Alto Neuroscience Completes Patient Enrollment for ALTO-101 Clinical Trial
Written by Emily J. Thompson, Senior Investment Analyst
Updated: 5 days ago
0mins
Should l Buy ANRO?
Alto Neuroscience announced the completion of patient enrollment in its Phase 2 proof-of-concept clinical trial evaluating ALTO-101, a novel, transdermal phosphodiesterase-4 inhibitor, for the treatment of cognitive impairment associated with schizophrenia. Topline data from the Phase 2 proof-of-concept study are expected following completion of dosing and data analysis and are anticipated to guide future development decisions for ALTO-101.
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Analyst Views on ANRO
Wall Street analysts forecast ANRO stock price to rise
8 Analyst Rating
8 Buy
0 Hold
0 Sell
Strong Buy
Current: 19.260
Low
25.00
Averages
35.67
High
50.00
Current: 19.260
Low
25.00
Averages
35.67
High
50.00
About ANRO
Alto Neuroscience, Inc. is a clinical-stage biopharmaceutical company focused on redefining psychiatry by leveraging neurobiology to develop personalized and effective treatment options. The Company's Precision Psychiatry Platform measures brain biomarkers by analyzing EEG activity, neurocognitive assessments, wearable data, and other factors to identify which patients are likely to respond to its product candidates. Its clinical-stage pipeline includes drug candidates in bipolar depression, major depressive disorder, treatment resistant depression (TRD), and schizophrenia, and other mental health conditions. Its product candidates include ALTO-100, ALTO-300, ALTO-207, ALTO-203, ALTO-101, ALTO-202, and ALTO-208. ALTO-100 is a first-in-class, oral small molecule believed to work through enhancing neural plasticity in the hippocampus, a brain region important for both cognition and mood. ALTO-203 is an oral small molecule histamine H3 receptor inverse agonist.
About the author
Emily J. Thompson
Emily J. Thompson, a Chartered Financial Analyst (CFA) with 12 years in investment research, graduated with honors from the Wharton School. Specializing in industrial and technology stocks, she provides in-depth analysis for Intellectia’s earnings and market brief reports.
Alto Completes Patient Enrollment for ALTO-101 Clinical Trial
- Clinical Trial Enrollment Completed: Alto Neuroscience announced the successful enrollment of 83 patients across 13 clinical sites in the U.S. for its Phase 2 trial of ALTO-101, marking a significant step in developing a novel treatment for cognitive impairment associated with schizophrenia.
- Innovative Drug Mechanism: ALTO-101 is a novel transdermal phosphodiesterase-4 (PDE4) inhibitor designed to mitigate gastrointestinal side effects commonly associated with oral medications, potentially offering the first effective pharmacological treatment for schizophrenia patients, addressing a significant unmet medical need.
- Study Design and Objectives: The trial employs a randomized, double-blind, placebo-controlled crossover design to assess the effects of ALTO-101 on electroencephalography (EEG) measures, with topline data expected to guide future development decisions and anticipated to be reported by the end of Q1.
- Scientific Rationale and Preliminary Findings: Baseline analyses indicated a significant association between reduced theta-band inter-trial coherence (ITC) and slower processing speed, supporting ALTO-101 as a potential biomarker for cognitive impairment in schizophrenia, thereby reinforcing the scientific rationale for the program.
See More
Healthcare Stocks Surge in After-Hours Trading
- Acumen Pharmaceuticals Surge: Acumen Pharmaceuticals, Inc. (ABOS) advanced 8.09% in after-hours trading to close at $2.94, adding $0.22, indicating strong investor confidence in its growth prospects.
- Fulgent Genetics Rise: Fulgent Genetics, Inc. (FLGT) rose 5.98% to $28.90 in after-hours trading, gaining $1.63, reflecting market optimism regarding its business outlook.
- Fractyl Health Growth: Fractyl Health, Inc. (GUTS) climbed 5.19% to $2.23 after hours, up $0.11, suggesting that its potential in the biotech sector is being recognized by the market.
- Coeptis Therapeutics Increase: Coeptis Therapeutics Holdings, Inc. (COEP) added 4.14% to finish at $13.85, gaining $0.55 in after-hours trading, demonstrating investor support for its strategic direction.
See More
Alto Neuroscience and Others Under Investigation for Shareholder Claims
- Shareholder Lawsuit Investigation: Johnson Fistel, PLLP is investigating shareholder claims against Alto Neuroscience (NYSE: ANRO) and others, alleging breaches of fiduciary duty that could lead to corporate governance reforms and return of funds.
- False Statements Allegations: Alto Neuroscience is accused of making false statements regarding the efficacy of its lead drug ALTO-100, resulting in investor losses when the truth was revealed, negatively impacting the company's reputation and stock price.
- Anticompetitive Pricing Practices: Atkore Inc. (NYSE: ATKR) faces a securities class action lawsuit alleging executives failed to disclose anticompetitive pricing practices related to PVC pipe products, which may lead to legal risks and diminished shareholder trust.
- Safety Risks Concealment: Fly-E Group (NASDAQ: FLYE) is accused of downplaying safety risks associated with its lithium battery technology in electric mobility products, leading to a stock price decline and harming investor interests, affecting the company's future growth prospects.
See More
Alto Neuroscience Secures Patent for ALTO-207, Enhancing Depression Treatment Potential
- Patent Protection Strengthened: Alto has secured U.S. Patent Number 12,521,374 covering methods for treating depression with ALTO-207, which protects the use of ondansetron to mitigate pramipexole-related side effects, enabling patients to achieve higher doses for antidepressant benefits, significantly enhancing ALTO-207's market competitiveness.
- Clinical Trial Success: In a randomized, placebo-controlled Phase 2a clinical trial involving 32 patients with depression, ALTO-207 demonstrated significantly improved MADRS scores, with patients reaching a mean dose of 4.1mg per day, indicating the drug's efficacy and tolerability in treating treatment-resistant depression.
- Intellectual Property Strategy: The issuance of this patent further solidifies Alto's intellectual property portfolio, expected to extend commercial opportunities for ALTO-207 into the mid-2040s, enhancing the company's long-term growth potential in the mental health sector.
- Innovative Treatment Platform: Alto's Precision Psychiatry Platform aims to provide personalized treatment options by analyzing EEG, neurocognitive assessments, and wearable data, driving the company's innovative advancements in depression and other mental health conditions.
See More
Alto Neuroscience Secures Patent for ALTO-207, Protecting Key Treatment Method Until Mid-2040s
- Patent Protection Extended: Alto Neuroscience announced the issuance of U.S. Patent Number 12,521,374 covering methods for treating depression with ALTO-207, expected to provide protection into the mid-2040s, thus offering the company a long-term commercial opportunity in the treatment of treatment-resistant depression.
- Innovative Combination Therapy: ALTO-207 combines pramipexole and ondansetron to mitigate side effects associated with pramipexole, enabling patients to achieve higher doses for more significant antidepressant effects, addressing the urgent market demand for new therapies.
- Clinical Trial Success: In a randomized, placebo-controlled Phase 2a trial involving 32 patients with depression, ALTO-207 demonstrated significant efficacy, with patients reaching a mean dose of 4.1mg per day and an adverse event rate similar to placebo, indicating good tolerability.
- Strategic Value Enhancement: CEO Amit Etkin emphasized that a robust intellectual property foundation is critical for advancing precision treatments, and this patent issuance not only reflects the novelty of ALTO-207 but also strengthens the company's competitive position in the mental health market.
See More
Alto Neuroscience Grants 150,000 Stock Options at $12.80 to New Employee
- Option Grant: On December 2, 2025, Alto Neuroscience granted a new employee an option to purchase 150,000 shares at an exercise price of $12.80, equal to the closing price on the grant date, aimed at attracting talent and enhancing employee loyalty.
- Long-term Incentive Structure: The option has a 10-year term and vests over four years, with 25% vesting on the first anniversary and the remainder in equal monthly installments, ensuring continued employee contribution during their service.
- Compliance Assurance: This grant complies with NYSE Listed Company Manual Rule 303A.08, ensuring the company's adherence to regulations while attracting and retaining key talent with transparency.
- Strategic Implications: By implementing this incentive plan, Alto not only enhances its attractiveness but also demonstrates confidence in future growth, aiming to reshape the field of psychiatry through innovative drug development.
See More
Alto Completes Patient Enrollment for ALTO-101 Clinical Trial
- Clinical Trial Enrollment Completed: Alto Neuroscience announced the successful enrollment of 83 patients across 13 clinical sites in the U.S. for its Phase 2 trial of ALTO-101, marking a significant step in developing a novel treatment for cognitive impairment associated with schizophrenia.
- Innovative Drug Mechanism: ALTO-101 is a novel transdermal phosphodiesterase-4 (PDE4) inhibitor designed to mitigate gastrointestinal side effects commonly associated with oral medications, potentially offering the first effective pharmacological treatment for schizophrenia patients, addressing a significant unmet medical need.
- Study Design and Objectives: The trial employs a randomized, double-blind, placebo-controlled crossover design to assess the effects of ALTO-101 on electroencephalography (EEG) measures, with topline data expected to guide future development decisions and anticipated to be reported by the end of Q1.
- Scientific Rationale and Preliminary Findings: Baseline analyses indicated a significant association between reduced theta-band inter-trial coherence (ITC) and slower processing speed, supporting ALTO-101 as a potential biomarker for cognitive impairment in schizophrenia, thereby reinforcing the scientific rationale for the program.
See More
Healthcare Stocks Surge in After-Hours Trading
- Acumen Pharmaceuticals Surge: Acumen Pharmaceuticals, Inc. (ABOS) advanced 8.09% in after-hours trading to close at $2.94, adding $0.22, indicating strong investor confidence in its growth prospects.
- Fulgent Genetics Rise: Fulgent Genetics, Inc. (FLGT) rose 5.98% to $28.90 in after-hours trading, gaining $1.63, reflecting market optimism regarding its business outlook.
- Fractyl Health Growth: Fractyl Health, Inc. (GUTS) climbed 5.19% to $2.23 after hours, up $0.11, suggesting that its potential in the biotech sector is being recognized by the market.
- Coeptis Therapeutics Increase: Coeptis Therapeutics Holdings, Inc. (COEP) added 4.14% to finish at $13.85, gaining $0.55 in after-hours trading, demonstrating investor support for its strategic direction.
See More
Alto Neuroscience and Others Under Investigation for Shareholder Claims
- Shareholder Lawsuit Investigation: Johnson Fistel, PLLP is investigating shareholder claims against Alto Neuroscience (NYSE: ANRO) and others, alleging breaches of fiduciary duty that could lead to corporate governance reforms and return of funds.
- False Statements Allegations: Alto Neuroscience is accused of making false statements regarding the efficacy of its lead drug ALTO-100, resulting in investor losses when the truth was revealed, negatively impacting the company's reputation and stock price.
- Anticompetitive Pricing Practices: Atkore Inc. (NYSE: ATKR) faces a securities class action lawsuit alleging executives failed to disclose anticompetitive pricing practices related to PVC pipe products, which may lead to legal risks and diminished shareholder trust.
- Safety Risks Concealment: Fly-E Group (NASDAQ: FLYE) is accused of downplaying safety risks associated with its lithium battery technology in electric mobility products, leading to a stock price decline and harming investor interests, affecting the company's future growth prospects.
See More
Alto Neuroscience Secures Patent for ALTO-207, Enhancing Depression Treatment Potential
- Patent Protection Strengthened: Alto has secured U.S. Patent Number 12,521,374 covering methods for treating depression with ALTO-207, which protects the use of ondansetron to mitigate pramipexole-related side effects, enabling patients to achieve higher doses for antidepressant benefits, significantly enhancing ALTO-207's market competitiveness.
- Clinical Trial Success: In a randomized, placebo-controlled Phase 2a clinical trial involving 32 patients with depression, ALTO-207 demonstrated significantly improved MADRS scores, with patients reaching a mean dose of 4.1mg per day, indicating the drug's efficacy and tolerability in treating treatment-resistant depression.
- Intellectual Property Strategy: The issuance of this patent further solidifies Alto's intellectual property portfolio, expected to extend commercial opportunities for ALTO-207 into the mid-2040s, enhancing the company's long-term growth potential in the mental health sector.
- Innovative Treatment Platform: Alto's Precision Psychiatry Platform aims to provide personalized treatment options by analyzing EEG, neurocognitive assessments, and wearable data, driving the company's innovative advancements in depression and other mental health conditions.
See More
Alto Neuroscience Secures Patent for ALTO-207, Protecting Key Treatment Method Until Mid-2040s
- Patent Protection Extended: Alto Neuroscience announced the issuance of U.S. Patent Number 12,521,374 covering methods for treating depression with ALTO-207, expected to provide protection into the mid-2040s, thus offering the company a long-term commercial opportunity in the treatment of treatment-resistant depression.
- Innovative Combination Therapy: ALTO-207 combines pramipexole and ondansetron to mitigate side effects associated with pramipexole, enabling patients to achieve higher doses for more significant antidepressant effects, addressing the urgent market demand for new therapies.
- Clinical Trial Success: In a randomized, placebo-controlled Phase 2a trial involving 32 patients with depression, ALTO-207 demonstrated significant efficacy, with patients reaching a mean dose of 4.1mg per day and an adverse event rate similar to placebo, indicating good tolerability.
- Strategic Value Enhancement: CEO Amit Etkin emphasized that a robust intellectual property foundation is critical for advancing precision treatments, and this patent issuance not only reflects the novelty of ALTO-207 but also strengthens the company's competitive position in the mental health market.
See More
Alto Neuroscience Grants 150,000 Stock Options at $12.80 to New Employee
- Option Grant: On December 2, 2025, Alto Neuroscience granted a new employee an option to purchase 150,000 shares at an exercise price of $12.80, equal to the closing price on the grant date, aimed at attracting talent and enhancing employee loyalty.
- Long-term Incentive Structure: The option has a 10-year term and vests over four years, with 25% vesting on the first anniversary and the remainder in equal monthly installments, ensuring continued employee contribution during their service.
- Compliance Assurance: This grant complies with NYSE Listed Company Manual Rule 303A.08, ensuring the company's adherence to regulations while attracting and retaining key talent with transparency.
- Strategic Implications: By implementing this incentive plan, Alto not only enhances its attractiveness but also demonstrates confidence in future growth, aiming to reshape the field of psychiatry through innovative drug development.
See More
