Recent Insider Transactions • Jun 01
Independent Director recently bought US$177k worth of stock On the 26th of May, Kurt Hilzinger bought around 400k shares on-market at roughly US$0.44 per share. This transaction increased Kurt's direct individual holding by 17x at the time of the trade. This was the largest purchase by an insider in the last 3 months. Insiders have collectively bought US$244k more in shares than they have sold in the last 12 months. Announcement • Jun 01
Outlook Therapeutics, Inc. Announces Resubmission of Biologics License Application to U.S. FDA for ONS-5010/LYTENAVA™ (bevacizumab-vikg) Outlook Therapeutics, Inc. announced the resubmission of its Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for ONS-5010/LYTENAVA™ for the treatment of neovascular age-related macular degeneration (nAMD). As previously announced, Outlook Therapeutics successfully appealed the December 2026 Complete Response Letter (CRL) related to the ONS-5010 Biologics License Application reviewed by the FDA. In their decision, the FDA Office of New Drugs concluded that substantial evidence of effectiveness has been established for LYTENAVA™ for the treatment of neovascular age-related macular degeneration (nAMD), therefore additional trials are not required. The FDR decision directed the Division of Ophthalmology and Office of Specialty Medicine to work with Outlook Therapeutics to focus on reaching an agreement on final product labeling. Additionally, as indicated in the formal decision, this will be a Class 1 resubmission with a PDUFA date and decision expected within 60 days of FDA’s receipt of the resubmission. When approved, ONS-5010/LYTENAVA™ will be the first and only FDA-approved ophthalmic formulation of bevacizumab supported by standardized manufacturing, FDA-approved labeling, and robust pharmacovigilance. ONS-5010/LYTENAVA™ is an ophthalmic formulation of bevacizumab produced in the United States for the treatment of wet AMD. LYTENAVA™ (bevacizumab gamma) is the subject of a centralized Marketing Authorization granted by the European Commission in the EU and Marketing Authorization granted by the Medicines and Healthcare products Regulatory Agency (MHRA) in the UK for the treatment of wet AMD. In certain European Union Member States, ONS-5010/LYTENAVA™ must receive pricing and reimbursement approval before it can be sold. In the United States, ONS-5010/LYTENAVA ™ (bevacizumab-vikg) is investigational. When approved, it will be the first ophthalmic formulation approved by the FDA. Bevacizumab-vikg (bevacizumab gamma in the EU and UK) is a recombinant humanized monoclonal antibody (mAb) that selectively binds with high affinity to all isoforms of human vascular endothelial growth factor (VEGF) and neutralizes VEGF’s biologic activity through a steric blocking of the binding of VEGF to its receptors Flt-1 (VEGFR-1) and KDR (VEGFR-2) on the surface of endothelial cells. Following intravitreal injection, the binding of bevacizumab to VEGF prevents the interaction of VEGF with its receptors on the surface of endothelial cells, reducing endothelial cell proliferation, vascular leakage, and new blood vessel formation in the retina. 
