Outlook Therapeutics (NASDAQ: OTLK) sets 2025 BLA resubmission timeline

Rhea-AI Filing Summary

Outlook Therapeutics, Inc. reported that it has completed a requested Type A meeting with the U.S. Food and Drug Administration regarding the complete response letter dated August 27, 2025 for its biologics license application resubmission for ONS-5010, an investigational ophthalmic formulation of bevacizumab for wet age-related macular degeneration. Based on this discussion and the FDA’s feedback, the company now expects to resubmit its BLA before the end of calendar year 2025. These details were disclosed through a press release dated September 29, 2025 that is filed as an exhibit.

Insights

Biopharma regulatory analyst

Company completed an FDA Type A meeting and plans a 2025 BLA resubmission for ONS-5010.

Outlook Therapeutics disclosed that it has held a Type A meeting with the FDA to discuss the complete response letter dated August 27, 2025 covering its biologics license application resubmission for ONS-5010, an investigational bevacizumab formulation for wet AMD. A Type A meeting is typically used to address significant regulatory setbacks and clarify paths forward.

Following this discussion, the company states that it expects to resubmit its BLA before the end of calendar year 2025. This indicates that the agency has provided feedback detailed enough for the company to plan a revised filing timeline, but the content of that feedback and any additional requirements are not described here.

The press release attached as an exhibit is the primary source of additional detail, while this disclosure mainly confirms completion of the meeting and the targeted resubmission timing. Actual regulatory outcomes will depend on how the resubmitted BLA addresses the issues raised in the August 2025 complete response letter.

8-K Event Classification

2 items: 8.01, 9.01

2 items

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.

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Accepted by SEC EDGAR 09/29/2025 - 05:00 PM Learn about SEC filing dates

FAQ

What did Outlook Therapeutics (OTLK) disclose in this 8-K filing?

Outlook Therapeutics disclosed that it has completed a requested Type A meeting with the U.S. Food and Drug Administration to discuss the August 27, 2025 complete response letter related to its biologics license application resubmission for ONS-5010, and that it expects to resubmit the BLA before the end of calendar year 2025.

What is ONS-5010 in the Outlook Therapeutics (OTLK) filing?

ONS-5010 is described as an investigational ophthalmic formulation of bevacizumab that Outlook Therapeutics is developing to treat wet age-related macular degeneration, and it is the subject of the company’s biologics license application discussed with the FDA.

How did the FDA interaction affect Outlook Therapeutics’ BLA timeline for ONS-5010?

Based on its discussion with the FDA during the Type A meeting and after reviewing the agency’s feedback and meeting minutes, Outlook Therapeutics states that it expects to resubmit its BLA for ONS-5010 before the end of calendar year 2025.

What was the purpose of the FDA Type A meeting mentioned by Outlook Therapeutics?

The Type A meeting was held to discuss the complete response letter dated August 27, 2025 concerning Outlook Therapeutics’ biologics license application resubmission for ONS-5010, allowing the company to receive feedback and clarify next steps for resubmission.

Where can investors find more detailed information about Outlook Therapeutics’ FDA meeting?

More detailed information is contained in the press release dated September 29, 2025, which Outlook Therapeutics has filed as Exhibit 99.1 and incorporated by reference into this current report.

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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 29, 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 September 29, 2025, Outlook Therapeutics, Inc (the “Company”) issued a press release announcing that it has completed the requested Type A Meeting with the U.S. Food and Drug Administration (FDA) to discuss the complete response letter (CRL) dated August 27, 2025 regarding the biologics license application (BLA) resubmission for ONS-5010, an investigational ophthalmic formulation of bevacizumab under development to treat wet AMD.

Based on the discussion with the FDA, Outlook Therapeutics expects to resubmit its BLA before the end of calendar year 2025, after reviewing the agency’s feedback and meeting minutes.

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 September 29, 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: September 29, 2025	By:	/s/ Lawrence A. Kenyon
		Lawrence A. Kenyon
		Chief Financial Officer