Get the Daily Brief
Latest Biotech News
Lyell launches head‑to‑head CAR‑T trial — first direct test against marketed products
Cell therapy developer Lyell announced the start of a first‑of‑its‑kind trial that will test its experimental CAR‑T product directly against marketed CAR‑T therapies. The randomized design pits...
Ultragenyx cuts 10% as FDA manufacturing and trial setbacks press cost plan
Ultragenyx announced a workforce reduction of roughly 130 employees (about 10% of staff) as part of a restructuring aimed at returning the company to profitability in 2027. The layoffs follow a...
PTC withdraws Translarna US bid — FDA doubts sufficiency of evidence
PTC Therapeutics withdrew its US filing for Translarna (ataluren) for nonsense‑mutation Duchenne muscular dystrophy after the FDA signaled that the submitted data were unlikely to meet the...
Quantx closes $85M series B to push oral STAT6 and IL‑17 programs to clinic
Quantx Biosciences raised an $85 million Series B to advance two oral immunology candidates — a STAT6 inhibitor and an IL‑17 inhibitor — into clinical trials. The oversubscribed round funds...
Australia launches world‑first pediatric mRNA brain‑cancer vaccine trial
Australia has opened the Paedneo‑Vax trial, the first multisite pediatric study testing individualized mRNA vaccines tailored to each child’s tumor. Funded by Providence Therapeutics, the...
Anterior raises $40M — AI to automate care approvals for health plans
Anterior closed a $40 million financing round to scale its AI platform that automates administrative prior‑authorization and care‑approval workflows for health plans. The company says the system...
FDA nixes Disc Medicine’s porphyria drug — expedited voucher route fails
The FDA rejected Disc Medicine’s bitopertin application for porphyria, citing uncertainties about the link between the blood biomarker used in trials and clinical benefit. The agency’s decision...
BridgeBio’s oral FGFR3 drug clears Phase III — adds oral option for achondroplasia
BridgeBio reported positive top-line results from Propel 3: oral infigratinib improved annualized height velocity versus placebo in children with achondroplasia and achieved significant secondary...
FDA refuses to file Moderna’s flu vaccine — company and regulators at odds
The FDA issued a refuse-to-file for Moderna’s next‑generation mRNA influenza vaccine, surprising the company after months of dialogue. Moderna says it provided additional supporting analyses...
Vertex’s CRISPR drug rebounds — Casgevy sales more than triple
Vertex reported a strong commercial rebound for Casgevy, the CRISPR‑based gene editing therapy marketed with CRISPR Therapeutics, with sales more than tripling sequentially. Management framed the...
Exact Sciences posts Q4 beat — shareholders to vote on $23B Abbott deal
Exact Sciences reported fourth‑quarter revenue of $878.4 million, up 23% year‑over‑year and ahead of analyst estimates, driven by screening product momentum and growth in precision oncology...
All of Us hits 1 million participants — NIH achieves representative cohort
The NIH’s All of Us research program reached its long‑term enrollment goal of 1 million diverse participants, delivering the promised representative cohort for precision medicine research. NIH...
Lyell launches head‑to‑head CAR‑T trial — first test against marketed therapies
Lyell Immunopharma initiated a first‑of‑its‑kind clinical trial testing its experimental CAR‑T therapy directly against marketed counterparts, setting up a comparative study of efficacy and...
Quantx raises $85M — funds oral STAT6 and IL‑17 programs
Quantx Biosciences closed an oversubscribed $85 million Series B to advance two oral immunology candidates: a STAT6 inhibitor and an IL‑17 inhibitor. The financing will support IND‑enabling work...
Anterior grabs $40M — AI to speed care approvals for payers
Anterior secured $40 million to scale an AI platform that automates administrative clinical work for health plans, aiming to compress care‑approval timelines from weeks to minutes. MedCity News...
FDA trims boxed warnings on menopausal HRTs — risk statements narrowed
The FDA removed boxed warnings tying menopausal hormone replacement therapies to increased risks of cardiovascular disease, breast cancer and probable dementia for six HRT products. The agency...
FDA rejects Disc’s therapy: voucher fast-track falters
The FDA formally rejected Disc Medicine’s bitopertin for porphyria after questioning the link between the blood biomarker used in trials and clear clinical benefit. Disc, an early recipient of the...
BridgeBio’s oral drug clears Phase 3 — oral rival to Voxzogo
BridgeBio reported positive top‑line results from Propel 3: oral infigratinib achieved statistically significant gains in annualized height velocity in children with achondroplasia versus placebo....
FDA refuses to file Moderna’s flu vaccine — company blindsided
The FDA issued a refusal‑to‑file letter for Moderna’s next‑generation mRNA influenza vaccine, a move the company says came unexpectedly after years of engagement with regulators. Moderna...
Ultragenyx trims staff 10% as FDA stalls gene‑therapy plans
Ultragenyx announced a programmatic restructuring that will eliminate roughly 130 jobs—about 10% of its workforce—after a year of clinical setbacks and regulatory friction. Management tied the...