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Celcuity Appoints David Gryska to Board of Directors
Celcuity (CELC) announced the appointment of David Gryska to its Board of Directors. Throughout the past 25 years, Gryska has served on the Boards of eight public biotechnology companies and currently serves on the Board of Directors of Definium Therapeutics (DFTX)
U.S. Stock Futures Plunge Amid AI Selloff
Stock futures are down sharply as investors contend with a fresh selloff in AI-related stocks, surging oil prices and growing expectations that the Federal Reserve will raise interest rates this week. The technology-heavy Nasdaq is bearing the brunt of the pressure as investors reassess the pace and economics of AI investment.Anthropic CEO Dario Amodei is calling for a slowdown in the development of increasingly powerful AI systems, warning that the technology could create significant economic and societal risks if deployment moves faster than safeguards. OpenAI CEO Sam Altman and other industry leaders have echoed concerns about AI's trajectory, helping trigger a broad selloff in chipmakers and other AI beneficiaries.Brent crude is above $107 a barrel and WTI is above $102 as the war with Iran continues to threaten regional supply. Saudi Arabia has shut its East-West pipeline following drone attacks, adding to concerns about the reliability of crude flows. The latest jump in energy prices comes just days after August CPI showed inflation accelerating, increasing the risk that the Fed faces a more difficult policy tradeoff between fighting inflation and supporting growth.Treasury yields remain elevated, with the 10-year around 4.97%, as traders prepare for Wednesday's Fed decision. Markets are now assigning a very high probability to a 25-basis-point rate increase after the stronger-than-expected August jobs report, hotter PPI and sticky CPI.In pre-market trading, S&P 500 futures fell 0.68%, Nasdaq futures fell 1.65% and Dow futures fell 0.40%.Check out this morning's top movers from around Wall Street, compiled by The Fly.HIGHER -Elmetup 43% after announcing a $450M committed investment from the United States Department of War and a Defense Logistics Agency contract with a ceiling value of up to $2BDefinium Therapeuticsup 13% after reporting its Panorama study of DT120 orally disintegrating tablet in adults with generalized anxiety disorder met the primary and secondary endpointsRum Groupup 11% after The InformationAnthropic has struck a $13.7B compute pact with the companyBaldwin Groupup 6% after entering into a definitive agreement under which an entity to be formed by Sequence Holdings and DFO Management will acquire a majority interest in the company in an all-cash transaction valued at approximately $7.7BLOWER -Corningdown 8% after entering into an equity distribution agreement with Goldman Sachsto sell shares of the company's common stockDOWN AMIDWIDESPREAD CONCERN OVER AI DEVELOPMENT -Marvelldown 7%Inteldown 6%Microndown 6%AMDdown 5%Nvidiadown 2%
Definium Therapeutics Reports Positive Phase 3 Results for DT120
Definium Therapeutics announced topline results from Panorama, the Company's second Phase 3 study of DT120 Orally Disintegrating Tablet in adults with generalized anxiety disorder. This is the Company's third positive Phase 3 readout for DT120 ODT, following the positive Emerge results in major depressive disorder announced in June and the positive Voyage results in GAD announced in August. Panorama met its primary endpoint, demonstrating a statistically significant and clinically meaningful improvement from baseline compared with placebo, as measured by the change in Hamilton Anxiety Rating Scale 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 100 microgram was -9.8 compared with -4.7 for participants who received placebo, an LS mean difference of -5.1 points, corresponding to a standardized effect size of d=0.64. Efficacy was rapid, with changes seen as early as Day 2 and sustained at all post-baseline timepoints in Part A. Participants were monitored for a minimum of 8 hours on dosing day and were assessed hourly beginning 5 hours after dosing on a structured end-of-session checklist. The average time to meet EoSC criteria was 6.2 hours for participants receiving DT120 ODT 100 undefined, with a median of 6.0 hours and 94% of participants meeting EoSC criteria by hour 8. Across over 1,000 treatment sessions in the Phase 3 program through September 10, 2026, 97% of participants met EoSC criteria by hour 8. The mean baseline HAM-A score at study entry was 28.3 in the DT120 ODT 100 microgram treatment group and 28.0 in the placebo group. Panorama included a DT120 ODT 50 microgram control arm that was not designed or powered for statistical comparisons. Consistent with the dose-response profile demonstrated in our Phase 2b trial, DT120 ODT 50 microgram demonstrated a placebo-adjusted change of -3.5 and -3.6 at Weeks 4 and 12, approximately 50% and 29% lower than was observed for DT120 ODT 100 microgram. DT120 ODT 100 undefined was generally well tolerated, with most 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 suicidality signal or suicidal behavior. There were no drug-related serious adverse events. Overall discontinuation rates were similar between DT120 ODT 100 undefined, DT120 50 undefined, and placebo groups. The overall TEAE rate for DT120 ODT 100 undefined, DT120 50 undefined, and placebo was 94.8%, 96.1%, and 62.9%. The most common TEAEs in the DT120 ODT 100 undefined and 50 undefined arms on dosing day were illusion, nausea, and headache. Adverse events were collected in accordance with the FDA Guidance for Psychedelic Drug Development, which includes expected effects of the drug that can be characterized as positive or neutral.
Optimi Health Plans to Initiate Phase 2 Trial in 2027
In this week's "Psychedelic," The Fly's recurring series focused on psychedelic stock news, The Fly looks back on study initiation plans, a Breakthrough Therapy designation and Phase 3 study data.OPTIMI TO INITIATE PHASE 2 TRIAL OF PSILOCYBIN-ASSISTED THERAPY:Optimi Healthannounced Thursday plansfor individuals with major depressive disorder. The trial is planned to be initiated in 1H27, with dosing expected to be complete by the end of 2027. The Phase 2 clinical trial is authorized to proceed by Health Canada and will enroll up to 200 participants across multiple sites in Canada, evaluating the safety and efficacy of a single supervised dose of natural psilocybin in the treatment of MDD. The primary efficacy endpoint is the change in Montgomery-Åsberg Depression Rating Scale total score from baseline, the most widely used clinician-rated measure of depressive symptom severity in trials of this kind."A 200-subject Phase 2 trial in major depressive disorder is the largest clinical commitment Optimi has made to date. We will supply our own naturally derived psilocybin, manufactured at our GMP facility, and we will have exclusive ownership of the trial results," said Dane Stevens, CEO "As we broaden our strategy to include clinical drug development, this Phase 2 trial is an initial step toward potential registration. Few companies in this sector are commercial today while also advancing their own clinical development. In Canada, we already hold a Drug Establishment Licence and supply psilocybin through Health Canada's Special Access Program. This trial builds directly on that foundation, and we can comfortably fund it with current cash on hand."DEFINIUM RECEIVES BREAKTHROUGH THERAPY DESIGNATION:Definium Therapeuticsannounced Tuesday that the U.S. Food and Drug Administration has grantedThe designation was supported by the significant unmet medical need in MDD and results from the company's Phase 3 Emerge study, in which a single 100 µg dose of DT120 ODT demonstrated a statistically significant 8.1-point placebo-adjusted improvement in MADRS total score at Week 6, with durable efficacy through Week 12. This milestone marks the second Breakthrough Therapy designation from the FDA for the DT120 development program, following its initial designation for the potential treatment of Generalized Anxiety Disorder."Securing our second Breakthrough Therapy designation, closely following the unprecedented results from our Phase 3 Emerge study, underscores the potential of DT120 to meaningfully transform the treatment landscape for people living with serious mental health disorders," said Rob Barrow, CEO. "This recognition of DT120's promise, first in GAD and now in MDD, reinforces the urgency to advance and deliver rapid, durable benefit across multiple indications. Our focus remains on developing innovative therapies that have the potential to expand treatment options and improve outcomes for the millions of people who continue to seek meaningful relief."COMPASS REPORTS DATA FROM PHASE 3 COMP005 TRIAL:Compass Pathwaysannounced Wednesday the toplinea synthetic, proprietary formulation of psilocybin, for treatment-resistant depression which further support COMP360's differentiated profile and potential for long lasting benefit. In the open-label Part C data, notable additional benefit was observed with an added reduction in MADRS score leading to an average 13-point reduction from baseline at Week 52 and extended out to one year for participants who were randomized to the 25 mg arm and received an additional dose in Part C. For participants in the Placebo arm who received their first dose of COMP360 25 mg in Part C, these findings further reinforce that a single dose of 25 mg has the potential to produce rapid onset, meaningful effect and durability. For all participants in Part C who received a 25 mg dose, strong response and remission rates were observed with 40%-45% responders and approximately 30% remitters across all timepoints in the six weeks post the Part C dose. The COMP360 safety profile in Part C is consistent with Parts A and B and continues to show a generally well-tolerated and safe profile with no new safety findings."COMP360 has now demonstrated rapid onset, substantial magnitude of effect and sustained durability through one year with just a few doses. This emerging clinical profile is unmatched in TRD and puts COMP360 in a league of its own," said Kabir Nath, CEO. "We are excited for what this means for TRD patients and for those who care for them and the potential to move beyond treatments that require daily or frequent administration. As we continue to advance COMP360 for patients, our rolling NDA submission and review are well underway, with final NDA submission expected in the fourth quarter and launch expected in the first half of next year, subject to FDA approval. With a robust clinical package, and growing patient and provider anticipation for COMP360 as a much-needed treatment for TRD, Compass is well-positioned and ready to deliver."Additionally on Thursday, Compass announced U.S. grant program recipients to create training programs for healthcare providers that will be involved in the delivery of psychedelic treatments, such as COMP360 psilocybin. These programs are intended to address both the need for foundational training in psychedelics, as well as ensuring HCPs are well-prepared to care for patients receiving treatment with COMP360 following its expected commercial launch, if approved. The recipients will remain independent training and education providers, retaining ownership and control of their training programs, content, faculty selection, and educational design, with Compass providing the grant program funding and recognizing them as grant awardees. In all, five organizations were awarded the grant, expanded from the originally three recipients due to the overall quality of applicants: CME Outfitters, Emory University, Fluence International, Integrative Psychiatry Institute and Strata Mental Health Solutions.CLEARMIND RECEIVES YALE IRB APPROVAL:Clearmind Medicineannounced Tuesday that thefor Parts B and C of its Phase I/II clinical trial evaluating CMND‑100. This approval advances the multicenter study, titled "A Phase I/II Single and Multiple Dose Tolerability, Safety and Pharmacokinetic Study of CMND‑100 in Healthy Volunteers and Subjects with Alcohol Use Disorder" and directly enables the company to accelerate enrollment at Yale School of Medicine's Department of Psychiatry. The Yale site now joins other centers already approved and actively recruiting patients for the trial, including Johns Hopkins University School of Medicine, Tel Aviv Sourasky Medical Center and Hadassah Medical Center. The trial at the Yale site is led by Anahita Bassir Nia, MD, a specialist in psychiatry and addiction medicine.Adi Zuloff-Shani, CEO, commented, "Yale IRB approval to proceed with Parts B and C is an important milestone for our CMND-100 clinical program. This clearance allows us to immediately expand and accelerate patient recruitment at another world‑class site, alongside Johns Hopkins and Israeli medical centers, as we continue evaluating our proprietary non-hallucinogenic, MEAI-based candidate for individuals with AUD."Additionally on Friday, Clearmind announced that it has entered into a definitive agreement to acquire a 51% stake in Charging Robotics, which develops dedicated intelligent wireless charging systems designed specifically for automated parking facilities, autonomous mobile platforms and robotaxi operations. Under the terms of the agreement, Clearmind will acquire the majority stake of Charging Robotics for an aggregate purchase price of $2.5M. In addition, in connection with and as a condition to the closing of the acquisition, the company shall extend a loan to Charging Robotics in the principal amount of $1.5M. The loan shall bear interest at a rate of 4% per annum. The closing of the acquisition is expected to occur during the week of September 7 subject to the satisfaction of certain closing conditions.FILAMENT COMPLETES DELIVERY OF PEX010 TO AUSTRALIA:Rhelion Life Sciencesannounced Tuesday that its wholly owned subsidiary, Filament Health, hasits patented, standardized, GMP manufactured botanical psilocybin drug candidate, from Canada to Australia in support of an investigator initiated clinical trial. The trial, known as PSI-PHY, investigates psilocybin-assisted physiotherapy in adults with refractory motor functional neurological disorder. It is sponsored by The University of Melbourne, conducted at Austin Health, a public tertiary teaching hospital in Melbourne, and funded by the Medical Research Future Fund of the Australian Government Department of Health and Aged Care. Filament supplies PEX010 as the investigational drug product."For a decade this field has been framed as a mental health story, but newer research is starting to show the potential of natural psychedelics to help patients go beyond that." said Todd Shapiro, CEO of Rhelion. "If a natural psychedelic can help the brain relearn how to move, we are talking about neurology, rehabilitation, and potentially even anti-aging, not only psychiatry. Functional neurological disorder is one of the most common conditions a neurologist sees, and there is no approved pharmacological treatment for it. That is the kind of gap this company exists to help close."OTHER PSYCHEDELIC STOCKS:Publicly-traded companies in the space include AtaiBeckley, Grey Matters Health, BetterLife, Bright Minds Biosciences, Enveric Biosciences, GH Research, Helus Pharma, Incannex, MIRA Pharmaceuticals, NRx Pharmaceuticals, Numinus Wellness, Pasithea Therapeutics, PharmAla Biotech, PharmaTher, Psyence Biomedical, Revive Therapeutics, Sibannacand Silo Pharma.
Definium Therapeutics Receives FDA Breakthrough Therapy Designation for DT120
Definium Therapeutics announced that the U.S. Food and Drug Administration, FDA, has granted Breakthrough Therapy designation for DT120 Orally Disintegrating Tablet, ODT. The designation was supported by the unmet medical need in major depressive disorder, MDD, and results from the Company's Phase 3 Emerge study, in which a single 100 microgram dose of DT120 ODT demonstrated a statistically significant 8.1-point placebo-adjusted improvement in Montgomery-Asberg Depression Rating Scale, MADRS, total score at Week 6, with durable efficacy through Week 12.
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