ATAI Chairman Predicts his Company will Capture most of a Market Generating over 40b in Revenue a Year. https://x.com/c_angermayer/status/1948412665065332773?s=46&t=vUrFTxjVRaTfEod7uaEXDA History shows how hard it is to grasp paradigm shifts early, especially in biotech/pharma: A decade ago, most analysts predicted cancer immunotherapy would peak at ~$5-10B annual revenues. Today, the top three checkpoint inhibitors generate $41B+ annually. I expect the same if not bigger smashing success for psychedelics. Because in mental health, unfortunately, the addressable population is even larger: ~17 million Americans have cancer. But nearly 80 million suffer from depression, anxiety, trauma, or substance use disorders. And countless more suffer in silence. And this number is only growing in our increasingly stress-inducing world. I believe $ATAI will capture most of those revenues, due to a mix of commercial reasons ("2-hour-window"), patents, formulations, delivery methods & more.
GH Research (GH001, inhalable 5‑MeO‑DMT): Reported strong Phase 2b data in February 2025, showing a placebo‑adjusted MADRS reduction of ~15.5 points by day 8, with ~57.7% remission in the treated group versus 0% for placebo. However, the FDA has placed GH’s IND on clinical hold since September 2023 due to inhalation-device and toxicology concerns, and the hold continues into mid‑2025 despite a submitted response. Atai + Beckley Psytech (BPL‑003, intranasal 5‑MeO‑DMT): Delivered successful Phase 2b results in a multicenter, double-blind study: single 8 mg or 12 mg intranasal dose reduced MADRS by 11.1–12.1 points at day 29 vs. 5.8 in the placebo comparator group.The trial met pre-agreed merger criteria, triggering formal progression of atai’s acquisition of Beckley Psytech. Status Summary: At present, Atai/Beckley has cleared Phase 2b without regulatory holds, while GH Research is delayed by FDA concerns preventing further advancement. Patent Protection & IP Landscape GH Research: Holds a granted European patent covering mebufotenin (5‑MeO‑DMT) salts for depression treatment. But in the U.S., its pivotal patent application (#18/675,614) was non‑finally rejected in May 2025 on grounds of lack of novelty/obviousness, largely due to prior art cited via third-party submissions from Porta Sophia. That potentially weakens GH’s U.S. exclusivity claims. Beckley Psytech (via atai): Controls patented intranasal formulation BPL‑003 (mebufotenin benzoate delivered via nasal spray in FDA‑approved device), with protected IP around that delivery platform and formulation specifics. This gives them an edge in U.S. and international markets for the nasal-spray version. Competitive Position — Who’s Winning? Advantages for Atai/Beckley: Completed Phase 2b with strong efficacy and clean regulatory pathway so far. No IND holds, allowing progression toward Phase 3 planning. Patent protection for the intranasal delivery system and proprietary salt formulation (BPL‑003). Strategic combination now underway, consolidating resources, branding, and trial operations into “atai Beckley”. Challenges for GH Research: Delayed by FDA clinical hold that significantly hampers U.S. development timeline. U.S. patent application rejected on novelty grounds—undermining future exclusivity. Although their Phase 2b data were impressive, lack of progress to Phase 3 gives Atai first-mover regulatory advantage. Verdict: Who Will Lead? Based on current data as of July 2025: Atai Beckley appears best positioned to lead the 5‑MeO‑DMT therapeutic space. They have intact clinical momentum, no regulatory holds, strong patent coverage for their intranasal format, and strategic consolidation underway. GH Research has high-quality Phase 2b results, but is hampered by regulatory holds and weakened U.S. IP position—both could significantly delay or limit their ability to capture market share, particularly in the U.S.
AbbVie in Talks to Acquire Gilgamesh in $1 Billion Deal https://www.bloomberg.com/news/arti...embedded-checkout=true&leadSource=reddit_wall AbbVie Inc. is in talks to acquire mental health therapeutics company Gilgamesh Pharmaceuticals in a deal highlighting growing takeover interest in the sector, according to people familiar with the matter.A potential deal could value privately held Gilgamesh at about $1 billion, the people said, asking not to be identified because the information is private. An announcement could be made in the coming weeks, the people said.Deliberations are ongoing and could still be delayed or fall apart, according to the people. A representative for AbbVie, which is scheduled to report earnings on Thursday, declined to comment, while Gilgamesh couldn’t be reached for comment.An acquisition would come a little more than a year after AbbVie and Gilgamesh entered into an option-to-license agreement to develop novel therapies for psychiatric disorders.Gilgamesh is developing what are known as neuroplastogens, a type of next-generation psychedelic compound. A deal would bolster AbbVie’s pipeline of potential treatments for psychiatric disorders after a drug it acquired for schizophrenia failed in mid-stage trials last year.AbbVie sells another drug, Vraylar, for schizophrenia and bipolar disorder.Separately, Atai Life Sciences NV is working with an investment bank to field early stage interest from major industry players, the people said. The Peter Thiel-backed firm, which recently acquired Beckley Psytech, has received positive results from a recent mid-stage trial of a psychedelic nasal spray dubbed BPL-003. A representative for Atai declined to comment.Psychedelic drugs for treating depression could be nearing a breakthrough over the next two years, with major late stage trials coming set to deliver key readouts, according to Bloomberg Intelligence analyst Jean Rivera Irizarry.Led by founder and Chief Executive Officer Jonathan Sporn, Gilgamesh focuses on developing treatments for depression, anxiety, drug addiction and other mental illnesses. In May, the company announced positive top-line results in a mid-stage trial for GM-2505, which targets major depressive disorders.“MindMed, Cybin and Gilgamesh are leading efforts in a fast-moving field aimed at large, underserved populations, with consensus projecting about $4.5 billion in sales for the segment by 2032,” he said in a note in April.
In rumored AbbVie deal, Wall Street sees momentum for psychedelics M&A A potentially billion-dollar acquisition of Gilgamesh Pharmaceuticals suggests big pharma may finally be willing to place significant bets on psychedelic research. https://www.biopharmadive.com/news/psychedelics-dealmaking-wall-street-abbvie-gilgamesh/756496/
