Outlook Therapeutics

OTLK

Market cap $34.4M

ISELIN, N.J., March 05, 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 provided an update following its recent Type A meeting with the U.S. Food and Drug Administration (FDA) to discuss the December 30, 2025 Complete Response Letter (CRL) for the Biologics License Application (BLA) for ONS-5010/LYTENAVA™ (bevacizumab-vikg).

Veteran ophthalmology leader with 35+ years of market expertise selected as exclusive Switzerland partner Mediconsult to seek Marketing Authorization and lead commercialization activities for LYTENAVA™ (bevacizumab gamma) in Switzerland Partnership advances European commercial expansion strategy, with LYTENAVA™ (bevacizumab gamma) expected to launch in Switzerland in 2027 ISELIN, N.J., Feb. 19, 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 and Mediconsult AG, Switzerland's leading full-service partner for ophthalmic professionals, today announced they have entered into an exclusive commercial distribution agreement for the sale and distribution of LYTENAVA™ (bevacizumab gamma) in the Switzerland market.

Oncobiologics, Inc. (OTLK) came out with a quarterly loss of $0.22 per share versus the Zacks Consensus Estimate of a loss of $0.17. This compares to a loss of $0.89 per share a year ago.

ISELIN, N.J., Feb. 17, 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 first quarter fiscal year 2026 and provided a corporate update.

ISELIN, N.J., Feb. 11, 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 that it has submitted a Type A meeting request to the U.S. Food and Drug Administration (FDA) following receipt of a Complete Response Letter (CRL) dated December 30, 2025, regarding the Company's Biologics License Application (BLA) for ONS-5010/LYTENAVA™ (bevacizumab-vikg) for the treatment of wet age-related macular degeneration (wet AMD).

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.