Alume Biosciences Announces FDA Acceptance of New Drug Application for Bevonescein for Use During Surgery

SAN DIEGO--(BUSINESS WIRE)--Alume Biosciences today announced that the U.S. Food and Drug Administration (FDA) has accepted for filing and review the company’s New Drug Application (NDA) for bevonescein (ALM-488), an investigational fluorescent drug intended to help surgeons visualize nerves in real time in adult patients undergoing head and neck surgery.

The NDA is supported by a Phase 3 program comprising three clinical trials conducted across 13 institutions in 11 states. Bevonescein received FDA Fast Track Designation in 2022 and Breakthrough Therapy Designation in 2026. In all three trials, bevonescein-enabled visualization produced a statistically significant improvement in nerve conspicuity, a co-primary endpoint, compared with white light alone. In the pooled analysis, bevonescein also produced statistically significant improvements in visible nerve length and branching delineation (p<0.0001 for each). Across the Phase 3 program, no serious drug-related adverse events and no deaths were reported.

“Acceptance of our NDA for review brings us an important step closer to making bevonescein available to surgeons and their patients,” said Quyen T. Nguyen, M.D., Ph.D., Co-Founder and Chief Executive Officer of Alume Biosciences, Professor of Otolaryngology and Pharmacology at the University of California San Diego School of Medicine, and Otolaryngologist at UC San Diego Health. “We are grateful to the patients, investigators, and clinical teams whose participation and dedication made this submission possible.”

Bevonescein is designed to provide fluorescent contrast between nerves and surrounding tissue to aid intraoperative nerve visualization. It remains investigational and has not been approved by the FDA. Alume will continue to work collaboratively with the FDA during its review and prepare for a potential commercial launch, if approved.

About Bevonescein

Bevonescein is a first-in-class, investigational fluorescent peptide-dye conjugate. It is administered intravenously before surgery and selectively highlights nerve tissue when viewed with fluorescence-capable equipment such as analog surgical microscopes or filter-modified surgical loupes. Bevonescein has not been approved by FDA or any other regulatory authority, and its safety and efficacy have not been established.

About Alume Biosciences

Alume Biosciences is a clinical-stage company developing molecularly targeted fluorescent drugs that help surgeons see critical anatomy in real time.

Cautionary Note Regarding Forward-Looking Statements

This press release contains forward-looking statements regarding the development, regulatory review, and potential benefits of bevonescein. These statements are based on current expectations and are subject to risks and uncertainties, including those inherent in drug development and regulatory review. As a result, actual results may differ materially. Breakthrough Therapy Designation does not guarantee or provide assurances of FDA approval or a shortened review timeline. Alume Biosciences undertakes no obligation to update any forward-looking statement.