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Alto Neuroscience develops clinical-stage precision medicines for neuropsychiatric disorders, using its Precision Psychiatry Platform™ to analyze EEG activity, neurocognitive assessments, wearable data and other biomarkers that may identify patient populations for its product candidates.
Company news centers on clinical data, trial initiations and pipeline decisions for programs including ALTO-207 in treatment-resistant depression and major depressive disorder, ALTO-101 in cognitive impairment associated with schizophrenia, and other candidates for bipolar depression, schizophrenia and mental health conditions. Updates also cover financial results, capital activity, regulatory designations, medical-meeting presentations and investor-conference participation.
Alto Neuroscience (NYSE: ANRO) completed enrollment in its Phase 2 proof-of-concept crossover trial of ALTO-101 for cognitive impairment associated with schizophrenia (CIAS) on February 13, 2026. The study enrolled 83 patients across 13 U.S. sites (NCT06502964) and uses EEG biomarkers and cognitive tests to assess treatment effects.
The randomized, double-blind, placebo-controlled crossover design delivers 10 days of ALTO-101 or placebo per period with a washout, and the study is 80% powered to detect a 0.3 Cohen’s d on theta-band inter-trial coherence (primary endpoint). Topline data are expected after dosing and analysis, guiding future development.
Alto Neuroscience (NYSE: ANRO) announced a peer-reviewed invited review in the American Journal of Psychiatry (2026) establishing neuroplasticity as a core, measurable driver of psychiatric disease and treatment.
The article, co-authored by Alto leaders, argues that restoring plasticity underlies efficacy across therapies and highlights the industry gap of translatable human biomarkers—supporting Alto’s precision psychiatry platform and biomarker-driven clinical programs.
Alto Neuroscience (NYSE: ANRO) announced the issuance of U.S. Patent No. 12,521,374 on January 14, 2026, covering methods of treating depression with ALTO-207, a combination of pramipexole and ondansetron. The patent specifically claims the use of ondansetron to mitigate pramipexole-related side effects, enabling higher pramipexole dose levels to achieve antidepressant effects. The company says issued and pending claims for ALTO-207, in the U.S. and internationally, are expected to provide protection into the mid-2040s, which it says strengthens the long-term commercial opportunity for the program.
Alto Neuroscience (NYSE: ANRO) presented multiple EEG biomarker analyses at the 64th ACNP meeting (Jan 12-15, 2026) that support its precision psychiatry programs. Key results include an independent replication in 155 schizophrenia cases and 272 controls validating Theta‑ITC as a CIAS biomarker; prospective replication showing ALTO‑203 improves sustained attention, lowers theta/beta ratio, and increases wakefulness without changing sleep efficiency; and an EEG biomarker that prospectively predicted placebo response and enhanced treatment effect detection in two randomized trials.
Alto Neuroscience (NYSE: ANRO) announced that on December 2, 2025 its Compensation and Management Development Committee granted a new employee an inducement stock option for 150,000 shares under the 2025 Inducement Plan in accordance with NYSE Rule 303A.08. The option has an exercise price of $12.80 (closing price on the grant date), a 10-year term, and standard service-based vesting over four years: 25% after one year and the remainder vesting in equal monthly installments over the following 36 months. Vesting is conditioned on continued service.
Alto Neuroscience (NYSE: ANRO) reported Q3 2025 results and pipeline updates on November 12, 2025. Key clinical milestones include an FDA meeting outcome for ALTO-207 with a Phase 2b start targeted in 1H 2026 and Phase 3 by early 2027. Topline readouts expected: ALTO-101 (CIAS) 1Q 2026, ALTO-300 (MDD) mid-2026, ALTO-100 (BPD) 2H 2026. Blinded PK analyses were positive for ALTO-101 (100% PK positive) and ALTO-100 (96% PK positive). The company closed a $50M PIPE and had $184.2M cash as of October 31, 2025, expected to fund operations into 2028.
Alto Neuroscience (NYSE: ANRO) said members of management will present at two investor conferences in November 2025: the Stifel 2025 Healthcare Conference (Nov 11-13) with a fireside chat and one-on-ones on Nov 12, 2025 at 10:00-10:30 AM ET in New York, and the Jefferies London Healthcare Conference (Nov 17-20) with a fireside chat and one-on-ones on Nov 17, 2025 at 3:30-3:55 PM GMT in London.
Presentations will be available via live webcast on Alto's Investors "Events and Presentations" page, with a replay accessible after the events.
Alto Neuroscience (NYSE: ANRO) entered a private placement (PIPE) to raise approximately $50 million in gross proceeds, led by Perceptive Advisors with participation from several biotech investors.
Alto is selling 3,832,263 common shares at $5.914 per share and issuing pre-funded warrants to buy up to 4,622,251 shares at $5.9139 each (exercise price $0.0001). The PIPE is expected to close on October 21, 2025 and was priced at-the-market under NYSE rules.
Proceeds are earmarked to accelerate development of ALTO-207 for treatment resistant depression after a successful FDA meeting; Alto expects to start a Phase 2b by mid-2026 and now also expects to initiate a Phase 3 by early 2027.
Alto Neuroscience (NYSE: ANRO) announced plans to accelerate development of ALTO-207 for treatment resistant depression after a successful FDA meeting and a $50 million private placement to support expanded development. The company expects to initiate a Phase 2b potentially pivotal trial by mid-2026 and to begin a Phase 3 study by early 2027 pending Phase 3 readiness and protocol alignment with the FDA. Alto reported blinded PK results showing 96% PK-positive samples for ALTO-100 and 100% for ALTO-101, and it now guides cash runway into 2028 while adding ALTO-207 activities. Topline data for ALTO-101 remain expected in 1Q 2026.
Alto Neuroscience (NYSE: ANRO) announced on October 3, 2025 that the U.S. FDA granted Fast Track designation to ALTO-101 for the treatment of cognitive impairment associated with schizophrenia (CIAS). ALTO-101 is a novel PDE4 inhibitor that increased cAMP and showed pro‑cognitive effects in healthy volunteers in Phase 1, with significant effects on EEG measures and cognitive performance. Enrollment is ongoing in a Phase 2 proof-of-concept study in patients with CIAS. Fast Track status may enable more frequent FDA interactions and potential eligibility for accelerated approval or priority review if criteria are met.