Abeona Therapeutics(US:ABEO)2025-03-20 19:22Pz-cel (Prademagene zamikeracel) for RDEB - Pz-cel is anticipated to receive potential FDA approval for RDEB with a PDUFA date of April 29, 2025 [4, 74] - Phase 3 VIITAL study showed 81.4% of pz-cel treated wounds achieved >50% healing compared to control wounds at Week 24 [12] - Phase 3 VIITAL study showed 65.1% of pz-cel treated wounds achieved >75% healing compared to control wounds at Week 24 [12] - Phase 3 VIITAL study showed 16.3% of pz-cel treated wounds achieved complete healing compared to control wounds at Week 24 [12] - Pz-cel demonstrated a mean pain reduction from baseline at Week 24 [12] - The company estimates a peak annual US revenue of over $500 million for pz-cel [41] - The company anticipates gross margins of approximately 85-90% after the initial ramp-up [42] Pipeline and Partnerships - Ultragenyx's BLA for UX111 (ABO-102) in MPS IIIA has a PDUFA date of August 18, 2025 [4, 74] - The company is developing ABO-503 for X-linked retinoschisis (XLRS), with first-in-human opportunity in 1H 2026 [62, 65] Financial Resources - The company had $110 million in cash resources as of September 30, 2024, providing a runway through potential launch into 2026 [71, 72]