FDA accepts Outlook Therapeutics BLA resubmission; Class 1 review

Rhea-AI Filing Summary

Outlook Therapeutics reported a key regulatory update for ONS-5010 (bevacizumab-vikg). The U.S. Food and Drug Administration acknowledged receipt of the company’s resubmitted Biologics License Application and designated it a Class 1 review, which provides a two-month review period from the date of resubmission.

The FDA established a PDUFA goal date of December 31, 2025. This sets a clear timeline for the agency’s action on the resubmission and marks formal acceptance into the expedited review track associated with a Class 1 review.

Insights

Biotech regulatory analyst

FDA accepted the BLA resubmission, set a Class 1 review and PDUFA date.

The FDA’s acknowledgment of the ONS-5010 BLA resubmission moves the program back into active review. A Class 1 designation indicates a shorter, two-month review window from resubmission, typically used for limited revisions.

This step does not imply approval but confirms the file is sufficiently complete for review. The agency set a PDUFA goal date of December 31, 2025, providing a specific decision timeline.

The next concrete milestone is the PDUFA date on December 31, 2025. Outcomes will depend on the adequacy of the resubmission addressing prior issues and the FDA’s final assessment.

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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): November 13, 2025

Outlook Therapeutics, Inc.

(Exact name of registrant as specified in its charter)

Delaware	001-37759	38-3982704
(State or other jurisdiction of incorporation)	(Commission File Number)	(IRS Employer Identification No.)

111 S. Wood Avenue, Unit #100 Iselin, New Jersey	08830
(Address of principal executive offices)	(Zip Code)

Registrant's telephone number, including area code: (609) 619-3990

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 pursuant to Section 12 (b) of the Act:

Title of Each Class		Trading Symbol(s)		Name of Each Exchange on Which Registered
Common Stock		OTLK		The Nasdaq Stock Market LLC

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 8.01 Other Events.

On November 13, 2025, Outlook Therapeutics, Inc. announced that the U.S. Food and Drug Administration (the “FDA”) had acknowledged receipt of its resubmission of the Biologics License Application (the “BLA”) for ONS-5010 (bevacizumab-vikg). The FDA determined that the BLA is a Class 1 review, which results in a two-month review period from the date of resubmission. The FDA set a Prescription Drug User Fee Act (PDUFA) goal date of December 31, 2025.

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 hereunto duly authorized.

	Outlook Therapeutics, Inc.
Date: November 13, 2025	By:	/s/ Lawrence A. Kenyon
		Lawrence A. Kenyon
		Chief Financial Officer

FAQ

What did OTLK announce in its 8-K?

The company announced the FDA acknowledged receipt of its ONS-5010 BLA resubmission, deemed a Class 1 review with a two-month review period.

What is the PDUFA date for OTLK’s ONS-5010?

The FDA set a PDUFA goal date of December 31, 2025 for ONS-5010 (bevacizumab-vikg).

What does Class 1 review mean for OTLK?

A Class 1 review provides a two-month review period from the date of resubmission.

Did the FDA approve OTLK’s ONS-5010?

No. The update covers acknowledgment of resubmission and review classification with a PDUFA date; it is not an approval.

Which product is covered in OTLK’s update?

ONS-5010 (bevacizumab-vikg), for which the BLA was resubmitted and accepted for Class 1 review.