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Alzheimer’s tau targeting resumes despite phase 2 endpoint miss
Biogen decided to advance diranersen (BIIB-080) into registrational development for early Alzheimer’s disease even after missing a phase 2 primary endpoint. In the Celia trial, low-dose diranersen...
FDA clears solid-tumor comprehensive genomic profiling test
Datar Cancer Genetics announced FDA clearance for its CellDx-Tissue comprehensive genomic profiling assay to profile DNA and RNA from solid tumors. The dual-analyte targeted next-generation...
Cancer diagnostics reimbursement win: Medicare expands Personalis NeXT Personal MRD coverage
Personalis shares rose after CMS expanded Medicare coverage for the company’s NeXT Personal minimal residual disease assay to include immunotherapy monitoring across late-stage solid tumors. The...
In vivo CAR-T funding boost for next wave of cell therapies
Create Medicines raised $122 million to expand its in vivo CAR-T platform, aiming to advance programs across cancers and autoimmune disease. The Series B funding co-led by Arch Venture Partners,...
Biotech financing megadeal for AI drug discovery model
Isomorphic Labs secured a $2.1 billion Series B round to scale its AI predictive drug discovery engine and advance its internal pipeline toward the clinic. Reports describe a syndicate led by...
FDA approval: BeOne’s Beqalzi wins accelerated nod in mantle cell lymphoma
BeOne Medicines received US accelerated approval for sonrotoclax (Beqalzi), a next-generation BCL2 inhibitor targeting relapsed or refractory mantle cell lymphoma following BTK inhibitor therapy....
Massive pharma-developer deal: BMS and Hengrui expand oncology and immunology collaboration
Bristol Myers Squibb and Hengrui Pharmaceuticals signed a collaboration that covers 13 early-stage programs spanning oncology/hematology and immunology, with potential deal value exceeding $15...
AI-enabled trial operations: Veristat launches automated biostatistics platform
Veristat launched InStat, a fully automated biostatistics platform aimed at compressing clinical trial data readout timelines from weeks to days. The software is designed to deliver...
COVID-19 and infectious disease surveillance
Researchers unveiled a wastewater surveillance approach that tracks SARS-CoV-2 genetic diversity rather than relying on viral abundance alone, aiming to improve early outbreak forecasting. The...
Biotech funding and platform scale-up
Isomorphic Labs announced a $2.1 billion Series B financing led by Thrive Capital, describing it as a step-change in scaling its AI drug design engine, IsoDDE. The company framed the round as a...
FDA approvals and regulatory milestones in oncology
BeOne Medicines won U.S. accelerated approval for sonrotoclax (Beqalzi) in relapsed or refractory mantle cell lymphoma, adding a new BCL-2 competition point against AbbVie and Roche’s Venclexta in...
Cell therapy development and in vivo CAR-T expansion
Create Medicines raised $122 million to advance its in vivo CAR-T programs for cancers and autoimmune diseases, continuing a push toward therapies manufactured inside the body. The financing...
FDA clinical holds and program strategy shifts
Aardvark Therapeutics disclosed it is moving to unblind data from its Phase 3 Prader-Willi syndrome program after the FDA imposed a full clinical hold. The hold follows a cardiac safety signal...
Alzheimer’s disease pipeline: tau-targeting development path
Biogen decided to advance diranersen (BIIB080) into registrational trials for early Alzheimer’s disease despite missing the primary dose-response endpoint in a Phase 2 study. Biogen reported...
Duchenne gene therapy: pivotal milestone toward FDA submission
Regenxbio reported that its Duchenne muscular dystrophy gene therapy RGX-202 met the primary endpoint in a pivotal trial, with the company targeting an FDA submission path in 2027. The update...
Cancer diagnostics: FDA clears solid-tumor genomic profiling
FDA cleared Datar Cancer Genetics’ CellDx-Tissue assay for comprehensive genomic profiling in solid tumors, enabling dual DNA and RNA analysis from formalin-fixed paraffin-embedded samples. The...
Antibiotic resistance and AI-driven optimization
Researchers at the University of Pennsylvania introduced ApexGO, an AI-powered method for peptide antibiotic optimization that starts with imperfect candidate peptides and iteratively improves...
Gene therapy safety: immune suppression may blunt efficacy
A study from Encoded Therapeutics reported that a gene-therapy safety strategy used to mitigate immune responses—steroids and sirolimus—may reduce the effectiveness of the delivered therapy. The...
Gene therapy & immune engineering momentum
Regenxbio said its Duchenne muscular dystrophy gene therapy RGX-202 cleared a key bar in a pivotal study, setting up an FDA submission process aimed at commercializing a new option for a market...
Cell therapy financing & scale-up
Create Medicines raised $122 million to advance in vivo CAR-T programs spanning autoimmune disease and oncology, betting on one-day manufacturing inside the patient rather than traditional ex vivo...