Articles from Newleos Therapeutics, Inc.

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.