FDA Accepts Roche's Vamikibart BLA for Uveitic Macular Edema; One-Year Phase III Data Positive
RHHBY sits 35% above its 52-week low of $40.07.
Summary
Genentech presented one-year Phase III data for vamikibart in uveitic macular edema (UME) at AAO 2026, showing sustained vision gains and reduced macular swelling versus sham. The FDA has accepted the BLA with a decision expected by July 2027; if approved, vamikibart would be the first non-steroid targeted therapy for UME. Regulatory submissions are also accepted in the EU, China, and Japan. This follows a series of positive Roche/Genentech ophthalmology and neurology updates in recent weeks, including Susvimo EU approval and fenebrutinib NDA acceptance. The data strengthen the case for a new standard of care in a disease with high unmet need and steroid-related side effects.
At the time of this announcement, RHHBY was trading at $54.09 on OTC in the Life Sciences sector, with a market capitalization of approximately $343.4B. The 52-week trading range was $40.07 to $60.85. This news item was assessed with positive market sentiment and an importance score of 8 out of 10. Source: BusinessWire.