Outlook Therapeutics

OTLK

Market cap $35M

Outlook Therapeutics stock plunges 67% in a week after the FDA issues a third CRL rejecting its ONS-5010 BLA for wet AMD, again seeking confirmatory data.

ISELIN, N.J., Jan. 06, 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 it has appointed Laura Cantrell as Vice President of Corporate Strategy and Business Development.

The U.S. Food and Drug Administration has declined to approve Outlook Therapeutics' drug for a type of eye disease, the company said on Wednesday, marking another setback to its prolonged effort to bring the treatment to market.

FDA issues Complete Response Letter (CRL) for resubmitted ONS-5010 BLA FDA issues Complete Response Letter (CRL) for resubmitted ONS-5010 BLA

Outlook Therapeutics (OTLK) faces a pivotal FDA decision for Lytenava on December 31st, following two prior rejections and a 2025 recovery in share price. My bullish stance is underpinned by the NORSE EIGHT trial, conducted under Special Protocol Assessment, and improved manufacturing controls addressing prior FDA concerns. OTLK reported initial Lytenava revenues in Europe, but maintains a high cash burn, with roughly four months of runway and a $139M enterprise value.

ISELIN, N.J., Dec. 26, 2025 (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 that effective December 19, 2025, the Outlook Therapeutics, Inc. Compensation Committee of the Board of Directors granted stock options to purchase an aggregate of 150,000 shares of Outlook Therapeutics common stock with a per share exercise price of $2.01 per share to two new employees.

Oncobiologics, Inc. (OTLK) came out with a quarterly loss of $0.22 per share versus the Zacks Consensus Estimate of a loss of $0.23. This compares to a loss of $0.77 per share a year ago.

ISELIN, N.J., Dec. 19, 2025 (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 fiscal year 2025.

ISELIN, N.J., Nov. 24, 2025 (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 that Bob Jahr, Chief Executive Officer of Outlook Therapeutics, will participate in a fireside chat at the Piper Sandler 37th Annual Healthcare Conference on Tuesday, December 2, 2025 at 10:00 AM ET.

ISELIN, N.J., Nov. 13, 2025 (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 that the U.S. Food and Drug Administration (FDA) has acknowledged receipt of the resubmission of the Biologics License Application (BLA) for ONS-5010 (bevacizumab-vikg), an investigational ophthalmic formulation of bevacizumab for the treatment of wet age-related macular degeneration (wet AMD). The FDA has advised that it considers the BLA resubmission a complete, Class 1 response to the August 27, 2025 action letter, which results in a 60 day review period from the date of resubmission. As a result, the FDA has set a Prescription Drug User Fee Act (PDUFA) goal date of December 31, 2025. ONS-5010, if approved, will be branded as LYTENAVA™ (bevacizumab-vikg) for the treatment of wet AMD.