Latest news with #ALTO-300
Business Wire
29-05-2025
- Health
- Business Wire
Alto Neuroscience Presents Data at the 2025 American Society of Clinical Psychopharmacology Annual Meeting Reinforcing Safety and Tolerability Profile for ALTO-300 in Major Depressive Disorder
MOUNTAIN VIEW, Calif.--(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 a presentation at the American Society of Clinical Psychopharmacology (ASCP) Annual Meeting, in Scottsdale, Arizona, held May 27-30, 2025. ALTO-300, also known as agomelatine, is an oral, small molecule designed to act as a melatonin agonist and 5-HT2C antagonist being developed at 25mg as an adjunctive treatment in the United States for patients with MDD, characterized by an EEG biomarker. Agomelatine is an approved antidepressant medication at both 25mg and 50mg in Europe and Australia but has not been approved in the United States. In clinical studies, the 50mg dose of agomelatine was associated with low levels of reversible liver enzyme elevations, which were not associated with liver failure. In comparison to the 50mg dose of agomelatine, the 25mg dose has been shown to have similar antidepressant activity while avoiding the rates of liver function test (LFT) elevations associated with the 50mg dose. 'Our ASCP presentation continues to support the unique biomarker opportunity for patient stratification and reinforces the well-established safety and tolerability profile for ALTO-300,' said Amit Etkin, M.D., Ph.D., founder and chief executive officer of Alto Neuroscience. 'Agomelatine has been studied in thousands of patients globally and evidence from meta-analyses and real-world clinical care demonstrates the 25mg dose achieves an optimal balance of antidepressant activity without the concern of LFT elevation. These data are consistent with the positive results from our completed Phase 2a trial, and we are encouraged by the safety and tolerability profile of ALTO-300 in our ongoing Phase 2b trial in patients with major depressive disorder. Taken together, we believe the selected 25mg dose of ALTO-300 is well positioned to demonstrate clinical effects while avoiding the low LFT elevation rates associated with the 50mg dose, which typically occur early, are non-cumulative, resolve quickly, and are not associated with liver failure.' Summary of Data Presented ALTO-300 Safety and Tolerability Profile The most common adverse event observed in the completed Phase 2a trial of ALTO-300 was headache. Additionally, the Phase 2a and Phase 2b trials have involved monitoring for elevated liver enzymes (≥ 3 times the upper limit of normal), with the Phase 2b trial including a stopping rule for elevated liver enzymes. No LFT elevations ≥ 3 times the upper limit of normal were observed in the Company's 239-patient completed Phase 2a trial, and no patients have been stopped in the ongoing Phase 2b trial due to liver enzyme elevation, which remains blinded. ALTO-300 EEG Biomarker The ALTO-300 biomarker signal likely reflects increased neural noise due to elevated 5-HT2C tone and reduced dopaminergic activity. Increasing 5-HT2C activity in a preclinical rodent model or directly depleting dopamine in a healthy human volunteer study—both the oppositive mechanistic effect of ALTO-300—resulted in greater EEG irregularity, consistent with a biomarker positive profile. These data reinforce the direct link between ALTO-300 and the EEG biomarker used to identify MDD patients who are more likely to be responders to treatment. The following poster presented at ASCP 2025 is available under ' Publications ' in the platform section of Alto's website: ALTO-300 as Adjunctive Treatment for Major Depressive Disorder Supported by Mechanistic Validation of Patient Selection Biomarker and Well-Established Safety and Tolerability Profile Poster First Author: Michael Avissar, Ph.D. About Alto Neuroscience Alto Neuroscience is a clinical-stage biopharmaceutical company with a mission to redefine psychiatry by leveraging neurobiology to develop personalized and highly effective treatment options. Alto's Precision Psychiatry Platform™ measures brain biomarkers by analyzing EEG activity, neurocognitive assessments, wearable data, and other factors to better identify which patients are more likely to respond to Alto product candidates. Alto's clinical-stage pipeline includes novel drug candidates in bipolar depression, major depressive disorder, schizophrenia, and other mental health conditions. For more information, visit or follow Alto on X. Forward-Looking Statements This press release may contain forward-looking statements made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. These statements may be identified by words such as 'expects,' 'plans,' 'will' and variations of these words or similar expressions that are intended to identify forward-looking statements, although not all forward-looking statements contain these words. Forward-looking statements in this press release include, but are not limited to, statements regarding Alto's expectations about the potential benefits, activity, and effectiveness of its product candidates, biomarkers, and Precision Psychiatry Platform ('Platform'); and Alto's expectations with regard to the design and results of its clinical trials. Actual results or events could differ materially from the plans, intentions and expectations disclosed in these forward-looking statements as a result of various factors, including uncertainties inherent in the initiation, progress and completion of clinical trials and other important factors, any of which could cause Alto's actual results to differ from those contained in the forward-looking statements, which are described in greater detail in the section titled 'Risk Factors' in Alto's Annual Report on Form 10-K for the fiscal year ended December 31, 2024 filed with the Securities and Exchange Commission ('SEC') as well as in other filings Alto may make with the SEC in the future. Any forward-looking statements contained in this press release speak only as of the date hereof, and Alto expressly disclaims any obligation to update any forward-looking statements contained herein, whether because of any new information, future events, changed circumstances or otherwise, except as required by law. Availability of Information on Alto's Website Alto routinely uses its investor relations website to post presentations to investors and other important information, including information that may be material. Accordingly, Alto encourages investors and others interested in Alto to review the information it makes public on its investor relations website.
Yahoo
02-03-2025
- Business
- Yahoo
Jefferies Predicts Up to ~500% Jump for These 2 ‘Strong Buy' Stocks
U.S. stocks staged a comeback on Friday, with the S&P 500 surging 1.59% and reversing a sharp sell-off driven by fears that Donald Trump's tariffs could disrupt the world's largest economy. See what stocks are receiving Strong Buy ratings from top-rated analysts. Filter, analyze, and streamline your search for investment opportunities with TipRanks' Stock Screener. Among the day's winners, biotech stocks joined the rebound, with the SPDR S&P Biotech ETF (XBI) gaining 1.85%. The sector has struggled to gain momentum over the past year, but Jefferies analyst Michael Yee sees a window of opportunity. 'XBI is trading roughly flat YTD and it has been a mixed bag overall for the sector with some big wins (e.g., AKRO) and big M&A but has also been a tougher tape for many SMID-cap companies with a prevailing higher-for-longer narrative for rates and investor nervousness around RFK and policy uncertainty. Our analysis finds that an increasing number of biotech companies are trading below cash which reflects the mixed tape – but we believe leads to opportunities for many companies with important catalysts coming this year,' Yee opined. And these opportunities could translate into significant gains. Few sectors offer the kind of extreme return potential found in biotech, where triple-digit gains – 300%, 400%, even 500% – are not uncommon. But, as Yee stresses, unlocking biotech's biggest winners comes down to identifying the right catalysts – clinical trials, regulatory approvals, and strategic launches. When those pieces start falling into place, savvy investors should take notice. Jefferies' analysts have done the legwork and pinpointed two biotech stocks with strong upside potential – one of which could skyrocket by nearly 500% in the coming months. And Jefferies isn't alone in its bullish call. According to TipRanks, both stocks boast a 'Strong Buy' rating from the analyst consensus. Let's dive in and uncover what's fueling the excitement. Alto Neuroscience (ANRO) We'll start with Alto Neuroscience, a clinical-stage biotech company focused on developing new drugs for the treatment of central nervous system (CNS) and psychiatric disorders. The company applies the principles of precision medicine to psychiatry, aiming to build a pipeline of drug candidates that target core brain processes and address difficult-to-treat conditions such as major depressive disorder (MDD), bipolar depression, and chronic schizophrenia. What sets Alto apart is its deep understanding of a major challenge in psychiatry: medications don't work the same way for everyone, and mental health conditions often evolve faster than available treatments. To tackle this, Alto has developed an AI-driven program that analyzes biomarkers from over a decade of testing data. Alto's key drug candidate, ALTO-300, is currently undergoing a Phase 2b clinical trial for the treatment of MDD. Designed as a novel antidepressant, ALTO-300 leverages Alto's biomarker-based approach to provide faster, more effective relief for patients who haven't responded well to existing therapies. Alto recently shared interim trial results for ALTO-300, which supported continuing the study with a targeted biomarker population of around 200 patients for final analysis. The company is on track to reveal topline results by mid-2026. In addition to the MDD study on ALTO-300, several other catalysts are lined up for the coming months. The company is set to release Phase 2a proof-of-concept data on ALTO-203 in the first half of 2025. This drug candidate addresses anhedonia, a symptom of MDD and schizophrenia that reduces the ability to experience pleasure and remains difficult to treat with existing therapies. ALTO-203 specifically targets neural pathways involved in reward processing, and positive results could position it as a key advancement in addressing treatment-resistant symptoms. Meanwhile, data from a Phase 2 proof-of-concept trial for ALTO-101, a potential treatment for cognitive impairment associated with schizophrenia (CIAS), is expected in the second half of 2025. Unlike standard schizophrenia medications that focus on hallucinations and delusions but offer little help for memory deficits, attention difficulties, and impaired decision-making, ALTO-101 aims to address these overlooked cognitive symptoms. Last but not least, ALTO-100's Phase 2b trial is underway, with topline data expected in 2026. Though an earlier MDD study fell short of statistical significance, the drug remains a compelling candidate for bipolar depression. By targeting stress-related brain circuits, ALTO-100 introduces a novel approach that could unlock meaningful benefits for a more targeted patient population. With a pipeline full of upcoming catalysts and innovative approach to psychiatric drug development, Jefferies analyst Andrew Tsai views Alto's $2.80 share price as a compelling entry point. 'In 2025, we think the stock has the potential to recover on 3+ Phase II datasets, where (+) data could instill investor confidence that mgmt's biomarker approach of tailoring treatments to maximize efficacy can be viable in psychiatry… the risk/reward looks favorably skewed,' Tsai opined. Regarding ALTO-300, in particular, Tsai notes several reasons for optimism: '(1) ALTO-300 is already approved in the EU/Australia for MDD broadly. However, it was not approved in the US as the former sponsor (NVS) was unable to have the same dose succeed in two Phase III studies, which speaks to level of inconsistency that comes with all-comer studies, (2) ALTO-300's prior open-label 8-week Phase IIa data showed a -17 point MADRS benefit in bio+ vs -12.3 points in bio-, (3) We think '300's safety is manageable at the lower dose of 25mg, (4) Note mgmt prospectively removed N=52 patients from this '300 study following site/subject case reviews, which raises the chances the Phase IIb is enrolling actual MDD patients.' With these factors in play, Tsai rates ANRO a Buy with a $17 price target, implying a robust 507% upside from current levels. (To watch Tsai's track record, click here) Wall Street echoes his bullish stance. ANRO holds a Strong Buy consensus rating based on 4 unanimous positive reviews in the past 3 months. With an average price target of $15, the stock could surge 435% higher in the next year. (See ANRO stock forecast) Instil Bio (TIL) Next up is Instil Bio, a clinical-stage biopharmaceutical company that has undergone a transformation. Initially, the company was centered on developing tumor-infiltrating lymphocyte (TIL) therapies. However, as part of a strategic pivot, Instil has shifted its focus toward in-licensing bispecific antibodies. This transformation gained momentum in August 2024, when Instil entered into a partnership with Chinese company ImmuneOnco Biopharmaceuticals to develop two drug candidates: SYN2510, a PD-L1xVEGF bispecific antibody, and IMM27M, a next-generation anti-CTLA-4 antibody. Through this collaboration, Instil secured global development and commercialization rights for these assets outside of Greater China. In mid-January 2025, ImmuneOnco initiated the first dose in a Phase 1b/2 clinical trial of SYN2510, in combination with chemotherapy, for patients with advanced non-small cell lung cancer (NSCLC) in China. Initial clinical data is expected in the second half of 2025. Meanwhile, Instil plans to begin enrollment in a U.S. trial evaluating SYN-2510 in combination with chemotherapy as a treatment for first-line (1L) NSCLC in 2H25, pending regulatory approval. In addition to NSCLC, Instil Bio is exploring the potential of SYN2510 for treating triple-negative breast cancer (TNBC). A Phase 1b/2 trial in China is planned to evaluate SYN2510 in combination with chemotherapy for first-line TNBC patients, with the study expected to begin in 1H25. Among the supporters is Jefferies analyst Kelly Shi, who sees considerable potential in the stock. 'TIL's initial focus is on NSCLC (Ph2 to start in 2H25) and TNBC with China partner running trials in multiple other indications with dose escalation data update in 1H25. SYN2510 presents a unique molecular design: 1) VEGF arm uses 'Trap' (VEGFR fusion protein) vs bev (mAb) used in ivo and BNT327; 2) an intact Fc domain vs silenced in ivo and BNT327; 3) PD-L1 (same w/ BNT327) vs PD-1 in ivo. The early (subtherapeutic doses) dose-esc data showed similar ORR vs BNT327. So far, we don't see enough evidence for differentiation. However, even the base case scenario (similar clinical profile to SMMT's or BNTX's) should reflect a largely undervalued opportunity. As the third asset with global trials in plan, we see significant upside for TIL shares,' Shi stated. These comments support Shi's Buy rating on TIL, and her $52 price target suggests a potential one-year upside of 158%. (To watch Shi's track record, click here) For the most part, other analysts are on the same page. With 3 Buys and 1 Hold, the word on the Street is that TIL is a Strong Buy. The stock's $20.10 trading price and $114 average price target together imply an upside of 467% for the coming year. (See TIL stock forecast) To find good ideas for stocks trading at attractive valuations, visit TipRanks' Best Stocks to Buy, a tool that unites all of TipRanks' equity insights. Disclaimer: The opinions expressed in this article are solely those of the featured analysts. The content is intended to be used for informational purposes only. It is very important to do your own analysis before making any investment. Sign in to access your portfolio
Yahoo
19-02-2025
- Business
- Yahoo
Alto Neuroscience Announces U.S. Patent Granted Covering ALTO-300 as a Treatment for Patients with Major Depressive Disorder Characterized by an Electroencephalogram Biomarker
– Patent supports Alto's precision approach to improve patient selection – MOUNTAIN VIEW, Calif., February 19, 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 that the U.S. Patent and Trademark Office has granted U.S. Patent Number 12,226,375, with method claims pertaining to treatment of major depressive disorder (MDD) in patients with inadequate response to an antidepressant. The method includes treatment with ALTO-300 as an adjunctive therapy and patient selection using specific electroencephalogram (EEG) measures. As granted, not accounting for any potential patent term extensions, the patent is expected to cover the use of ALTO-300 in the EEG-defined patient population until 2044. ALTO-300, also known agomelatine, is an oral, small molecule designed to act as a melatonin agonist and 5-HT2C antagonist and is being developed as an adjunctive treatment in the United States for biomarker-characterized patients with MDD who have had an inadequate response to current standard of care antidepressants. "The granting of this patent underscores our novel approach to patient selection in neuropsychiatric treatment using objective biomarkers," said Amit Etkin, M.D., Ph.D., founder and chief executive officer of Alto Neuroscience. "We are dedicated to developing more effective, targeted treatments for patients with MDD and deepening our understanding of the patient phenotype that is most likely to benefit, based on our unique ALTO-300 biomarker." About Alto Neuroscience Alto Neuroscience is a clinical-stage biopharmaceutical company with a mission to redefine psychiatry by leveraging neurobiology to develop personalized and highly effective treatment options. Alto's Precision Psychiatry Platform™ measures brain biomarkers by analyzing EEG activity, neurocognitive assessments, wearable data, and other factors to better identify which patients are more likely to respond to Alto product candidates. Alto's clinical-stage pipeline includes novel drug candidates in depression, schizophrenia, and other mental health conditions. For more information, visit or follow Alto on X. Forward-Looking Statements This press release may contain forward-looking statements made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. These statements may be identified by words such as "expects," "plans," "will" and variations of these words or similar expressions that are intended to identify forward-looking statements, although not all forward-looking statements contain these words. Forward-looking statements in this press release include, but are not limited to, statements regarding Alto's expectations about the potential benefits, activity, effectiveness and safety of its product candidates and Precision Psychiatry Platform ("Platform"); Alto's expectations with regard to the design and results of its clinical trials and other statements that are not historical fact. Actual results or events could differ materially from the plans, intentions and expectations disclosed in these forward-looking statements as a result of various factors, including uncertainties inherent in the progress and completion of clinical trials and clinical development of Alto's product candidates and other important factors, any of which could cause Alto's actual results to differ from those contained in the forward-looking statements, which are described in greater detail in the section titled "Risk Factors" in Alto's Quarterly Report on Form 10-Q for the fiscal quarter ended September 30, 2024 filed with the Securities and Exchange Commission ("SEC") as well as in other filings Alto may make with the SEC in the future. Any forward-looking statements contained in this press release speak only as of the date hereof, and Alto expressly disclaims any obligation to update any forward-looking statements contained herein, whether because of any new information, future events, changed circumstances or otherwise, except as required by law. Availability of Information on Alto's Website Alto routinely uses its investor relations website to post presentations to investors and other important information, including information that may be material. Accordingly, Alto encourages investors and others interested in Alto to review the information it makes public on its investor relations website. View source version on Contacts Investor Contact: Nick Smithinvestors@ Media Contact: Mari Purpuramedia@ Sign in to access your portfolio
