HekaBio K.K., (Headquarters: Chuo-ku, Tokyo) announces that the innovative solid tumor treatment device ‘Alpha DaRT (Diffusing Alpha Radiation Therapy),’ developed by Alpha Tau Medical Ltd. (Headquarters: Jerusalem, Israel) has received official approval in Japan. HekaBio led the approval process as the Designated Marketing Authorization Holder (DMAH) and will be responsible for launching the product in the Japanese market.With this approval, Japan becomes the first country in the world outside

IntraBio Inc. today announced that a positive opinion recommending Orphan Medicinal Product Designation for Acetylleucine for the treatment of CACNA1A disorders has been granted by the Committee for Orphan Medicinal Products (COMP) of the European Medicines Agency (EMA). The European Commission is expected to grant the designation in Q2 2026. CACNA1A-related disorders are rare, genetic neurological conditions characterized by progressive impairment in coordination, balance, speech, and overall

Preclinical proof-of-concept data in GM2 gangliosidosis demonstrated survival benefit, functional improvement and target engagement Results are published in the 7 January issue of the Journal of Inherited Metabolic Disease Nizubaglustat is currently in Phase 3 registrational studies in GM1/GM2 gangliosidoses and Niemann-Pick type C disease (NPC) Azafaros, a company aiming to become a leader in lysosomal storage disorders (LSDs), focused on addressing especially neurological symptoms, today ann

- Blinded evaluation of safety and tolerability data by the Safety Monitoring Committee from Cohort 1 and advancement to Cohort 2 is expected in 3Q 2026 – - Advancement reflects continued execution of capital-efficient development strategy leveraging POZ Platform™- Feb. 24, 2026 -- Serina Therapeutics, Inc. ("Serina" or the "Company") (NYSE American: SER), a clinical-stage biotechnology company advancing drug candidates enabled by its proprietary POZ Platfor drug optimization technology, today

Feb. 25, 2026 -- Melodia Therapeutics AG today announced that the United States Patent and Trademark Office (USPTO) has granted a key U.S. patent covering a structurally novel DPP1 (Cathepsin C) inhibitor, currently developed as MLD-151 by Melodia Therapeutics and discovered by its partner, Alivexis, Inc., strengthening the intellectual property foundation supporting Melodia's lead development program. The newly issued patent (U.S. Patent No. 12,522,593; International Application No. PCT/JP2023

Approval in adults and children aged 6 years and older supported by Phase 3 trial demonstrating Dupixent significantly reduced nasal signs and symptoms, and systemic corticosteroid use or surgery compared to placebo AFRS is a chronic type 2 inflammatory disease of the sinuses characterized by an allergic hypersensitivity to fungi, often requiring surgery with high rates of post-operative recurrence Dupixent is now approved in the U.S. to treat nine distinct diseases driven in part by type 2 i

Feb. 23, 2026 -- TransCode Therapeutics, Inc. (NASDAQ: RNAZ), a clinical stage company pioneering immuno-oncology and RNA therapeutics for the treatment of high risk and advanced cancers, today announced the publication of a manuscript titled Template-Directed RIG-I Agonist Assembly for Image-guided Targeted Cancer Immunotherapy in the journal Molecular Imaging and Biology. The paper, published February 19, 2026, reports on a novel tumor-selective immunotherapy approach that activates innate imm

First patient dosed in Phase 1b randomized, placebo-controlled study evaluating safety, tolerability and weight loss over 12 weeks Market research indicates strong demand for ketogenic-metabolic approaches, including among adults with obesity who are not currently receiving treatment BL-001 positioned as a potential oral ketogenic-metabolic therapy designed for gradual, sustained weight loss with improved tolerability Feb. 24, 2026 -- Bloom Science, Inc., a clinical-stage biotech company focuse

Looking to redeem its IL-17A/F nanobody after a mixed showing in hidradenitis suppurativa (HS) last year, MoonLake Immunotherapeutics unveiled Phase II data Monday for sonelokimab that it believes could change the treatment paradigm in axial spondyloarthritis (axSpA). The 12-week S-OLARIS study enrolled patients with both the radiographic and non-radiographic forms of the chronic inflammatory spine disease. According to topline results, 81% of treated patients (n=26) achieved at least a 40% imp

Feb. 23, 2026 -- Tessera Therapeutics, the biotechnology company pioneering a new approach in genetic medicine known as Gene Writing™, today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track and Orphan Drug designations to TSRA-196, its lead in vivo gene editing program. TSRA-196 is being jointly developed with Regeneron for the treatment of adults with alpha-1 antitrypsin deficiency (AATD) who are homozygous for the PiZ allele (PiZZ). TSRA-196 is designed to pr