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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...
FDA reversal on rare pediatric gene therapy
The FDA will reconsider Regenxbio’s Hunter syndrome gene therapy application after the agency reversed course on whether the company needed additional placebo-controlled enrollment. Regenxbio said...
HHS pushes to speed early clinical trials
HHS unveiled a broad effort to speed up and modernize early-stage clinical trials, aiming to cut development timelines by six to 12 months. The push includes a pilot program focused on the...
NCCN expands adoption of MRD testing in bladder cancer
NCCN updated muscle-invasive bladder cancer guidance to include Natera’s Signatera ctDNA minimal residual disease test, supporting its use for risk stratification after cystectomy. The guideline...
Definium’s Phase 3 win for single-dose LSD in major depression
Definium Therapeutics reported positive top-line results from a first randomized, double-blind, placebo-controlled Phase 3 study of single-dose DT-120 (lysergide) in major depressive disorder. The...
CFO leadership changes across biotechs
A round of biotech and pharma finance leadership appointments landed across companies with active clinical programs and commercialization plans. CatalYm named Peter Garcia as CFO, bringing IPO and...
AI automation for clinical trial protocols
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. Medable said the system can...
CRISPR safety framework for intended and unintended edits
Researchers led by Professor Akitsu Hotta developed a CRISPR safety-evaluation framework aimed at assessing both intended and unintended mutations after gene editing delivered via lipid...
New antimicrobial peptides hidden inside prion proteins
University of Pennsylvania researchers used deep learning (APEX 1.1) to scan thousands of prion and prion-like proteins and identify more than 1,000 candidate antimicrobial peptides termed...
Bionyra emerges with TL1A-targeting antibody portfolio and $165M Series A
Bionyra Pharma launched with a $165 million oversubscribed Series A to develop antibodies with extended half-lives targeting TL1A and related inflammatory pathways. The startup said it has a...
FDA accelerates rare-disease gene therapy reconsideration for Hunter syndrome
Regulators reversed course again on Regenxbio’s childhood gene therapy for Hunter syndrome, setting up a new resubmission for RGX-121. Regenxbio said FDA staff now consider the company’s existing...