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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...
AbbVie bets on long-acting immunology with $10.9B Apogee acquisition
AbbVie agreed to buy Apogee Therapeutics in a deal valued at $10.9 billion in cash, positioning the pharma company to expand in long-acting immune therapies. The transaction gives AbbVie Apogee’s...
Merck’s anti–TL1A antibody logs Phase 3 win in ulcerative colitis
Merck said its anti-TL1A antibody tulisokibart (developed from the Prometheus Biosciences acquisition) achieved a positive Phase 3 result in ulcerative colitis. In the ATLAS-UC induction-only...
Definium’s single-dose LSD therapy clears Phase 3 bar in major depression
Definium reported that its single-dose LSD-inspired therapy DT120 produced clinically meaningful improvement in a Phase 3 trial for major depressive disorder. Six weeks after dosing, patients...
FDA and pediatric trial acceleration plan
The U.S. Department of Health and Human Services outlined efforts designed to speed up early-stage clinical trials by 6 to 12 months, as the biotech community convenes for BIO 2026 in San Diego....
LSD-focused investor response: Definium’s latest Phase 3 data drive market expectations
Definium’s latest Phase 3 topline results reinforced investor confidence in DT120 as the biotech described the dataset as its best to date for a pivotal depression program. The company said the...
Intellia’s CRISPR HAELO data advances BLA path after secondary endpoint success
Intellia’s CRISPR therapy lonvoguran ziclumeran (lonvo-z) drew further market momentum after additional Phase 3 readouts in hereditary angioedema. The company said the HAELO trial met the primary...
Bionyra launches with $165M to pursue TL1A-driven immune therapies
Bionyra Pharma emerged from stealth with $165 million to develop immune disorder therapeutics centered on TL1A. The startup, co-founded by Sofinnova Partners and Frédéric Marrache (formerly...
Lilly and BioArctic form neurodegeneration collaboration with Braintransporter tech
BioArctic and Eli Lilly announced a research and collaboration agreement to build a new neurodegeneration candidate. BioArctic will generate the therapy by combining its Braintransporter...
Nura Bio raises $73.8M to advance SARM1 inhibitors into early clinical testing
Nura Bio secured a $73.8 million Series B round to fund two programs through early clinical development targeting SARM1 for neurodegeneration. The company said it will use the funding to support...
Big biotech deal – AbbVie’s bet on long-acting immunology drugs
AbbVie agreed to acquire Apogee Therapeutics for $10.9 billion in cash, a move aimed at building out its pipeline in inflammatory diseases. The purchase adds Apogee’s long-acting immunology...