Get the Daily Brief
Latest Biotech News
Ophthalmology gene therapy: Beacon pushes laruparetigene zovaparvovec toward BLA
Beacon Therapeutics reported pivotal Phase 2/3 results for laruparetigene zovaparvovec in X-linked retinitis pigmentosa, with the trial meeting the FDA-endorsed primary endpoint in the...
Autoimmunity: Amgen’s dazodalibep hits Phase 3 bar in Sjögren’s
Amgen said dazodalibep, its CD40 ligand antagonist for Sjögren’s disease, met statistically significant and clinically meaningful goals in preliminary Phase 3 results. The company framed the...
Immunology oncology: New checkpoint biology explains PD-1 resistance in gastric cancer
Researchers published findings in Advanced Science describing genetically engineered mouse models of gastric cancer designed to mirror the human disease’s histological diversity and “lethal”...
AI and clinical safety: Framework flags hidden failure modes in medical language models
A new framework argues that hospitals’ rapid deployment of large language models is outpacing safety guardrails, with benchmarking that emphasizes aggregate accuracy potentially masking critical...
Clinical operations and regulation: FDA pilots site activation support for faster Phase I starts
The U.S. FDA launched a pilot program pairing sponsors with prequalified research institutions to speed investigational new drug (IND) application preparation and reduce delays between pre-IND...
Radiopharmaceuticals: Telix to acquire ITM, consolidating isotope and manufacturing capacity
Telix agreed to acquire ITM Isotope Technologies Munich in a transaction valued at up to $2.35 billion, seeking greater control of isotope supply and manufacturing capacity as radiopharmaceutical...
Radiopharma pipeline: Otsuka and Ionis position for ALS expedited discussions after Phase 3 endpoint
Ionis Pharmaceuticals and Otsuka said their amyotrophic lateral sclerosis therapy met its primary endpoint in a Phase 3 study, setting up talks with regulators regarding potential expedited...
Neuroinflammation: New stem-cell secretome strategy targets skin aging via mitophagy
A study reports that an umbilical cord stem cell secretome can reverse aspects of skin aging by boosting mitophagy, the cell process that clears damaged mitochondria. The approach focuses on...
Microbiome and immunometabolism: Gut metabolites reach bone cells through AKT1-linked signaling
A computational study in International Microbiology proposes a pathway connecting gut microbe metabolites to bone-cell activity via an AKT1 signaling network. The work builds an argument that...
Late-stage wins in rare ophthalmology gene therapy
Beacon Therapeutics reported that its X-linked retinitis pigmentosa gene therapy laruparetigene zovaparvovec (laru-zova) met the primary endpoint in the FDA-endorsed Phase II/III VISTA trial,...
Big pharma partnerships expand in RNA splicing and precision oncology
Boehringer Ingelheim struck a potential $1B multi-year collaboration with Envisagenics, centered on the company’s RNA splicing platform (SpliceCore) to identify tumor-specific targets. The deal...
Radiopharma consolidation accelerates with Telix/ITM merger
Telix Pharmaceuticals agreed to acquire Isotope Technologies Munich (ITM) in a deal worth up to $2.35B, aiming to secure greater control of isotope supply and manufacturing capacity as radiopharma...
Regulatory pressure on clinical data workflows: MHRA warns on eHR compliance
The UK Medicines and Healthcare products Regulatory Agency (MHRA) warned that inadequate electronic health record (eHR) systems are causing problems for clinical trial participation by NHS trusts....
US moves to streamline early drug trials via FDA IND pilot
The U.S. FDA launched a pilot program pairing drug sponsors with prequalified research institutions (QRIs) to expedite preparation for Phase I studies. Under the model, sponsors and selected sites...
FDA review outcome delayed in biliary cancer as Compass reports further trial request
Compass Therapeutics’ shares fell after the company reported that the FDA recommended conducting another trial before it can file a regulatory submission for tovecimig in previously treated...
Autoimmune innovation: Amgen claims Phase 3 progress in Sjögren’s
Amgen reported preliminary Phase 3 results for dazodalibep (a CD40 ligand antagonist) in Sjögren’s disease, saying the program met statistically significant and clinically meaningful goals. The...
Drug discovery investment: Regcell raises $66M to move Nobel-linked Treg platform to clinic
Regcell raised $66 million, with Japanese government support included, to advance its regulatory T-cell (Treg) platform toward clinical development. The company’s approach is based on converting...
Pipeline setback in oncology: Worsening safety profile clouds Celldex hives readout
Celldex reported that its experimental barzolvolimab met primary endpoints in two Phase 3 trials for chronic spontaneous urticaria, but safety questions emerged due to two life-threatening...
Obesity therapeutics broaden into psychiatric and addiction indications
Eli Lilly presented early data on brenipatide, a long-acting dual GIP/GLP-1 receptor agonist, as the company explores use beyond weight loss and type 2 diabetes. At Psych Congress 2026, Lilly...
Autoimmune drug trial readouts and regulatory timing
Amgen’s dazodalibep (a CD40 ligand antagonist) cleared the bar in preliminary Phase 3 results in Sjögren’s disease, with the company characterizing the data as statistically significant and...