Latest news with #CompassPathways
Yahoo
3 hours ago
- Business
- Yahoo
Atai and Beckley, set to merge, reveal study success for psychedelic drug
This story was originally published on BioPharma Dive. To receive daily news and insights, subscribe to our free daily BioPharma Dive newsletter. Atai Life Sciences and Beckley Psytech are making plans to push the psychedelic drug mebufotenin into Phase 3 testing after it safely and significantly reduced symptoms of treatment-resistant depression in a Phase 2b study. Shares of Atai jumped 20% after the companies' announcement Tuesday. Atai also announced a $50 million private placement in a financing round led by Ferring Ventures and Apeiron Investment, the family office of Atai founder and Chairman Christian Angermayer. With the successful study in hand and a new infusion of cash, the companies are proceeding with plans to merge in the second half of this year. The combination, announced in June, was contingent on positive results from the Phase 2b trial. Atai had previously scooped up a 36% stake in privately held Beckley in 2024. Atai and Beckley are looking to benefit from a new openness to psychedelic drugs for the treatment of mental health conditions. Both Health and Human Services Secretary Robert F. Kennedy Jr. and Food and Drug Administration Commissioner Martin Makary have touted the potential benefits of the medicines for patients, while Johnson & Johnson's Spravato, a derivative of ketamine, has generated blockbuster sales. Investors so far have shown a willingness to support the research but are looking for strong results. Compass Pathways recently failed to meet that mark with a medicine that succeeded in a Phase 3 trial but nevertheless disappointed shareholders by only reducing scores on a scale used to gauge depressive symptoms by a mean difference of 3.6 points compared with placebo. Beckley's mebufotenin showed a difference of 5.3 points and 6.3 points for the two therapeutic doses it tested as compared with a low-dose group used as a control when measured at Day 29 after treatment. Wall Street was looking for a difference of at least 5 points, Jefferies analyst Andrew Tsai wrote in a note to clients. Like Spravato, mebufotenin is administered through the nose. Atai and Beckley said participants in its study generally were able to leave the clinic within 90 minutes, which would put the drug in the conventional treatment window established by Spravato. The study also found no serious side effects and no evidence of suicidal intent or behavior in patients given mebufotenin. Researchers tested an 8 milligram dose and a 12 milligram dose against an 0.3 milligram control. The larger difference in depression symptom measurement was in the 8 mg dose, though the companies said they consider efficacy equivalent between the 8 mg and 12 mg doses. They plan to advance the 8 mg dose into Phase 3 testing after consulting with regulators. The companies said improvements were seen as early as one day after treatment and generally lasted at least eight weeks. While the results need to be confirmed in a continuing open-label study of a second dose and the eventual Phase 3 trial, the data suggests Atai and Beckley may be able to offer a longer window between treatments, possibly giving their drug an advantage over rivals such as Spravato, Tsai said. Recommended Reading Compass' big psychedelic study doesn't impress investors
Yahoo
2 days ago
- Business
- Yahoo
This Psychedelic Drug Flopped on Trial Results. Should You Buy the Dip?
Psychedelic stocks are gaining attention as new ways to treat mental illnesses like depression and post-traumatic stress disorder (PTSD). Companies in the niche use substances like psilocybin to develop treatments that present alternatives to traditional pharmaceutical compounds. Investors are hopeful, but the road to approval is risky and drawn out. Compass Pathways (CMPS) just faced one of those setbacks when it ran a late‐stage (Phase 3) trial of its synthetic psilocybin drug (COMP360) in 258 adults with treatment-resistant depression. Those receiving the treatment had a 3.6-point greater reduction in symptoms versus those receiving the placebo, which met the trial's predefined goal of at least a 3-point difference, but came up short of the 5-point gap Wall Street had hoped for. As a result, shares plunged nearly 50% on Monday, June 23. Analysts: AMD Stock Will 'Close the Gap' With Nvidia by 2026. Should You Buy AMD Stock Here? The Saturday Spread: Data-Driven Trades That Cut Through the Noise (GILD, MCD, DJT) Why This Wildcard Stock Could Be a Future Star Get exclusive insights with the FREE Barchart Brief newsletter. Subscribe now for quick, incisive midday market analysis you won't find anywhere else. Despite the drop, analysts remain mostly bullish. The company has another major trial underway, with results expected next year. If that data is stronger, the stock could rebound sharply. Compass is also pushing ahead in studies for PTSD. For investors who believe in the future of mental health innovation, this dip might be an opportunity to get in at a better price. Based in London, Compass Pathways is a biotechnology company focused on developing innovative treatments for mental health conditions, primarily targeting psilocybin for treatment-resistant depression (TRD). Valued at $248 million in market cap, shares of this psychedelic drug company have plunged 54% over the past 52 weeks and are down 27% year to date, significantly underperforming the broader S&P 500 Index ($SPX). After the haircut, CMPS is more attractively valued with a price-book ratio of 1.31x, significantly cheaper than the sector median of 2.7x. This pricing suggests CMPS may offer a good entry point relative to its peers. While COMP360 met its goal in the COMP005 trial, the modest 3.6-point improvement disappointed markets, causing a sharp stock correction. Still, Compass Pathways is gearing up for a key catalyst in 2026, its 26-week readout from two Phase 3 trials testing its psilocybin-based treatment for treatment-resistant depression (TRD). While earlier data showed promising six- and twelve-week effects, investors remain cautious about long-term durability and patient variability. Some fear the treatment may be too niche or selective, especially with reports of adverse events in prior trials. Still, if the results are positive, Compass could gain serious momentum toward FDA approval. Compass Pathways appears to be on stable financial footing as it advances its clinical programs. In Q1 2025, the company reported $260.1 million in cash and cash equivalents. This capital base was secured through a combination of financing mechanisms, including a private investment in public equity (PIPE) deal, a loan agreement with Hercules Capital, and an established at-the-market (ATM) offering program. With a current quarterly cash burn of approximately $49.6 million, comprising $30.9 million in research and development expenses and $18.7 million in general and administrative costs, Compass projects that its existing cash reserves will support operations through the second half of 2026. This timeline aligns with the anticipated data release from its ongoing Phase 3 COMP006 trial. Wall Street analysts remain confident about the company's future growth prospects, as reflected in their consensus 'Strong Buy' rating. Among the 10 analysts covering the stock, eight rate it a 'Strong Buy,' one gives a 'Moderate Buy,' and one rates it a 'Hold.' The 12-month average price target is $16.40, implying upside potential of 483% from current levels. Compass Pathways is still a high-risk bet, with regulatory hurdles and clinical uncertainty ahead. But for investors who believe in the future of psychedelic medicine, this dip could be an attractive entry. While caution is warranted, the upside remains compelling for those with a long-term view. On the date of publication, Nauman Khan did not have (either directly or indirectly) positions in any of the securities mentioned in this article. All information and data in this article is solely for informational purposes. This article was originally published on Error in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
Yahoo
4 days ago
- Business
- Yahoo
Psychedelic: Compass Pathways achieves primary endpoint in COMP360 trial
In this week's 'Psychedelic,' The Fly's recurring series focused on psychedelic stock news, The Fly looks back on a primary endpoint achievement, a clinical site addition and additional development candidate data. Easily unpack a company's performance with TipRanks' new KPI Data for smart investment decisions Receive undervalued, market resilient stocks right to your inbox with TipRanks' Smart Value Newsletter COMPASS PATHWAYS ACHIEVES PRIMARY ENDPOINT IN COMP360 TRIAL: Compass Pathways (CMPS) announced Monday the achievement of the primary endpoint in the ongoing Phase 3 COMP005 trial, the first of two Phase 3 trials evaluating COMP360, a synthetic, proprietary formulation of psilocybin, for treatment-resistant depression. The primary endpoint is the difference in change from baseline in the Montgomery-Åsberg Depression Rating Scale scores between the active treatment group and the placebo group at week 6. A single dose of COMP360 25 mg versus placebo demonstrated a highly statistically significant reduction in symptom severity with a p-value of <0.001 and a clinically meaningful difference of -3.6 in change at the primary endpoint. The company plans to discuss these preliminary COMP005 data with the U.S. Food and Drug Administration, which has not yet reviewed the data. The ongoing Phase 3 COMP005 trial is the first study of an investigational, synthetic psilocybin, and the first classic psychedelic to report Phase 3 efficacy data. This randomized, double-blind, placebo-controlled study, which dosed 258 participants with TRD across 32 sites in the United States, aims to assess the efficacy and safety of a single dose of COMP360 25 mg versus placebo for reducing symptom severity in TRD. KBased on the latest review of the data for the 005 and 006 studies, safety findings are consistent with previous studies of COMP360 and there are no new or unexpected safety findings. From this review of the data, there is no evidence of a clinically meaningful imbalance between treatment arms in suicidality in either study. "The positive top-line results at week 6 from the COMP005 trial underscore the innovative potential of psilocybin treatment in mental health care for which Compass Pathways continues to pave the way," said Kabir Nath, CEO. "We are proud of this significant progress, which reflects our scientific rigor, operational excellence and steadfast commitment to serving patients living with TRD. We eagerly anticipate further insights once we have the full dataset, and also look forward to findings from COMP006, which will explore the efficacy of two fixed doses. We remain focused on our goal of transforming the landscape of mental health treatment." Following the report, Evercore ISI downgraded Compass Pathways (MNMD) initiation, durability is a key component for commercial success and this will remain a question with relatively unclear durability in the Phase 2b and a weaker effect at 6 weeks here, the analyst said. Meanwhile, H.C. Wainwright said that meeting the primary endpoint in the Phase 3 COMP005 trial in treatment-resistant depression marks 'a historic first for a psychedelic therapy.' In addition to this readout representing the first-ever positive Phase 3 efficacy data for a classic psychedelic, it positions COMP360 as 'a potential first-in-class treatment in a large, underserved depression market,' said the analyst, who reiterated a Buy rating and $45 price target on the shares. Stifel acknowledged that the 3.6 point MADRS delta between drug-vs-placebo for COMP360 was 'a little lighter than expected,' but argued that the magnitude of the stock reaction is 'significantly overdone'. The COMP360 data represents 'a clearly positive result from a regulatory perspective,' and the effect-size is 'actually pretty good for a treatment-resistant population,' according to the analyst, who added that it is 'simply not clear' that effect size is a major driver of commercial success in neuropsychiatry. The firm has a Buy rating and $11 price target on Compass shares. Additionally, Canaccord said the weakness in Compass Pathways following the release of top-line results from its eagerly-awaited COMP005 Phase 3 trial is a buying opportunity. Canaccord believes updates from the FDA could eventually move the stock and there is no change to their model pending additional data. Canaccord reiterated its Buy rating and $15 price target on Compass Pathways shares. BTIG lowered the firm's price target on Compass Pathways to $7 from $12 but kept a Buy rating on the shares. The firm noted that COMP360 represents the 'very careful development of a mediocre drug' relative to other options in the psychedelic and neuro-plastic pipeline, the analyst said. CLEARMIND ADDS ISRAELI CLINICAL SITE TO AUD TRIAL: Clearmind Medicine (CMND) announced Monday the addition of Tel Aviv Sourasky Medical Center in Tel Aviv, Israel, as an additional clinical site for its ongoing Phase I/IIa clinical trial evaluating CMND-100, a proprietary MEAI-based oral drug candidate, for the treatment of Alcohol Use Disorder. This expansion follows the recent enrollment of the first patient in the trial. The study at Tel Aviv Sourasky Medical Center will be led by Dr. David Zeltser, Director of the Emergency Medicine Department. Tel Aviv Sourasky Medical Center joins other institutions participating in the trial, including Yale School of Medicine's Department of Psychiatry and Johns Hopkins University School of Medicine. The inclusion of Tel Aviv Sourasky Medical Center further strengthens Clearmind's clinical network, enhancing the trial's capacity to evaluate the safety, tolerability, and pharmacokinetic profile of CMND-100, while also exploring its potential to reduce alcohol cravings and consumption in patients with AUD. 'We are pleased to welcome Tel Aviv Sourasky Medical Center to our Phase I/IIa clinical trial, alongside esteemed partners like Yale and Johns Hopkins,' said Adi Zuloff-Shani, CEO. 'The enrollment of our first patient earlier this month was a pivotal moment, and expanding our clinical trial to additional leading clinical sites like TASMC underscores our commitment to addressing the global burden of AUD, which affects millions and accounts for 2.6M deaths annually.' ENVERIC REPORTS ADDITIONAL DATA ON EB-003: On Tuesday, Enveric Biosciences (ENVB) unveiled additional data indicating that its lead development candidate, EB-003, acts as an agonist of the serotonin receptor 5-HT1B, in addition to its other previously disclosed receptor engagement activities. The 5-HT1B receptor is a recognized therapeutic target for treating several central nervous system conditions, including major depressive disorder, Parkinson's disease, migraines, and cluster headaches. The study results demonstrated agonism of 5-HT1B by EB-003 and added to the existing receptor engagement data supporting that EB-003 acts as a partial agonist of the 5-HT2A receptor, which is key to the compound's potential ability to elicit neuroplastogenic effects without inducing adverse hallucinogenic outcomes. EB-003 is currently in preclinical development, with IND-enabling activities planned to continue through 2025. 'The 5-HT1B receptor, found predominantly in the frontal cortex, basal ganglia and hippocampus, is a validated therapeutic target of some well-known CNS drugs,' said Joseph Tucker, CEO. 'Enveric previously announced positive pharmacology, in vitro safety and oral bioavailability data of EB-003, including achieving therapeutically relevant brain exposure in rodent models. The newly revealed ability to target 5-HT1B illustrates EB-003's differentiated and multifaceted mechanism of action and broadens its utility and the range of potential target indications to pursue in future development.' SILO PHARMA ENTERS LOI FOR JV WITH HOTH: Silo Pharma (SILO) announced Wednesday that it has entered into a non-binding letter of intent to form a strategic 50:50 joint venture with Hoth Therapeutics (HOTH) to develop and commercialize a potential treatment for obesity and metabolic disease based on technology Hoth has exclusively licensed from the U.S. Department of Veterans Affairs that was co-developed by the VA and Emory University. The novel therapeutic platform centers on glial cell line-derived neurotrophic factor, a VA-invented biologic with demonstrated anti-obesity effects and metabolic regulation in preclinical models. The platform is protected under U.S. Patent No. 10,052,362 and targets multiple high-burden conditions, including non-alcoholic fatty liver disease, type 2 diabetes, and central obesity. 'With obesity at epidemic levels and no curative therapies available, we believe the VA's biologic GDNF is potentially a game-changer,' said Eric Weisblum, CEO. 'We believe that our potential JV collaboration with Hoth aligns with our mission to accelerate groundbreaking science into human trials.' HOPE THERAPEUTICS TO ACQUIRE INTEREST IN COHEN: HOPE Therapeutics, a wholly-owned subsidiary of NRx Pharmaceuticals (NRXP), announced Thursday the signing of a binding Letter of Intent to purchase a 49% interest in Cohen and Associates, founded by Dr. Rebecca Cohen. Cohen is expected to serve as a foundational clinic for HOPE in the Sarasota-Bradenton region of western Florida. The clinic offers a full range of treatments for suicidal depression, PTSD and other CNS disorders, including ketamine, Spravato, Transcranial Magnetic Stimulation as well as medication management. 'We are delighted to welcome Rebecca and her team to the HOPE family. Her extensive experience with neuroplastic therapies, combined with compassionate patient care exemplify our culture of bringing HOPE to life,' said Jonathan Javitt and Matthew Duffy, Co-CEOs of HOPE. Additionally on Monday, NRx Pharmaceuticals announced filing for the newly-announced FDA Commissioner's National Priority Voucher program on behalf of NRX-100, its patent-pending, preservative-free formulation of ketamine for intravenous use. Concurrent with the CNPV process, the company is preparing a citizen petition to seek withdrawal of preservative-containing forms of ketamine, based on the toxicity associated with the benzethonium chloride preservative used in the historic formulation. The company has also filed a patent on its preservative-free manufacturing process. 'NRx is highly encouraged by the newly-announced Commissioner's National Priority Voucher Program, and believes that NRX-100 meets each of the criteria for acceptance,' said Jonathan Javitt, CEO. 'As previously determined by FDA, our products are innovative treatments that address the current health crisis of suicidal depression and PTSD, and address an unmet medical need. We will be seeking New Drug Approval for NRX-100 in the treatment of suicidal depression and PTSD. The FDA's announcement has now validated our company's focus on manufacturing and CMC by identifying CMC as a pre-requisite to the CNPV program. The timelines announced for the CNPV program are consistent with NRx's previous guidance of FDA decisions by year-end 2025. Our application under the CNPV program is accretive to the Abbreviated New Drug Application filed last week for preservative-free ketamine, for which we are seeking priority review.' OTHER PSYCHEDELIC STOCKS: Publicly-traded companies in the space include Algernon Pharmaceuticals (AGNPF), Allied Corp. (ALID), atai Life Sciences (ATAI), BetterLife (BETRF), Bright Minds (DRUG), Cybin (CYBN), Entheon Biomedical (ENTBF), Filament Health (FLHLF), GH Research (GHRS), Incannex (IXHL), MIRA Pharmaceuticals (MIRA), Mydecine Innovations (MYCOF), Numinus Wellness (NUMIF), Optimi Health (OPTHF), Pasithea Therapeutics (KTTA), PharmAla (MDXXF), PharmaTher (PHRRF), Psyence Biomedical (PBM), Psyence Group (PSYGF), Quantum BioPharma (QNTM), Relmada Therapeutics (RLMD), Revive Therapeutics (RVVTF), SciSparc (SPRC) and Seelos Therapeutics (SEEL). Published first on TheFly – the ultimate source for real-time, market-moving breaking financial news. Try Now>> See Insiders' Hot Stocks on TipRanks >> Read More on CMPS: Disclaimer & DisclosureReport an Issue Mike Davis to become CDER deputy director, Pink Sheet's Gingery says Compass Pathways price target lowered to $7 from $12 at BTIG Compass Pathways weakness a buying opportunity, says Canaccord Compass Pathways Achieves Phase 3 Trial Success Compass Pathways downgraded to In Line from Outperform at Evercore ISI Error in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
Yahoo
5 days ago
- Health
- Yahoo
Iowa lawmaker who supports medicinal mushrooms cheers veto of psilocybin bill
Laboratory technician holding a micro dose of psilocybin. (Photo by Getty Images) An Iowa lawmaker who pushed for the passage of a bill to create a state program allowing the medicinal use of psilocybin said Gov. Kim Reynolds' decision to veto a bill pertaining to the psychoactive compound in magic mushrooms was a 'great decision.' Rep. Jeff Shipley, R-Fairfield, said rather than focus on rescheduling a synthetic version of the drug, the state should instead prioritize creating a state program legalizing the psychiatric use of naturally occurring psilocybin. House File 383 would have allowed for the prescription and distribution of synthetic psilocybin immediately following federal approval of the drug, and mirrored a similar bill, which was signed into law, in Colorado. SUBSCRIBE: GET THE MORNING HEADLINES DELIVERED TO YOUR INBOX The bill dealt with crystalline polymorph psilocybin, a compound commonly known as COMP360, which is a treatment developed by the biotechnology company Compass Pathways to help patients with treatment of resistant depression, post traumatic stress disorder and anorexia nervosa. Shipley said he 'condemns Compass Pathways' for its approach at creating, and patenting, a synthetic version of the 'natural psilocybin that God has given us that everyone knows and loves.' Compass Pathways declined to comment on the veto of the bill, which it lobbied in support of, and on Shipley's comment. Shipley's emailed statement also apologized for his vote in favor of the bill, which passed unanimously in both the House and Senate. 'The proper legal framework is to reschedule psilocybin to schedule IV or III, and allow the relevant state regulatory boards to make it available as medicine,' Shipley said. Reynolds, in her explanation of the veto, similarly said the state should have time to review any federal action on the synthetic version of the drug before it legalizes it at the state level. Shipley was a vocal supporter of House File 978, which would have legalized the use of psilocybin for psychiatric treatment through a state program. The proposed program would have operated similarly to the state's medical cannabis program. The bill passed the House with an overwhelming majority in late April, but was not taken up by the Senate. 'It's my hope and prayer that the Governor's office and the Iowa Senate will agree to take up … HF978 as an immediate priority next January,' Shipley said. SUPPORT: YOU MAKE OUR WORK POSSIBLE
Medscape
24-06-2025
- Health
- Medscape
Psilocybin Safe, Effective for TRD: Phase 3 Data
A single dose of a synthetic form of psilocybin known as COMP360 (Compass Pathways) is both statistically significant and clinically meaningful in reducing treatment-resistant depression (TRD) in a new phase 3 trial, its manufacturer announced in a press release. Topline results from the ongoing COMP005 trial showed that a single 25-mg dose of the investigational drug was associated with a greater reduction in symptom severity on the Montgomery-Åsberg Depression Rating Scale (MADRS) at 6 weeks than matching placebo, meeting the study's primary endpoint. Additionally, there were 'no unexpected safety findings and no clinically meaningful imbalance in suicidal ideation between treatment and placebo arms,' the company added. This is 'the first study of an investigational, synthetic psilocybin, and the first classic psychedelic, to report phase 3 efficacy data,' the company said. The results are important for patients with TRD who do not respond to currently approved and available treatment options, Guy Goodwin, MD, chief medical officer at Compass, said in the release. 'This achievement provides hope that they can finally receive appropriate care and live the life they deserve,' Goodwin added. Ongoing Research COMP360 is a synthetic and proprietary formulation of psilocybin. As reported by Medscape Medical News, results presented at the 2023 European Psychiatric Association Congress from a phase 2 study assessing a single 25-mg dose of the drug were associated with improvements of core symptoms in patients with TRD. It has also appeared to be effective for bipolar depression and for anorexia nervosa in two separate small studies. COMP005 is the first of two ongoing and parallel-running phase 3 trials assessing the investigational drug. In it, 258 patients with TRD were enrolled across 32 US sites and randomly assigned to receive one administration of either the active drug at a dose of 25 mg or matching placebo. The newly released results are from the first part of the trial, which included blinding through 6 weeks. From baseline to 6 weeks, the participants who received the active treatment had a significantly greater reduction in symptom severity on the MADRS compared to those who received placebo ( P < .001). In addition, there was a mean score treatment difference of -3.6 (95% CI, -5.7 to -1.5), demonstrating a clinically meaningful reduction, the company noted. The trial's data, which were reviewed by an independent Data Safety Monitoring Board, showed no new or unexpected safety findings and were consistent with those from previous COMP360 studies. Part 2 of the ongoing trial will be evaluating results blinded through week 26, and part 3 will contain open-label treatment from week 26 to week 52. 'We eagerly anticipate further insights once we have the full dataset,' Kabir Nath, Compass' chief executive officer, said in the release. For now, the company reported that it is planning to discuss these preliminary results with the US Food and Drug Administration. In addition, the ongoing phase 3 COMP006 trial is aiming to enroll 568 participants from North America and Europe and will assess two fixed doses of the active treatment. Compass is expecting to receive 26-week data during the second half of 2026.
