First-line trastuzumab deruxtecan extended blinded-review median progression-free survival to 14.3 from 8.3 months versus pembrolizumab plus platinum-pemetrexed in the randomized Phase III DESTINY-Lung04 trial. Response rate was 70.0% versus 44.5%. The result establishes a…
SonoThera appointed Adam J. Shaywitz, M.D., Ph.D., chief medical officer. He joins after serving as chief medical officer of BridgeBio Gene Therapy and brings experience across AAV gene therapy, rare disease, enzyme replacement and…
Zipalertinib plus platinum chemotherapy reduced the risk of progression or death by 50% versus chemotherapy alone in first-line EGFR exon 20 insertion-positive advanced NSCLC. Median PFS improved from 8.5 to 14.5 months and response…
FDA issued a “study may proceed” notice for a Phase Ib study of TBS-2025, a VISTA-inhibiting monoclonal antibody, in relapsed or refractory acute myeloid leukemia with mutant NPM1 after failure of or relapse on…
The FDA granted Breakthrough Therapy designation to intravenous AP-SA02 as an adjunct to antibiotics for complicated methicillin-sensitive or methicillin-resistant Staphylococcus aureus bacteremia. The decision was based on preliminary randomized Phase 1b/2a evidence and adds…
Tyra priced an underwritten primary offering expected to raise approximately $400 million gross through common shares and nearly fully funded pre-funded warrants. The capital is earmarked for dabogratinib development across urothelial cancer and achondroplasia,…
Cellectis will cease internal development of lasme-cel and eti-cel, seek partners for both allogeneic CAR T assets, and concentrate internal resources on two preclinical liver-directed programs: .HEAL-101, an APOC3 TALE base editor for severe…
Slate Medicines appointed Kenneth Koblan, PhD, as chief scientific officer while advancing the PACAP/VIP antibody SLTE-1009 for migraine. Koblan brings neuroscience, translational, RNA-therapeutics, and drug-development experience from Vesalius, Sumitomo/Sunovion, Merck, and Alnylam. The effective…
A bioRxiv preprint reports that small “molecular editing” changes converted LLC0424, a dual NSD2/GSPT1 degrader, into two selective compounds: fluorine substitution produced the NSD2-directed PROTAC 424-ND, while methylene insertion produced the GSPT1 molecular glue…
The final overall-survival analysis of PAPILLON reported median survival of 34.3 months with first-line amivantamab plus chemotherapy versus 27.9 months with chemotherapy alone, but the intent-to-treat comparison was not statistically significant (HR 0.87; P=0.307)….
