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FDA reverses on Regenxbio’s Hunter syndrome gene therapy, signaling accelerated review path
The FDA will reconsider Regenxbio’s childhood gene therapy for Hunter syndrome after a recent rejection, according to Regenxbio. The company said the agency now acknowledges its existing Navsunli...
Insilico and SK Biopharmaceuticals launch $2.5B neuroimmune AI partnership at BIO
Insilico Medicine and SK Biopharmaceuticals announced an AI-driven collaboration worth more than $2.5 billion to discover neuroimmune disorder drug candidates for central nervous system targets....
FDA adds MRD testing guidance: Natera Signatera included for muscle-invasive bladder cancer
The National Comprehensive Cancer Network updated muscle-invasive bladder cancer guidance to include Natera’s tumor-informed Signatera minimal residual disease test. Under the update, Genentech’s...
FDA accelerates early clinical trial timelines via HHS initiative
HHS announced a plan to speed up and expand early-stage clinical trials, with the goal of reducing development timelines by 6 to 12 months. The initiative comes as the Trump administration...
Pfizer’s first Seagen ADC hits setback in Phase 3 NSCLC
Pfizer said its first new antibody-drug conjugate following the $43 billion Seagen acquisition, sigvotatug vedotin, failed a Phase 3 trial in non-small cell lung cancer. The readout marks another...
Genomics and single-cell AI advance: new framework aims at gene regulatory network inference
Researchers introduced a deep learning approach, ZINB-GRAN, designed to reconstruct gene regulatory networks from single-cell RNA sequencing data by integrating learned global network topology...
Single-cell to cell-to-cell mapping: Nature Biotechnology pushes ‘interactome’ tooling
Nature Biotechnology published work outlining technologies needed to map and engineer the human cell–cell interactome, with an emphasis on linking cellular communication to functional biology. The...
Medable launches AI agent to convert clinical protocols into machine-readable data
Medable launched its DDF Agent, a software tool that converts static clinical trial protocols into machine-readable structured data in CDISC USDM 4.0 JSON format. The company said the system...
Natera and transplant monitoring expand: Pirche and Natera collaborate on transplant risk and dd-cfDNA monitoring
Pirche announced a collaboration with Natera to connect pre-transplant risk stratification with post-transplant monitoring using Natera’s Prospera dd-cfDNA test. The companies plan to combine...
M&A: AbbVie’s $10.9B bet on IL-13 and long-acting immunology
AbbVie agreed to acquire Apogee Therapeutics for $10.9 billion in cash, paying $135.11 per share, a nearly 50% premium. The deal targets zumilokibart (APG777), a subcutaneous, half-life extended...
MDD late-stage: Definium’s single-dose LSD shows Phase 3 benefit
Definium reported positive top-line results from its Phase 3 Emerge trial of DT-120 (lysergide) in major depressive disorder, using a single dose delivered as an orally disintegrating tablet (100...
Regulatory shift: FDA reverses course for Regenxbio’s Hunter syndrome gene therapy
Regenxbio said the FDA will reconsider its application for Navsunli (RGX-121), after the agency had rejected the company’s bid for accelerated approval for Hunter syndrome in February. Regenxbio...
Dealmaking: Insilico and SK Biopharmaceuticals expand AI drug discovery for neuroimmune targets
Insilico Medicine and SK Biopharmaceuticals announced a collaboration at BIO 2026 that could total more than $2.5 billion, aiming to accelerate discovery of therapeutics for neuroimmune disorders...
Clinical diagnostics and coverage: NCCN adds Natera Signatera MRD for muscle-invasive bladder cancer
Natera’s Signatera minimal residual disease (MRD) test gained formal inclusion in new National Comprehensive Cancer Network (NCCN) guidelines for muscle-invasive bladder cancer, creating an...
Corporate finance and runway: Bionyra emerges with $165M to build next-gen TL1A immune drugs
Bionyra Pharma launched from stealth with $165 million in funding and a portfolio of three extended-half-life biologics targeting TL1A signaling, alone and in combination. The company was formed...
Corporate leadership: Sanofi R&D head exits as Paulo Fontoura steps in at AI-linked startup
Sanofi said its R&D head Houman Ashrafian will depart, with Paulo Fontoura—chief medical officer at Xaira Therapeutics—set to take over as global head of R&D starting Sept. 1. The move comes under...
Rare disease policy and trial operations: HHS moves to speed Phase 1 trials
HHS unveiled a plan aimed at speeding Phase 1 clinical trials by reducing development timelines by 6 to 12 months. The effort includes a pilot program intended to streamline processes for...
Genetics and cancer risk monitoring: AI trust framework enhances cancer subtyping reliability
A new AI framework targets one of the main failure modes in medical machine learning: uncertainty quantification in cancer subtyping. The work, framed around recognizing when a model encounters...
Biotech innovation: Abiologics uses AI to design mirror-image proteins
Abiologics, the Flagship Pioneering startup, said it has used artificial intelligence to design proteins built from mirror-image amino acid components, a strategy intended to increase durability...
Biopharma M&A and pipeline expansion
AbbVie agreed to buy Apogee Therapeutics for $10.9 billion in cash, staking on long-acting immunology assets led by IL-13–targeting antibody zumilokibart. The acquisition is structured to bolster...