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CareDx plans AlloHeme launch — assay spots relapse with 41-day lead
CareDx disclosed validation results for AlloHeme, its allogeneic hematopoietic cell transplant (HCT) surveillance cfDNA assay, from the observational ACROBAT study: sensitivity 85%, specificity...
PacBio posts revenue beat; long‑read push gains clinical traction
Pacific Biosciences reported Q4 revenue of $44.6 million, a 14% year‑over‑year increase that beat Street estimates, and full‑year 2025 revenue of $160.0 million. The company flagged record...
Ribbon opens early access to cell‑free long‑DNA — GMP‑friendly supply for CGT
Ribbon Bio launched an early‑access program for its cell‑free manufacturing of long synthetic DNA, offering linear molecules up to ~11 kb with reported accuracy above 90% and average ~95% for...
Thermo Fisher links PPD to Datavant — real‑world data linkage expanded
Thermo Fisher Scientific’s PPD clinical research unit struck a strategic partnership with Datavant to enable privacy-preserving tokenized linkage of de‑identified research datasets with real‑world...
Quantx raises $85M to start trials — oral STAT6 and IL‑17 programs
Quantx Biosciences closed an oversubscribed $85 million Series B to advance two oral immunology programs into the clinic: a STAT6 small‑molecule inhibitor and an IL‑17 oral inhibitor. The company...
Microbiotica’s live microbiome shows phase Ib remission signal in UC
Microbiotica reported positive Phase Ib data for MB‑310, an oral live biotherapeutic for ulcerative colitis: 12 of 19 treated patients achieved clinical remission versus 3 of 10 on placebo, with...
FDA refuses to review Moderna flu shot — agency cites trial design
The U.S. Food and Drug Administration issued a rare refusal-to-file for Moderna’s mRNA influenza vaccine (mRNA-1010), citing deficiencies in the pivotal trial’s comparator and overall study...
BridgeBio's oral dwarfism drug clears pivotal test — FDA filing planned
BridgeBio reported positive top-line results from Propel 3, a global Phase 3 trial of oral infigratinib in children with achondroplasia, meeting the primary endpoint for annualized height velocity...
Madrigal bets big on siRNA — $60M upfront, $4.4B potential deal with Ribo
Madrigal Pharmaceuticals struck a licensing and development agreement with Suzhou Ribo Life Science (Ribocure) to license six preclinical siRNA programs targeting metabolic dysfunction-associated...
CareDx’s AlloHeme flags relapse weeks early — high sensitivity and specificity
CareDx presented validation data from the observational ACROBAT study showing its AlloHeme cell‑free DNA assay for allogeneic hematopoietic cell transplant (HCT) surveillance achieved 85%...
Seres pauses lead program and trims workforce — microbiome strategy shifts
Microbiome specialist Seres Therapeutics announced a strategic reboot that pauses its flagship program and cuts about 30% of staff, refocusing resources toward earlier-stage immunology research....
Ribbon Bio launches cell‑free long‑DNA service — clinics and gene therapy makers targeted
Ribbon Bio opened an early‑access program for its new cell‑free long DNA manufacturing process, offering linear constructs up to ~11 kb with reported average accuracy near 95% and guaranteed...
Oncolytic virus injection reprograms glioblastoma microenvironment — single‑dose immune effect
A collaborative team from Mass General Brigham and Dana‑Farber reported that a single intratumoral injection of a genetically engineered oncolytic virus can remold the glioblastoma tumor...
Microbiotica posts positive Phase Ib data in ulcerative colitis — oral live therapeutic shows remission
Microbiotica reported Phase Ib results for MB‑310, an orally delivered live biotherapeutic for ulcerative colitis, showing 12 of 19 treated patients reached clinical remission versus 3 of 10 on...
Thermo Fisher, Datavant tie up — encrypted tokens to link RWD across trials and registries
Thermo Fisher Scientific’s PPD clinical research business announced a strategic partnership with Datavant to enable privacy‑preserving linkage of de‑identified real‑world data (RWD) across more...
Dewpoint nominates MYC condensate modulator — small molecule targets transcriptional condensates
Dewpoint Therapeutics announced a development candidate in its MYC program — a first‑in‑class small molecule designed to modulate aberrant biomolecular condensates that organize oncogenic...
FDA refuses to review Moderna flu shot: agency cites trial design
The U.S. Food and Drug Administration has refused to begin review of Moderna’s mRNA influenza vaccine application, flagging problems with the trial’s control arm rather than safety or efficacy...
BridgeBio’s oral dwarfism drug wins Phase 3 — company eyes approval push
BridgeBio reported that its oral FGFR inhibitor infigratinib met the primary and key secondary endpoints in a pivotal Phase 3 study for achondroplasia, producing statistically significant...
Madrigal inks Ribo siRNA pact — $60M up front, $4.4B in milestones
Madrigal Pharmaceuticals struck a global licensing agreement with Suzhou Ribo Life Science and Ribocure granting Madrigal rights to six preclinical siRNA programs targeting metabolic...
QuidelOrtho waits on FDA for Lex Dx clearance — acquisition conditional
QuidelOrtho told investors that its planned acquisition of UK molecular system developer Lex Diagnostics depends on imminent FDA clearance of Lex’s point‑of‑care PCR Velo system and the agency’s...