FDA accepts Outlook Therapeutics' BLA resubmission for ONS-5010; PDUFA date Dec 31, 2025

Outlook Therapeutics, Inc.

FDA acknowledged receipt of BLA resubmission for ONS-5010 (bevacizumab-vikg) and assigned Class 1 review.
Class 1 review results in a two-month review period from resubmission date.
PDUFA goal date set for December 31, 2025.

item 8.01

Machine-readable event card

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accession: 0001104659-25-111316
form_type: 8-K
ticker: OTLK
cik: 0001649989
company_name: Outlook Therapeutics, Inc.
filed_at: 2025-11-13T23:59:59+00:00
discovered_at: 2026-05-14T18:02:40.043855+00:00
generated_at: 2026-05-16T20:26:10.125473+00:00
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event_type: regulatory
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Source: SEC EDGAR

accession 0001104659-25-111316

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