Get the Daily Brief
Latest Biotech News
European investors form life‑sciences coalition — capital push for biotech
Leading venture firms and research institutions launched the European Life Science Coalition to mobilize private and public capital for the continent’s biotech sector. Members managing over €24...
NIH All of Us reaches 1M participants — dataset hits diversity target
The NIH announced that the All of Us Research Program achieved its goal of collecting genetic and health data from 1 million Americans representative of national diversity. The milestone provides...
Quantx closes $85M Series B — oral immunology drugs move toward clinic
Quantx Biosciences raised an $85 million Series B to advance two oral immunology candidates—an oral STAT6 inhibitor and an IL‑17 oral inhibitor—into clinical trials. The oversubscribed round will...
Ultragenyx cuts 10% of staff amid manufacturing and regulatory setbacks
Ultragenyx announced a workforce reduction of about 130 roles, roughly 10% of its headcount, as part of a restructuring aimed at reaching profitability in 2027. The move follows disappointing...
FDA refuse-to-file — Moderna’s mRNA flu program stumbles
The FDA issued a refuse‑to‑file for Moderna’s next‑generation mRNA influenza vaccine, halting the agency review the company expected and prompting scrutiny of trial design and comparator choice....
Rare‑disease approvals derail: Disc and PTC hit regulatory roadblocks
The FDA rejected Disc Medicine’s bitopertin for a rare porphyria disorder, citing uncertainties about the surrogate biomarker that underpinned the company’s efficacy claims. The decision came even...
BridgeBio’s win — infigratinib clears Phase III hurdle in achondroplasia
BridgeBio announced positive top‑line results from a global Phase III study of oral infigratinib in children with achondroplasia, meeting the trial’s primary endpoint for accelerated annualized...
Lyell launches head‑to‑head CAR‑T trial — experimental therapy to face marketed rivals
Cell therapy developer Lyell has initiated a first‑of‑its‑kind trial that tests its experimental CAR‑T product directly against marketed CAR‑T therapies. The head‑to‑head design aims to generate...
Ribo and Madrigal team up: $60M upfront to push siRNA portfolio in MASH
Suzhou Ribo Life Science and Madrigal Pharmaceuticals agreed a global licensing deal to develop six preclinical siRNA programs targeting metabolic dysfunction‑associated steatohepatitis (MASH)....
Quantx raises $85M to advance oral immunology candidates
Quantx Biosciences closed an oversubscribed $85 million Series B to advance two lead oral immunology programs: a STAT6 small‑molecule inhibitor and an IL‑17 oral inhibitor. The financing positions...
CareDx readies AlloHeme launch after validation shows early relapse lead time
CareDx reported validation data for AlloHeme, its cell‑free DNA sequencing assay for allogeneic hematopoietic cell transplant (HCT) surveillance, demonstrating 85% sensitivity and 92% specificity...
All of Us hits 1 million: NIH milestone expands precision‑medicine resource
NIH’s All of Us research program announced it has reached its goal of collecting genetic and health data from 1 million Americans representative of the country’s diversity. The cohort includes...
World‑first pediatric mRNA brain‑cancer trial launches in Australia
Australia has started the Paedneo‑Vax trial, the first multisite pediatric study to evaluate individualized mRNA vaccines tailored to each child’s brain tumor. Funded by Providence Therapeutics...
Inhaled gene therapy shows early promise in lung cancer delivery
Researchers reported early results from the first inhalable gene‑therapy program for lung cancer, demonstrating feasibility of delivering therapeutic nucleic acids via aerosolized formulations....
FDA refuses to review Moderna flu shot — company says letter blindsided team
The FDA issued a refusal-to-file for Moderna’s next-generation mRNA influenza vaccine, stopping the agency from even beginning a formal review. Moderna’s executives, including President Stephen...
NIAID told to drop 'biodefense' and 'pandemic preparedness' — agency shifts funding focus
Senior NIH leadership instructed the National Institute of Allergy and Infectious Diseases (NIAID) to remove the terms “biodefense” and “pandemic preparedness” from its website and to reprioritize...
BridgeBio’s oral FGFR3 inhibitor posts Phase 3 win — files planned this year
BridgeBio reported positive top-line results from its global Phase 3 Propel 3 trial of infigratinib in children with achondroplasia, the most common genetic form of dwarfism. The oral FGFR3...
PTC withdraws US approval bid for Translarna — FDA doubts clinical benefit
PTC Therapeutics withdrew its U.S. filing for Translarna (ataluren) after the FDA signaled the submitted data were unlikely to meet the agency’s standard for substantial evidence of effectiveness...
Ultragenyx cuts 10% of workforce as FDA presses on gene therapy review
Ultragenyx announced a workforce reduction of about 130 people (roughly 10%) amid restructuring intended to reach profitability by 2027. The company reported that the FDA again delayed approval...
Lyell starts first head-to-head CAR‑T trial... testing new cell therapy against market leaders
Lyell Immunopharma initiated a first-of-its-kind randomized trial that will compare its experimental CAR‑T therapy directly against established marketed CAR‑T products. The head-to-head design...