ATAI

AtaiBeckley Inc. (NASDAQ:ATAI) is one of the 10 Best Penny Stocks to Buy for Long Term. On May 12, 2026, AtaiBeckley Inc. (NASDAQ:ATAI) reported Q1 EPS of (8c), versus the consensus estimate of (11c). Revenue totaled $954,000, versus the consensus estimate of $90,910. Co-Founder and CEO Srinivas Rao said the company’s $209.9M cash position is expected to fund operations through anticipated Phase 3 topline readouts for BPL-003 as the program advances into late-stage development. Rao added that the company’s near-term priorities include initiating the Phase 3 ReConnection program for BPL-003 during the current quarter, while VLS-01 continues progressing toward anticipated Phase 2 topline results later this year. Management also highlighted positive Phase 2a data for EMP-01 in Social Anxiety Disorder and said the company’s capital position, pipeline breadth, and upcoming clinical catalysts position it to pursue longer-term clinical and shareholder value creation. Last month, Guggenheim raised the firm’s price target on AtaiBeckley Inc. (NASDAQ:ATAI) to $16 from $11 and kept a Buy rating on the shares. The firm said recent meetings with management reinforced its conviction in the BPL-003 program ahead of Phase 3 initiation this quarter. AtaiBeckley Inc. (NASDAQ:ATAI) is a clinical-stage biopharmaceutical company focused on developing mental health treatments in the United States, Germany, and Canada. While we acknowledge the potential of ATAI as an investment, we believe certain AI stocks offer greater upside potential and carry less downside risk. If you're looking for an extremely undervalued AI stock that also stands to benefit significantly from Trump-era tariffs and the onshoring trend, see our free report on the best short-term AI stock. READ NEXT: 33 Stocks That Should Double in 3 Years and Cathie Wood 2026 Portfolio: 10 Best Stocks to Buy. Disclosure: None. Follow Insider Monkey on Google News.

Phase 3 pivotal program initiation for BPL-003 in treatment-resistant depression on track for Q2 2026 VLS-01 Phase 2 Elumina topline results anticipated in Q4 2026 Consistent, convergent improvements demonstrated in EMP-01 Phase 2a trial across independent clinician-rated and patient-reported outcomes in Social Anxiety Disorder Cash and cash equivalents expected to fund operations through anticipated BPL-003 Phase 3 topline readouts, with runway into 2029 NEW YORK, May 12, 2026 (GLOBE NEWSWIRE) -- AtaiBeckley Inc. (NASDAQ: ATAI) (“AtaiBeckley” or “Company”), a clinical-stage biotechnology company on a mission to transform patient outcomes by developing rapid-acting, durable and convenient mental health treatments, today reported financial results for the first quarter ended March 31, 2026, and provided a business update across its clinical pipeline. First Quarter 2026 Highlights BPL-003 (TRD): Phase 3 pivotal ReConnection program on track to initiate in Q2 2026. VLS-01 (TRD): Elumina Phase 2 topline results anticipated in Q4 2026. EMP-01 (SAD): Phase 2a data provided validation of EMP-01's potential in Social Anxiety Disorder. Corporate: Inclusion during Q1 2026 in the S&P Biotechnology Select Industry Index and CRSP U.S. indices, which are tracked by a broad range of institutional and passive investor exposure. Cash position: Cash and cash equivalents as of March 31, 2026 expected to fund operations through anticipated BPL-003 Phase 3 topline readouts, with runway into 2029. Srinivas Rao, Co-Founder and Chief Executive Officer of AtaiBeckley, said: “Our $209.9 million in cash is expected to provide a runway through our anticipated Phase 3 topline readouts for BPL-003, as we advance toward the late-stage execution phase. Our near-term priority is initiating the Phase 3 ReConnection program for BPL-003 this quarter, while VLS-01 continues to progress toward anticipated Phase 2 topline results later this year. The positive Phase 2a data for EMP-01 further demonstrated its potential in Social Anxiety Disorder. Collectively, our capital position, pipeline breadth, and multiple near- and mid-term clinical catalysts position us well as we seek to build sustained clinical and shareholder value.” Program Updates BPL-003: mebufotenin benzoate nasal spray for treatment-resistant depression (TRD) On track to initiate Phase 3 program in Q2 2026, following a successful E...

AtaiBeckley Inc. (NASDAQ:ATAI) is one of the best fast growing penny stocks to buy right now. On April 22, AtaiBeckley announced expanded Phase 2a results for EMP-01 (oral R-MDMA), showing significant and consistent improvements for adults with Social Anxiety Disorder/SAD. The trial showed a 38% reduction in patient-reported symptoms and a 32% reduction in real-world avoidance behaviors at Day 43, following a two-dose regimen administered without psychotherapy. Notably, 49% of patients treated with EMP-01 were identified as “responders” by both clinicians and themselves, compared to just 12–15% in the placebo group. The data suggested that EMP-01 may offer a more rapid and durable alternative to current standards of care, such as SSRIs, which typically require daily dosing and longer treatment periods. Improvements were observed across both fear and avoidance subscales, indicating that participants were more capable of engaging in social situations with reduced distress. Clinical experts highlighted the reduction in subtle avoidance behaviors as a particularly meaningful outcome that is rarely captured in traditional medication trials. On the safety front, EMP-01 was well tolerated with a 97% patient retention rate and no severe or serious adverse events reported. The company plans to continue the development of this candidate as a differentiated, intermittent treatment option designed for scalable outpatient use. With ~30 million adults affected by SAD in the US alone, AtaiBeckley Inc. (NASDAQ:ATAI) aims to address a major unmet need for the roughly 50% of patients who do not respond adequately to existing first-line therapies. AtaiBeckley Inc. (NASDAQ:ATAI) is a clinical-stage biopharmaceutical company focused on developing treatments for mental health disorders. While we acknowledge the potential of ATAI as an investment, we believe certain AI stocks offer greater upside potential and carry less downside risk. If you're looking for an extremely undervalued AI stock that also stands to benefit significantly from Trump-era tariffs and the onshoring trend, see our free report on the best short-term AI stock. READ NEXT: 33 Stocks That Should Double in 3 Years and Cathie Wood 2026 Portfolio: 10 Best Stocks to Buy. Disclosure: None. Follow Insider Monkey on Google News.

AtaiBeckley Inc. (NASDAQ:ATAI) is one of the best new penny stocks to buy. On March 6, AtaiBeckley reported full-year 2025 earnings, which were highlighted by the pivotal execution phase following the strategic combination of Atai Life Sciences and Beckley Psytech and its subsequent US redomiciliation. A primary focus is the BPL-003 nasal spray for treatment-resistant depression/TR, which is on track to initiate a Phase 3 pivotal program in Q2 2026. This program, supported by the FDA, will include two major studies, ReConnection-1 and ReConnection-2, with topline results anticipated by early 2029. The company also reported positive clinical progress across its broader pipeline, including the VLS-01 buccal film and EMP-01 for Social Anxiety Disorder/SAD. VLS-01 is expected to yield Phase 2 topline data in H2 2026. Meanwhile, an exploratory Phase 2a trial of EMP-01 successfully met its primary safety objectives and showed clinically meaningful improvements in efficacy measures. To protect these innovations, AtaiBeckley secured a new US patent for EMP-01, extending its expected exclusivity through 2043. Copyright: nexusplexus / 123RF Stock Photo AtaiBeckley Inc. (NASDAQ:ATAI) ended 2025 with $220.7 million in cash, cash equivalents, and short-term securities driven by equity-related issuances. While the company reported a net loss of $660 million for the full year, largely due to a $530 million non-cash charge related to the Beckley Psytech acquisition, it maintains a strong capital position. Management expects current liquidity to fund operations into early 2029, covering the timeline for its major Phase 3 readouts. AtaiBeckley Inc. (NASDAQ:ATAI) is a clinical-stage biopharmaceutical company that researches, develops, and commercializes mental health treatments in the US, Germany, and Canada. While we acknowledge the potential of ATAI as an investment, we believe certain AI stocks offer greater upside potential and carry less downside risk. If you’re looking for an extremely undervalued AI stock that also stands to benefit significantly from Trump-era tariffs and the onshoring trend, see our free report on the best short-term AI stock. READ NEXT: 40 Most Popular Stocks Among Hedge Funds Heading Into 2026 and Goldman Sachs Value Stocks: 10 Stocks to Buy. Disclosure: None. Follow Insider Monkey on Google News.

Phase 3 pivotal program initiation for BPL-003 in treatment-resistant depression remains on track for Q2 2026 following successful End‑of‑Phase 2 meeting with the U.S. Food and Drug Administration On-track for VLS-01 Phase 2 Elumina trial topline data readout anticipated in H2 2026 Exploratory Phase 2a trial of EMP-01 in Social Anxiety Disorder met its primary safety and tolerability objective and demonstrated clinically meaningful improvements across key efficacy measures Cash runway through the planned early-2029 topline readouts from both Phase 3 pivotal studies Virtual Investor Day scheduled for March 6, 2026 NEW YORK, March 06, 2026 (GLOBE NEWSWIRE) -- AtaiBeckley Inc. (NASDAQ: ATAI) (“AtaiBeckley” or the “Company”), a clinical-stage biotechnology company on a mission to transform patient outcomes by developing rapid-acting, durable and convenient mental health treatments, today announced fourth quarter and full year 2025 financial results and provided key regulatory, clinical and business updates. “Following our strategic combination of atai Life Sciences and Beckley Psytech, and U.S. redomiciliation, we have entered a pivotal execution phase,” said Srinivas Rao, M.D., Ph.D., Chief Executive Officer and Co-Founder of AtaiBeckley. “We received constructive feedback from the FDA on the Phase 3 development plan for BPL-003 in treatment-resistant depression, positioning us to initiate our pivotal program in the second quarter of 2026. We also reported positive topline results from our exploratory Phase 2a study of EMP-01 in Social Anxiety Disorder, which met its primary safety objective and demonstrated clinically meaningful improvements across key efficacy measures after just two administrations and without adjunct psychotherapy. With multiple clinical catalysts ahead and capital expected to fund operations into 2029, we believe AtaiBeckley is well positioned to advance a differentiated portfolio of rapid-acting mental health therapies.” Program Updates and Anticipated Milestones BPL-003: mebufotenin benzoate nasal spray for TRD In March 2026, the Company announced a successful End‑of‑Phase 2 meeting with the FDA regarding the development of BPL‑003 for treatment‑resistant depression (TRD), a debilitating and chronic condition affecting millions of people around the world but with limited rapid-acting treatment options. The FDA indicated support for advan...

In this week’s “Psychedelic,” The Fly’s recurring series focused on psychedelic stock news, The Fly looks back on study results, FDA alignment and a DSMB recommendation. Unlock hedge fund-level data and powerful investing tools for smarter, sharper decisions Stay ahead of the market with the latest news and analysis and maximize your portfolio's potential HELUS PHARMA REPORTS PHASE 2 HLP004 RESULTS: Helus Pharma (HELP) announced Thursday topline results from a Phase 2 signal detection study evaluating HLP004 as a potential treatment for adults with moderate-to-severe generalized anxiety disorder who remained symptomatic despite ongoing SoC antidepressant therapy, including selective serotonin reuptake inhibitors and related agents. In the Phase 2 signal detection study, 36 patients were randomized 2-to-1 active-to-placebo to HLP004 20 mg or 2mg and received two intramuscular doses three weeks apart. Patients were followed through Week 12, with continued observational follow-up extending up to one year. Participants had an average baseline HAM-A score of 22 and a General Anxiety Disorder-7 score of greater than or equal to 10 at screening. All study participants were already being treated, and continued treatment throughout the trial, with SoC medications for generalized anxiety disorder. The 10-point improvement in anxiety symptoms is above and beyond what was already being seen with SoC treatment. Patients that received 20mg HLP004 adjunctive to SoC therapy achieved mean reduction of 10.4-points in the HAM-A from baseline at six weeks. The study population consisted of moderate-to-severe patients who remained symptomatic despite ongoing antidepressant or anxiolytic therapy. At six months, the pooled study population showed 67% responders and 39% remitters. Participants randomized to both 20 mg and 2mg dosing arms experienced meaningful subjective effects and showed clinically significant responses over SoC, with 59% meeting the criteria for response and 32% for remission in the 20mg arm and a 30% responder and remitter rate in the 2mg arm at week 6. The study also found a short in-clinic treatment experience with acute drug effects lasting approximately 90 minutes and discharge readiness within approximately three hours, fitting within the treatment paradigm of existing interventional psychiatry clinics. Additionally, results show a favorable tolerability p...

AtaiBeckley Inc. (NASDAQ:ATAI, XETRA:9VC) has reported its fourth quarter and full-year 2025 financial results, highlighting progress across several clinical programs targeting mental health disorders and outlining upcoming milestones for its pipeline. The clinical-stage biotechnology company said it remains on track to initiate a Phase 3 pivotal program for BPL-003, its mebufotenin benzoate nasal spray for treatment-resistant depression (TRD), in the second quarter of 2026. The timeline follows a successful End-of-Phase 2 meeting with the US Food and Drug Administration, which indicated support for advancing the therapy into late-stage studies and provided feedback on the potential regulatory pathway. The planned Phase 3 program will consist of two randomized, placebo-controlled trials, ReConnection-1 and ReConnection-2, evaluating the therapy in adults with TRD. Each study will include a 12-week core trial followed by a 52-week open-label extension. Topline results from the core studies are expected by early 2029. The company is also advancing VLS-01, a dimethyltryptamine (DMT) buccal film designed to fit within a two-hour interventional psychiatry treatment model for TRD. Topline data from the Phase 2 Elumina study are anticipated in the second half of 2026. Another program, EMP-01, an oral R-enantiomer of MDMA being studied for social anxiety disorder, recently reported results from an exploratory Phase 2a trial. The study met its primary safety and tolerability objective and showed placebo-adjusted improvements on the Liebowitz Social Anxiety Scale, along with a higher responder rate compared with placebo. During 2025, the company also completed a strategic combination between atai Life Sciences and Beckley Psytech, forming AtaiBeckley. The company subsequently redomiciled to the United States as a Delaware-incorporated firm headquartered in New York and was added to the NASDAQ Biotechnology Index in December. Srinivas Rao, AtaiBeckley’s CEO, said the company has entered a pivotal executions phase following the strategic combination of atai Life Sciences and Beckley Psytech, and US redomiciliation. “We received constructive feedback from the FDA on the Phase 3 development plan for BPL-003 in treatment-resistant depression, positioning us to initiate our pivotal program in the second quarter of 2026,” Rao said. “We also reported positive topline results...

AtaiBeckley Inc (NASDAQ:ATAI) is among the best NASDAQ penny stocks to buy according to analysts. On February 26, AtaiBeckley Inc (NASDAQ:ATAI) reported topline results from a Phase 2a trial of its drug candidate EMP-01 (oral R-MDMA), which is aimed for treating social anxiety disorder. According to AtaiBeckley, the study met its primary objectives, with EMP-01 showing efficacy signals with a favorable safe profile. In the US alone, social anxiety disorder is estimated to affect 30 million adults. The release of these study results come on the back of AtaiBeckley making a key executive appointment. On February 19, AtaiBeckley Inc (NASDAQ:ATAI) announced that it had appointed Michael Faerm as its chief financial officer. It said the appointment is effective March 9. As CFO, Faerm will lead AtaiBeckley’s financial operations, financial strategy, and capital market strategies. The latest analyst action on AtaiBeckley came on January 13, where Cantor Fitzgerald analysts reiterated their Overweight rating on ATAI stock without assigning it a price target. In reaffirming their bullish outlook for AtaiBeckley, Cantor Fitzgerald analysts pointed to the potential of the company’s BPL-003 compound, saying it has the potential to become a key player in tackling treatment-resistant depression. For this view, the analysts cited the compound’s compelling efficacy outcome in Phase 2a and Phase 2b studies. Based in Berlin, Germany, AtaiBeckley Inc (NASDAQ:ATAI) is a clinical-stage drug developer with a deep focus on mental health. It has several potential drugs in various development stages. Its most advanced project is the BPL-003, which is aimed for treatment-resistant depression. The BPL-003 is in Phase 3 development stage. Its other projects include VLS-01 and EMP-01, which are both in Phase 2. While we acknowledge the potential of ATAI as an investment, we believe certain AI stocks offer greater upside potential and carry less downside risk. If you're looking for an extremely undervalued AI stock that also stands to benefit significantly from Trump-era tariffs and the onshoring trend, see our free report on the best short-term AI stock. READ NEXT: 40 Most Popular Stocks Among Hedge Funds Heading Into 2026 and 11 Best Italian Stocks to Buy in 2026. Disclosure: None. Follow Insider Monkey on Google News.

EMP-01 met its primary objective on safety and tolerability, demonstrating a generally favorable and manageable safety and tolerability profile EMP-01 demonstrated a clinically meaningful placebo-adjusted least squares mean reduction of 11.85 points on the Liebowitz Social Anxiety Scale (LSAS) at Day 43 (Hedges’ g = 0.45; p-value = 0.036, one-tailed) EMP-01 demonstrated a robust separation from placebo on the Clinician Global Impression–Improvement (CGI-I) assessment: 49% responders vs. 15% for placebo, corresponding to a Number Needed to Treat (NNT) of 2.95 EMP-01 demonstrated improvements across both Fear and Avoidance sub-domains of the LSAS, including improvement in social avoidance behaviors after two administrations over six weeks, and without adjunctive psychotherapy More detailed analyses of the data will be described in upcoming scientific venues and will guide subsequent development Conference call scheduled for 8:00 a.m. ET today, February 26, 2026 NEW YORK, Feb. 26, 2026 (GLOBE NEWSWIRE) -- AtaiBeckley Inc. (NASDAQ: ATAI) (“AtaiBeckley” or the “Company”), a clinical‑stage biotechnology company on a mission to transform patient outcomes by developing rapid‑acting, durable and convenient treatments for mental health conditions, today announced topline results from its exploratory, double‑blind, placebo‑controlled, first-in-patient Phase 2a study (NCT06693609) evaluating EMP‑01 (oral R‑MDMA) in adults with Social Anxiety Disorder (SAD). The study met its primary safety objective and generated encouraging secondary and exploratory efficacy signals in a highly severe, difficult‑to‑treat population. Commenting on the results, Professor Murray Stein, Distinguished Professor of Psychiatry and Public Health at the University of California San Diego (UCSD), and consultant to AtaiBeckley, said: “The initial findings from this trial of R-MDMA (EMP-01) are remarkable. Social Anxiety Disorder is a serious, often chronic and disabling condition affecting millions of Americans, and there have been no therapeutic advances in its pharmacological treatment in over 20 years. While preliminary, this study suggests that EMP-01 has the potential to make a tremendous impact on the lives of patients and their families. I hope future trials will be conducted to confirm these very exciting findings.” The multi-center study enrolled 71 adults with moderate-to-severe SAD acr...

AtaiBeckley NV (NASDAQ:ATAI, XETRA:9VC) reported positive topline results from an exploratory Phase 2a trial evaluating its oral R-MDMA candidate, EMP-01, in adults with social anxiety disorder (SAD), with the study meeting its primary safety objective and showing encouraging efficacy signals. The clinical-stage biotechnology company said the randomized, double-blind, placebo-controlled study enrolled 71 adults with moderate-to-severe SAD across seven sites in the United Kingdom. Participants received two in-clinic administrations of EMP-01 (225 mg) or placebo spaced 28 days apart, without adjunctive psychotherapy. The trial’s primary endpoint of safety and tolerability through Day 43 was achieved. The company reported no serious adverse events and no treatment-emergent suicidal behaviour or intent. Most adverse events were mild or moderate and resolved without intervention. On secondary measures, EMP-01 demonstrated greater symptom reduction than placebo on the Liebowitz Social Anxiety Scale (LSAS). At Day 43, the treatment group showed a least squares mean reduction of 28.53 points from baseline compared with 16.67 points for placebo. The placebo-adjusted reduction of 11.85 points corresponded to a moderate effect size. AtaiBeckley noted the study was not powered for statistical significance but said the magnitude of improvement was consistent with clinically meaningful benefit. The company also highlighted that symptom reductions observed after two doses over six weeks were comparable in cross-trial comparisons to outcomes typically reported after 8 to 12 weeks of daily SSRI or SNRI therapy. On the Clinician Global Impression–Improvement (CGI-I) scale, 49% of patients receiving EMP-01 were rated as “very much improved” or “much improved,” compared with 15% in the placebo arm, according to AtaiBeckley. The 34-percentage-point difference equated to a number needed to treat of 2.95. Subscale analysis of the LSAS showed improvements in both fear and avoidance domains. By Day 43, fear scores improved by 13.7 points (25.4%) in the EMP-01 group versus 8.1 points (15.5%) for placebo, while avoidance improved by 15.1 points (28.6%) versus 8.5 points (17.1%), respectively. The company said the early, parallel improvements across both emotional and behavioral measures, observed after two dosing sessions without psychotherapy, suggest EMP-01 may affect multiple dimen...

AtaiBeckley solidifies position as a global leader in transformative mental health therapies with a short psychedelic duration BPL-003 (mebufotenin benzoate nasal spray) granted Breakthrough Therapy designation by the U.S. Food and Drug Administration (FDA) for treatment-resistant depression (TRD) Reported positive topline data from the Phase 2b open-label extension (OLE) study of BPL-003 showing the potential added and sustained antidepressant effects following a second dose in patients with TRD Reported positive open-label Phase 2a data demonstrating improved outcomes with a two-dose induction regimen of BPL-003 in patients with TRD An End-of-Phase 2 meeting is scheduled with the FDA for BPL-003, anticipate providing guidance on the Phase 3 clinical program in the first quarter of 2026 Completed enrollment in the exploratory Phase 2a trial of EMP-01 (oral R-MDMA) for patients with social anxiety disorder (SAD) Awarded a grant by the National Institute on Drug Abuse (NIDA) to fund the optimization and early-stage development of novel 5-HT2A/2C receptor agonists with non-hallucinogenic potential for opioid use disorder Closed an approximate $150 million public offering and expect cash, cash equivalents, short-term investments and other liquid assets to fund operations into 2029, through anticipated topline data from the first Phase 3 trial of BPL-003 NEW YORK and AMSTERDAM, Nov. 12, 2025 (GLOBE NEWSWIRE) -- Atai Beckley N.V. (NASDAQ: ATAI) (“AtaiBeckley” or “Company”), a clinical-stage biopharmaceutical company on a mission to transform patient outcomes by developing effective, rapid-acting and convenient mental health treatments, today announced third quarter 2025 financial results and provided corporate updates. “This has been a transformational quarter, highlighted by the establishment of AtaiBeckley, which solidifies our position as a global leader in developing transformative mental health therapies with short psychedelic duration,” stated Srinivas Rao, M.D., Ph.D., Chief Executive Officer and Co-founder of atai. “The FDA’s Breakthrough Therapy designation for BPL-003 represents a major milestone, reinforcing its potential to address the significant unmet need in treatment-resistant depression. Alongside positive Phase 2a and Phase 2b data for BPL-003, we believe we are well positioned to advance BPL-003 into pivotal development pending discussions with...

atai Life Sciences (ATAI) said Tuesday that it and Beckley Psytech reported positive phase 2a open-l