Outlook Therapeutics

OTLK

Market cap $249M

Outlook Therapeutics stock surges 35% after the FDA accepts the resubmitted Lytenava BLA for wet AMD for review, setting a July 29, 2026, decision date.

Outlook Therapeutics Inc. (NASDAQ:OTLK) shares are rising in Wednesday premarket trading after the company announced the FDA accepted its resubmitted Biologics License Application (BLA) for ONS-5010/LYTENAVA.

ISELIN, N.J., June 16, 2026 (GLOBE NEWSWIRE) -- Outlook Therapeutics, Inc. (Nasdaq: OTLK), a biopharmaceutical company focused on enhancing the standard of care for bevacizumab for the treatment of retina diseases, today announced the U.S. Food and Drug Administration (FDA) has acknowledged receipt of the resubmission of the Biologics License Application (BLA) for ONS-5010/LYTENAVA™ for the treatment of neovascular age-related macular degeneration (nAMD), or wet AMD.

Outlook Therapeutics receives a buy rating due to a recent FDA appeal victory, improving the probability of US approval for Lytenava. OTLK's near-term upside is driven by regulatory catalysts, despite ongoing concerns about commercial viability and a precarious financial position. Insider buying and a key shareholder's participation in recent offerings signal confidence ahead of binary FDA and Nasdaq compliance catalysts.

ISELIN, N.J., June 01, 2026 (GLOBE NEWSWIRE) -- 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).

ISELIN, N.J., May 28, 2026 (GLOBE NEWSWIRE) -- 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 that it has entered into a definitive agreement providing for the purchase and sale of an aggregate of 8,539,709 shares of its common stock at a purchase price of $0.5855 per share in a registered direct offering priced at-the-market under Nasdaq rules to GMS Ventures and Investments, the Company's largest stockholder. The closing of the offering is expected to occur on or about May 29, 2026, subject to the satisfaction of customary closing conditions. The aggregate gross proceeds to the Company from the offering are expected to be $5.0 million, before deducting offering expenses payable by the Company. The Company intends to use the net proceeds from this offering, together with existing cash and cash equivalents, for working capital and general corporate purposes.

Outlook Therapeutics, Inc. (NASDAQ:OTLK) shares are trading higher Tuesday after the company announced that the U.S. Food and Drug Administration granted its appeal following the Formal Dispute Resolution process for ONS-5010 or LYTENAVA (bevacizumab-vikg).

ISELIN, N.J., May 26, 2026 (GLOBE NEWSWIRE) -- 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 that the U.S. Food and Drug Administration (FDA) has granted the appeal following completion of the Formal Dispute Resolution (FDR) process with the Office of New Drugs (OND).

Oncobiologics, Inc. (OTLK) came out with a quarterly loss of $0.16 per share versus the Zacks Consensus Estimate of a loss of $0.12. This compares to a loss of $0.4 per share a year ago.

ISELIN, N.J., May 15, 2026 (GLOBE NEWSWIRE) -- Outlook Therapeutics, Inc. (Nasdaq: OTLK), a biopharmaceutical company focused on enhancing the standard of care for bevacizumab for the treatment of retina diseases, today announced financial results for the second quarter of fiscal year 2026 ended March 31, 2026, and provided a corporate update.