FDA intends to rescind Breakthrough Therapy Designation for rusfertide; PN-943 Ph2 data due mid-May 2022

Protagonist Therapeutics, Inc

FDA notified Protagonist of intent to rescind Breakthrough Therapy Designation for rusfertide in polycythemia vera; company requesting meeting to appeal.
PN-943 Phase 2 top-line data for ulcerative colitis expected in first half of Q2 2022 (by mid-May 2022).
Rusfertide Phase 3 VERIFY study screening underway; no anticipated changes to development plan or timelines.
Observed malignancies in rusfertide-treated patients explained; stopping rules align with background rates in PV population.
Fast Track and Orphan Drug designations for rusfertide remain active.

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