Outlook Therapeutics resubmits FDA BLA for ONS-5010 (8-K)

Outlook Therapeutics filed an 8-K stating it has resubmitted the Biologics License Application for ONS-5010 to the U.S. Food and Drug Administration.

Rhea-AI Filing Summary

Outlook Therapeutics filed an 8-K stating it has resubmitted the Biologics License Application for ONS-5010 to the U.S. Food and Drug Administration. The company also furnished a related press release as Exhibit 99.1 dated November 3, 2025.

The filing identifies the earliest event as November 3, 2025 and confirms the company’s Nasdaq listing under the symbol OTLK. The report was signed by Lawrence A. Kenyon, Chief Financial Officer.

Insights

Biopharma regulatory analyst

OTLK resubmitted ONS-5010’s BLA to the FDA; outcome not disclosed.

Resubmitting a Biologics License Application indicates the sponsor addressed prior agency feedback and is seeking approval for ONS-5010. An 8-K confirms the step and attaches a press release as Exhibit 99.1, which typically provides additional context.

This is a regulatory milestone rather than a financial event. Approval timing or review status is not stated in the excerpt, so investment impact depends on subsequent FDA actions and any details the company may release later.

8-K Event Classification

Item 8.01 — Other Events

1 item

Item 8.01 Other Events Other

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

FAQ

AI-generated questions and answers. How Rhea-AI works. Not financial advice.

What did OTLK announce in its 8-K?

Outlook Therapeutics announced it resubmitted the BLA for ONS-5010 to the FDA.

Which exhibit was included with the 8-K for OTLK?

The company attached a press release as Exhibit 99.1 dated November 3, 2025.

What is the earliest event date in the OTLK filing?

The earliest event date is November 3, 2025.

Who signed the OTLK report?

It was signed by Lawrence A. Kenyon, Chief Financial Officer.

What is Outlook Therapeutics’ trading symbol and exchange?

The common stock trades as OTLK on The Nasdaq Stock Market LLC.

AI-generated analysis. How Rhea-AI works. Not financial advice.

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Accepted by SEC EDGAR 11/03/2025 - 05:01 PM Learn about SEC filing dates

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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 3, 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 3, 2025, Outlook Therapeutics, Inc (the “Company”) issued a press release announcing that it has resubmitted the Biologics License Application for ONS-5010 to the U.S. Food and Drug Administration.

The press release is attached as Exhibit 99.1 to this Current Report on Form 8-K and incorporated into this item 8.01 by reference.

Item 9.01. Financial Statements and Exhibits.

(d) Exhibits

Exhibit No.		Description
99.1		Press Release, dated November 3, 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 hereunto duly authorized.

	Outlook Therapeutics, Inc.
Date: November 3, 2025	By:	/s/ Lawrence A. Kenyon
		Lawrence A. Kenyon
		Chief Financial Officer