Ivonescimab Cuts Death Risk 27% vs Keytruda, With Strongest Gain in High PD-L1 Patients
HARMONi-2: Summit’s Ivonescimab extended median survival by 8.2 months vs Keytruda. 42% lower death risk in PD-L1-high patients.
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FDA Approves First SMA Drug That Targets Muscle Loss, Not Just Nerves
The FDA approved Scholar Rock’s Isembyld, the first SMA therapy aimed at muscle wasting in patients already on nerve-targeted treatment.
AstraZeneca’s Etcamah Combination Falls Short of Statistical Significance in SERENA-4
The Phase III SERENA-4 trial did not meet its primary PFS endpoint in untreated advanced ER-positive, HER2-negative breast cancer, despite a numerical benefit.
FDA Approves First Treatment for Children Ages 4–11 With Rare Immune Disease APDS
The FDA has approved Pharming’s Joenja as the first U.S. treatment for children ages 4–11 with APDS who weigh at least 27 kg.
Karyopharm Warns of Going-Concern Risk Without New Funding by Mid-October
Karyopharm skipped a $15.8M loan payment and won a pause until Oct. 15. Cash may last only that long without a new raise or deal.
FDA Extends Review of Exelixis Colorectal Cancer Combo to March 2027
FDA adds three months to its review of Exelixis’ zanzalintinib plus Tecentriq for metastatic colorectal cancer after a major amendment.