UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM
CURRENT REPORT
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| Item 8.01 | Other Events. |
On July 8, 2024, Outlook Therapeutics, Inc. (“Outlook”) announced that the United Kingdom Medicines and Healthcare products Regulatory Agency (“MHRA”) has granted Marketing Authorization for LYTENAVA™ (bevacizumab gamma), an ophthalmic formulation of bevacizumab for the treatment of wet age-related macular degeneration (wet AMD) in the United Kingdom. LYTENAVA™ (bevacizumab gamma) is the first and only authorized ophthalmic formulation of bevacizumab for use in treating wet AMD in the European Union and United Kingdom.
The Marketing Authorization Application submission to the MHRA was completed under the new International Recognition Procedure, which allows the MHRA to rely on a positive opinion by the European Medicines Agency’s Committee for Medicinal Products for Human Use concerning an application for granting marketing authorization for the same product in the European Union in the MHRA’s authorization decision.
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: July 8, 2024 | By: | /s/ Lawrence A. Kenyon |
| Lawrence A. Kenyon | ||
| Chief Financial Officer | ||