ORMP biotech catalysts & pipeline

ORAMED PHARMACEUTICALS INC · Data as of 2026-10-25

Upcoming catalysts

Alpha DaRT — Topline data

Sep 2026–Apr 2027

Alpha Tau has begun submitting modules of its Modular Pre-Market Approval (PMA) application to the FDA and has finished treating patients in its ReSTART pivotal trial, with top-line data from the trial expected in late 2026 or early 2027.

Source filing

Alpha DaRT — NDA/BLA submission

Late 2026

As of January 2026, Alpha Tau targeted completion of patient recruitment in Q1 2026 and has begun submitting modules of its Modular Pre-Market Approval (PMA) application to the FDA, with expected completion of the full submission by year-end 2026.

Source filing

Alpha DaRT — Initial data

Q1 2027

Alpha Tau is targeting completion of accrual in Q3 2026, with initial results approximately six months later.

Source filing

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