08:08 AM EDT, 10/14/2025 (MT Newswires) -- Rocket Pharmaceuticals ( RCKT ) said Tuesday the US Food and Drug Administration accepted its resubmitted biologics license application for Kresladi to treat severe Leukocyte Adhesion Deficiency-I and set a March 28, 2026, target action date.

The filing is backed by a phase 1/2 study showing 100% survival at 12 months, fewer serious infections, and improved wound healing, with no treatment-related serious adverse events and all primary and secondary endpoints met, the company said.

If approved, Rocket would be eligible for a rare pediatric disease priority review voucher, the company added.

Severe LAD-I is a rare inherited immune disorder that leaves children highly vulnerable to life-threatening infections and is often fatal in early childhood without a stem-cell transplant, Rocket said.

Shares of the company were up 13% in recent Tuesday premarket activity.