Alume Biosciences Announces U.S. FDA Breakthrough Therapy Designation Granted for Bevonescein, a First-in-Class adjunct in the real-time intraoperative visualization of nerves during head and neck surgical procedures in adults
Alume Biosciences, Inc. announced today that the U.S. Food and Drug Administration (FDA) has granted Breakthrough
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Alume Biosciences, Inc. announced today that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation (BTD) for bevonescein for use as an adjunct in the real-time intraoperative visualization of nerves during head and neck surgical procedures in adults. Bevonescein is an investigational, intravenously administered fluorescent peptide-dye conjugate that binds to nerve tissue. Because the fluorescent signal is in the visible spectrum, surgeons can see highlighted nerves directly with their eyes in real time during surgery, without the need for a camera, imaging interface, or display monitor. The designation follows Fast Track designation for bevonescein, which FDA granted in 2022.
“Iatrogenic nerve injury remains one of the most consequential complications for patients undergoing surgical procedures in the head and neck,” said Quyen T. Nguyen, M.D., Ph.D., Co-Founder and Chief Executive Officer of Alume Biosciences and Professor of Otolaryngology–Head and Neck Surgery and Pharmacology at UC San Diego Health.
“Dr. Nguyen and Alume’s work has, I feel, changed the landscape of modern head and neck cranial nerve surgery. This Breakthrough Therapy Designation recognizes the potential impact of bevonescein, if approved by FDA, for patients undergoing surgical procedures where inadvertent nerve injury is a known risk by allowing improved nerve detection and visualization beyond what is available to the surgical eye alone,” said Gregory W. Randolph, M.D., Professor of Otolaryngology Head and Neck Surgery, Director Thyroid/Parathyroid Endocrine Surgical Division, Massachusetts Eye and Ear Infirmary, Bertucci Endowed Chair in Thyroid Surgical Oncology, Harvard Medical School, who was one of the clinical trial principal investigators.
Alume has completed three multicenter, prospective, randomized Phase 3 trials of bevonescein in thyroid, parathyroid, parotid, and neck dissection surgery: (NCT05377554; NCT06227585). In each trial, the same nerves were assessed under white light alone and under white light plus fluorescence. Bevonescein-enabled fluorescence visualization produced a statistically significant improvement in the co-primary endpoint of Nerve Conspicuity in all three trials. 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 programs, no serious drug-related adverse events were reported.
Phase 3 data were presented at the 2026 American Head and Neck Society (AHNS) meeting in Boston and the 2026 Collegium Otorhinolaryngology Amitiae Sacrum (CORLAS) meeting in Groningen, the Netherlands.
FDA grants BTD to expedite the development and review of investigational drugs intended to treat a serious or life-threatening condition. The investigational drug must also have preliminary clinical evidence indicating that it may demonstrate substantial improvement over available therapy on at least one clinically significant endpoint.
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 Iatrogenic Nerve Injury in Head and Neck Surgery
More than 250,000 head and neck procedures that place critical nerves at risk are performed each year in the United States. Injury to the facial, recurrent laryngeal, or spinal accessory nerves can cause facial paralysis, voice and airway impairment, or shoulder dysfunction. Current intraoperative nerve monitoring with electromyography can signal nerve electrical activity, but it does not allow surgeons to directly see highlighted nerves during active dissection.
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.
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