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Biotech Stocks Facing FDA Decision In March 2026

Rocket Pharmaceuticals
Rocket Pharmaceuticals

Rocket Pharmaceuticals Inc.’s (RCKT) gene therapy candidate, KRESLADI, proposed for the treatment of severe Leukocyte Adhesion Deficiency-I (LAD-I), awaits the FDA decision on March 28, 2026.

This is the company’s second attempt to secure approval for KRESLADI in the proposed indication.

The FDA declined to approve the one-time gene therapy KRESLADI in June 2024 and requested limited additional Chemistry Manufacturing and Controls (CMC) information to complete its review.

Addressing the concerns raised by the FDA, Rocket Pharma resubmitted the Biologics License Application (BLA) for KRESLADI last year, with the U.S. regulator accepting it for review and assigning the above-mentioned decision date.

Currently, the only potential curative treatment is an allogeneic hematopoietic stem cell transplant.

RCKT closed Tuesday’s (Feb.24, 2026) trading at $4.25, up 6.52%.