Definium Reports Emerge Study Meets Primary Endpoint

In this week's "Psychedelic," The Fly's recurring series focused on psychedelic stock news, The Fly looks back on a study meeting its primary endpoint, an enrollment update and a treatment completion.DEFINIUM REPORTS EMERGE STUDY MEETS PRIMARY ENDPOINT:Definium Therapeuticsannounced Monday topline results from Emerge, its100 µg in adults with major depressive disorder. Emerge met its primary endpoint, demonstrating a statistically significant and clinically meaningful improvement from baseline compared with placebo, as measured by the change in Montgomery-Asberg Depression Rating Scale total score at week 6. The Least Squares mean change from baseline in MADRS total score at Week 6 in participants who received DT120 ODT 100 µg was -13.3 compared with -5.2 for patients who received placebo, a LS mean difference of -8.1 points. Beyond the primary endpoint, the effect was rapid with a placebo-adjusted LS mean reduction in MADRS total score at Week 1 of -14.2 and durable with a placebo-adjusted LS mean reduction in MADRS total score of -7.3 at Week 12. DT120 ODT was generally well tolerated with 99% of treatment-emergent adverse events mild to moderate in severity, transient, and predominantly occurring on the day of dosing. No new safety signals were identified, including no increase in suicidal ideation or behavior, and discontinuation rates were low and comparable between treatment groups. On the day of dosing, participants were assessed hourly from hours 5 to 8 on a structured end of session checklist. The average time to meeting EoSC criteria was 5.8 hours for participants receiving DT120 ODT in Part A, with a median of 5.1 hours and 100% of participants meeting the EoSC criteria by hour 8."The Emerge topline results represent unprecedented and highly differentiated efficacy, demonstrating that a single dose of DT120 ODT can deliver rapid, robust, and durable relief in MDD," said Rob Barrow, CEO. "As the first of our Phase 3 studies to report results, Emerge marks a major milestone in our development program and strengthens our confidence in DT120 as a potential best-in-class treatment for mental health disorders. These findings could support a fundamentally new approach to treating MDD for patients and providers who continue to face the limitations of existing treatment options. We are deeply grateful to the patients and investigators who participated in this trial. Grounded in decades of scientific research, these results bring us one step closer to potentially delivering a transformative new treatment option as we advance toward FDA submission."Following the news, Jefferies said it thought Definium's stock would climb higher by 50%-100% after the "robust" 12-plus week Phase 3 data, noting that a single dose of DT120 safely produces rapid, robust and durable efficacy in MDD patients in the study. The effect size beats all the approved therapies and upon repeat dosing, DT120's absolute efficacy improves further by Month 6 in the ongoing 40-week Part B portion, added the analyst, who has a Buy rating and $35 price target on Definium.Following Definium's call detailing the Phase 3 results, RBC Capital raised the firm's price target to $57 from $36 and kept an Outperform rating on the shares, citing further conviction in the likelihood of success for the DT120 program across multiple indications and in the potential for a higher market opportunity in MDD than previously anticipated. The "best-case data" substantially de-risks '120's potential in MDD, as well as generalized anxiety disorder, the analyst said.Additionally, Oppenheimer raised the firm's price target on Definium to $60 from $40 and kept an Outperform rating on the shares.Canaccord raised the firm's price target on Definium to $60 from $38 and kept a Buy rating on the shares, citing higher conviction in the likelihood of success for the DT120 program following the Phase 3 results. The firm sees "more room" for shares to run as it believes the MDD data "also bode very well" for upcoming Phase 3 readouts for DT120 in GAD, said the analyst, who sees the product emerging as "a very solid contender."Meanwhile, Baird raised the firm's price target on Definium to $57 from $37 and kept an Outperform rating on the shares. The firm updated its model following the results of the Emerge trial.JonesResearch also raised the firm's price target on Definium to $74 from $61 and kept a Buy rating on the shares. The results "were not only statistically significant, but achieved an impressive magnitude of effect," the analyst said.HELUS SAYS APPROACH ENROLLMENT 'PROGRESSING AS PLANNED':Helus Pharmaannounced Wednesday thatfor the adjunctive treatment of MDD is progressing as planned and has surpassed 86% enrollment. The APPROACH trial is one of the company's Phase 3 studies evaluating HLP003, Helus Pharma's lead proprietary NSA, which has received Breakthrough Therapy Designation from the U.S. FDA. The APPROACH study is evaluating the efficacy and safety of HLP003 as an adjunctive treatment in patients with MDD. The trial is part of the company's broader Phase 3 PARADIGM program, which also includes the EMBRACE study and the EXTEND long-term extension study, supporting the continued advancement of HLP003 toward potential commercialization. In previous reported Phase 2 data, HLP003 demonstrated long-term efficacy with ~23-point reduction in MADRS score compared to baseline at 12 months after two 16 mg doses of HLP003 three weeks apart. Phase 2 HLP003 results showed response and remission rates of 75% at week 18 and by the 12-month mark, response and remission rates improved to 100% and 71% respectively."We are pleased with the continued progress of the APPROACH study as we surpass 86% enrollment," said Eric So, Interim CEO. "This milestone underscores the execution of our clinical program and brings us closer to the anticipated topline data readout in the fourth quarter of 2026. We remain focused on advancing HLP003 as a potential transformative treatment option for patients living with MDD."CLEARMIND COMPLETES PART A TREATMENT FOR CMND-100 TRIAL:Clearmind Medicineannounced Monday theevaluating CMND-100 for the treatment of Alcohol Use Disorder. All 24 participants across Cohorts 1 through 4 have completed treatment according to the study protocol. The company is currently assessing the dataset and, assuming results remain favorable, intends to initiate the next stage of the clinical program in AUD patients."We are pleased to have successfully completed treatment for all participants in Part A of the study, fully aligned with the clinical protocol," said Adi Zuloff‑Shani, CEO. "This achievement reflects the dedication of our clinical teams and the value of our partnerships with world‑class research centers across the United States and Israel. With data review now underway, we are eager to progress to the next phase of development and continue advancing CMND‑100 as a promising therapeutic candidate for Alcohol Use Disorder."NRX GRANTED EXPANDED ACCESS PROTOCOL FOR NRX-101:NRx Pharmaceuticalsannounced Monday thea fixed dose combination of D-cycloserine and lurasidone for the augmentation of accelerated Transcranial Magnetic Stimulation. The company has announced initiation of a pivotal clinical trial to assess the effect of NRX-101 in augmenting TMS to achieve remission from depression and suicidality in patients being treated with mechanism-guided augmentation of neuronavigated robotic TMS, a study that will be conducted in both civilian and military treatment facilities. NRx has elected to make NRX-101 available to physicians and their patients under the Expanded Access Protocol while pivotal clinical trials are underway in an effort to assure that this potentially life-saving drug is immediately available for patients who qualify. Initially, the company will be charging only for shipping and FDA-required data collection costs, but not for the investigational drug."We at NRx deeply appreciate the engagement of the FDA Division of Psychiatry Products and their support of expanded access to regulated and GMP-manufactured D-cycloserine to enhance TMS effectiveness," said Joshua Brown, chief medical innovation officer. "We look forward to reporting the results of our upcoming pivotal trial, SPARC-TMS, which aims to determine the efficacy of the NRX-101–TMS combination in achieving remission from depression and suicidality in patients with Treatment-Resistant Depression."Additionally on Wednesday, Kadima Neuropsychiatry Institute and its founder, David Feifel, announced they have filed a complaint against NRX and two of its subsidiaries in San Diego County Superior Court, alleging breach of contract and misrepresentation in connection with an acquisition agreement that the defendants warranted they had the financial capacity to close. The complaint names NRx, its subsidiary Hope Therapeutics, and Hope's subsidiary HTX Management Company as defendants. It seeks specific performance in a court order compelling the defendants to close the transaction on the terms set forth in the parties' executed agreement."We are confident that the evidence will demonstrate a clear pattern of intentional deceit by NRx, as it used Kadima's and Dr. Feifel's reputations to boost its share price through press releases and joint investor presentations, but then refused to fulfill its commitment to close the transaction," said Andrew Selesnick, counsel to Kadima. "Though confidentiality clauses in the agreement prohibit us from disclosing certain transaction details in a public filing, we look forward to presenting the complete set of facts in court."SILO REPORTS SPC-15 STABILITY DATA:Silo Pharmaannounced Tuesday that it has confirmed the physical, chemical and microbiologicalthrough nine months of real-time testing. The stability data demonstrates that SPC-15's formulation maintains physical, chemical, and microbiological integrity over nine months at long term and six months at accelerated conditions. The stability program was conducted under long-term and accelerated storage conditions aligned with requirements for investigational new drug-enabling chemistry, manufacturing, and controls documentation. Data showed that SPC-15's formulation and device remained within predefined specifications for assay, impurities, pH, and microbiological quality through nine months, and the product remained in trend for predefined key device spray performance tests. Six-month accelerated stability data was consistent and aligned with long term data."The positive stability data support continued advancement of our IND-enabling development program and contribute to the manufacturing information required in an IND submission for a first-in-human Phase 1 clinical study," said Eric Weisblum, CEO. "This important milestone validates our adherence to current Good Manufacturing Practice standards."ATAIBECKLEY TO JOIN RUSSELL INDEXES:AtaiBeckleyannounced Thursday that it will be added to theeffective at the open of U.S. markets on June 29 as part of the first 2026 Russell indexes reconstitution.Srinivas Rao, CEO, said, "Joining the Russell Indexes - which collectively benchmark approximately $12.2T in assets - represents another meaningful milestone for AtaiBeckley as we continue to expand our presence across the U.S. equity benchmark landscape, and increase visibility with a broad base of institutional investors. With our Phase 3 study of BPL-003 advancing, this development comes at an important time for the Company and reflects the maturity and strength of both our team and our late-stage mental health pipeline."OTHER PSYCHEDELIC STOCKS:Publicly-traded companies in the space include Grey Matters Health, BetterLife, Bright Minds, Compass Pathways, Enveric Biosciences, Filament Health, GH Research, Incannex, MIRA Pharmaceuticals, Numinus Wellness, Optimi Health, Pasithea Therapeutics, PharmAla Biotech, PharmaTher, Psyence Biomedical, Psyence Group, Revive Therapeuticsand Sibannac.