Definium Therapeutics Inc（DFTX）资讯与事件DFTXDefinium Therapeutics Inc

TD Cowen Raises Helus Price Target to $62

In this week's "Psychedelic," The Fly's recurring series focused on psychedelic stock news, The Fly looks back on earnings, analyst notes and a notice of allowance.EARNINGS:On Monday, Bright Minds Biosciencesreported a third quarter loss per share of (C$0.24), which compared to a loss per share of (C$0.74) for the same period last year. At June 30, the company had working capital of C$307,739,740 including cash and cash equivalents of C$307,828,515. The company's current and expected cash resources are sufficient to satisfy working capital requirements of running the operations for the following twelve months; however, the company has not realized a source of revenue therefore, management will continue to seek new sources of capital to maintain its operations.Also on Monday, NRx Pharmaceuticalsreported a Q2 loss per share of (44c), which compared to a loss per share of (98c) for the same period last year. As of June 30, the company had approximately $26.7M in cash and cash equivalents versus $7.8M as of December 31, 2025. The increase was primarily related to the company's completion of a public offering of common stock with gross proceeds of more than $22M. Management believes current cash resources, anticipated growth in clinic revenue, and opportunistic utilization of the company's active at-the-market offering facility will be sufficient to support operations for at least one year. "The second quarter of 2026 was a major inflection point for NRx as we advance our mission to bring hope to the most vulnerable patients battling depression and suicidal ideation," said Jonathan Javitt, CEO. "We have continued to drive towards our key objective of first commercial ketamine sales in 2026 with corresponding manufacturing operations and build-out of our first commercial team. Our path to approval of NRX-100 has been advanced by support from the White House and Congress for the use of Real World Evidence that our drug has comparable or superior efficacy to that of current market leaders. Our partnership with the Department of War and its Defense Advanced Research Projects Agency led by Prof. Brown and Dr. Dennis McBride is the culmination of a multi-year endeavor. Similarly, our acquisition of the GeNeuro assets and the resulting partnership with NIH offers a clinical stage and potentially humanity-changing opportunity for the Company – including potentially the first disease-modifying drug to treat ALS – in ALS and other serious disorders, with strong governmental partnership and support from non-dilutive sources of capital. Combat veterans face a two-fold increased risk of ALS, and advancing a cure remains a high priority with strong Congressional support."On Friday, Enveric Biosciencesreported a Q2 loss per share of (76c), which compared to a loss per share of ($11.65) last year. The company had cash-on-hand of $8.3M as of June 30. "The second quarter was highlighted by important progress across the key activities supporting our planned first-in-human clinical trial of EB-003," said Joseph Tucker, CEO. "Over the past several months, we advanced multiple IND-enabling studies and generated additional preclinical data that support EB-003's potential non-hallucinogenic profile. Collectively, these accomplishments strengthen the scientific foundation of our lead program as we work toward an IND submission for the anticipated Phase 1 trial…As we enter the second half of 2026, our priorities remain clear: complete the remaining IND-enabling activities, submit our planned IND application, and advance EB-003 into a first-in-human clinical trial. We believe the progress over the past several months has strengthened both our lead development program and the broader Enveric platform, positioning the Company to continue creating long-term strategic and shareholder value."Helus Pharmaalso reported earnings Friday, with a Q1 loss per share of (91c), which compared to loss per share of ($1.10) for the same period last year. Cash totaled $166.4M as of June 30. "Since joining Helus Pharma, I have been impressed by the quality of the Company's science, the strength of its development programs, and the team's disciplined execution," said Michael Halstead, CEO. "With enrollment in APPROACH completed and topline data expected in Q4 2026, we are entering an important period for HLP003. We are also advancing HLP004 as a promising short-acting candidate for generalized anxiety disorder and remain focused on executing our clinical, regulatory and commercial priorities in support of our mission to deliver transformative treatment options for patients."TD Cowen raised the firm's price target on Helus to $62 from $8 and kept a Buy rating on the shares. The firm said its target increase is due to three major recent value-creating tailwinds to their thesis. The increased visibility into Phase 3 HLP003 adjunct MDD data timing, now expected mid-November, a new, seasoned CEO with an extensive operational and strategic track record in neuropsych, and new M&A, regulatory and executive branch tailwinds for the psychedelic neuropsych sector.DEFINIUM INITIATED WITH A BUY:BofA initiated coverage of Definium Therapeuticswith a Buy rating and $75 price target. The company's lead asset, DT120 – LSD, is in pivotal studies for major depressive disorder and generalized anxiety disorder with recent best-in-class potential demonstrated in the phase 3 studies for both indications, the analyst said. If replicated in ongoing pivotal studies, the firm believes that DT120 could be a go-to option for patients with severe MDD and GAD, representing multi-billion dollar commercial opportunities, BofA added.Maxim raised the firm's price target on Definium to $55 from $50 and kept a Buy rating on the shares. The firm cited the company having announced topline data from Voyage, its first pivotal study in GAD, meeting the primary and all key secondary endpoints, also noting that data from the confirmatory pivotal study, Panorama, are expected in September, the analyst said.ATAIBECKLEY DOWNGRADE:Oppenheimer downgraded AtaiBeckleyto Perform from Outperform without a price target after Eli Lillyagreed to acquire the company for $6.75 per share upfront cash plus up to $2.50 per share in contingent payments.SILO PHARMA RECEIVES NOTICE OF ALLOWANCE:Silo Pharmaannounced Tuesday that the Canadian Intellectual Property Office has issued a Notice of Allowance for a patent application covering its lead asset, SPC-15, an intranasal 5-HT4 receptor agonist targeting post-traumatic stress disorder and other stress-induced psychiatric disorders. The company has an exclusive license for the Canadian patent application as part of its broader license agreement with Columbia University to further develop, manufacture, and commercialize SPC-15 globally. The allowed patent application, titled "Prophylactic Efficacy of Serotonin 4 Receptor Agonists Against Stress," covers methods of preventing or delaying stress-induced fear and depressive-like behavior and methods for inducing and/or enhancing stress resilience by administering selected serotonin 4 receptor agonists prior to a stressor."The Canadian patent allowance adds to our momentum in securing broad international protection for SPC-15," said Eric Weisblum, CEO. "With corresponding claims receiving protection across multiple markets, we continue to strengthen the global IP position of SPC-15 and our broader therapeutic portfolio."OTHER PSYCHEDELIC STOCKS:Publicly-traded companies in the space include Grey Matters Health, BetterLife, Clearmind, Compass Pathways, Filament Health, GH Research, Incannex, MIRA Pharmaceuticals, Numinus Wellness, Optimi Health, Pasithea Therapeutics, PharmAla Biotech, PharmaTher, Psyence Biomedical, Revive Therapeutics, Sibannacand Silo Pharma.

Definium Therapeutics Reports DT120 ODT Phase 3 Study Results, RBC Raises Price Target to $66

In this week's "Psychedelic," The Fly's recurring series focused on psychedelic stock news, The Fly looks back on study results, an analyst downgrade and completion of an FDA review.DEFINIUM REPORTS PHASE 3 VOYAGE STUDY MEETS ENDPOINTS:Definium Therapeuticsannounced Wednesday topline results from Voyage, its firstin adults with generalized anxiety disorder. The results mark the company's second DT120 ODT Phase 3 readout, following the Emerge results in major depressive disorder announced in June. Voyage met its primary endpoint, demonstrating a statistically significant and clinically meaningful improvement from baseline compared with placebo, as measured by the change in HAM-A total score at Week 12. The Least Squares mean change from baseline in HAM-A total score at Week 12 in participants who received DT120 ODT was -11.6 compared with -6.2 for participants who received placebo, an LS mean difference of -5.4 points, corresponding to a standardized effect size of d=0.81. Efficacy was rapid, with changes seen as early as Day 2 and sustained at all post-baseline timepoints in Part A. DT120 ODT was generally well tolerated, with treatment-emergent adverse events mild to moderate in severity, transient, and predominantly occurring on the day of dosing in Part A. No new safety signals were identified, including no suicidality signal or suicidal behavior. On the day of dosing, participants were assessed hourly beginning at hour 5 post-dose on a structured end-of-session checklist. The average time to meeting EoSC criteria was 6.4 hours for participants receiving DT120 ODT in Part A, with a median of 6.1 hours and 92% of participants meeting the EoSC criteria by hour 8."The unprecedented efficacy demonstrated in Voyage should raise the bar for what patients and clinicians expect from GAD treatments and reinforces our belief that DT120 has the potential to redefine care for the millions of patients in need," said Rob Barrow, CEO. "Importantly, the consistent, large effect size we've now observed across three studies underscores the potential of DT120 to transform psychiatry and usher in a new era of mental health care. With our Panorama topline results in GAD expected in September, we remain focused on bringing this potential new treatment to patients as quickly as possible. We are deeply grateful to the patients, investigators, site personnel, and our team whose commitment made this milestone possible."Following the report, RBC Capital raised the firm's price target on Definium to $66 from $57 and kept an Outperform rating on the shares citing the "strong" data. While RBC suspects the muted upside stock reaction might reflect some profit-taking ahead of regulatory and commercial next steps that some may perceive as less certain, the firm told investors that its convinced based on prior survey work and KOL feedback that the opportunity will be robust. RBC Capital added that based on the data to date from both Emerge/Voyage it believes that the Panorama/Ascend trials are likely to also read out positively.Canaccord raised the firm's price target on Definium to $64 from $58 and kept a Buy rating on the shares. The firm said the "solid" Phase 3 data in anxiety bodes well heading into the Panorama readout and raised their probability of approval for DT120 in GAD from 55% to 70%, which they see as very reasonable based on Voyage data.Additionally, Jones raised the firm's price target on Definium to $90 from $74 and kept a Buy rating on the shares. The firm said the results represent the "second compelling clinical dataset" supporting DT120 in a GAD-specific population. It increased its probability of success for DT120 in generalized anxiety disorder to 50% from 30%.CLEARMIND REPORTS PERMEATION RESULTS FOR INTRANASAL MEAI:Clearmind Medicineannounced TuesdayThe new findings confirm that the enhanced nasal residence time previously demonstrated with the proprietary intranasal MEAI formulation does not compromise the permeation characteristics of Clearmind's proprietary MEAI. The company said, "Clearmind's early-stage studies of its intranasal MEAI formulation have generated highly promising results, supporting the continued development of this innovative treatment approach. The positive data generated to date supports the company's development strategy and provide compelling support for the continued advancement of the intranasal program. Together, these findings provide additional support for the continued evaluation of MEAI as a differentiated therapeutic candidate for mental-health disorders, including alcohol use disorder, as well as for weight management, obesity, and metabolic conditions."The permeation study builds on recently reported ex vivo mucoadhesion results demonstrating that intranasal MEAI remains associated with nasal tissue substantially longer than a conventional MEAI solution. These findings show markedly enhanced retention of MEAI on nasal mucosa reinforcing its potential to achieve extended nasal residence time within the nasal cavity. To evaluate whether the enhanced retention of intranasal MEAI influences its release and membrane transport, permeation studies were performed using Franz diffusion cells, a widely accepted model for assessing intranasal drug delivery performance. The experiments used a cellulose dialysis membrane and simulated nasal electrolyte solution under physiologically relevant conditions. Equivalent MEAI doses were applied as either the intranasal formulation or a conventional reference solution, enabling a direct head-to-head comparison of permeation behavior over time. The results showed rapid and extensive permeation for both formulations. While intranasal MEAI displayed a slightly more gradual early‑phase release profile, overall permeation was highly comparable to the reference solution. By 180 minutes, both formulations achieved near- complete permeation with cumulative permeation reaching 97.35% for intranasal MEAI and 98.34% for the conventional formulation. This data indicates that incorporating MEAI into the mucoadhesive intranasal delivery system does not materially impair drug transport. When combined with previously reported mucoadhesion results, the findings suggest that Clearmind's intranasal strategy may successfully extend nasal residence time while maintaining efficient permeation."These results represent an important milestone in our efforts to advance MEAI as a differentiated therapeutic candidate for alcohol use disorder," said Adi Zuloff Shani, CEO. "The significantly enhanced nasal retention demonstrated by intranasal MEAI underscores the potential advantages of intranasal delivery as a promising administration route for MEAI. We are encouraged by the formulation's ability to maintain prolonged contact with nasal tissue while demonstrating permeation characteristics comparable to a conventional MEAI formulation, and believe these findings further support the overall development program."Clearmind also noted Thursday that it recently announced that its independent Data and Safety Monitoring Board has unanimously approved advancing thecCompany's ongoing FDA-regulated Phase I/II clinical trial to parts B and C of the clinical trial, evaluating CMND-100 in patients actively suffering from AUD as well as in healthy participants. The part B phase will enroll, sequentially, two cohorts of six patients receiving 80 mg and 160 mg doses, respectively, and will assess safety, tolerability, and early signals of clinical activity, including CMND100's potential to reduce alcohol consumption and craving. Part C will be conducted, concurrently with Part B, in healthy participants and will evaluate CMND‑100 at a fixed daily dose of 160 mg administered over five consecutive days.ATAIBECKLEY DOWNGRADED:Deutsche Bank downgraded AtaiBeckleyto. The firm cites the pending acquisition by Eli Lillyfor the downgrade.NRX SAYS FDA COMPLETES REVIEW OF KETAMINE ANDA:NRx Pharmaceuticalsannounced Friday that thefor its preservative-free ketamine, with no major deficiencies related to the drug product, ingredients, proposed labeling, Chemistry, Manufacturing and Controls, or other drug-related review matters. No new clinical, safety, efficacy, or drug-related data are required for ANDA approval. Following receipt of the FDA comments, the company held a clarification meeting with FDA on August 6 to confirm the remaining information required to support approval.FDA identified a remaining question related to evidence that the luer lock tip of the medication vial would perform properly when connected to a syringe by a licensed health professional. Because the question related to the product's container closure system, it was classified by FDA as a Major Deficiency. Importantly, this remaining item is packaging-related and does not relate to the ketamine drug product itself, its ingredients, proposed labeling, CMC, or other drug-related review matters. The luer lock medication vial is used in three currently-approved ANDA products that collectively shipped 11.9M doses of medication in the U.S. over the past 12 months, without complaints, returns, recalls, or adverse events. NRx included testing data in its ANDA on more than 3,500 vials from seven manufactured lots of its ketamine product, with no observed failures in operation of the luer lock tip. At the August meeting, FDA requested that NRx provide a manufacturer attestation confirming that the product is manufactured on the same manufacturing lines with the same methods as the currently approved products, together with an attestation of the above complaint-free history. The company is providing this attestation to FDA for immediate review and FDA committed to reviewing the requested certification in the shortest possible review cycle."We believe this outcome meaningfully de-risks the path to approval because the remaining issue is not related to the ketamine drug product, but to certification of a vial system already used in approved commercial products. We appreciate FDA's proactive engagement in clarifying the path to approval for our preservative-free ketamine at a time when ketamine remains listed on the FDA drug shortage list and has been identified as a strategically important drug by the Secretary of Health and the FDA Commissioner" said Jonathan Javitt, CEO. "Importantly, FDA identified no major deficiencies related to the drug product, ingredients, proposed labeling, CMC, or other drug-related review matters, which is a highly encouraging outcome on first-cycle ANDA review. Importantly, the August 6 meeting provided a clear and defined path to resolution of the remaining FDA question. We are encouraged by FDA's commitment at the meeting to review this remaining information in the shortest-possible review cycle and remain focused on advancing our ANDA toward approval and commercialization."SILO GRANTED PATENT FOR PTSD THERAPY:Silo Pharmaannounced Tuesday that the European Patent Office has granted a, a novel intranasal, nose-to-brain treatment targeting post-traumatic stress disorder and stress-induced affective disorders. The company has an exclusive license for the European patent from Columbia University. The granted patent, European Patent No. EP3952852, "Prophylactic Efficacy of Serotonin 4 Receptor Agonists Against Stress," covers methods of preventing stress-induced fear, depressive-like behavior and associated affective disorders by administering selected serotonin 4 receptor agonists ahead of a stressor such as potential extreme stress exposure."We continue to strengthen the powerful intellectual property moat around SPC-15's technology—a differentiated approach to PTSD treatment that targets pathways associated with stress resilience rather than relying solely on symptom management after PTSD has developed," said Eric Weisblum, CEO. "We are pleased with the EPO's decision recognizing the novelty of this preventative approach and extending important patent protection for SPC-15 in the European market. We believe the ability to intervene before exposure to acute trauma could represent an entirely new paradigm for protecting individuals at high risk of developing PTSD and other stress-related disorders."OTHER PSYCHEDELIC STOCKS:Publicly-traded companies in the space include Grey Matters Health, BetterLife, Bright Minds, Compass Pathways, Enveric Biosciences, Filament Health, GH Research, Helus Pharma, Incannex, MIRA Pharmaceuticals, Numinus Wellness, Optimi Health, Pasithea Therapeutics, PharmAla Biotech, PharmaTher, Psyence Biomedical, Revive Therapeuticsand Sibannac.

Definium Therapeutics Reports Positive Clinical Results for DT120

Definium Therapeutics announced positive topline results from Voyage, its first Phase 3 study of DT120 Orally Disintegrating Tablet, ODT, 100 microgram in adults with generalized anxiety disorder, GAD. The results mark the Company's second positive DT120 ODT Phase 3 readout, following the positive Emerge results in major depressive disorder, MDD, announced in June. Voyage met its primary endpoint, demonstrating a statistically significant and clinically meaningful improvement from baseline compared with placebo, as measured by the change in HAM-A total score at Week 12. "The unprecedented efficacy demonstrated in Voyage should raise the bar for what patients and clinicians expect from GAD treatments and reinforces our belief that DT120 has the potential to redefine care for the millions of patients in need," said Rob Barrow, Chief Executive Officer of Definium Therapeutics. "Importantly, the consistent, large effect size we've now observed across three studies underscores the potential of DT120 to transform psychiatry and usher in a new era of mental health care. With our Panorama topline results in GAD expected in September, we remain focused on bringing this potential new treatment to patients as quickly as possible. We are deeply grateful to the patients, investigators, site personnel, and our team whose commitment made this milestone possible."