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Roche Holding
2 posts
Roche’s vamikibart sustains vision gains for 52 weeks as July 2027 FDA decision approaches
Genentech has reported sustained visual improvements and reduced retinal swelling through one year in two Phase III studies of vamikibart for uveitic macular edema. Approximately two-thirds of eligible patients required no retreatment after week 16, strengthening the potential treatment's durability profile. However, mixed statistical results between the pivotal trials and the absence of a direct steroid comparison remain important considerations ahead of the expected July 2027 FDA decision.
Scholar Rock (NASDAQ: SRRK) wins FDA approval for ISEMBYLD in spinal muscular atrophy
Scholar Rock has secured its first U.S. Food and Drug Administration approval with ISEMBYLD, moving from a pre-revenue biotechnology company into commercial execution as analysts model a multibillion-dollar opportunity in spinal muscular atrophy.