Cytokinetics’ ACACIA-HCM trial met both co-primary endpoints for aficamten, marketed as MYQORZO for obstructive hypertrophic cardiomyopathy, in patients with non-obstructive hypertrophic cardiomyopathy, positioning the company to pursue a supplemental filing that would extend the…
Spyre Therapeutics reported Week 12 results from the 143-patient Phase II SKYWAY-RA trial of the anti-TL1A antibody SPY072 in moderate-to-severe rheumatoid arthritis. The low-dose arm met the primary DAS28-CRP endpoint and showed nominally significant…
A 245-patient real-world study found that immune effector cell-associated hematotoxicity (ICAHT) after BCMA-directed CAR-T therapy was less frequent when treatment occurred after one to three prior lines rather than four or more lines, but…
The French Myelodysplasia Group reported Phase II IDIOME results for single-agent ivosidenib in 48 older adults with IDH1-mutant myelodysplastic neoplasms. Overall response after three cycles was 63.6% in higher-risk disease after azacitidine failure and…
BioNTech terminated the Phase II BNT122-01 trial of its individualized neoantigen mRNA cancer vaccine autogene cevumeran in colorectal cancer after an independent data safety monitoring board identified a numerical overall survival imbalance, following the…
AstraZeneca and Amgen reported that the 368-patient Phase III CROSSING trial of tezepelumab in eosinophilic esophagitis met both co-primary endpoints at Week 24: histologic remission and improvement in dysphagia. Both tested doses also met…
Kazia Therapeutics reported early efficacy signals from a small cohort of metastatic triple-negative breast cancer patients treated with paxalisib combined with pembrolizumab and chemotherapy, with five of six evaluable patients achieving objective responses and…
Akeso reported that the 682-patient, randomized Phase III HARMONi-GI1 trial met its primary overall-survival endpoint at a prespecified interim analysis: ivonescimab plus gemcitabine and cisplatin produced a statistically significant and company-described clinically meaningful benefit…
The FDA approved Priovant Therapeutics’ Lisraya (brepocitinib), a once-daily oral TYK2/JAK1 inhibitor, for adult dermatomyositis, making it the first oral, targeted therapy approved for the disease and validating the pivotal VALOR trial’s disease-activity and…
FDA approved Revolution Medicines’ once-daily oral Rasonque (daraxonrasib) for adults with metastatic pancreatic adenocarcinoma who received at least one prior systemic therapy or are not candidates for multiagent systemic therapy. In the 500-patient randomized…
