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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.

Clearmind Medicine Advances CMND-100 Clinical Trial to Parts B and C

Clearmind Medicine announced that its independent DSMB has unanimously approved advancing the company'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 DSMB's approval follows the successful completion of Part A of the study, where CMND-100 achieved its primary safety endpoint, demonstrating a favorable safety and tolerability profile across all planned dose levels in healthy participates. After reviewing the full safety dataset from Part A, the DSMB unanimously recommended advancing the study to Parts B and C in accordance with the previously approved study protocol. Part B marks a clinical milestone for Clearmind, as CMND100 will be evaluated for the first time in human patients with moderate to severe AUD, unlike Part A that included only 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. This double-blind, placebo-controlled segment is expected to further characterize the safety and tolerability profile of CMND-100.