Get the Daily Brief
Latest Biotech News
Regulatory approvals in oncology and rare disease
The FDA delivered back-to-back rare-disease and oncology wins Wednesday, highlighting a still-active accelerated-approval pathway for rare conditions. Corcept Therapeutics’ oral selective...
Competitive kidney disease pipeline and Vertex-style targeting
Maze Therapeutics reported positive mid-stage efficacy for MZE829, its oral APOL1 inhibitor for broad APOL1-mediated kidney disease (AMKD), setting up a direct race toward a pivotal program. In...
Big pharma M&A reshapes oncology pipeline priorities
Merck struck a large cash acquisition of Terns Pharmaceuticals as it looks to fortify its oncology portfolio ahead of Keytruda revenue erosion. Merck agreed to buy Terns for about $6.7 billion in...
Gene editing advances move from concept to clinical momentum
Beam Therapeutics reported further progress on BEAM-302, its base-editing program for alpha-1 antitrypsin deficiency (AATD), and said the updated clinical dataset supports moving forward toward...
Rare disease manufacturing access in Europe
Countable Labs received CE marking for its Countable 4 single-molecule PCR platform, expanding availability in Europe and supporting work in variant detection, rare event quantification, and...
AI-enabled clinical operations and compliance tooling
PhaseV launched AI Conductor, an offering designed to automate major parts of the clinical development workflow, from protocol work through compliance and regulatory submission...
Somatic genomics partnerships deepen in inflammatory bowel disease
Quotient Therapeutics continued to draw major pharma partnerships for its somatic genomics platform, this time with Merck focused on inflammatory bowel disease (IBD). Merck will pay Quotient $20...
Autoimmune T-cell engager M&A expands Gilead’s inflammation cell-therapy portfolio
Gilead Sciences agreed to acquire Ouro Medicines in a deal designed to add a BCMAxCD3 T-cell engager to its autoimmune pipeline, while also potentially reshaping its partnership with...
Translational ocular gene therapy advances to Phase 3 with investor sensitivity
Ocugen said it will move its gene therapy for geographic atrophy (GA) into Phase 3 after mixed results in a prior, smaller study. The company’s decision reflects an attempt to convert earlier...
Oncology imaging and AI pathology workflows expand in clinical research
Mindpeak and Discovery Life Sciences partnered to apply AI-assisted pathology workflows to tissue biomarker analysis, aiming to streamline clinical trials and reduce variability in slide...
Regulatory approvals and evidence standards in rare disease
The FDA approved Denali Therapeutics’ Hunter syndrome medicine Avlayah, a decision that arrives amid a more stringent posture toward rare-disease evidence. The agency’s approval is notable because...
Rare disease RNA therapeutics—early clinical readouts reshape expectations
Sarepta Therapeutics shared preliminary clinical data that lifted sentiment around its next wave of RNA-based muscle disease programs, including SRP-1001 and SRP-1003. The company reported early...
Big Pharma M&A—Merck expands oncology with Terns acquisition
Merck agreed to buy Terns Pharmaceuticals for $6.7 billion in cash, aiming to secure TERN-701, an oral allosteric BCR::ABL tyrosine kinase inhibitor candidate in chronic myeloid leukemia. The deal...
Immunology deals—Gilead buys Ouro for $2B and targets autoimmune reset
Gilead Sciences is acquiring Ouro Medicines in a deal valued at $2.17 billion, adding a BCMAxCD3 T-cell engager to its inflammation and autoimmune pipeline. The transaction is front-loaded with...
Clinical signals in oncology—Maze reports phase 2 kidney data while stock reacts
Maze Therapeutics released topline phase 2 results for its genetic kidney disease program MZE829, reporting an average 35.6% reduction in disease-related measures. The company’s readout put the...
Autoimmune and oncology funding—seed expansion for dark proteome discovery
RyboDyn raised $10 million in seed funding to accelerate its efforts to decode the dark proteome for oncology target discovery. The company combines deep sequencing of non-canonical RNAs with...
Therapeutic pipeline advancement—IND clearances and clinic entry in China
Sichuan Kelun-Biotech announced China’s NMPA cleared IND application for SKB-103, a solid-tumor therapy program entering clinical evaluation. The clearance is a direct step toward trial initiation...
Phase 3 readouts in skin inflammation—Pfizer tilrekimig advances after eczema trial
Pfizer reported topline Phase II results for tilrekimig, a trispecific antibody targeting IL‑4, IL‑13, and TSLP for atopic dermatitis. The company said the study met its primary endpoint with a...
Diagnostic and clinical data platform partnerships—real-world oncology data integration
Verana Health and Guardant Health partnered to combine regulatory-grade electronic health record datasets with clinicogenomic testing data, enabling biopharma researchers to connect tumor genomics...
Regulatory enforcement—FDA warning over misleading claims for Anktiva
The FDA issued a warning letter to ImmunityBio over what the agency described as false and misleading marketing claims for Anktiva, including messaging in a podcast and television advertisements....