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FDA rejects Disc’s porphyria drug: biomarker link questioned
The FDA has refused approval for Disc Medicine’s bitopertin, rejecting the company’s rare‑disease submission over uncertainties that the blood biomarker used as the trial’s efficacy endpoint...
FDA refuses to file Moderna’s flu shot — company says it was blindsided
The FDA issued a refusal‑to‑file for Moderna’s next‑generation mRNA influenza vaccine, prompting sharp pushback from company leaders who say the agency had previously signaled willingness to...
Lyell launches head‑to‑head CAR‑T trial versus marketed therapies
Lyell Immunopharma has opened a first‑of‑its‑kind CAR‑T clinical trial that will test its experimental cell therapy directly against marketed CAR‑T products. The randomized, comparative design...
Vertex’s CRISPR therapy rebounds — Casgevy sales surge
Vertex reported a sharp uptick in sales of Casgevy, its CRISPR‑based, gene‑edited therapy developed with CRISPR Therapeutics, driving a notable improvement in the company’s recent earnings...
Exact Sciences posts 23% Q4 revenue gain — Abbott acquisition heads to vote
Exact Sciences reported fourth‑quarter revenue of $878.4 million, a 23% year‑over‑year increase driven by growth in its cancer‑screening business and precision oncology testing. CEO Kevin Conroy...
BridgeBio’s oral infigratinib matches Voxzogo on height — adds pill option
BridgeBio reported data showing its oral FGFR3 inhibitor infigratinib matched the height outcomes achieved by Voxzogo (vosoritide) in achondroplasia patients, while offering an oral dosing option....
Quantx raises $85M to advance oral immunology drugs into trials
Quantx Biosciences closed an oversubscribed $85 million Series B to accelerate two oral immunology candidates: a STAT6 small‑molecule inhibitor and an oral IL‑17 inhibitor. The company plans to...
Anterior grabs $40M — AI to speed payer approvals to minutes
Anterior raised $40 million to expand its AI platform that automates administrative clinical workflows for health plans, with the stated goal of compressing care‑approval cycles from weeks to...
Australia launches world‑first pediatric individualized mRNA brain‑cancer trial
Australia has launched Paedneo‑Vax, the first multisite pediatric trial testing individualized mRNA vaccines for aggressive childhood brain tumors. Funded by Providence Therapeutics, the...
Nektar, Evommune post positive Phase II readouts in atopic dermatitis
Nektar Therapeutics and Evommune reported positive Phase II results in atopic dermatitis, delivering data that supported upbeat investor reactions and subsequent financings covered in BioCentury’s...
FDA rejects Disc’s porphyria drug — biomarker link questioned
The FDA rejected Disc Medicine’s experimental porphyria therapy bitopertin, citing uncertainties about the blood-based biomarker used as the efficacy endpoint. The agency said the surrogate...
FDA refuse-to-file blindsides Moderna — flu program under scrutiny
The FDA issued a refuse-to-file letter for Moderna’s mRNA influenza vaccine, asserting concerns about trial design and the choice of comparator, and declined to proceed with a formal review....
Infigratinib phase III clears bar — BridgeBio adds oral option for achondroplasia
BridgeBio reported positive top-line results from its global phase III Propel 3 trial of oral infigratinib in children with achondroplasia, meeting growth and body-composition endpoints. The drug,...
All of Us reaches 1 million participants — diversity milestone for precision medicine
NIH’s All of Us research program has reached its target of collecting genetic and health-related data from one million Americans, the agency announced. The dataset aims to represent the country's...
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...