• Mapi Pharma reported initial Phase I/IIa results from Cohort 1 for its once-monthly subcutaneous Cariprazine Depot.
• The readout supported continued development, with safety and tolerability consistent with oral cariprazine and no serious adverse events.
• Plans call for a U.S. FDA IND filing by end-2026 with a partner to back Phase 3 and commercialization.
• Manufacturing for trials and commercial supply is expected to come from the company’s GMP-approved facilities.
• An NDA filing is targeted for 2029 if Phase 3 succeeds; oral Vraylar posted $3.6 billion in 2025 global sales.

Disclaimer: This news brief was created by Public Technologies (PUBT) using generative artificial intelligence. While PUBT strives to provide accurate and timely information, this AI-generated content is for informational purposes only and should not be interpreted as financial, investment, or legal advice. Mapi-Pharma Ltd. published the original content used to generate this news brief on August 12, 2026, and is solely responsible for the information contained therein.