Praxis Precision Medicines Wins FDA Breakthrough Status for Elsunersen in Rare Epilepsy
Phase 2 data showed 77% seizure reduction and sustained benefits up to 1 year.
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Phase 2 data showed 77% seizure reduction and sustained benefits up to 1 year.
Decision due Aug 5, 2026. Potential 2026–27 launch.
Entera Bio receives positive FDA feedback on its pivotal Phase 3 trial design for EB613, the potential first once-daily oral tablet to stimulate bone formation in postmenopausal women with osteoporosis.
Another major exit follows Noam Shazeer’s move to OpenAI.