Welcome to our dedicated page for Atai Beckley news (Ticker: ATAI), a resource for investors and traders seeking the latest updates and insights on Atai Beckley stock.
AtaiBeckley Inc. (NASDAQ: ATAI) is a clinical-stage biopharmaceutical and biotechnology company focused on developing effective, rapid-acting and convenient mental health treatments. The AtaiBeckley news feed on Stock Titan aggregates company announcements, press releases and regulatory disclosures so readers can follow how its clinical programs and corporate developments evolve over time.
News about AtaiBeckley frequently highlights progress across its pipeline of investigational therapies. This includes updates on BPL-003, a mebufotenin (5-MeO-DMT) benzoate nasal spray for treatment-resistant depression and alcohol use disorder; VLS-01, a DMT buccal film for treatment-resistant depression; and EMP-01, an oral R-MDMA formulation for social anxiety disorder. Company releases have covered Phase 2b and open-label extension data for BPL-003, enrollment and site expansion for VLS-01 trials, and exploratory Phase 2a work for EMP-01, as well as regulatory milestones such as FDA Breakthrough Therapy designation for BPL-003.
Investors and observers can also use the ATAI news page to follow corporate events, including the strategic combination of atai Life Sciences N.V. and Beckley Psytech Limited to form AtaiBeckley, the company’s redomiciliation to the United States as AtaiBeckley Inc., and its addition to the Nasdaq Biotechnology Index. Filings and press releases related to public offerings, grants from organizations such as the National Institute on Drug Abuse, and intellectual property developments like the U.S. patent granted for EMP-01 are also reflected in the news flow.
By reviewing AtaiBeckley news in one place, readers can track key clinical milestones, financing activities, regulatory designations and strategic transactions that shape the company’s efforts in mental health therapeutics. The ATAI news page can be revisited regularly to see new company communications and related market updates as they are released.
atai Life Sciences (NASDAQ: ATAI) priced an underwritten public offering of 23,725,000 common shares at $5.48 per share and granted underwriters a 30-day option to buy up to an additional 3,558,750 shares. Gross proceeds are expected to be approximately $130 million before fees. The company said it will use net proceeds, together with existing cash and short-term investments, to advance clinical development of product candidates and for working capital and general corporate purposes. The offering is expected to close on October 20, 2025, subject to customary closing conditions, with Jefferies as lead bookrunner.
atai Life Sciences (NASDAQ: ATAI) announced on October 16, 2025 the commencement of a proposed registered underwritten offering of its common shares.
The company said it expects to grant underwriters a 30-day option to purchase additional common shares and that all shares will be sold by atai. The offering is subject to market and other conditions and may not be completed.
atai intends to use net proceeds, together with existing cash and short-term investments, to advance clinical development, and for working capital and general corporate purposes. Jefferies is lead bookrunner.
atai Life Sciences (NASDAQ: ATAI) and Beckley Psytech announced that the U.S. FDA has granted Breakthrough Therapy designation to BPL-003 (mebufotenin benzoate) nasal spray for adult patients with treatment-resistant depression (TRD).
Designation follows positive Phase 2b topline results where a single 8 mg or 12 mg dose produced clinically meaningful, statistically significant symptom reductions within 24 hours with effects sustained through an 8-week trial; most patients were ready for discharge by 90 minutes post-dose. The companies state Phase 3 trials are expected to begin in Q2 2026, subject to FDA alignment.
atai Life Sciences (NASDAQ: ATAI) and Beckley Psytech announced positive Phase 2a data for their treatment-resistant depression (TRD) drug BPL-003. The study evaluated a two-dose regimen (8mg followed by 12mg after two weeks) in 13 TRD patients.
Key findings showed rapid and durable efficacy with mean MADRS score reductions of 13.3 points at Day 2 and further improvement to 19.0 points after the second dose. Remission rates increased from 25% after the first dose to 50% at Week 8. The treatment demonstrated strong tolerability with only mild to moderate adverse events.
Following these positive results and pending FDA feedback, the companies plan to initiate Phase 3 clinical trials in H1 2026.
atai Life Sciences (NASDAQ: ATAI) has secured a significant $11.4 million UG3/UH3 grant from the National Institute on Drug Abuse (NIDA) to develop novel treatments for opioid use disorder (OUD). The grant will fund the development of non-hallucinogenic 5-HT2A/2C receptor agonists, marking the first external validation of atai's AI-driven polypharmacology drug discovery approach.
The funding will support lead optimization, translational proof-of-concept studies, and preparations for an IND application. The company aims to develop compounds that maintain therapeutic efficacy while minimizing hallucinogenic effects and avoiding cardiac risks. This initiative addresses a critical global health crisis, with OUD affecting 16 million people worldwide and causing over 120,000 annual deaths, with associated costs exceeding $750 billion annually.
atai Life Sciences (NASDAQ: ATAI), a clinical-stage biopharmaceutical company focused on mental health treatments, has announced its participation in three major investor conferences this September.
The company will participate in fireside chat sessions at the Cantor Global Healthcare Conference on September 5th, the H.C. Wainwright Global Investment Conference on September 8th, and the TD Cowen Novel Mechanisms in Neuropsychiatry & Epilepsy Summit on September 17th. All presentations will be available via webcast on the company's investor relations website, with replays accessible after the events.
atai Life Sciences (NASDAQ: ATAI) reported Q2 2025 financial results and corporate updates, highlighting its planned strategic combination with Beckley Psytech. The company announced positive Phase 2b results for BPL-003 (intranasal mebufotenin benzoate) in treatment-resistant depression, meeting primary and secondary endpoints with a single dose showing effects for up to 8 weeks.
Financial position shows $95.9 million in cash and equivalents as of June 30, 2025, with funding expected into second half of 2027. Q2 2025 saw R&D expenses of $11.1 million (down from $12.6M YoY) and net loss of $27.7 million (improved from $57.3M YoY). The company raised nearly $140 million in 2025 through fundraising efforts.
Pipeline updates include delayed VLS-01 Phase 2 trial data now expected in H2 2026, ongoing EMP-01 Phase 2 study for social anxiety disorder, and development of novel 5-HT2A receptor agonists.
Recognify Life Sciences, a subsidiary of atai Life Sciences (NASDAQ:ATAI), announced that its Phase 2b clinical trial for inidascamine in treating cognitive impairment associated with schizophrenia (CIAS) did not meet its primary endpoint of statistical significance. The study, involving 242 patients across the US and Europe, showed modest numerical improvements in cognitive and functional measures.
Despite not achieving statistical significance, inidascamine demonstrated consistent improvement across multiple cognitive domains and maintained a favorable safety profile with no sedation, weight gain, or extrapyramidal symptoms. The company will continue analyzing secondary endpoints and subgroup data to identify potential responder populations and guide future development.
atai Life Sciences (NASDAQ: ATAI) has secured a significant $50 million private placement financing through the sale of 18,264,840 ordinary shares and pre-funded warrants for 4,566,210 additional shares. The financing round was co-led by Ferring Ventures S.A. and Apeiron Investment Group, with participation from healthcare-focused investors including Ally Bridge Group and ADAR1.
The company plans to use the proceeds for general corporate purposes, working capital, and advancement of its clinical development programs. The private placement, expected to close in Q3 2025, is subject to certain conditions, including HSR Act waiting period expiration.
This strategic investment positions atai to transition from a clinical-stage biotech into a commercial entity, with plans for FDA discussions and Phase 3 planning in early 2026. TD Cowen, Leerink Partners, Guggenheim Securities, and Berenberg are serving as joint-lead placement agents for this transaction.
atai Life Sciences (NASDAQ: ATAI) and Beckley Psytech announced positive topline results from their Phase 2b study of BPL-003 (intranasal mebufotenin) in treatment-resistant depression (TRD). The study, involving 193 patients across 38 sites in six countries, met its primary and all key secondary endpoints.
Both 8mg and 12mg single doses showed statistically significant improvements in depression symptoms compared to the 0.3mg control group. At Day 29, the 12mg dose showed a mean MADRS score reduction of 11.1 points versus 5.8 points in the control group (p=0.0038), while the 8mg dose achieved a 12.1-point reduction (p=0.0025). Effects were observed as early as Day 2 and maintained through Week 8.
The treatment demonstrated favorable safety with 99% of adverse events being mild or moderate, no drug-related serious adverse events, and no suicide-related safety signals. Most patients were ready for discharge within 90 minutes post-dose, suggesting compatibility with existing clinical treatment paradigms. Based on the results, the 8mg dose has been selected for Phase 3 development, pending regulatory consultation.
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