Outlook Therapeutics, Inc.

Outlook Therapeutics Submits HCPCS Level II Application to CMS for Permanent J-Code for LYTENAVA™ (bevacizumab-vikg)

Outlook Therapeutics submitted an HCPCS Level II application to CMS requesting a permanent, product-specific J-code for LYTENAVA, its FDA-approved ophthalmic bevacizumab for wet AMD. A permanent J-code would streamline billing and reimbursement for U.S. retina practices, though CMS notes the code is separate from coverage and payment decisions and assignment is not guaranteed. The company remains on track for a U.S. commercial launch before the end of 2026, with J-code review conducted on a quarterly cycle.

•1mo ago

Outlook Therapeutics CEO, Bob Jahr, Discusses FDA Approval and Commercial Opportunity for LYTENAVA™ in Virtual Investor CEO Connect Segment

Outlook Therapeutics CEO Bob Jahr appeared in a Virtual Investor CEO Connect segment discussing the FDA approval of LYTENAVA and the company's plans for its U.S. commercial launch. He positioned LYTENAVA as the only FDA-approved ophthalmic formulation of bevacizumab for wet AMD, with a management target of more than $500 million in annual U.S. sales by 2030, driven largely by converting existing off-label use to the approved product. The company says it is preparing a U.S. launch before the end of 2026, with readiness work across manufacturing, distribution, market access, reimbursement, and physician education, building on earlier launches in Germany, Austria, and the UK.

•1mo ago

Outlook Therapeutics Appoints Kevin Lundquist as Chief Financial Officer as It Prepares for U.S. Commercial Launch of LYTENAVA™

Outlook Therapeutics appointed Kevin Lundquist as Chief Financial Officer, effective September 1, 2026, bringing over 20 years of experience in pharmaceutical and medical technology finance to the role as the company prepares for the U.S. commercial launch of LYTENAVA. Outgoing CFO Lawrence Kenyon will step down on September 1 but will remain as a non-executive employee through the end of the month to ensure a smooth transition. The company issued an inducement grant to Mr. Lundquist for an option to purchase 500,000 shares of common stock, vesting over four years.

•2mo ago

Outlook Therapeutics Reports Third Quarter Fiscal Year 2026 Financial Results and Provides Business Update Highlighting FDA Approval of LYTENAVA™

Outlook Therapeutics reported a narrower adjusted net loss of $10.9 million, or $0.09 per share, for the third quarter of fiscal 2026, compared to an adjusted net loss of $15.8 million a year ago. GAAP net loss was $20.3 million, or $0.15 per share. The company is advancing the U.S. commercial launch of LYTENAVA, the only FDA-approved ophthalmic bevacizumab, with rollout planned by the end of calendar 2026. Management believes the product has the potential to exceed $500 million in annual U.S. sales by 2030. Subsequent to the quarter end, the company closed a public offering raising approximately $51.1 million in net proceeds to support the launch, ending the quarter with $11.2 million in cash.

•2mo ago

Outlook Therapeutics Announces LYTENAVA™ FDA Approval as the First and Only FDA-Approved Ophthalmic Bevacizumab for the Treatment of Wet AMD

Outlook Therapeutics secured FDA approval for LYTENAVA for the treatment of wet AMD, marking the first FDA-approved ophthalmic formulation of bevacizumab in the U.S. The drug targets a roughly $8.5 billion U.S. retina market and benefits from an anticipated 12 years of Reference Product Exclusivity under the BPCIA. Management has initiated the commercial launch and expects the product to be available to eligible patients in the United States before year-end.

•3mo ago

Outlook Therapeutics Announces FDA Acceptance of Resubmitted Biologics License Application for ONS-5010/LYTENAVA™ (bevacizumab-vikg) as a Treatment for Wet AMD

Outlook Therapeutics announced that the FDA has accepted the resubmitted Biologics License Application for ONS-5010/LYTENAVA for the treatment of wet AMD, assigning it a Class 1 review. The agency set a PDUFA target action date of July 29, 2026, marking the final step toward potential approval for the first FDA-approved ophthalmic formulation of bevacizumab. The company has initiated pre-launch activities in anticipation of the regulatory decision.

•4mo ago

Outlook Therapeutics Announces Resubmission of Biologics License Application to U.S. FDA for ONS-5010/LYTENAVA™ (bevacizumab-vikg)

Outlook Therapeutics resubmitted its Biologics License Application for LYTENAVA to the FDA for the treatment of neovascular age-related macular degeneration. The FDA accepted the resubmission as Class 1, confirming that substantial evidence of effectiveness is established and no additional trials are required. A regulatory decision is expected within 60 days of receipt, marking a critical inflection point for the company's lead asset which already holds marketing authorization in Europe and the UK.

•5mo ago

Outlook Therapeutics Wins Appeal Following Formal Dispute Resolution Process for ONS-5010/LYTENAVA™ (bevacizumab-vikg)

The FDA granted Outlook Therapeutics' appeal following the Formal Dispute Resolution process, concluding that substantial evidence of effectiveness has been established for LYTENAVA in treating neovascular age-related macular degeneration. This decision reverses the December 2025 Complete Response Letter and directs the FDA divisions to work with the company on final labeling, clearing the path for a Class 1 resubmission of the Biologics License Application in June 2026. A PDUFA decision is expected within 60 days of the resubmission, potentially making LYTENAVA the first FDA-approved ophthalmic formulation of bevacizumab with an approved manufacturing process and labeling.

•5mo ago