OTLK

Outlook Therapeutics (OTLK) receives both FDA and European approval for LYTENAVA, targeting wet AMD, but faces significant commercialization challenges. I downgrade OTLK to 'Hold' due to acute cash constraints and the urgent need for strategic funding or a partnership to support U.S. launch. LYTENAVA offers a lower-cost, ophthalmic bevacizumab alternative in a competitive $8.5B U.S. anti-VEGF retina market, but market capture remains uncertain.

Outlook Therapeutics said on Friday the ​U.S. Food and Drug Administration has ‌approved its drug for a type of eye disease that can cause severe vision ​loss.

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.

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.

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.

ISELIN, N.J., April 23, 2026 (GLOBE NEWSWIRE) -- Outlook Therapeutics, Inc. (Nasdaq: OTLK) (“Outlook Therapeutics” or the “Company”), a biopharmaceutical company focused on enhancing the standard of care for bevacizumab for the treatment of retina diseases, today announced the closing of its previously announced registered direct offering priced at-the-market under Nasdaq rules for the purchase and sale of an aggregate of 16,129,033 shares of its common stock at an offering price of $0.31 per share of common stock. Additionally, in a concurrent private placement, the Company issued unregistered warrants to purchase up to an aggregate of 16,129,033 shares of common stock at an exercise price of $0.31 per share. The unregistered warrants will become exercisable on the later of (i) the date of stockholder approval of the issuance of the shares underlying the warrants and (ii) the effective date of an amendment to the Company's certificate of incorporation to increase the authorized shares of the Company and will expire five years following the later of (x) the date the unregistered warrants are first exercisable and (y) the effective date of the registration statement registering the resale of the shares of common stock issuable upon exercise of the unregistered warrants.

ISELIN, N.J., April 22, 2026 (GLOBE NEWSWIRE) -- Outlook Therapeutics, Inc. (Nasdaq: OTLK) (“Outlook Therapeutics” or the “Company”), a biopharmaceutical company focused on enhancing the standard of care for bevacizumab for the treatment of retina diseases, today announced that it has entered into a definitive agreement for the purchase and sale of an aggregate of 16,129,033 shares of its common stock (or pre-funded warrants in lieu thereof) at an offering price of $0.31 per share of common stock (or per pre-funded warrants in lieu thereof) in a registered direct offering priced at-the-market under Nasdaq rules.