Articles from Newleos Therapeutics, Inc.

Newleos Therapeutics, Inc., a clinical-stage biotechnology company developing innovative treatments for neuropsychiatric disorders, today announced that the National Institute on Drug Abuse (NIDA), part of the National Institutes of Health (NIH), has awarded the company up to $15.5 million to fund the development of NTX-2001 in cocaine use disorder (CUD). NTX-2001 is the company’s novel partial agonist of trace amine-associated receptor 1 (TAAR1), which is being developed as a potential first-in-class therapeutic for substance use disorders, including alcohol use disorder (AUD) and CUD. The five-year, milestone-based grant, which is Newleos’ first federal grant, funds the development of NTX-2001 through a Phase 1 drug-drug interaction study and a subsequent Phase 2 efficacy study. The funds were awarded based on strong preclinical evidence supporting a clear mechanistic rationale for NTX-2001 in treating CUD, along with its validated safety and tolerability profile in humans.

Newleos Therapeutics, Inc., a clinical-stage biotechnology company developing innovative treatments for neuropsychiatric disorders, today announced the appointment of Rohan Palekar to its Board of Directors. Most recently, Mr. Palekar served as founding Chief Executive Officer at 89bio where he led multiple programs from preclinical studies through Phase 3 development in liver and cardiometabolic diseases. 89bio was acquired by Roche in 2025 for up to $3.5 billion.

Newleos Therapeutics, Inc., a clinical-stage biotechnology company developing innovative treatments for neuropsychiatric disorders, today announced that the first participant has been dosed in its Phase 1b study of NTX-2001, the company’s novel partial agonist of trace amine-associated receptor 1 (TAAR1), which is being developed as a potential first-in-class therapeutic for alcohol use disorder (AUD). The Phase 1b study is a randomized, double-blind, placebo-controlled clinical trial conducted in collaboration with Yale School of Medicine to measure reductions in alcohol consumption and cravings within an observational setting, as well as safety, tolerability and pharmacokinetics of NTX-2001 in individuals with AUD.

Newleos Therapeutics, Inc., a clinical-stage biotechnology company developing innovative treatments for neuropsychiatric disorders, today announced that the first participant has been dosed in the company’s third Phase 1b study of NTX-1955, designed to evaluate its safety and tolerability in generalized anxiety disorder (GAD). NTX-1955 is Newleos’ GABAA-γ1 positive allosteric modulator (PAM) and represents a potential first-in-class treatment for GAD. The Phase 1b study is a multi-center randomized, double-blind, placebo-controlled trial being conducted in the U.K. in adults with GAD. The company previously announced the initial dosing of participants in two other Phase 1b trials being conducted in the EU in July and September 2025. Data from these three Phase 1b studies are expected to inform the dose selection and design of a Phase 2 efficacy study of NTX-1955.

Newleos Therapeutics, Inc., a clinical-stage biotechnology company developing innovative treatments for neuropsychiatric disorders, today announced that the first participant has been dosed in the SOAR (SOcial Anxiety Reduction) Phase 2 study of NTX-1472, the company’s novel vasopressin 1a (V1a) receptor antagonist, which is being developed for the treatment of social anxiety disorder (SAD). SOAR is a randomized, double-blind, placebo-controlled, multi-center Phase 2 study designed to assess the safety, tolerability, and efficacy of NTX-1472 in adults with SAD.

Newleos Therapeutics, Inc., a clinical-stage biotechnology company developing innovative treatments for neuropsychiatric disorders, today announced the appointment of Timothy Noyes as President and Chief Executive Officer. Mr. Noyes succeeds David Donabedian, Ph.D., Founding President and Chief Executive Officer of Newleos and Executive Partner at Longwood Fund, who will continue to serve the company in an advisory capacity.

Newleos Therapeutics, Inc., a clinical-stage biotechnology company developing innovative treatments for neuropsychiatric disorders, today announced that Goldman Sachs (NYSE:GS) is recognizing David H. Donabedian, Ph.D., Newleos’ Founding Chief Executive Officer and Executive Partner at Longwood Fund, as one of the Most Exceptional Entrepreneurs of 2025 at its Builders and Innovators Summit in Healdsburg, California.

Newleos Therapeutics, Inc., a clinical-stage biotechnology company developing innovative treatments for neuropsychiatric disorders, today announced that the first subject has been dosed in the company’s second Phase 1b study of NTX-1955 in the European Union (EU). NTX-1955 is a GABAA-γ1 positive allosteric modulator (PAM) and represents a novel approach for the treatment of generalized anxiety disorder (GAD). The company announced the initiation of dosing in the first Phase 1b study of NTX-1955 in the EU in July 2025.

Newleos Therapeutics, Inc., a clinical-stage biotechnology company developing innovative treatments for neuropsychiatric disorders, today announced the presentation of a poster related to the company’s first-in-class GABAA γ1 positive allosteric modulator (PAM), NTX-1955, at the 17th World Congress of Biological Psychiatry (WCBP). Organized by the World Federation of Societies of Biological Psychiatry, WCBP is taking place September 9-12 in Berlin, Germany. Newleos is conducting two Phase 1b studies in the European Union (EU) to assess the pharmacology and proof-of-mechanism for NTX-1955 in Generalized Anxiety Disorder (GAD).

Newleos Therapeutics, Inc., a clinical-stage biotechnology company developing innovative treatments for neuropsychiatric disorders, today announced the appointment of Stephen (Steve) Brannan, M.D., to its Board of Directors. Dr. Brannan is an expert in neuroscience and neuropsychiatric drug development with a proven track record of developing innovative medicines through regulatory approval and commercialization. Most recently, he served as Chief Medical Officer at Karuna Therapeutics (acquired by Bristol Myers Squibb in 2024 for $14 billion) where he led the clinical strategy for KarXT (xanomeline–trospium), the first new mechanism of action for schizophrenia approved in over 30 years.

Newleos Therapeutics, Inc., a clinical-stage neuroscience company co-founded by Longwood Fund and seasoned leaders in CNS drug development, today announced the inaugural members of its Clinical Advisory Board to support the development of its neuropsychiatric product pipeline, including NTX-1955 for generalized anxiety disorder and NTX-1472 for social anxiety disorder. Members of the Clinical Advisory Board are internationally recognized leaders in psychiatry and neuroscience with deep expertise in the development of novel therapeutics for mood, anxiety, and stress-related disorders. Focused on Newleos’ promising programs targeting anxiety disorders, the Clinical Advisory Board has a shared goal of addressing the increasing global burden of mental health conditions.

Newleos Therapeutics, Inc., a clinical-stage neuroscience company co-founded by Longwood Fund and seasoned leaders in CNS drug development, today announced the expansion of its leadership team with the appointment of experienced professionals across clinical, medical, and corporate functions.

Newleos Therapeutics, Inc., a clinical stage neuroscience company co-founded by Longwood Fund and seasoned leaders in CNS drug development, today announced the closing of an oversubscribed $93.5 million Series A financing. The financing was led by Goldman Sachs Alternatives with participation from Novo Holdings A/S, Longwood Fund, DCVC Bio, and Arkin Bio Capital. Newleos’ clinical-stage pipeline was in-licensed from Roche and includes multiple oral small molecules targeting novel mechanisms across a broad range of indications including generalized anxiety, social anxiety, substance use disorders and cognitive impairment.