ANRO

– Phase 2b clinical trial of ALTO-207 in treatment-resistant depression (TRD) initiated – – New ALTO-101 analyses support significant effects on EEG markers of general cognition as well as a test of attention – – Closed $120 million PIPE in March 2026; cash balance of approximately $264 million expected to fund planned operations through 2029, including a potential NDA submission for ALTO-207 – MOUNTAIN VIEW, Calif., May 13, 2026--(BUSINESS WIRE)--Alto Neuroscience, Inc. ("Alto") (NYSE: ANRO), a clinical-stage biopharmaceutical company focused on the development of novel precision medicines for neuropsychiatric disorders, today reported financial results for the quarter ended March 31, 2026, and highlighted recent progress across its pipeline of clinical-stage product candidates. "2026 is off to a strong start across our pipeline, highlighted by the initiation of the Phase 2b trial of ALTO-207 in TRD," said Amit Etkin, M.D., Ph.D., founder and chief executive officer of Alto Neuroscience. "ALTO-207 is supported by one of the largest independently validated efficacy signals reported in TRD, and we believe the potentially registrational Phase 2b trial is designed to build on those results, and we are ahead of schedule on site initiations and patient recruitment. With $264 million on the balance sheet, Alto is well capitalized — with runway expected to extend through 2029 and, importantly, through a planned Phase 3 trial and potential NDA submission for ALTO-207." Pipeline Highlights ALTO-207: Phase 2b trial in TRD initiated; potentially pivotal trial designed to replicate PAX-D antidepressant effects ALTO-207 is a fixed-dose combination of pramipexole, a dopamine D3-preferring D3/D2 agonist with demonstrated antidepressant effect, and ondansetron, a selective 5-HT3 receptor antagonist. The fixed-dose combination is designed to enable rapid titration to higher pramipexole doses by mitigating the dose-limiting nausea and vomiting historically associated with pramipexole. ALTO-207 is being developed to address the significant unmet medical need in TRD, which is estimated to affect up to 7 million adults in the United States. The core mechanism of ALTO-207 is supported by the PAX-D study, conducted by the University of Oxford and published in The Lancet Psychiatry, which demonstrated a Cohen’s d = 0.87 effect size for pramipexole versus placebo at 12 weeks — an ef...

– Acquisition of ALTO-207 targets Treatment-Resistant Depression (TRD) with a clinically-validated mechanism; Phase 2b trial on track to be initiated in the first half of 2026 – – External PAX-D study published in The Lancet Psychiatry demonstrated a 0.87 effect size for the core mechanism of ALTO-207; this effect represents a significantly larger effect size than current standard-of-care treatments – – ALTO-101 granted FDA Fast Track Designation for CIAS; Topline Phase 2 Proof-of Concept data expected around the end of 1Q 2026 – – Year-end cash balance of $177 million expected to fund planned operations into 2028, covering four key data readouts across Alto’s precision psychiatry pipeline – MOUNTAIN VIEW, Calif., March 16, 2026--(BUSINESS WIRE)--Alto Neuroscience, Inc. ("Alto") (NYSE: ANRO), a clinical-stage biopharmaceutical company focused on the development of novel precision medicines for neuropsychiatric disorders, today reported financial results for the full year ended December 31, 2025, and highlighted recent progress across its pipeline of clinical-stage product candidates. "Alto enters 2026 with a very strong clinical and financial foundation," said Amit Etkin, M.D., Ph.D., founder and chief executive officer of Alto Neuroscience. "The acquisition of ALTO-207 is a potential game-changer for the millions of patients who fail to respond to current depression therapies. We believe the Lancet-published PAX-D study provides robust, independent validation of our approach, and we are moving ALTO-207 into a potentially pivotal Phase 2b trial with high conviction. Our $177 million cash balance puts us in an excellent position to reach the finish line on four major data readouts, providing shareholders with multiple value-inflection points over the next 2 years." Recent Business Highlights Acquisition and Accelerated Development of ALTO-207 for TRD: In June 2025, Alto acquired ALTO-207, a fixed-dose combination of pramipexole (a dopamine D3/D2 agonist) and ondansetron (an antiemetic 5-HT3 receptor antagonist). ALTO-207 is designed to overcome historic tolerability barriers associated with dopamine agonists, potentially unlocking a rapid and robust antidepressant effect for patients in need. Following a successful FDA meeting and a $50 million private placement financing (PIPE) in October 2025, Alto has accelerated the program's development. The Company expe...

– Successful outcome from FDA meeting on ALTO-207 in treatment-resistant depression; on track to initiate Phase 2b trial in the first half of 2026 and Phase 3 trial by early 2027 – – Positive blinded pharmacokinetic (PK) analyses from ALTO-100 and ALTO-101 trials support clinical execution – – Topline data for Phase 2 trials of ALTO-101 in CIAS expected 1Q 2026 and ALTO-300 in MDD expected mid-2026 – – Closed $50 million PIPE; strong cash position of $184.2 million as of October 31 expected to fund planned operations into 2028, and through 4 upcoming clinical study readouts – MOUNTAIN VIEW, Calif., November 12, 2025--(BUSINESS WIRE)--Alto Neuroscience, Inc. ("Alto") (NYSE: ANRO) a clinical-stage biopharmaceutical company focused on the development of novel precision medicines for neuropsychiatric disorders, today reported financial results for the quarter ended September 30, 2025, and highlighted recent progress across its pipeline of clinical-stage product candidates. "These past months marked a period of significant strategic execution and validation for Alto. The successful outcome of our FDA meeting for ALTO-207 and the subsequent $50 million financing allow us to rapidly accelerate this promising program for patients with treatment-resistant depression," said Amit Etkin, M.D., Ph.D., founder and chief executive officer of Alto Neuroscience. "With cash supporting operations into 2028, we are in an excellent position to deliver on multiple anticipated upcoming data readouts, including for ALTO-101, ALTO-300, ALTO-100, and ALTO-207, as we advance our mission of developing personalized, more effective medicines for patients." Pipeline Highlights ALTO-207: Accelerating development following successful FDA meeting, on track to initiate a Phase 2b trial in the first half of 2026 and a Phase 3 trial by early 2027. ALTO-207 is a fixed-dose combination of pramipexole, a dopamine D3-preferring D3/D2 agonist, approved for the treatment of Parkinson’s disease with demonstrated antidepressant effect, and ondansetron, an antiemetic, selective 5-HT3 receptor antagonist. As a fixed-dose combination, ALTO-207 is designed to enable rapid titration and higher dosing by mitigating the dose-limiting adverse events typically experienced with pramipexole. ALTO-207 is being developed to address the significant unmet need for patients with TRD. In October 2025, the Company annou...

The third-quarter 2025 reporting cycle of the Medical sector is currently approaching its end. The sector primarily comprises pharma/biotech and medical device companies. Many pharma giants, like Amgen, Novo Nordisk and Pfizer, reported earnings last week. While results for Amgen and Pfizer were strong on both earnings and sales, both companies also raised their EPS outlook for 2025. However, things did not look good for Novo Nordisk, which reported weaker-than-expected Q3 results. The Danish drugmaker also slashed its guidance outlook for the full year due to the slower growth of its GLP-1 portfolio amid increased availability of compounded alternatives and intensifying competition from arch-rival Eli Lilly. The Earnings Trends report indicates that as of Nov. 5, nearly 82% of the companies in the Medical sector — representing 92% of the sector’s market capitalization — reported quarterly earnings. While about 92% of participants beat on earnings, around 84% outperformed revenues. Earnings rose over 4% year over year, while revenues increased nearly 11%. Overall, third-quarter earnings and sales are expected to rise 3.0% and 10.5%, respectively, from the year-ago quarter’s reported figures. While most companies in the sector have reported earnings, there are some companies which are yet to report. Out of them, we have highlighted four biotech companies — Alto Neuroscience ANRO, Autolus Therapeutics AUTL, Ascendis Pharma ASND and Immuneering IMRX — that seem poised to deliver a beat in their upcoming quarterly results. Earnings ESP is our proprietary methodology for determining the stocks with the best chance to deliver an earnings surprise. It shows the percentage difference between the Most Accurate Estimate and the Zacks Consensus Estimate. According to the Zacks model, the combination of a positive Earnings ESP and a Zacks Rank #1 (Strong Buy), 2 (Buy) or 3 (Hold) increases the odds of an earnings beat. The selection can be made with the help of the Zacks Stock Screener. Our research shows that the chance of an earnings surprise for stocks with this combination is as high as 70%. You can uncover the best stocks to buy or sell before they’re reported with our Earnings ESP Filter. Alto is a clinical-stage biotech focused on developing a broad range of novel pipeline therapies targeting neuroscience indications like bipolar depression, major depressive diso...

Alto Neuroscience Inc. (NYSE:ANRO) is one of the best IPO stocks to buy according to Wall Street analysts. On June 26, Alto Neuroscience announced positive pharmacodynamic results from an exploratory Phase 2 proof-of-concept/POC trial of its drug candidate, ALTO-203. The trial enrolled 69 patients with major depressive disorder/MDD who also had elevated anhedonia, a condition characterized by a reduced ability to feel pleasure. While the trial was not powered to show statistical significance on traditional depression scales like MADRS, it successfully identified a robust patient selection biomarker. This biomarker, the EEG high-theta/beta ratio, is a well-validated measure of abnormal cortical arousal and poor attentional control. The findings from this trial replicate results from a previous Phase 1 study in healthy volunteers, confirming that ALTO-203’s pro-cognitive and wake-promoting effects are linked to a reduction in this specific EEG ratio. A closeup of a laboratory assistant, holding up a vial of a newly developed pharmaceutical product. The drug is an oral histamine H3 inverse agonist and was well-tolerated in the trial, with insomnia being the most frequent adverse event. Alto Neuroscience plans to report additional results from this exploratory study at a future medical meeting and will determine the next development steps for ALTO-203 after a complete analysis of the data. The company’s goal is to use its Precision Psychiatry Platform to use objective biomarkers for targeted neuropsychiatric drug development. Alto Neuroscience Inc. (NYSE:ANRO) is a clinical-stage biopharmaceutical company in the US. While we acknowledge the potential of ANRO 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: 30 Stocks That Should Double in 3 Years and 11 Hidden AI Stocks to Buy Right Now. Disclosure: None. This article is originally published at Insider Monkey.

– Acquisition of potentially best-in-class dopamine agonist combination product candidates, including ALTO-207, expands precision psychiatry pipeline; guided by compelling PAX-D study results published in The Lancet Psychiatry – – ALTO-207 adds expected late-stage readout in treatment resistant depression within current cash runway; planned Phase 2b trial, designed to be a potentially pivotal study expected to initiate by mid-2026 – – Topline data expected from Phase 2 proof-of-concept (POC) trial of ALTO-101 in schizophrenia in the second half of 2025; Phase 2b topline data readouts include ALTO-300 in MDD expected mid-2026 followed by ALTO-100 in bipolar depression expected in the second half of 2026 – – Identified a patient selection biomarker and reported positive pharmacodynamic results from the Phase 2 POC trial of ALTO-203, a non-stimulant product candidate demonstrating pro-cognitive and wake-promoting effects – – Strong cash position of approximately $148.1 million expected to fund planned operations into 2028, and through four upcoming clinical study readouts – MOUNTAIN VIEW, Calif., August 13, 2025--(BUSINESS WIRE)--Alto Neuroscience, Inc. ("Alto") (NYSE: ANRO) a clinical-stage biopharmaceutical company focused on the development of novel precision medicines for neuropsychiatric disorders, today reported financial results for the quarter ended June 30, 2025, and highlighted recent progress across its pipeline of clinical-stage product candidates. "We have had an exciting past few months marked by a promising addition to our pipeline with ALTO-207 and encouraging clinical data that provide further validation of our biomarker-driven approach to drug development," said Amit Etkin, M.D., Ph.D., Founder and CEO of Alto Neuroscience. "The robust clinical effects of pramipexole observed in the PAX-D study give us strong conviction in the therapeutic potential of ALTO-207 to become a meaningful option for patients with treatment resistant depression (TRD), and we look forward to initiating a potentially pivotal Phase 2b trial by mid-2026. We continued our diligent execution across our pipeline to enroll high-quality subjects and are looking forward to the upcoming clinical study readouts." Dr. Etkin continued, "The recent data from our exploratory study of ALTO-203 highlights our ability to better guide indication selection and trial design through our us...

– Demonstrated target engagement and response prediction for ALTO-203 by theta/beta ratio, a commonly used EEG index of cortical arousal and attentional control – – ALTO-203, a non-stimulant compound which demonstrated pro-cognitive and wake-promoting effects, has the potential to address sustained attention abnormalities in EEG biomarker characterized patients – – Pharmacodynamic activity is aligned with the proposed mechanism of ALTO-203; improvements in attention and corresponding reductions in EEG theta/beta ratio, as well as response prediction biomarker replicate Phase 1 study findings – MOUNTAIN VIEW, Calif., June 26, 2025--(BUSINESS WIRE)--Alto Neuroscience, Inc. ("Alto") (NYSE: ANRO) a clinical-stage biopharmaceutical company focused on the development of novel precision medicines for neuropsychiatric disorders, today announced the identification of a patient selection biomarker and positive pharmacodynamic results from its exploratory Phase 2 proof-of-concept (POC) trial of ALTO-203 in major depressive disorder (MDD) patients with elevated levels of anhedonia. ALTO-203 is a novel, oral, histamine H3 inverse agonist, designed to modulate circuits underlying cognition, wakefulness, and alertness. The profile exhibited by ALTO-203 in the exploratory POC trial demonstrated clear effects on objective measures of attention and wakefulness, with observed improvements linked to changes in the EEG theta/beta ratio—a biomarker indexing cortical arousal and attentional control. These findings replicate results from the Phase 1 study in healthy volunteers, where ALTO-203 treatment led to improvements in sustained attention and reductions in the EEG theta/beta ratio. Baseline EEG theta/beta ratio predicted attentional benefits of ALTO-203 in both the Phase 1 study and Phase 2 POC trial. "We aim to leverage objective biomarkers to enable targeted neuropsychiatric drug development so that patients can get better, faster," said Amit Etkin, M.D., Ph.D., founder and CEO of Alto Neuroscience. "In this exploratory trial, we identified a robust biomarker for ALTO-203, EEG high-theta/beta ratio, which is a well-validated measure of abnormal cortical arousal and poor attentional control. Notably, this biomarker is FDA-cleared for use alongside clinical evaluation in the diagnosis of ADHD, reinforcing its clinical relevance. These positive results replicate findings from...

– Phase 2 proof-of-concept trials remain on track: Topline data expected from ALTO-203 in MDD in the second quarter of 2025 followed by ALTO-101 in schizophrenia in the second half of 2025 – – Late-stage programs advancing: Topline data expected from the Phase 2b trial of ALTO-300 in MDD in mid-2026 followed by the Phase 2b trial of ALTO-100 in bipolar depression in the second half of 2026 – – New data presented at recent scientific conferences support Alto’s biomarker-driven pipeline and patient stratification approach – – Strong cash position of approximately $161.3 million expected to fund planned operations into 2028, and through at least four upcoming clinical study readouts – MOUNTAIN VIEW, Calif., May 14, 2025--(BUSINESS WIRE)--Alto Neuroscience, Inc. ("Alto") (NYSE: ANRO) a clinical-stage biopharmaceutical company focused on the development of novel precision medicines for neuropsychiatric disorders, today reported financial results for the first quarter ended March 31, 2025, and highlighted recent progress across its pipeline of clinical-stage product candidates. "In the first quarter of 2025 we took important steps to deliver on our clinical and corporate objectives," said Amit Etkin, M.D., Ph.D., founder and chief executive officer of Alto Neuroscience. "We have continued to execute across each of our four ongoing clinical trials, and in addition we have advanced our biomarker platform to further support our precision psychiatry approach. We believe the recent presentation of our EEG-based placebo response biomarker and dopamine-related biomarkers highlight our leadership position in targeted neuropsychiatric drug development. We look forward to exploring opportunities to maximize the therapeutic impact of our platform to address the high unmet needs of patients. With a strong balance sheet expected to support several key clinical milestones in the coming years, we believe we are well positioned to redefine how neuropsychiatric conditions are treated." Pipeline Highlights ALTO-100: Enrollment ongoing in Phase 2b bipolar depression trial; data expected in the second half of 2026. ALTO-100, a first-in-class, oral small molecule believed to work through enhancing neuroplasticity, is in development for the treatment of bipolar depression (BPD) in patients characterized by a cognitive biomarker. Enrollment in the randomized, double-blind, placebo-contr...

– Favorable outcome from interim analysis of ongoing ALTO-300 Phase 2b MDD trial; topline results expected in mid-2026 – – Completed enrollment in ALTO-203 Phase 2 proof-of-concept MDD trial; on track to report topline data in the second quarter of 2025 – – Novel transdermal formulation of ALTO-101 demonstrated greater drug exposure and improved tolerability profile; topline data from Phase 2 trial of ALTO-101 in schizophrenia expected in the second half of 2025 – – Company’s precision psychiatry approach underpins recently granted patents covering the use of ALTO-100 and ALTO-300 in biomarker defined populations – – Strong cash position of approximately $169 million expected to fund planned operations into 2028, and through at least four upcoming clinical study readouts – MOUNTAIN VIEW, Calif., March 20, 2025--(BUSINESS WIRE)--Alto Neuroscience, Inc. ("Alto") (NYSE: ANRO) a clinical-stage biopharmaceutical company focused on the development of novel precision medicines for neuropsychiatric disorders, today reported financial results for the full-year ended December 31, 2024, and highlighted recent progress across its pipeline of clinical-stage product candidates. "In 2024 we continued to advance our mission to change the way medicines are developed for neuropsychiatric conditions," said Amit Etkin, M.D., Ph.D., founder and chief executive officer of Alto Neuroscience. "Using our proprietary platform we have evaluated brain-based biomarkers in over 2,000 participants and have completed six clinical studies across our pipeline programs since our founding. Further, we believe the outcome of the recent interim analysis of the ongoing ALTO-300 trial is suggestive of antidepressant activity, and we believe the sample re-estimation improves the overall probability of success in that trial." Dr. Etkin continued, "Successfully completing our IPO in 2024 has provided us with a strong balance sheet to support several key clinical milestones in the coming years. As a scientific founder with a sincere passion to move the field forward, I am very proud of all our team has accomplished and I look forward to building on this momentum." Pipeline Highlights ALTO-100: Enrollment ongoing in Phase 2b in Bipolar Depression; Phase 2b in MDD complete. ALTO-100, a first-in-class, oral small molecule believed to work through enhancing neuroplasticity, is in development for the treat...