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The July 24, 2026 FDA PCAC review will specifically discuss Semax for cerebral ischemia and trigeminal neuralgia

In December, the companys shares rocketed 209% when it announced that the candidate had hit both primary endpoints and a secondary endpoint in the Phase III MAESTRO-NASH biopsy trial

In a move signaling a major shift in federal priorities, the Centers for Medicare & Medicaid Services (CMS) recently announced it will limit federal funding for state Medicaid initiatives that support services beyond direct medical care

The Phase 2 trial protocol permitted injection at any time of day, provided the once-weekly interval was maintained consistently

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