Get the Daily Brief
Latest Biotech News
FDA regulatory turnaround for rare disease gene therapy
Regenxbio said the FDA will reconsider its Hunter syndrome gene therapy after the agency previously rejected the application. Regenxbio’s update follows another apparent policy reversal after...
US federal push to speed up early clinical trials
HHS unveiled a plan aimed at speeding early-stage clinical trials by 6 to 12 months, targeting the development bottleneck from IND to first patient dosing. The initiative is described as part of a...
AI-driven drug discovery partnerships
Insilico Medicine and SK Biopharmaceuticals announced a $2.5 billion AI-enabled collaboration targeting neuroimmune disorders in the CNS, formalized during BIO 2026. Insilico will apply its...
Clinical and guideline update for tumor-informed MRD testing
NCCN updated muscle-invasive bladder cancer guidance to include Natera’s Signatera minimal residual disease test as a tumor-informed ctDNA option after cystectomy. In the guideline update,...
Biotech financing and cash infusions
Bionyra emerged from stealth with $165 million in funding to advance three extended-half-life antibodies aimed at chronic inflammation. The startup was co-founded by Sofinnova Partners and...
Pharma–policy and compliance fallout in 340B pricing
Hospital groups challenged Eli Lilly’s decision to withhold 340B discounts from hospitals that refuse to submit claims data, calling the policy unlawful. The dispute centers on whether Lilly can...
Phase 3 success in immunology acquisition pipeline
Merck reported a positive Phase 3 result for tulisokibart, an anti-TL1A antibody acquired through its $10.8 billion Prometheus deal, in an ulcerative colitis induction-only study. The company said...
AI-enabled trial operations technology
Medable launched its Digital Data Flow (DDF) Agent to convert static clinical trial protocols into machine-readable, standardized data structures in CDISC USDM 4.0 JSON. The company says the...
Biotech leadership and CFO appointments for capital-raising momentum
CatalYm, eGenesis, and Hansa Biopharma made CFO changes as companies navigate IPO recovery, clinical progression, and capital raising. CatalYm appointed Peter Garcia as CFO, bringing experience...
AI dealmaking in neuroimmune drug discovery
Insilico Medicine and SK Biopharmaceuticals announced a $2.5 billion AI-driven collaboration at BIO 2026 to discover neuroimmune disorder candidates for CNS indications. Insilico will apply its...
Big pharma bets on immunology after $10.9B acquisition
AbbVie agreed to buy Apogee Therapeutics for $10.9 billion in cash, a move aimed at bolstering AbbVie’s immunology pipeline with long-acting assets including zumilokibart, an IL-13 inhibitor being...
Regulatory reversal: FDA reopens Regenxbio’s Hunter gene therapy path
The FDA will reconsider approval for Regenxbio’s childhood gene therapy Navsunli (RGX-121) after the agency recently reversed key positions. Regenxbio said FDA staff acknowledged its existing...
Clinical setbacks in colorectal cancer drug under FDA review
Exelixis reported that its zanzalintinib (as the next franchise following Cabometyx) failed to hit a primary endpoint in a colorectal cancer trial while the FDA review continues. The setback adds...
Phase 3 win supports FDA thinking in hereditary angioedema
Intellia reported additional positive Phase 3 results for lonvoguran ziclumeran (lonvo-z) in hereditary angioedema, extending the readout beyond the primary endpoint announced earlier in the year....
Major depression: single-dose LSD therapy clears another Phase 3 hurdle
Definium Therapeutics said its DT-120 (lysergide, administered as a 100 µg orally disintegrating tablet) significantly improved major depressive disorder symptoms in a Phase 3 trial, pushing the...
CAR-T safety: wearable monitoring targets early CRS detection
Mount Sinai researchers reported evidence that wearable health monitoring devices could flag cytokine release syndrome (CRS) earlier in CAR-T-treated multiple myeloma patients. Published in JCI...
Regulatory expansion of MRD testing in muscle-invasive bladder cancer
NCCN updated its muscle-invasive bladder cancer guidance to include Natera’s Signatera ctDNA minimal residual disease testing. The guideline recommendation ties MRD status to Genentech’s Tecentriq...
Clinical evidence in pediatric hyperthyroidism treatment target
Ethyreal Bio reported preclinical data for ETHY-001, a half-life-extended monoclonal antibody targeting the thyroid-stimulating hormone receptor (TSHR) to prevent production of pathogenic...
AI automation for clinical trial protocol standardization
Medable launched its Digital Data Flow (DDF) Agent to convert static clinical trial protocols into machine-readable structured data in CDISC USDM 4.0 JSON format. The company said the agent...
Eczema and wider immunology M&A deal
AbbVie agreed to acquire Apogee Therapeutics for $10.9 billion in cash, betting that Apogee’s long-acting IL-13 inhibitor zumilokibart can expand in immunology beyond atopic dermatitis. The deal...