The FDA approved Atebrioz for FOP on a change in new bone volume, a measure the trial registry listed as secondary, after the lesion-count primary missed statistical significance at week 24.
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KRAS sat on the undruggable list for decades. Silexion's SIL204 is built to silence the mutation earlier in the cell, and the Phase 2/3 program is now moving into patients.
IntraBio’s Aqneursa cleared the FDA as the first treatment for ataxia-telangiectasia on a -1.88 SARA point crossover win, treating downstream neurodegeneration rather than an intractable 305 kDa kinase defect.
FDA approved Lilly's Inluriyo plus Verzenio for ESR1-mutated ER+/HER2- metastatic breast cancer after endocrine progression, doubling median PFS to 11.1 months in EMBER-3. The clinical gain comes with 86% diarrhea and neutropenia rates, challenging early liquid biopsy switching models.