Dyne Therapeutics (Nasdaq: DYN) has announced the initiation of the Phase III FORZETTO trial of zeleciment rostudirsen (z-rostudirsen; DYNE-251) in Duchenne muscular dystrophy, with the first site now open for enrollment and a biologics license application for US accelerated approval planned for later this quarter. The FORZETTO trial is a global, randomized, double-blind, placebo-controlled Phase III study evaluating z-rostudirsen in approximately 90 ambulatory male participants aged 4 to 18 ye

In the sprawling metropolis of Houston, a new biotech has emerged to tackle the biology underlying a lung disease that has no clear cause. Oorja Bio launched yesterday afternoon with $30 million and an in-licensed, novel approach to treat idiopathic pulmonary fibrosis. Oorja’s funds come from founding investor Westlake BioPartners, according to the May 19 release. The biotech’s lead asset is ORJ-001, an activator of a receptor called β1 integrin that is key for maintaining the structure and sta

May 19, 2026 -- Myosin Therapeutics, a clinical stage biotechnology company developing innovative therapies for oncology, today announced that the first patient has been dosed in its Phase 1/2 STAR-GBM study. The trial is designed to assess safety, tolerability, pharmacokinetics, and preliminary signals of clinical activity with longitudinal imaging in adults with newly diagnosed glioblastoma (GBM). With support from the National Cancer Institute (NCI/NIH), the trial is being conducted in collab

Incyte is paying Genesis $80 million upfront to expand use of its partner’s AI platform across a broader range of drug targets, continuing the biotech’s rapid embrace of AI in drug discovery and development. Delaware-based Incyte partnered with Genesis in February 2025. That deal, which included a $30 million upfront payment, positioned the companies to collaborate on two targets and gave Incyte the option to nominate a third target for a predetermined fee. Genesis has now secured an expanded a

IND submission marks Matter Bio's transition toward clinical stage and advances its lead Listeria-based immunotherapy into one of oncology's highest-need indications May 19, 2026 -- Matter Bio today announced the submission of its first Investigational New Drug (IND) application to the U.S. Food and Drug Administration (FDA) for Lm-LLO-TT, the company's lead therapeutic candidate, for a first-in-human Phase 1/2a clinical trial in patients with pancreatic ductal adenocarcinoma (PDAC). If the IN

In a head-to-head psoriatic arthritis trial, UCB's Bimzelx achieved reduced disease activity in 49% of patients vs. 38% of those on AbbVie's Skyrizi. Bimzelx showed numerical superiority in secondary measures, but none that achieved statistical significance. Two months after UCB revealed the success of Bimzelx in a head-to-head trial against AbbVie’s Skyrizi in patients with psoriatic arthritis (PsA), the Belgian drugmaker has unveiled the detailed results. In the phase 3b study that included

The Xofluza license deal between Roche and the Medicines Patent Pool comes as ongoing hantavirus and Ebola outbreaks have once again thrust pandemic preparedness into the spotlight. (Roche/Genentech) Roche has signed a voluntary license agreement providing its popular influenza antiviral drug Xofluza (baloxavir marboxil) for generic drugmakers to copy in 129 developing countries. The deal with the Medicines Patent Pool will enable generic supply of baloxavir in 129 low- and middle-income count

Exelixis has secured supplies of subcutaneous Keytruda from Merck & Co. for a planned phase 3 study, completing the trio of contributors needed to run the colorectal cancer trial. California-based Exelixis partnered with Natera on the trial in January. Natera is providing its molecular residual disease (MRD) test for use in the study, as it did for a Roche trial that supported a recent label expansion for Tecentriq. Echoing Roche’s strategy in a different indication, Exelixis will enroll patien

This endocrine essential advances the diagnosis, confirmation and monitoring of Canine Cushing's and Addison's May 19, 2026 -- Dechra is proud to announce the U.S. Food and Drug Administration's (FDA) approval of CosACTHen® (cosyntropin injection), the first and only cosyntropin specifically indicated for use in canine patients. This milestone reinforces Dechra's ongoing commitment to advancing veterinary endocrinology and providing veterinarians with innovative, high-quality solutions for endo

New preclinical data further demonstrate GLIX1's robust efficacy in a dose-dependent manner, with strong anti-tumor activity observed even at the lowest doses tested Results highlight GLIX1's potential to address the high unmet need for patients with GBM May 19, 2026 -- BioLineRx Ltd. (NASDAQ: BLRX) (TASE: BLRX), a clinical development stage biopharmaceutical company pursuing life-changing therapies in oncology and rare diseases, and Hemispherian AS, a clinical-stage oncology company developing