Corbus Pharmaceuticals Holdings, Inc. secures U.S. FDA alignment on CRB-701 study for HNSCC and cervical cancer

Corbus Pharmaceuticals Holdings, Inc. secures U.S. FDA alignment on CRB-701 study for HNSCC and cervical cancer
Corbus wins U.S. FDA alignment

Corbus Pharmaceuticals Holdings, Inc. announced broad alignment with the U.S. FDA on the registration pathway for its investigational drug CRB-701 in second-line head and neck squamous cell carcinoma (HNSCC) and cervical cancer.

This agreement enables the company to move forward with its planned registrational study design and endpoints, supporting potential accelerated approval for the therapy. The alignment with regulators is seen as a critical step for advancing CRB-701 development. Shares of Corbus Pharmaceuticals Holdings, Inc. trade under the ticker $CRBP.

Corbus is advancing CRB-701, an antibody-drug conjugate therapy targeting Nectin-4 overexpression in aggressive solid tumors, according to a previous update from the company. Earlier this year, Corbus reported its financial results for the fourth quarter and full year ended December 31, 2025, including a corporate update on its pipeline progress. The recent earnings release outlined operational priorities as the company moves toward registrational studies.

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