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CDMO and diagnostics deals: Fortrea pairs with SCTbio — Pillar, AstraZeneca expand into China
Fortrea signed a collaboration with Prague‑based SCTbio to offer combined clinical study and cell‑and‑gene therapy (CGT) manufacturing services, targeting developers that need integrated trial...
BioNTech’s CTLA‑4 wins survival — tolerability in question
BioNTech and OncoC4 reported a late‑stage win for their anti‑CTLA‑4 antibody, with the Phase 3 trial showing a greater than 50% reduction in risk of death. The lead dataset marks a major efficacy...
Mirum buys Bluejay for $620M — hepatitis D antibody joins rare‑disease portfolio
Mirum Pharmaceuticals agreed to acquire Bluejay Therapeutics for $620 million in cash and stock to secure brelovitug, a monoclonal antibody in late‑stage development for chronic hepatitis D (HDV)....
Dyne prepares FDA push after strong dystrophin gains in DMD
Dyne Therapeutics said its exon‑51 targeting candidate produced unprecedented dystrophin increases in a registrational cohort, prompting plans to seek accelerated FDA approval next year. The...
Structure’s oral GLP‑1 posts rival weight loss — nausea clouds outlook
Structure Therapeutics reported mid‑stage results showing its oral GLP‑1 candidate produced substantial weight loss—placebo‑adjusted averages in double‑digits at extended timepoints—putting the...
Pillar, AstraZeneca expand liquid‑biopsy rollout to China
Pillar Biosciences and AstraZeneca announced an expansion of their liquid‑biopsy collaboration into China to increase availability of plasma‑based tumor profiling kits at major clinical labs. The...
MRD advances as potential surrogate — lymphoma and AML data strengthen case
New data presented at ASH highlighted circulating tumor DNA (ctDNA)‑based and flow cytometry‑based minimal residual disease (MRD) assays as prognostic tools across blood cancers and as candidate...
Anito‑cel deep responses at ASH — Gilead, Kite position CAR‑T for broader launch
Gilead and partners reported deep and durable responses with anito‑cel in a pivotal multiple myeloma trial, with a high overall response rate and a substantial complete remission fraction in the...
Menin inhibitors show high early responses in AML — push to earlier lines
Kura Oncology and Kyowa Kirin reported early data for oral menin inhibitors showing a 73% complete response rate in newly‑diagnosed patients with specific acute myeloid leukemia subtypes. The...
Engineered‑bacteria implantable sensor enables wireless molecular tracking
Researchers in Turkey described an implantable biosensor that uses genetically engineered E. coli to detect molecular signals in vivo and transmit data wirelessly without external batteries. The...
Cogent’s bezuclastinib clears Phase 3 goal in advanced mastocytosis — regulatory filing planned
Cogent Biosciences reported that its Phase 3 study of bezuclastinib achieved the primary endpoint in patients with advanced systemic mastocytosis, including benefits in sicker patient subgroups....
Structure pill cuts weight up to 14%—nausea, vomiting rates mount
Structure Therapeutics reported robust mid‑stage efficacy for its small‑molecule GLP‑1 candidate aleniglipron, with patients on higher doses losing as much as 14.2% of body weight at 36 weeks. The...
Ascletis posts 7.7% weight loss in US oral GLP‑1 trial
China’s Ascletis reported phase 2 topline data from a U.S. study of ASC30, showing placebo‑adjusted weight reductions of 5.4%, 7.0% and 7.7% at 13 weeks across three dose cohorts; the highest dose...
Kymera pill rivals Dupixent in Phase 1b—early efficacy seen
Kymera Therapeutics reported positive early‑stage results for KT‑621 in atopic dermatitis, with a Phase 1b BroADen study showing an average 63% reduction in Eczema Area and Severity Index (EASI)...
BioNTech CTLA‑4 antibody improves survival—tolerability clouds picture
A deeper read of phase 3 data for BioNTech and OncoC4’s anti‑CTLA‑4 antibody confirmed a survival benefit but highlighted a challenging safety profile. Analysts and clinicians flagged tolerability...
Mirum to buy Bluejay for $620M—adds late‑stage hepatitis D antibody
Mirum Pharmaceuticals agreed to acquire Bluejay Therapeutics for $620 million upfront to obtain brelovitug, a monoclonal antibody in late‑stage development for chronic hepatitis D. The deal...
Dyne aims to file after late‑stage Duchenne exon‑skipper meets endpoints
Dyne Therapeutics announced that its next‑generation exon‑skipping therapy for Duchenne muscular dystrophy met its late‑stage study endpoints, positioning the company to submit for regulatory...
MRD nears surrogate status in AML—ASH data supports accelerated paths
Researchers presented pooled data at ASH indicating that minimal residual disease (MRD) negativity correlates with longer overall survival in acute myeloid leukemia and could serve as a surrogate...
Gilead, Arcellx show deep responses with anito‑cel in pivotal myeloma study
Gilead Sciences and partner Arcellx reported pivotal‑stage data for anito‑cel in multiple myeloma showing high overall response rates and substantial complete remissions: 96% response and 74% CR...
Kallyope’s migraine drug clears Phase 2b—company moves to Phase 3
Kallyope said elismetrep, its experimental acute migraine therapy, succeeded in a Phase 2b study and will advance to Phase 3. The mid‑stage win marks a decade‑old biotech’s first clear clinical...