August 12, 2026
NAPLES, Fla., August 12, 2026 — Attralus, Inc., a clinical stage biopharmaceutical company developing transformative medicines to improve the lives of patients with systemic amyloidosis, today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for zamubafusp alfa (AT-02) for the treatment of light chain (AL)-associated amyloidosis, a rare, progressive, debilitating, and often fatal condition.
Zamubafusp alfa, the company’s lead pan-amyloid removal candidate, has been evaluated in a completed Phase 1 study and an ongoing Phase 2 open-label trial, both of which have enrolled patients with AL amyloidosis. The granting of Fast Track designation indicates that clinical data from the Phase 1 / 2 program demonstrate that zamubafusp alfa has the potential to address an important unmet medical need in AL amyloidosis.
“We are pleased to have received Fast Track designation from the U.S. FDA for zamubafusp alfa in AL amyloidosis,” said Glen Firestone, President of Attralus. “Current approved therapies for AL target light-chain production, reducing the formation of new amyloid, but there is a significant unmet need for new therapies that can remove existing toxic amyloid fibrils that cause organ damage and mortality. This Fast Track designation will allow our team to work closely with the Agency on the most efficient clinical development pathway to advance AT-02 and address the significant unmet need.”
The Fast Track designation was granted based on the interim AL amyloidosis data from the Phase 2 AT02-003 study which was presented at the 67th ASH Annual Meeting and Exposition in Orlando, FL on December 6-9, 2025. All study participants have completed study visits, and the final data is anticipated during the second half of this year.
The FDA Fast Track Designation is a program designed to facilitate and expedite the development and review of drugs and biologics intended to treat serious or life-threatening conditions. Its primary purpose is to ensure that promising new therapies reach patients as quickly as possible through several key regulatory advantages, which include opportunity for more frequent interactions with the review division at FDA to discuss the potential for expedited development and eligibility for both Rolling Review and Priority Review of the BLA.
Zamubafusp alfa has also been granted four orphan designations globally. The FDA granted Orphan Drug Designation for the treatment of light chain amyloidosis (AL), and transthyretin-associated amyloidosis (ATTR). In addition, the European Medicines Agency’s Committee for Orphan Medicinal Products (COMP) adopted positive opinions for orphan medicinal product designations for zamubafusp alfa for the treatment of transthyretin-associated amyloidosis (ATTR) and immunoglobulin light-chain-associated (AL) amyloidosis.
