Atai and Beckley, set to merge, reveal study success for psychedelic drug
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.
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The Hill
14 hours ago
- The Hill
Coke with cane sugar may not be that big of a MAHA victory
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Kennedy 'hasn't tackled ultra-processed food yet. That'll be where he could make an impact on health in the U.S. and all the non-communicable diseases, including obesity. But he hasn't gone there yet,' Popkin said. The coming months will reveal more on the MAHA movement's plans to change how Americans eat. New dietary guidelines will be released 'in the next several months,' Kennedy said recently. In addition, a second MAHA report focused on policy recommendations is expected in August. 'We have to be considering that there could be real potential down the road,' Popkin said. 'But [there's been] nothing yet. That document will tell us if there ever be.'
Miami Herald
15 hours ago
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Pepsi copies Coca-Cola to win back health-conscious consumers
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Newsweek
21 hours ago
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Is the FDA Doing Enough About Food Additives?
Based on facts, either observed and verified firsthand by the reporter, or reported and verified from knowledgeable sources. Newsweek AI is in beta. Translations may contain inaccuracies—please refer to the original content. Food additives have come under increasing scrutiny in recent months, and Health Secretary Robert F. Kennedy Jr. recently announced a ban on eight frequently used food dyes from food and beverages. Two petroleum-based synthetic dyes are set to be phased out imminently, while the other six must be removed from products by the end of 2026. Kennedy Jr has been a vocal critic of food additives, based on their impact on health, particularly their potential neurological effect on children, and the Food and Drug Administration (FDA) has been approving alternative food dyes that come from natural, rather than synthetic, sources. 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The FDA recently banned several food dyes: Citrus Red No. 2 and Orange B, which will lose their authorization soon, and six FD&C dyes which are scheduled for removal by 2026, Green No. 3, Red No. 40, Yellow Nos. 5 and 6, and Blue Nos. 1 and 2. The FDA has also requested that food companies remove FD&C Red No. 3 sooner than the 2027 to 2028 deadline previously required. Earlier this month, the FDA also approved the use of the color gardenia (genipin) blue in various foods, which is derived from the fruit of the evergreen, gardenia. This was the fourth naturally-derived color approved by the FDA for use in foods in the last two months. The FDA is also currently reviewing a number of other additives, with potassium bromate, propylparaben and titanium dioxide all on the FDA's list of "chemicals in the food supply under FDA review." According to the Environmental Working Group (EWG), titanium dioxide has been associated with potential immunotoxicity and neurotoxicity, while potassium bromate is associated with an increased risk of cancer. Propylparaben is thought to be a hormone disrupter. More recently, the FDA added butylated hydroxyanisole (BHA) and azodicarbonamide (ADA) to its list for reviewing and has moved to ban brominated vegetable oil (BVO) . BHA is believed to increase risk of cancer and cause hormone disruption, while ADA is believed to form carcinogenic byproducts, and BVO is believed to harm the nervous system, reproductive system and thyroid hormone system, according to EWG. An FDA spokesperson told Newsweek the FDA has also recently released for public comment its Post-market Assessment Prioritization Tool for ranking chemicals in the food supply, enabling it to "determine which chemicals the agency would prioritize for post-market assessments." This will allow the FDA to "allocate resources more efficiently, ensuring that the agency focuses on food chemicals that may present the greatest potential public health risk, including risk to sensitive populations, and are of high public concern," they said. "Determining if a chemical—either one intentionally added to food or a contaminant that is not intentionally added—needs to be further evaluated based on new information takes a structured and science-based approach to ensure that the FDA's reviews are protective of the health of consumers," FDA spokesperson said. "The FDA is committed to radical transparency as the agency develops processes for prioritizing chemicals in food for a post-market assessment. These processes will help to ensure that FDA is taking a risk-informed approach in reviewing data and information about the safety of chemicals in the food supply to protect the health of consumers." Photo-illustration by Newsweek/Getty What States Are Doing About Food Additives California was the first state in the country to ban certain food dyes, and it has already enacted legislation banning the sale, distribution, and production of food products containing BVO. Since then, more states have followed suit with similar proposals. Many other states now have pending legislation introduced this year to ban food dyes and additives—particularly in school settings to protect children from potential health risks. Florida proposed legislation to ban schools serving food containing BHA, ADA, BHT and BVO, and many other additives. However, the bill (SB 560) died in the Senate Appropriations Committee on June 16. Iowa, Minnesota, Michigan, New York, North Carolina, South Carolina, Vermont and Washington, are also considering bans on BVO and other additives under FDA review in school meals, while New Jersey and Wisconsin are seeking to ban ADA as well as BVO and others. Pennsylvania is trying to ensure any products containing BHA come with a clear warning. Some states like Hawaii, Illinois, and Ohio have sought to ban the use of single-use food packaging and serving containers being intentionally manufactured to have "forever chemicals," known as PFAS, which are carcinogenic to humans. Broad Leib told Newsweek that some states, including Louisiana, are also trying to ban the use of aspartame, an artificial sweetener, cottonseed oil, and grapeseed oil. Does the FDA's Review of Food Chemicals Go Far Enough? Sheela Sathyanarayana, a professor of pediatrics and environmental and occupational health sciences at the University of Washington and Seattle Children's Research Institute, told Newsweek it was "absolutely not" the case that the FDA's current process for regulating and reviewing additives in food went far enough. "We have some of the most lax regulations through generally recognized as safe (GRAS) provisions," she said. "While FDA focusing on dyes and these three additives is a good first step, it is very minuscule in the scope of the broader picture." "I think that FDA has been a little haphazard in their review of chemicals to date," Broad Leib said. Last fall, the agency introduced a discussion paper on how to better manage the process for post-market review of chemicals, however, Broad Leib said that, in her opinion, this "was not strong enough." The Harvard Food Law and Policy Clinic suggested in a comment to the FDA on its proposal that if a state or peer jurisdiction bans a chemical, it should trigger an immediate 120-day review period for FDA to assess the chemical in question. Broad Leib said that FDA has not yet issued any "general response to that docket and has not put out an updated discussion paper." Commenting on the agency's release of a new document for public comment on how to prioritize chemicals for review, Broad Leib said: "I think [it] shows that they are thinking about the issue and trying to get better at flagging chemicals of concern." Overall, despite the FDA's efforts, Broad Leib said that she thought "there are some serious gaps in FDA's review of chemicals, both premarket and post-market." She said that there is a "loophole" in premarket review, whereby companies can "self-designate a substance to be GRAS and thus avoid the additive process, avoid FDA oversight, and even avoid FDA notification." All of these processes are voluntary for GRAS substances, meaning that this enables many substances to sneak into food "without FDA even having them on its radar," she added. She said that the FDA "has long been without a strong process for transparently identifying substances of concern, quickly reviewing evidence, and then taking decisive action when needed."
