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Ulcerative colitis — efficacy wins, safety concerns hit Abivax
Abivax reported positive Phase 3 efficacy for obefazimod (miRNA-124 enhancer) in ulcerative colitis maintenance, but the company disclosed malignancy cases among participants that weighed on...
EU regulatory science — adaptive trial protocols called for
Researchers warned that faster regulatory approvals in Europe will not solve clinical trial failures without more adaptive trial designs. A study published in Clinical Microbiology and Infection...
Sustainability + EU biotech — genomic rules reshape farming goals
Europe is moving toward a new regulatory framework for emerging genomic techniques (NGTs), with potential implications for food sustainability targets. The update is positioned as a pivot point...
Gene therapy analytics — NanoMosaic and Solid Biosciences pair up
NanoMosaic signed a comarketing agreement with gene therapy developer Solid Biosciences to support manufacturing analytics for AAV gene therapies. The companies will jointly promote NanoMosaic’s...
Cell and gene therapy regulation — FDA guidance leverages prior knowledge
The FDA expanded guidance for cell and gene therapy developers on how to leverage prior knowledge across clinical, nonclinical and manufacturing work. In a new CBER draft guidance, the agency...
Sickle cell and epigenetics pipeline funding — large raises in aging and obesity tech
NewLimit secured a $435 million Series C financing at a $3B+ valuation ahead of its first clinical trial, signaling continued investor appetite for advanced rejuvenation approaches with near-term...
Gene therapy for Alzheimer’s — tau-targeted IND clears
Voyager Therapeutics received IND clearance from the FDA for VY-1706, an investigational gene therapy targeting intracellular and extracellular tau for Alzheimer’s disease. The company said the...
Clinical trial starts and platform scale — $53M Series A for immune profiling
IMU Biosciences closed an expanded £40 million ($53.9 million) Series A round to scale its high-definition immune profiling technology. The financing follows an earlier January close and brings...
Pancreatic cancer survival jump in Phase 3
Revolution Medicines’ daraxonrasib delivered a major survival improvement in previously treated metastatic pancreatic ductal adenocarcinoma, based on results from the Phase 3 RASolute 302 study...
Sickle-cell PRC2 inhibitor derailed by FDA cancer-risk concerns
Fulcrum Therapeutics halted development of its sickle cell disease candidate pociredir after the FDA raised heightened concerns about risks and benefits, the company said. Fulcrum’s decision...
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...