FDA Grants Fast Track Designation to Corbus Pharmaceuticals’ Nectin-4 Targeting ADC CRB-701 in Head and Neck Squamous Cell Carcinoma
Rhea-AI Summary
Corbus Pharmaceuticals (NASDAQ: CRBP) has received Fast Track designation from the FDA for its antibody drug conjugate CRB-701 in treating recurrent or metastatic head and neck squamous cell carcinoma (HNSCC). This marks the second Fast Track designation for CRB-701, following its December 2024 designation for relapsed/refractory metastatic cervical cancer.
CRB-701 is a next-generation Nectin-4 targeting ADC featuring a site-specific, cleavable linker and a precise drug antibody ratio of 2 using MMAE payload. The company is conducting a Phase 1/2 clinical trial evaluating CRB-701's safety, pharmacokinetics, and efficacy in advanced solid tumors with high Nectin-4 expression. Initial dose optimization data will be presented at ESMO 2025 on October 19, 2025.
Positive
- Second Fast Track designation from FDA, demonstrating regulatory support
- Ongoing Phase 1/2 trial showing progress in development pipeline
- Upcoming data presentation at major conference (ESMO 2025)
Negative
- Drug still in early clinical development phases
- No efficacy data disclosed yet
News Market Reaction
On the day this news was published, CRBP gained 9.61%, reflecting a notable positive market reaction. Argus tracked a peak move of +20.5% during that session. Our momentum scanner triggered 37 alerts that day, indicating elevated trading interest and price volatility. This price movement added approximately $13M to the company's valuation, bringing the market cap to $148M at that time. Trading volume was very high at 4.0x the daily average, suggesting strong buying interest.
Data tracked by StockTitan Argus on the day of publication.
- Dose optimization data from the Phase 1/2 study to be presented next month at ESMO 2025
- Second Fast Track designation granted by FDA for CRB-701
NORWOOD, Mass., Sept. 16, 2025 (GLOBE NEWSWIRE) -- Corbus Pharmaceuticals Holdings, Inc. (NASDAQ: CRBP) (“Corbus” or the “Company”), a clinical stage oncology and obesity company, announced today that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to CRB-701 for the treatment of recurrent or metastatic head and neck squamous cell carcinoma (HNSCC) previously treated with platinum-based chemotherapy and an anti-PD(L)-1 therapy. A Fast Track designation for relapsed or refractory metastatic cervical cancer was granted by the FDA in December 2024.
CRB-701 (SYS6002) is a next-generation antibody drug conjugate (ADC) targeting Nectin-4 that contains a site-specific, cleavable linker and a precise drug antibody ratio of 2 using MMAE as the payload. The FDA’s Fast Track designation is designed to facilitate the development and expedite the review of drugs intended to treat serious conditions that demonstrate the potential to fill an unmet medical need.
An ongoing Phase 1/2 clinical trial is evaluating the safety, pharmacokinetics, and efficacy of CRB-701 in patients with advanced solid tumors known to be associated with high Nectin-4 expression. Corbus presented dose escalation data at ASCO-GU 2025 from the Phase 1/2 clinical trial of CRB-701 (SYS6002) (NCT06265727) that is being conducted in the U.S. and Europe. The Company will be presenting the first data from its Phase 1/2 dose optimization at ESMO 2025 on October 19, 2025. The study enrolled primarily HNSCC and cervical patients.
About Corbus
Corbus Pharmaceuticals Holdings, Inc. is a clinical stage oncology and obesity company and is committed to helping people defeat serious illness by bringing innovative scientific approaches to well-understood biological pathways. Corbus’ pipeline includes CRB-701, a next generation antibody drug conjugate that targets the expression of Nectin-4 on cancer cells to release a cytotoxic payload, CRB-601, an anti-integrin monoclonal antibody which blocks the activation of TGFβ expressed on cancer cells, and CRB-913, a highly peripherally restricted CB1 receptor inverse agonist for the treatment of obesity. Corbus is headquartered in Norwood, Massachusetts. For more information on Corbus, visit corbuspharma.com. Connect with us on X, LinkedIn and Facebook.
Forward-Looking Statements
This press release contains certain forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934 and Private Securities Litigation Reform Act, as amended, including those relating to the Company's trial results, product development, clinical and regulatory timelines, market opportunity, competitive position, possible or assumed future results of operations, business strategies, potential growth opportunities and other statement that are predictive in nature. These forward-looking statements are based on current expectations, estimates, forecasts and projections about the industry and markets in which we operate and management's current beliefs and assumptions.
These statements may be identified by the use of forward-looking expressions, including, but not limited to, "expect," "anticipate," "intend," "plan," "believe," "estimate," "potential,” "predict," "project," "should," "would" and similar expressions and the negatives of those terms. These statements relate to future events or our financial performance and involve known and unknown risks, uncertainties, and other factors on our operations, clinical development plans and timelines, which may cause actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements. Such factors include those set forth in the Company's filings with the Securities and Exchange Commission. Prospective investors are cautioned not to place undue reliance on such forward-looking statements, which speak only as of the date of this press release. The Company undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise.
All product names, logos, brands and company names are trademarks or registered trademarks of their respective owners. Their use does not imply affiliation or endorsement by these companies.
INVESTOR CONTACT:
Sean Moran
Chief Financial Officer
Corbus Pharmaceuticals
smoran@corbuspharma.com
Dan Ferry
Managing Director
LifeSci Advisors, LLC
daniel@lifesciadvisors.com
FAQ
What is the FDA Fast Track designation granted to Corbus Pharmaceuticals (NASDAQ: CRBP)?
How many Fast Track designations has CRB-701 received from the FDA?
What is CRB-701 and how does it work?
When will Corbus present the Phase 1/2 dose optimization data for CRB-701?
What type of clinical trial is currently ongoing for CRB-701?
