Corbus Pharmaceuticals (NASDAQ: CRBP) wins FDA Fast Track for CRB-701 cancer therapy

Rhea-AI Filing Summary

Corbus Pharmaceuticals Holdings, Inc. reported that the U.S. Food and Drug Administration has granted Fast Track designation to its drug candidate CRB-701 for the treatment of recurrent or metastatic head and neck squamous cell carcinoma in patients previously treated with platinum-based chemotherapy and an anti-PD(L)-1 therapy. The company disclosed this designation through a current report and attached the related press release as an exhibit.

Positive

• FDA Fast Track designation granted to CRB-701 for recurrent or metastatic head and neck squamous cell carcinoma previously treated with platinum-based chemotherapy and an anti-PD(L)-1 therapy, marking a significant regulatory milestone for the program.

Negative

• None.

Insights

Biotech regulatory and pipeline analyst

FDA Fast Track status marks a key regulatory milestone for CRB-701.

The company states that the FDA granted Fast Track designation to CRB-701 for recurrent or metastatic head and neck squamous cell carcinoma after prior platinum-based chemotherapy and anti-PD(L)-1 therapy. This places CRB-701 on a defined regulatory pathway in a difficult-to-treat cancer setting, signaling that the agency views the program as addressing a serious condition.

Fast Track designation can allow more frequent interactions with the FDA and potential eligibility for expedited review mechanisms, though the filing does not detail these aspects. The impact for investors centers on CRB-701’s progression within the development pipeline, with future disclosures likely to elaborate on clinical data, trial plans, and timing as the program advances under this designation.

8-K Event Classification

3 items: 7.01, 8.01, 9.01

3 items

Item 7.01 Regulation FD Disclosure Disclosure

Material non-public information disclosed under Regulation Fair Disclosure, often investor presentations or guidance.

Item 8.01 Other Events Other

Voluntary disclosure of events the company deems important to shareholders but not covered by other items.

Item 9.01 Financial Statements and Exhibits Exhibits

Financial statements, pro forma financial information, and exhibit attachments filed with this report.

Understanding 8-K Material Events →

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UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549

FORM 8-K

CURRENT REPORT

Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934

Date of Report (Date of earliest event reported): September 16, 2025

CORBUS PHARMACEUTICALS HOLDINGS, INC.

(Exact name of Registrant as Specified in Its Charter)

Delaware			001-37348	46-4348039
(State or Other Jurisdiction of Incorporation)			(Commission File Number)	(IRS Employer Identification No.)
500 River Ridge Drive
Norwood, Massachusetts				02062
(Address of Principal Executive Offices)				(Zip Code)

Registrant’s Telephone Number, Including Area Code: (617) 963-0100

Not Applicable

(Former Name or Former Address, if Changed Since Last Report)

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:

☐Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

☐Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

☐Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

☐Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

Securities registered pursuant to Section 12(b) of the Act:

Title of each class		Trading Symbol(s)		Name of each exchange on which registered
Common Stock, par value $0.0001 per share		CRBP		The Nasdaq Capital Market

Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§ 230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§ 240.12b-2 of this chapter).

Emerging growth company ☐

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐

Item 7.01 Regulation FD Disclosure.

On September 16, 2025, Corbus Pharmaceuticals Holdings, Inc. (the “Company”) issued a press release announcing that the U.S. Food and Drug Administration (the “FDA”) has granted Fast Track designation to CRB-701 for the treatment of recurrent or metastatic head and neck squamous cell carcinoma previously treated with platinum-based chemotherapy and an anti-PD(L)-1 therapy. A copy of the press release is attached hereto as Exhibit 99.1.

The information in this Current Report on Form 8-K under Item 7.01, including the information contained in Exhibit 99.1, is being furnished to the Securities and Exchange Commission, and shall not be deemed to be “filed” for the purposes of Section 18 of the Securities Exchange Act of 1934 or otherwise subject to the liabilities of that section, and shall not be deemed to be incorporated by reference into any filing under the Securities Act of 1933 or the Securities Exchange Act of 1934, except as shall be expressly set forth by a specific reference in such filing.

Item 8.01 Other Events.

On September 16, 2025, the Company announced that the FDA granted Fast Track Designation to CRB-701 for the treatment of recurrent or metastatic head and neck squamous cell carcinoma previously treated with platinum-based chemotherapy and an anti-PD(L)-1 therapy.

Item 9.01 Financial Statements and Exhibits.

(d) The following exhibit is furnished with this report:

Exhibit No.		Description
99.1		Press Release issued by Corbus Pharmaceuticals Holdings, Inc. dated September 16, 2025.
104		Cover Page Interactive Data File (embedded within the Inline XBRL document).

SIGNATURES

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned thereunto duly authorized.

			Corbus Pharmaceuticals Holdings, Inc.
Date:	September 16, 2025	By:	/s/ Yuval Cohen
			Name: Yuval Cohen Title: Chief Executive Officer

FAQ

What did Corbus Pharmaceuticals (CRBP) announce in this 8-K filing?

Corbus Pharmaceuticals reported that the FDA granted Fast Track designation to its drug candidate CRB-701 for recurrent or metastatic head and neck squamous cell carcinoma in patients previously treated with platinum-based chemotherapy and an anti-PD(L)-1 therapy.

Which drug candidate received FDA Fast Track designation for Corbus Pharmaceuticals (CRBP)?

The filing states that CRB-701 received Fast Track designation from the FDA for recurrent or metastatic head and neck squamous cell carcinoma after prior platinum-based chemotherapy and anti-PD(L)-1 therapy.

For which indication did CRB-701 receive FDA Fast Track designation?

CRB-701 was granted Fast Track designation for the treatment of recurrent or metastatic head and neck squamous cell carcinoma in patients previously treated with platinum-based chemotherapy and an anti-PD(L)-1 therapy.

How did Corbus Pharmaceuticals (CRBP) communicate the Fast Track news?

Corbus Pharmaceuticals issued a press release announcing the FDA Fast Track designation for CRB-701 and furnished that press release as Exhibit 99.1 to this 8-K.

Does this 8-K filing include financial results for Corbus Pharmaceuticals (CRBP)?

No, the 8-K focuses on the regulatory update that the FDA granted Fast Track designation to CRB-701 and does not provide financial results.

Is the Fast Track information considered filed or furnished in this 8-K?

The company states that the information provided under Item 7.01, including Exhibit 99.1, is being furnished to the SEC and is not deemed "filed" for purposes of Section 18 of the Exchange Act.