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Abivax ulcerative colitis: Efficacy lands, but cancer cases trigger investor pullback
Abivax’s Phase 3 Abtect maintenance trial of obefazimod (miR-124 enhancer) in ulcerative colitis reported strong efficacy, but a small number of cancer cases led to a sharp stock drop and...
Genomics and imaging diagnostics: Foundation Medicine CDx cleared for Pfizer’s Talzenna plus Xtandi
The FDA cleared Foundation Medicine’s FoundationOne CDx assays as companion diagnostics for identifying eligible patients for Pfizer’s Talzenna (talazoparib) plus Xtandi (enzalutamide) in...
Regulatory maneuvering: FDA provides flexibilities for cell and gene therapy developers to use prior knowledge
The FDA’s Center for Biologics Evaluation and Research (CBER) issued draft guidance clarifying how cell and gene therapy sponsors can leverage prior knowledge across clinical, nonclinical, and...
Antibody delivery physics: Vanderbilt-Stanford spatial single-cell platform maps stromal barriers
A Vanderbilt University Medical Center and Stanford University team introduced a spatial single-cell pharmacology (SSP) platform designed to visualize drug–tumor interactions inside human solid...
Oncology translational biomarkers: Spatial transcriptomics predicts docetaxel benefit in prostate cancer
Researchers presented a spatial transcriptomics–guided biomarker approach at ASCO 2026 that predicted which metastatic hormone-sensitive prostate cancer patients are most likely to benefit from...
Sickle cell and oncology safety class caution: regulatory constraints continue to reshape PRC2 approaches
The FDA-driven reversal of Fulcrum’s SCD program highlighted how class effects in epigenetic modulation can tighten clinical development pathways. Fulcrum’s pociredir discontinuation was...
Diagnostics rollout: Veracyte launches Prosigna LDT in the US after OPTIMA trial support
Veracyte launched its Prosigna Breast Risk of Recurrence assay as a laboratory-developed test (LDT) in the U.S., citing Phase 3 OPTIMA trial evidence that supports safely guiding adjuvant therapy...
Therapeutics manufacturing and analytics: NanoMosaic pairs with Solid Biosciences on AAV titer assessment and capsid analytics
NanoMosaic and Solid Biosciences signed a comarketing agreement focused on AAV genetic medicine manufacturing analytics, pairing NanoMosaic’s Tessie platform with Solid’s Polaris-101 capsid...
Pancreatic cancer — RAS pathway inhibition in Phase 3
Revolution Medicines reported Phase 3 results for daraxonrasib (RASolute 302) showing a substantial survival benefit in previously treated, metastatic pancreatic ductal adenocarcinoma. The trial,...
Sickle cell — FDA flags malignancy risk for PRC2 inhibitor
Fulcrum Therapeutics ended development of pociredir, its PRC2 inhibitor for sickle cell disease, after the FDA raised heightened concerns about risks and benefits. The company disclosed at an FDA...
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...