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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...
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...