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Fulcrum exits sickle-cell path as shares crash on regulatory stance
Fulcrum’s stock plunged after it announced it was discontinuing its sole clinical-stage sickle cell candidate pociredir and pursuing strategic alternatives, following a regulatory finding that...
EU food sustainability faces new genomic-tech rules
The European Union is poised to reshape how emerging genomic techniques (NGTs) are overseen, as regulators move toward a new framework with direct implications for food sustainability goals. The...
Abivax’s UC efficacy report undermined by malignancy cases
Abivax reported positive Phase 3 maintenance efficacy for obefazimod in ulcerative colitis, but said a small number of malignancies in the higher-dose cohort triggered major market fallout. In...
Travel/rare kidney pipeline deal expands Travere with Everest asset
Travere Therapeutics expanded its rare kidney disease pipeline in a deal with Everest Medicines, licensing civorebrutinib for development and commercialization outside China and parts of East and...
AAV gene-therapy manufacturing analytics get a comarketing boost
NanoMosaic and Solid Biosciences announced a comarketing agreement aimed at improving AAV gene-therapy delivery development and manufacturing analytics. Under the collaboration, NanoMosaic will...
FDA flexibilities guide how companies leverage existing knowledge in C>
The FDA issued additional draft guidance describing how cell and gene therapy developers can use prior knowledge—covering clinical, nonclinical, and manufacturing contexts—to support future...
Darxonrasib rivals: rapid clinician-grade ovarian and prostate signals at ASCO
ASCO 2026 showcased early-stage cancer signals across multiple non-overlapping targets, including WEE1 inhibition and precision stratification approaches intended to refine which patients...
Series C lifts anti-aging startup NewLimit toward first-in-human
Longevity startup NewLimit raised $435 million in a Series C round ahead of planned first-in-human testing for its lead liver reprogramming approach. Founders Fund led the financing, joined by...
Sickle cell regulatory setback and strategic exit
Fulcrum Therapeutics scrapped its lead sickle cell disease program, pociredir, and launched a comprehensive strategic review after FDA raised heightened concerns about malignancy risk tied to PRC2...
Neurodegenerative translational push
The Allen Institute is launching a $200 million effort, the Brain Health Accelerator, aimed at translating brain atlas-scale understanding into medicines for neurodegenerative diseases. The...
Gene therapy and manufacturing analytics partnership
NanoMosaic and Solid Biosciences moved to co-market and technically align their gene therapy workflow tools, targeting AAV vector development and manufacturing analytics. The deal pairs...
Large-scale oncology imaging and diagnosis
A portable bedside PET scanner technology was presented as a new option for real-time imaging during interventional procedures. Researchers at Washington University in St. Louis described a...
Diabetes and obesity pipeline and commercial momentum
A new licensing push highlighted Lilly’s continued expansion in GLP biology with a $75 million upfront deal for Hanmi’s long-acting GLP-2 analog sonefpeglutide. Lilly secured exclusive worldwide...
Big-cap clinical-stage signal with safety overhang
Abivax’s Phase 3 ulcerative colitis maintenance readout showed strong efficacy, but the stock moved sharply lower after malignancy cases emerged among treatment recipients. In the Abtect trial,...
Oncology companion diagnostics approval in prostate cancer
The FDA approved Foundation Medicine’s FoundationOne CDx assay as a companion diagnostic to identify patients for Pfizer’s Talzenna plus Xtandi regimen in HRR-mutated metastatic...
Biotech finance: major private anti-aging round
Anti-aging startup NewLimit raised $435 million at a valuation above $3 billion in a Series C financing led by Founders Fund. The company said it expects to start human testing next year for its...
Cell and gene therapy regulatory guidance
The FDA released additional CBER draft guidance detailing how cell and gene therapy developers can leverage prior knowledge. The agency outlined the types of information companies may reuse across...
Gene therapy manufacturing and partner standardization
Evosep and Molecular You announced a partnership intended to standardize high-throughput multiomic biomarker testing workflows. The collaboration integrates Evosep’s Eno liquid chromatography...
Gene therapy manufacturing and analytics
NanoMosaic and Solid Biosciences announced a comarketing agreement focused on improving AAV manufacturing analytics for gene therapy developers. NanoMosaic will promote its Tessie automated plate...
Large partnerships and deals in rare neuromuscular disease
Servier will acquire Edgewise Therapeutics’ muscular dystrophy business in a deal valued at up to $2.65 billion, including $1.55 billion upfront and as much as $1.1 billion tied to regulatory and...