Latest news with #Atai
Mint
02-07-2025
- Health
- Mint
A promising depression drug works. Psychedelics are back.
Positive data on depression treatment based on a drug related to the psychedelic DMT is breathing life into shares of biotechs working on psychedelic medicines, after years of disappointments. Just as top Trump administration health officials have begun to show a more receptive attitude to psychedelics, atai Life Sciences and Beckley Psytech said Tuesday that patients with difficult-to-treat depression symptoms who took Beckley's drug BPL-003 saw improvement in an eight-week trial. Atai is in the process of acquiring Beckley. Patients on a higher dose of BPL-003 had an average decrease of 11.5 points on a rating scale that tracks depression symptoms. That compared with a 5.8 point drop among patients in the control group, who received a tiny dose of BPL-003. The companies will need to continue testing BPL-003. But analysts said Tuesday that based on the results, they see the drug eventually hitting $1 billion in annual sales. 'The dataset should instill confidence in a $1B+ drug," Jefferies analyst Andrew Tsai wrote in a research note. Atai shares were up 24% at midday. Shares of other biotechs working on psychedelic drugs took off as well: Compass Pathwards climbed 13%, while shares of MindMed were up 5.4%. The Beckley drug, BPL-003, is a nasal spray version of the psychedelic 5-MeO-DMT, a close relation to DMT and other similar psychedelics. A long list of biotechs have been looking toward psychedelic medicines in recent years. The aim is to find ways to treat neurological conditions like depression and post-traumatic stress disorder that have proven hard to cure with existing medicines. None have been approved by the Food and Drug Administration so far, though in 2019, Johnson & Johnson received FDA permission to sell a depression medicine called Spravato, which is a derivative of the dissociative anesthetic ketamine. The field hit a major roadblock last summer, when the FDA rejected an application from a private company called Lykos Therapeutics for approval of a treatment protocol for PTSD that combined use of the drug MDMA with talk therapy. At the time, analysts said that other psychedelic treatments might be easier to get approved than Lykos's MDMA treatment, for reasons having to do with the specifics of the Lykos protocol. Now, the positive data from atai and Beckley's drug comes as attitudes within the FDA appear to be shifting in favor of psychedelics. In an interview with the reality show fitness expert Jilian Michaels on NewsNation last month, FDA Commissioner Dr. Marty Makary suggested he was very open to approving psychedelic therapies. 'When I listen to the individuals who have tried some of these for real medical conditions – post-traumatic stress disorder, severe refractory depression – people tell me that they believe that psilocybin was successful, was curative, or significantly helped their severe mood disorder," Makary said. 'I'm saying we have to listen to doctors who have these experiences. And this is one of our top priorities at FDA: To listen to doctors, to listen to patients." Those comments, and similar rhetoric from Robert F. Kennedy Jr., the U.S. health secretary, point to a potentially friendly attitude among regulators toward BPL-003 and similar medicines. In the results announced Tuesday, atai and Beckley said that the two higher dose levels of BPL-003 they tested led to 'statistically significant improvements" in depression symptoms as soon as one day after treatment. The companies said that patients were ready to leave the treatment center two hours after receiving the medication on average. Atai noted that patients who take Johnson & Johnson's Spravato need to stay at their doctor's office for two hours after taking the medicine, which sets a precedent for a similar protocol.
Yahoo
01-07-2025
- 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
10-06-2025
- Business
- Yahoo
Partsol Launches Partsol Futures: A New Era in AI Innovation and Strategic Research
TAMPA, Fla., June 10, 2025 /PRNewswire/ -- Partsol, the global innovator behind Cognitive AI and the Absolute Truth methodology, announces the launch of Partsol Futures, a pioneering research and innovation lab focused on accelerating breakthrough AI applications for national security, smart infrastructure, life sciences, and beyond. Built on the success of Partsol's Cognitive AI and Absolute Truth algorithms, Partsol Futures will function as a powerful engine of innovation within the company, ensuring its continued leadership in national security, life sciences, legal, smart infrastructure, and education. The newly formed Partsol Futures Lab is modeled on best practices from the world's most successful R&D centers and innovation labs. It is designed to bridge the gap between "blue-sky" research and practical, deployable technologies. The lab's operational ethos is focused on lean experimentation, interdisciplinary collaboration, and accelerated prototyping to deliver enterprise-grade solutions at startup speed. "At Partsol, innovation has never been an isolated effort. Partsol Futures will serve as the core accelerator for the next phase of our AI breakthroughs," said Alan Williams, President of Partsol Futures. "From national security to smart schools, our lab will be the place where bold ideas are transformed into tangible solutions that make a global impact." Partsol Futures is dedicated to advancing scientific discovery and transforming it into real-world, scalable AI solutions. The lab will drive cross-disciplinary collaboration with academia, government, and industry to ensure rapid, responsible deployment across domains like cybersecurity, diagnostics, and autonomous systems. While Partsol's Atai platform is transforming the AI landscape with its science-driven Cognitive AI and Absolute Truth algorithms, Partsol Futures will push the boundaries even further. The lab will work behind the scenes to incubate the next phases of Atai's evolution, with particular focus on expanding the applications of Partsol's AI Stem Cell technology. This foundational approach will empower new generations of intelligent systems, bringing to life the company's guiding belief: "Revealing What You've Yet to Find." About Partsol Partsol, a Partnership Solutions International company, is an industry leader in Cognitive AI- driven decision intelligence solutions. Leveraging its proprietary Absolute Truth methodology, Partsol provides high-fidelity, bias-free AI technology that enhances strategic decision-making in complex environments. Partsol's AI solutions are widely adopted across finance, national security, private equity, and advanced manufacturing, helping organizations transform raw data into actionable intelligence. With a strong foundation in scientific methodologies, forensic analysis, and AI automation, Partsol empowers businesses with the tools they need to make data-informed decisions with confidence. To learn more, visit or connect with Partsol on LinkedIn. Media ContactTeresa View original content to download multimedia: SOURCE Partsol
Yahoo
05-06-2025
- Business
- Yahoo
Regeneron makes obesity push; Atai, Alto ink brain drug deals
This story was originally published on BioPharma Dive. To receive daily news and insights, subscribe to our free daily BioPharma Dive newsletter. Today, a brief rundown of news involving Regeneron and Bluebird bio, as well as updates from Atai Life Sciences, Alto Neuroscience and UniQure that you may have missed. Regeneron Pharmaceuticals on Monday disclosed Phase 2 study results that it claimed suggest the addition of one or two of its experimental medicines to Novo Nordisk's Wegovy might help people with obesity preserve muscle mass. Leerink Partners analyst David Risinger, however, described the results in a research note as "mixed," highlighting how the addition of Regeneron's drug resulted in either numerically lower weight loss with "comparable tolerability" or "greater weight loss with worse tolerability." The effects on muscle function, which haven't yet been disclosed, will be "critical,' Risinger added. Draft guidance published by the Food and Drug Administration has indicated muscle-protecting medicines "need to demonstrate functional benefits" to succeed. — Ben Fidler Regeneron also expanded its portfolio of weight-loss medicines, announcing on Monday a deal for most worldwide rights to a drug developed by Hansoh Pharmaceuticals Group that's currently in late-stage testing in obesity in China. Regeneron paid Hansoh $80 million upfront for the drug, which, like Eli Lilly's Zepbound targets the gut hormones GLP-1 and GIP. It could add nearly $2 billion in additional payouts. In testing, the drug has demonstrated a "potentially similar profile" to Zepbound, Regeneron said. — Ben Fidler Carlyle Group and SK Capital on Monday closed a deal to acquire and take private gene therapy developer Bluebird bio. The two private equity firms said they've provided 'significant primary capital' to support and scale Bluebird's gene therapies for rare blood and brain diseases, and that the company will now prioritize building up its manufacturing capabilities and strengthening relationships with insurers. Bluebird's stock, which will no longer trade on the Nasdaq, last closed at around $5 per share. — Ben Fidler Psychedelics developer Atai Life Sciences is absorbing the rest of a U.K.-based biotechnology company through an all-share transaction announced Monday. Atai last year took a nearly 36% stake in Beckley Psytech, providing it access to an experimental version of the mind-altering compound mebufotenin. Now, the two developers are combining in a deal that values Beckley at $390 million and is expected to close in the back half of this year. Beckley's investors other than Atai will be issued around 105 million new shares as consideration, representing about 31% of the combined company. Additionally, the investment firms Ferring Ventures and Adage Capital Partners are making a concurrent $30 million private placement. Atai said the new entity will have enough cash to keep it running through 'multiple' readouts of important mid-stage clinical trials. — Jacob Bell Alto Neuroscience has, for just under $2 million, acquired a portfolio of dopamine-boosting drugs in development for depression. The deal with Chase Therapeutics, disclosed Tuesday, hands Alto a fixed-dose combination of pramipexole, which is already used to treat Parkinson's disease, and ondansetron, the active ingredient in the nausea medication Zofran. Now code-named ALTO-207, this combination recently succeeded in a mid-stage study of patients with major depressive disorder. Alto plans to start by mid-2026 a Phase 2b trial designed to potentially enable an approval application. The trial would focus on treatment-resistant depression and report high-level data sometime in 2027. — Jacob Bell UniQure, the Belgium-based gene therapy developer, said it has reached an agreement with the FDA on 'several key components' of an approval application for its closely watched treatment for Huntington's disease. Those components include the manufacturing process for the treatment, named AMT-130, as well as updated statistical analysis plans that UniQure expects to submit before the end of June. Looking ahead, the company intends to have another pre-filing meeting with the FDA late this year and then formally submit its application for priority review sometime between January and March of 2026. Analysts at TD Cowen have estimated that peak annual sales of AMT-130 could reach or surpass around $1 billion. — Jacob Bell Recommended Reading Sanofi reaches consumer health deal; Supernus antidepressant fails study 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
Business Wire
03-06-2025
- Business
- Business Wire
ATAI Stock Alert: Halper Sadeh LLC is Investigating Whether the Merger of Atai Life Sciences N.V. is Fair to Shareholders
NEW YORK--(BUSINESS WIRE)--Halper Sadeh LLC, an investor rights law firm, is investigating whether the merger of Atai Life Sciences N.V. (NASDAQ: ATAI) and Beckley Psytech Limited is fair to Atai shareholders. Halper Sadeh encourages Atai shareholders to click here to learn more about their legal rights and options or contact Daniel Sadeh or Zachary Halper at (212) 763-0060 or sadeh@ or zhalper@ The investigation concerns whether Atai and its board violated the federal securities laws and/or breached their fiduciary duties to shareholders by failing to, among other things: (1) obtain the best possible consideration for Atai shareholders; and (2) disclose all material information necessary for Atai shareholders to adequately assess and value the merger consideration. On behalf of Atai shareholders, Halper Sadeh LLC may seek increased consideration for shareholders, additional disclosures and information concerning the proposed transaction, or other relief and benefits. We would handle the action on a contingent fee basis, whereby you would not be responsible for out-of-pocket payment of our legal fees or expenses. Halper Sadeh LLC represents investors all over the world who have fallen victim to securities fraud and corporate misconduct. Our attorneys have been instrumental in implementing corporate reforms and recovering millions of dollars on behalf of defrauded investors. Attorney Advertising. Prior results do not guarantee a similar outcome.
