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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...
Genetically engineered pig liver sustains human life—xeno trial underscores complexity
Surgical teams implanted a genetically modified pig liver into a human recipient and demonstrated that the graft could perform key liver functions for an extended period before complications...
Xenotransplant milestone: Genetically engineered pig liver sustains human
Researchers implanted a genetically modified pig liver into a human patient and demonstrated that the graft could support core liver functions for an extended period before complications forced...
Gene therapies push into children — CRISPR and commercial players aim pediatric expansion
Vertex reported early positive outcomes for its CRISPR-based therapy in children with blood disorders, and ASH briefings signaled broader industry momentum to extend one-time gene therapies into...
Gilead, Arcellx CAR‑T posts deep, durable responses in multiple myeloma
Gilead and partner Arcellx reported pivotal‑stage CAR‑T data showing deep and durable responses in multiple myeloma, with the companies citing high overall response rates and a large proportion of...
MRD as a fast path: New pooled data support surrogate endpoint in AML
A large prospective pooled dataset presented at ASH found that multiparameter flow cytometry–based minimal residual disease (MRD) before consolidation correlates with longer overall survival in...
ctDNA outperforms scans: Natera data show MRD prognostic across lymphoma subtypes
Natera presented real‑world data at ASH showing that circulating tumor DNA (ctDNA) positivity at end of treatment was prognostic across lymphoma subtypes and performed better than PET imaging for...
Clascoterone surprises market — Cosmo stock jumps after baldness Phase III wins
Cosmo Pharmaceuticals released topline results from two identical Phase III trials (SCALP 1 and SCALP 2) for clascoterone 5% solution in androgenetic alopecia and reported statistically...
Axoltis raises $18m to advance BBB‑repair drug for ALS
Axoltis closed an $18 million Series A to advance NX210c, a cyclic peptide derived from an embryonic neuronal protein, through clinical development for amyotrophic lateral sclerosis (ALS). The...