Corbus Pharmaceuticals Secures FDA Alignment for CRB-701 Registration Path in Head & Neck and Cervical Cancers

Norwood, MA – April 7, 2026: Corbus Pharmaceuticals Holdings, Inc. (NASDAQ: CRBP), a clinical-stage biopharmaceutical company focused on oncology and obesity therapies, has announced a significant regulatory milestone: broad alignment with the U.S. Food and Drug Administration (FDA) on the registration pathway for its next-generation antibody drug conjugate (ADC), CRB-701. This alignment covers the development of CRB-701 for second-line treatment in both head and neck squamous cell carcinoma (HNSCC) and cervical cancer. The company also shared updates on clinical data presentations, upcoming leadership changes, and future development plans.

Key Highlights

• FDA Alignment on Registration Path: Corbus has received FDA feedback enabling it to proceed with its proposed registrational study design and endpoints for CRB-701 in both second-line HNSCC and cervical cancer. This sets the stage for potential accelerated approval based on objective response rate (ORR) and potential full approval based on overall survival (OS).
• Study Design Details:
  • HNSCC: A single, randomized controlled trial (RCT) will compare CRB-701 to physician’s choice chemotherapy. Accelerated approval may be granted based on ORR, with full approval contingent on OS benefit.
  • Cervical Cancer: A parallel RCT will compare CRB-701 to physician’s choice chemotherapy or Tivdak®, again with ORR as the potential accelerated approval endpoint and OS for full approval.
  • Corbus will continue discussions with the FDA to finalize study protocols and statistical analysis plans.
• Upcoming Data Presentations:
  • ASCO 2026: Updated monotherapy data from the ongoing Phase 1/2 study of CRB-701 in both HNSCC and cervical cancer have been accepted for presentation at the American Society of Clinical Oncology (ASCO) Annual Meeting, May–June 2, 2026, in Chicago. The data will include clinical response durability and subgroup analysis for HNSCC patients.
  • Previous ESMO 2025 Data: Corbus has already presented encouraging dose optimization, efficacy, and safety findings at the 2025 European Society for Medical Oncology Congress.
  • Future Combination Data: The company expects to report data from a study of CRB-701 in combination with Keytruda® in first-line HNSCC patients in Q4 2026. These data will inform potential additional registration-enabling trials.
• Leadership Transition: Dr. Dominic Smethurst, MA, MRCP, will step down as Chief Medical Officer effective June 30, 2026. Corbus plans to add several key new senior leaders this year to support its transition to late-stage development and potential regulatory submission.

Details for Investors and Shareholders

• Regulatory Progress is Price Sensitive: The agreement with the FDA on study designs and endpoints for both HNSCC and cervical cancer represents a major inflection point. It de-risks the clinical development path, potentially accelerating the timeline to market and regulatory submission for CRB-701. This could be a significant driver for share value.
• Upcoming Clinical Data Readouts: The acceptance of updated CRB-701 data for presentation at ASCO 2026 is a noteworthy catalyst. Positive efficacy and durability findings could further validate CRB-701’s profile and enhance investor confidence.
• Pipeline Expansion: Beyond monotherapy, Corbus is advancing combination studies with Keytruda® in first-line HNSCC, which, if successful, may substantially expand the market opportunity for CRB-701.
• Leadership Stability: The planned transition in the Chief Medical Officer role and recruitment of new senior leaders signal organizational preparation for late-stage development and eventual commercialization, a key consideration for long-term investors.
• Fast Track Designations: CRB-701 has received FDA Fast Track status for both HNSCC and cervical cancer, potentially streamlining review and approval processes.

About CRB-701

CRB-701 (SYS6002) is a next-generation antibody drug conjugate targeting Nectin-4, a clinically validated, tumor-associated antigen in urothelial cancer. The ADC employs a site-specific, cleavable linker and a homogenous drug-antibody ratio of 2, using MMAE as the payload. CRB-701 is licensed from CSPC Megalith Biopharmaceutical Co. Ltd., China.

About Corbus Pharmaceuticals

Corbus is a clinical-stage company based in Norwood, Massachusetts, focused on discovering and developing new therapies in oncology and obesity. Its pipeline includes CRB-701 and CRB-913, a peripherally restricted CB1 inverse agonist for obesity.

Investor and Media Contacts

• Sean Moran, Chief Financial Officer, Corbus Pharmaceuticals ([email protected])
• Dan Ferry, Managing Director, LifeSci Advisors, LLC ([email protected])
• Liz Melone, Founder & Principal, Melone Communications, LLC ([email protected])

Disclaimer

This article contains forward-looking statements subject to risks and uncertainties, including those described in Corbus Pharmaceuticals’ filings with the Securities and Exchange Commission. Actual results may differ materially from those projected. Investors should not place undue reliance on these statements and are encouraged to review all regulatory filings and consult with financial professionals before making investment decisions. Corbus undertakes no obligation to update forward-looking statements as a result of new information or future events.

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