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Quantx raises $85M to advance oral STAT6 and IL‑17 programs
Quantx Biosciences closed an $85 million Series B to finance IND-enabling work and early clinical trials for two oral immunology candidates: a STAT6 inhibitor and an IL‑17 inhibitor. The raise,...
CareDx’s AlloHeme shows high sensitivity, 41‑day lead time — commercial launch planned
CareDx reported validation data from the ACROBAT observational study showing its AlloHeme cell‑free DNA assay detected mixed chimerism and relapse signals in allogeneic hematopoietic cell...
European VCs form coalition — new push to keep biotech funding and exits in the EU
Leading European life‑science investors including Forbion, Novo Holdings and Sofinnova launched the European Life Science Coalition to mobilize private and public capital for the region’s biotech...
Gilead buys global rights to Genhouse oral cancer drug — $80M upfront
Gilead Sciences acquired global rights to an oral oncology candidate from China‑based Genhouse Bio for $80 million upfront, expanding Gilead’s small‑molecule oncology footprint. The deal follows...
FDA refusal halts Moderna flu review — mRNA vaccine program in limbo
The FDA issued a refusal-to-file for Moderna’s mRNA influenza vaccine, prompting an immediate public dispute between the company and regulators. Moderna said the agency’s letter cited procedural...
BridgeBio’s oral drug boosts growth in children — Phase 3 win sets up FDA filing
BridgeBio announced positive top-line results from Propel 3: oral infigratinib produced a statistically significant increase in annualized height velocity in children with achondroplasia. The...
Ultragenyx cuts 10% as late‑stage failures force restructuring — gene therapy review stalled
Ultragenyx disclosed a strategic restructuring that includes laying off roughly 10% of staff after a year of disappointing late‑stage trial results. The company reported that two brittle bone...
FDA removes black‑box warnings from six menopausal therapies — labeling overhaul
The FDA removed the most severe 'black box' warnings related to breast cancer, cardiovascular disease and dementia from labeling for six hormone replacement therapies used in menopause....
PacBio posts 14% Q4 revenue rise — clinical customers and Europe drive growth
Pacific Biosciences reported a 14% year‑over‑year revenue increase in Q4, attributing gains to expanded adoption by clinical customers and stronger demand in Europe. The company said consumables...
CareDx’s AlloHeme posts strong validation — company eyes 2027 commercial launch
CareDx released validation data for AlloHeme, its allogeneic hematopoietic cell transplant surveillance assay, showing 85% sensitivity, 92% specificity and a median 41‑day lead time in detecting...
Quantx closes $85M Series B — oral STAT6 and IL‑17 programs move to clinic
Quantx Biosciences raised $85 million in an oversubscribed Series B to advance two oral immunology candidates: a STAT6 inhibitor and an IL‑17 inhibitor. The company said proceeds will underwrite...
Policy shakeup at HHS and FDA — RFK Jr. tenure and Prasad scrutiny reshape regulation
A year into Robert F. Kennedy Jr.'s leadership at HHS, the agency has enacted sweeping personnel and policy changes that critics say have disrupted established scientific norms. The tenure...
Madrigal buys into siRNA MASH pipeline — $60M up front, $4.4B potential
Madrigal Pharmaceuticals struck a licensing deal with Ribo Life Science (and Ribocure) to acquire global rights to six preclinical siRNA programs targeting metabolic dysfunction‑associated...
Ribbon Bio launches cell‑free long‑DNA service — targets nucleic acid therapeutics
Ribbon Bio unveiled an early‑access program for its cell‑free long DNA manufacturing process, offering synthetic linear DNA products up to ~11 kb with high reported accuracy and no bacterial...
FDA refuses Moderna flu review — industry warns of chilling precedent
The U.S. Food and Drug Administration issued a refusal-to-file (RTF) for Moderna’s mRNA influenza application, prompting immediate pushback from the company and alarm across the vaccine sector....
BridgeBio phase 3 win — infigratinib readies for FDA filing
BridgeBio reported positive top-line results from Propel 3, a global Phase 3 trial of oral infigratinib in children with achondroplasia, meeting its primary endpoint for increased annualized...
MAHA movement outlines anti‑vaccine strategy — policy shifts accelerate
Reports and investigative coverage show the Make America Healthy Again (MAHA) movement and HHS leadership under Robert F. Kennedy Jr. have advanced policy changes that reduce recommended childhood...
Ultragenyx cuts 10% as FDA stalls gene therapy approval
Ultragenyx announced a strategic restructuring that will remove about 10% of its workforce and refocus resources after two failed late‑stage trials and a delayed gene‑therapy approval pathway. The...
CareDx eyes launch of AlloHeme transplant surveillance test
CareDx disclosed validation data from the ACROBAT study showing its AlloHeme cell‑free DNA assay for allogeneic hematopoietic cell transplant surveillance achieved 85% sensitivity and 92%...
Ribbon rolls out cell‑free long‑DNA service — aims at nucleic‑acid developers
Ribbon Bio launched an early‑access program for a cell‑free manufacturing process that synthesizes long linear and circular DNA with claimed high accuracy, addressing demand from cell and gene...