Dotinurad is a next-generation URAT1 inhibitor in two Phase 3 clinical trials with potential for best-in-class safety and efficacy Urica sold dotinurad to Crystalys Therapeutics in 2024 in exchange for equity and a 3% royalty on future net sales of dotinurad Oct. 01, 2025 -- Urica Therapeutics, Inc. (“Urica” or the “Company”), a Fortress Biotech, Inc. (Nasdaq: FBIO) (“Fortress”) subsidiary, today announced that Crystalys Therapeutics, Inc. (“Crystalys”), in which Urica maintains an equity pos

CRYPTICS study met the primary efficacy endpoint measure, 24-hour chest tube drainage (Difference in LS Means was 142.0 mL; 95.576% confidence interval of volume difference lower than noninferiority margin) Sensitivity analyses of the primary endpoint were consistent and supportive Comprehensive review of the study efficacy data based on clinically relevant secondary endpoints further supports noninferiority of CLPH-511 to room temperature platelets Adverse events were well balanced between the

Based on previously reported positive Phase 1 results, Kynexis is advancing KYN-5356, a first-in-class KAT-II inhibitor, into a Phase 2 clinical trial in patients with cognitive impairment associated with schizophrenia Phase 2 trial seeks to establish proof-of-concept of KYN-5356; topline results are expected by Q4 2026 Sept. 30, 2025 -- Kynexis, a clinical-stage biotechnology company focused on precision therapeutics for brain diseases, today announced that the first patient has been dosed in

Oct. 01, 2025 -- COUR Pharma, a clinical-stage biotechnology company developing first-in-class, antigen-specific immune tolerance therapies for autoimmune diseases, announced today the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation (ODD) to CNP-106, an investigational therapy for the treatment of generalized myasthenia gravis (gMG). CNP-106 is a biodegradable nanoparticle that encapsulates seven acetylcholine receptor (AChR) antigens. It is being evaluated for its p

Groundbreaking study demonstrates that targeted oligodendrocyte gene therapy leads to decreased N-acetylaspartate (NAA) levels and increased brain myelin volume, resulting in promising functional improvements in children with Canavan Disease Oct. 01, 2025 -- Myrtelle Inc. (“Myrtelle” or the “Company), a pioneering clinical-stage gene therapy company developing transformative treatments for neurodegenerative diseases, today announced the publication of interim results from its Phase 1/2 clinica

Sept. 30, 2025 -- Fifty 1 Labs Inc. (OTC: FITY), a leader in AI-powered healthcare and biotechnology solutions, is excited to announce the signing of a Letter of Intent (LOI) to acquire BioSpark AI Technologies Inc., a Vancouver-based innovator specializing in patented artificial intelligence systems for clinical data extraction, structuring, and real-time analysis. This strategic move builds on a successful history of collaboration between the two companies, reinforcing Fifty 1 Labs' commitme

October 1, 2025 – Athernal Bio today announced its official launch alongside £3.5 million funding from founding investor Delin Ventures. The company is focused on the development of targeted immunotherapies for high-risk clonal haematopoiesis (CH), a widespread cancer precursor condition which can lead to acute myeloid leukaemia (AML) and other haematological cancers. This new funding supports key preclinical milestones as Athernal Bio moves rapidly toward clinical trials in high-risk patient po

Sept. 30, 2025 -- Umoja Biopharma, the clinical-stage leader of in vivo cell therapies that aim to realize the full reach and promise of CAR T cells, announced today that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to UB-VV111 for the treatment of relapsed/refractory Large B-cell Lymphoma following two or more lines of prior therapy and relapsed/refractory Chronic Lymphocytic Leukemia following two or more lines of prior therapy. UB-VV111 is an investigation

Sept. 30, 2025 -- PolyPid Ltd. (Nasdaq: PYPD) ("PolyPid" or the "Company"), a late-stage biopharma company aiming to improve surgical outcomes, today announced that Dr. Shmuel Sharoni will present the topline results from the Company's successful Phase 3 SHIELD II trial of D-PLEX₁₀₀ at the upcoming 2025 American College of Surgeons (ACS) Clinical Congress in Chicago, IL. Dr. Shmuel Sharoni will deliver a presentation titled "Efficacy Of A Novel Local Prolonged-release Incisional Doxycycline On

Publication title: “Oral Blarcamesine Phase IIb/III Trial Confirms Identified Precision Medicine Patient Population – Significant Broad Clinical and Quality of Life Improvements for Early Alzheimer’s Disease Patients” Significant improvement in self-assessed Quality of Life (QoL-AD) scores indicating a reversal of negative trajectory for Alzheimer's disease clinical trial participants was observed Using a novel Precision Medicine approach, up to ~70% of Alzheimer's disease participants benefited