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Rare disease regulator action – Denali accelerated approval and prior rejection context
FDA cleared Denali Therapeutics’ Avlayah (tividenofusp alfa) for Hunter syndrome under the accelerated approval pathway, a notable decision as the agency has recently rejected several rare disease...
Kidney disease pipeline – Maze Phase 2 AMKD readout
Maze Therapeutics reported positive topline Phase 2 data for MZE829, an oral dual-mechanism APOL1 inhibitor, in patients with broad APOL1-mediated kidney disease (AMKD). In the company’s Horizon...
Cell therapy pipeline decision – Innate ends NK cell engager study
Innate Pharma discontinued its Phase 1/2 study of IPH6501, a tetraspecific antibody-based NK cell engager being evaluated in B-cell non-Hodgkin lymphoma. The company said the program was halted as...
Gene editing advance – Beam base editing update for AATD
Beam Therapeutics provided updated evidence supporting its base editing program BEAM-302 in alpha-1 antitrypsin deficiency (AATD). In the ongoing Phase 1/2 study, Beam reported that patients...
Immunotherapy+data – Tempus and Daiichi Sankyo build AI models for ADC patient selection
Tempus AI partnered with Daiichi Sankyo to develop proof-of-concept AI models aimed at improving success rates for novel oncology antibody-drug conjugates (ADCs). Under the agreement, Daiichi...
Diagnostics + manufacturing systems – CE mark for Countable Labs single-molecule PCR
Countable Labs obtained a CE mark for its Countable 4 single-molecule PCR platform, extending access to European biopharma and contract manufacturing customers. The company described the...
CDMO + site expansion – Rentschler’s Milford manufacturing growth
Rentschler Biopharma highlighted progress and expansion at its U.S. Milford, Massachusetts facility, describing a transition into a new phase of multi-product growth. The company said it is...
Startup financing – Excalipoint seed for solid-tumor T-cell engagers
Excalipoint Therapeutics launched with an oversubscribed $68.7 million seed round to advance a portfolio of T-cell engagers for solid tumors. The financing positions the company among the larger...
M&A
Merck has agreed to acquire Terns Pharmaceuticals for about $6.7 billion, securing TERN-701, an oral BCR::ABL tyrosine kinase inhibitor in phase 1/2 for Philadelphia chromosome-positive...
M&A & Immunology Bispecifics
Gilead announced it will acquire Ouro Medicines for about $2.17 billion, adding the autoimmune-stage BCMAxCD3 T-cell engager gamgertamig (OM336). The front-loaded structure includes $1.675 billion...
Regulatory Approvals – Oncology
The FDA approved Corcept Therapeutics’ Lifyorli (relacorilant) in combination with nab-paclitaxel for adults with platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal...
Regulatory Approvals – Rare Disease
The FDA granted Denali Therapeutics accelerated approval for Avlayah (tividenofusp alfa), a Hunter syndrome gene therapy, in a decision that runs counter to recent rare-disease rejection patterns...
Clinical Development – NK Cell Engagement Shutdown
Innate Pharma discontinued its phase 1/2 NK cell engager program IPH6501, ending the B-cell non-Hodgkin lymphoma study as part of a strategic pipeline prioritization. Innate had been evaluating...
Clinical Development – Gene Editing in Rare Liver/Lung Disease
Beam Therapeutics reported positive proof-of-concept readouts for its base editing therapy BEAM-302 in alpha-1 antitrypsin deficiency, showing restored functional protein production and meaningful...
Clinical Development – Kidney Disease Proteinuria Reduction
Maze Therapeutics said its phase 2 program for MZE829, an oral dual-mechanism APOL1 inhibitor, achieved a clinically meaningful mean reduction in urine protein levels in APOL1-mediated kidney...
Diagnostics – CE Mark for Single-Molecule PCR
Countable Labs secured CE marking for its Countable 4 single-molecule PCR platform, positioning the instrument for European biopharma and contract manufacturing customers. The company says its...
AI for Drug Development – Clinical Trial Automation
PhaseV debuted AI Conductor, an AI-driven clinical development offering aimed at automating trial execution tasks from protocol development through regulatory submission readiness. The platform is...
Biomanufacturing & Analytical Methods – Targeted HCP Proteomics
Researchers from Université Claude Bernard Lyon’s Institut des Sciences Analytiques reported a targeted proteomics workflow to improve host-cell protein (HCP) monitoring across variable...
M&A: Merck-Terns deal reshapes targeted oncology pipeline
Merck & Co. has agreed to buy Terns Pharmaceuticals for about $6.7 billion, securing Terns’ lead oral BCR::ABL1 tyrosine kinase inhibitor TERN-701 as it prepares for major patent expirations...
Regulatory: FDA greenlights Denali’s Avlayah for Hunter syndrome
The FDA approved Denali Therapeutics’ Avlayah (tividenofusp alfa) for Hunter syndrome (mucopolysaccharidosis II) under the accelerated approval pathway, a notable win amid scrutiny that has...