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Outlook Therapeutics resubmeteu sua BLA para ONS-5010/LYTENAVA após apelar com sucesso da CRL de dezembro de 2026. O FDA Office of New Drugs determinou que evidências substanciais de eficácia foram estabelecidas, portanto nenhum ensaio adicional é necessário. A resubmissão é designada como Classe 1 com decisão PDUFA esperada em até 60 dias após o recebimento.
EX-99.1 2 tm2616461d1_ex99-1.htm EXHIBIT 99.1 Exhibit 99.1 Outlook Therapeutics Announces Resubmission of Biologics License Application to U.S. FDA for ONS-5010/LYTENAVA™ (bevacizumab-vikg) ISELIN, N.J., June 1, 2026 — Outlook Therapeutics, Inc. (Nasdaq: OTLK), a biopharmaceutical company focused on the development and commercialization of ONS-5010/LYTENAVA™ (bevacizumab-vikg, bevacizumab gamma) for the treatment of retinal diseases, today 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-50