Welcome to our dedicated page for Alto Neuroscienc news (Ticker: ANRO), a resource for investors and traders seeking the latest updates and insights on Alto Neuroscienc stock.
Alto Neuroscience Inc (ANRO) is a new paradigm in mental health treatment, developing personalized therapies for depression and schizophrenia through neurobiological biomarkers. This page serves as the definitive source for verified updates about this clinical-stage biopharmaceutical innovator.
Investors and researchers will find essential information about ANRO's drug development pipeline, including clinical trial progress for assets like ALTO-100 and ALTO-300. Our curated news collection covers regulatory milestones, research partnerships, and scientific advancements in precision psychiatry.
Key updates include biomarker validation studies, FDA designations, and trial result analyses. All content undergoes strict verification to ensure alignment with financial disclosure standards and medical reporting best practices.
Bookmark this page for streamlined access to ANRO's latest developments in brain-based treatment innovation. Check regularly for authoritative updates on psychiatric drug development and personalized medicine breakthroughs.
Alto Neuroscience (NYSE: ANRO) reported that its Phase 2b study of ALTO-100 for major depressive disorder (MDD) did not meet its primary endpoint. The treatment failed to show significant improvement in depressive symptoms compared to placebo in patients with a memory-based cognitive biomarker. However, ALTO-100 maintained a favorable safety and tolerability profile.
The study, involving 301 adults with MDD across 34 U.S. sites, used the Montgomery-Åsberg Depression Rating Scale (MADRS) to assess changes in depressive symptoms. Despite the disappointing results, Alto Neuroscience remains committed to its mission and expects its strong cash position to support operations through 2027 and multiple near-term clinical milestones.
The company is also evaluating ALTO-100 in a Phase 2b study for bipolar depression and anticipates additional readouts for ALTO-203 and ALTO-300 in MDD in the first half of 2025.
Alto Neuroscience (NYSE: ANRO) has published a peer-reviewed analysis in The Journal of Clinical Psychiatry, revealing that baseline cognitive performance does not moderate response to standard antidepressants in major depressive disorder (MDD) patients. The study, involving 1,812 participants across four placebo-controlled trials, found that vortioxetine, despite its cognitive benefits, does not show greater efficacy in MDD patients with cognitive impairment.
This underscores the unmet need for effective treatments for MDD patients with cognitive impairment, who comprise up to 50% of the MDD population. Alto Neuroscience is developing ALTO-100, a first-in-class oral small molecule designed to enhance neural plasticity, as a potential treatment for this subgroup. Topline data from the Phase 2b MDD study of ALTO-100 is expected in October 2024.
Alto Neuroscience (NYSE: ANRO), a clinical-stage biopharmaceutical company developing precision medicines for neuropsychiatric disorders, has announced its participation in several upcoming investor conferences in September 2024. The company will host an Investor Day on September 9, focusing on ALTO-100 for Major Depressive Disorder, ahead of expected topline data in October 2024.
Alto will also present at the Baird Global Healthcare Conference (September 10-11), the Cantor Global Healthcare Conference (September 17-19), and the TD Cowen 4th Annual Novel Mechanisms in Neuropsychiatry Summit (September 26). These events will feature presentations, one-on-one investor meetings, and a fireside chat, providing insights into Alto's progress and strategies.
Alto Neuroscience (NYSE: ANRO) reported Q2 2024 financial results and business highlights. Key points include:
- Completed enrollment of 301 patients in Phase 2b MDD study for ALTO-100; topline data expected in October 2024
- Initiated Phase 2 studies for ALTO-101 in schizophrenia, ALTO-203 in MDD with anhedonia, and ALTO-100 in bipolar depression
- Reported positive Phase 1 data on transdermal formulation of ALTO-101
- Strong cash position of $194 million expected to fund operations into 2027
- Q2 2024 R&D expenses increased to $13.2 million from $7.1 million in Q2 2023
- Net loss for Q2 2024 was $16.0 million compared to $8.7 million in Q2 2023
The company has five Phase 2 studies ongoing across four novel product candidates, with topline data expected before the end of 2026.
Alto Neuroscience (NYSE: ANRO) has received an $11.7 million funding award from Wellcome Trust to advance ALTO-100, a first-in-class small molecule, in a 200-patient Phase 2b study for bipolar depression. The study will leverage a cognitive biomarker previously identified in MDD and PTSD patients. This marks the first precision psychiatry trial in bipolar depression, an area of high unmet need.
ALTO-100 is believed to enhance neural plasticity and is currently in Phase 2b development for MDD, with results expected in October 2024. The new study for bipolar depression will use the same memory biomarker and design as the ongoing MDD study. The primary endpoint is the change from baseline on the Montgomery-Åsberg Depression Rating Scale (MADRS) over a six-week treatment period.
Alto Neuroscience (NYSE: ANRO) has completed enrollment in its Phase 2b study of ALTO-100 for major depressive disorder (MDD). The study includes 300 adult patients with and without a specific cognitive biomarker. Topline results are expected in October 2024. The randomized, double-blind, placebo-controlled study aims to determine ALTO-100's efficacy in MDD patients defined by an objective cognitive biomarker. The primary endpoint is the change in the Montgomery-Åsberg Depression Rating Scale (MADRS) over a 6-week treatment period. Alto plans to host an investor day on September 9, 2024, focusing on ALTO-100 and providing information on study participants, mechanistic rationale, and the predictive cognitive test used for patient selection.
Alto Neuroscience announced the initiation of a Phase 2 trial for ALTO-101, a PDE4 inhibitor aimed at treating cognitive impairment in schizophrenia. The study, expected to conclude by the second half of 2025, will involve 70 adults and compare a transdermal formulation of ALTO-101 against a placebo. Previous Phase 1 trials showed positive cognitive effects and fewer adverse events compared to oral administration. CEO Amit Etkin highlighted the potential of ALTO-101 to improve cognitive function across various psychiatric disorders.
The primary outcome will measure the effect on theta band activity using EEG. This follows promising data presented at the SOBP Annual Meeting, affirming the relevance of EEG measures in assessing cognitive function in schizophrenia.
Amit Etkin, M.D., Ph.D., founder and CEO of Alto Neuroscience, was named an EY Entrepreneur Of The Year 2024 Bay Area Award winner. Dr. Etkin was selected from a pool of 26 finalists by an independent panel of judges. The award celebrates innovative leaders across various industries. Alto Neuroscience, under Dr. Etkin's leadership, has been recognized for its mission to advance precision psychiatry. The winners were evaluated based on entrepreneurial spirit, purpose, growth, and impact. Regional winners, announced on June 14, 2024, will now compete for the National Awards in November.
Alto Neuroscience (NYSE: ANRO) announced its participation in the Jefferies Global Healthcare Conference in New York from June 5-6, 2024. Founder and CEO Amit Etkin, M.D., Ph.D., will engage in a fireside chat on June 6, 2024, at 2:30 p.m. ET. Additionally, the company's management will hold one-on-one meetings with investors. A live webcast of the discussion will be available on Alto's investor relations webpage, with a replay accessible afterward.
Alto Neuroscience (NYSE: ANRO) has appointed Michael Hanley as its new Chief Operating Officer (COO). Hanley brings over 25 years of expertise in the life sciences industry, particularly in neuropsychiatric conditions like major depressive disorder and schizophrenia. His role will involve new product planning, portfolio strategy, and cross-functional leadership to enhance Alto's clinical-stage programs and biomarker platform. Hanley's extensive background includes leadership positions at Aeglea BioTherapeutics and Horizon Therapeutics. He holds a Bachelor of Business Administration from the University of Notre Dame and an MBA from Kellogg School of Management.
