Latest Outlook Therapeutics News & Updates

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Outlook Therapeutics

Late-stage biopharmaceutical company developing ophthalmic bevacizumab

outlooktherapeutics.com

Headquarters: Cranbury, United States
Founded year: 2011
Company type: Public company
Number of employees: 10–70

Last updated Today

Latest news about Outlook Therapeutics

In short: Outlook Therapeutics resubmitted its ONS-5010 BLA to the FDA and regained Nasdaq compliance following a reverse stock split.

Company announcements

June 16 Outlook Therapeutics

Outlook Therapeutics announces FDA acceptance of BLA resubmission

The BLA is for ONS-5010/LYTENAVA as a treatment for wet AMD, with a PDUFA date of July 29, 2026.

June 1 Outlook Therapeutics

Outlook Therapeutics resubmitted its BLA for ONS-5010/LYTENAVA to the FDA

The Class 1 resubmission has a 60-day PDUFA date and could lead to first FDA-approved ophthalmic bevacizumab.

May 28 Outlook Therapeutics

Outlook Therapeutics prices $5.0 million registered direct offering

The offering to GMS Ventures at $0.5855 per share will close May 29, 2026, with proceeds for working capital.

May 26 Outlook Therapeutics

Outlook Therapeutics wins FDA appeal for ONS-5010

Company plans to resubmit BLA in June 2026 after FDA confirmed substantial evidence of effectiveness for nAMD.

Media coverage

July 5 MSN

OTLK Stock Crashes 54% as FDA Issues Second CRL for Eye Disease Drug

Shares of Outlook Therapeutics OTLK tumbled 54.1% after the FDA issued a second complete response letter (CRL) rejecting its biologics license application (BLA) resubmission for...

June 27 TradingView

Outlook Therapeutics Disclosed Failure to Satisfy a Continued Listing Rule or Standard — TradingView News

On June 26, 2026, Nasdaq notified the company that it regained compliance with Listing Rule 5550(a)(2) after its closing bid price was at or above...

June 27 Börse Express

Outlook Therapeutics Stock: Decision on July 29

The FDA is reviewing the approval application for Lytenava. Analysts raise forecasts while the stock has already gained strongly.

June 27 Ophthalmology Times

Outlook Therapeutics stock undergoes 1-for-20 reverse stock split | Ophthalmology Times - Clinical Insights for Eye Specialists

The reverse stock split is “part of the Company’s plan to regain compliance with the minimum bid price requirement for continued listing on The Nasdaq...

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