CRSP BENCHMARK INDICES:AtaiBeckleyannounced Tuesday its addition toThe company added that its BPL-003 Phase 3 program remains on track to initiate in Q2, and topline data from the VLS-01 Phase 2b study is expected in 2H26.Srinivas Rao, CEO, said, "Being added to the S&P Total Market Index, S&P Completion Index, and CRSP U.S. benchmark indices reflects meaningful recognition of AtaiBeckley's enhanced presence in U.S. equity markets, with the CRSP index alone tracking more than $3T in passively managed assets. These inclusions broaden our reach across index-tracking strategies and build on our earlier addition to the Nasdaq Biotechnology Index in December 2025. We see these additions as a natural progression as AtaiBeckley's market profile grows alongside our advancing clinical pipeline, including BPL-003's anticipated Phase 3 initiation in the second quarter."OTHER PSYCHEDELIC STOCKS:Publicly-traded companies in the space include Algernon Health, BetterLife, Bright Minds, Clearmind, Definium Therapeutics, Enveric Biosciences, Filament Health, Helus Pharma, Incannex, MIRA Pharmaceuticals, Numinus Wellness, Pasithea Therapeutics, PharmaTher, Psyence Biomedical, Psyence Group, Relmada Therapeutics, Revive Therapeuticsand Silo Pharma.

NRx Pharmaceuticals has received a letter from the Bioequivalence Program of the FDA Office of Generic Drugs stating that "FDA has not identified any bioequivalence deficiencies at this time." The determination is deemed preliminary until final supervisory review of NRx's Abbreviated New Drug Application with anticipated approval in summer 2026. This determination by FDA is meaningful in that the proposed NRx product is the first ketamine formulation to be free of benzethonium chloride, a known toxic preservative. Benzethonium chloride is not listed by FDA as Generally Recognized as Safe and is no longer permitted in certain topical consumer applications. NRx has filed patents in the US and Internationally to support its preservative-free formulation and has the potential to create a "branded generic" product. In addition to the pending ANDA application for Preservative Free Ketamine, NRx is preparing a New Drug Application under Fast Track Designation to expand the use of intravenous ketamine to treat patients with severe depression, who may have suicidal ideation.

NRx Pharmaceuticals has received confirmatory minutes from an in-person Type C guidance meeting at the headquarters of the US Food and Drug Administration. The meeting was attended by leaders of the FDA Division of Psychiatry Products, the FDA Office of Neuroscience, and the FDA Center for Drug Evaluation and Research. The minutes support FDA's willingness to review NRx's application for New Drug Approval of NRX-100 based on Substantial Evidence of Effectiveness derived from existing adequate and well controlled trials. No additional clinical trials were requested. NRx agreed with FDA to submit existing patient-level data for review. In the trials discussed with FDA, ketamine has demonstrated dramatic superiority to placebo and to active placebo, together with non-inferiority versus electroshock therapy. Moreover, ketamine has demonstrated statistically significant reduction in suicidal ideation. Notably, electroshock therapy, the only currently-approved treatment for suicidal ideation demonstrated a 30% incidence of memory loss, whereas ketamine did not. The FDA minutes additionally confirm FDA's willingness to review Real World Evidence as confirmatory evidence of efficacy. Preliminary analysis of that Real World Evidence confirms the effectiveness of intravenous ketamine both in reducing depression and suicidal ideation. Based on the meeting minutes, NRx will seek a primary indication to treat depression in patients with severe depression who may have suicidal ideation, in place of the Company's original plan to treat only those with suicidal ideation. According to the CDC, more than 16 million Americans experience depression each year and 3.6 million Americans contemplate suicide. FDA confirmed in the minutes that no additional nonclinical data would be required for review of NRx's New Drug Application and that no bridging studies would be needed to support NRx's preservative-free formulation, for which the Company anticipates at least three years of room temperature shelf stability. In addition to the pending New Drug Application for NRX-100 based on treatment of depression, NRx has a pending Abbreviated New Drug Application for the sale of preservative-free ketamine under its current label for use in anesthesia. As previously announced, FDA agreed to receive that application in September 2025 and assigned a Summer 2026 decision date.