Outlook Therapeutics

OTLK

Market cap $58.2M

ISELIN, N.J., Sept. 29, 2025 (GLOBE NEWSWIRE) -- Outlook Therapeutics, Inc.  (Nasdaq: OTLK), a biopharmaceutical company focused on optimizing the standard of care for bevacizumab for the treatment of retina diseases, today announced that it has completed the Type A Meeting with the U.S. Food and Drug Administration (FDA) to discuss the complete response letter (CRL) dated August 27, 2025 regarding the biologics license application (BLA) resubmission for ONS-5010, an investigational ophthalmic formulation of bevacizumab under development to treat wet AMD. Based on the discussion with the FDA, Outlook Therapeutics expects to resubmit its BLA before the end of calendar year 2025, after reviewing the agency's feedback and meeting minutes.

ISELIN, N.J., Sept. 03, 2025 (GLOBE NEWSWIRE) -- Outlook Therapeutics, Inc. (Nasdaq: OTLK), a biopharmaceutical company focused on optimizing the standard of care for bevacizumab for the treatment of retina diseases, today announced that it will present at the EURETINA Innovation Spotlight being held as part of the 25th EURETINA Congress on September 3, 2025 in Le Palais des Congrès, Paris.

ISELIN, N.J., Sept. 02, 2025 (GLOBE NEWSWIRE) -- Outlook Therapeutics, Inc. (Nasdaq: OTLK), a biopharmaceutical company focused on optimizing the standard of care for bevacizumab for the treatment of retina diseases, today announced that a Type A Meeting request has been submitted to the U.S. Food and Drug Administration (FDA) to discuss the complete response letter (CRL) dated August 27, 2025 regarding the biologics license application (BLA) resubmission for ONS-5010, an investigational ophthalmic formulation of bevacizumab under development to treat wet AMD.

Outlook Therapeutics stock plunges 54% after the FDA rejects ONS-5010 BLA again, citing lack of efficacy data in confirmatory study.

Shares of Outlook Therapeutics fell sharply on Thursday after the US Food and Drug Administration (FDA) rejected the company's application for its experimental eye drug ONS-5010, a proposed treatment for wet age-related macular degeneration (wet AMD).

Outlook Therapeutics, Inc. OTLK stock plunged on Thursday after the U.S. Food and Drug Administration (FDA) update.

The U.S. Food and Drug Administration has declined to approve Outlook Therapeutics' experimental drug to treat a type of eye condition that causes blurred vision, the company said on Thursday.

ISELIN, N.J., Aug. 28, 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 issued a complete response letter (CRL) to its biologics license application (BLA) resubmission, indicating that the FDA cannot approve the application in its present form for the treatment of wet age-related macular degeneration (wet AMD).

FDA approval for Lytenava might come next week, I see Outlook Therapeutics at a pivotal inflection point, offering a rare asymmetric risk/reward setup. Lytenava's European approval, decade-long exclusivity, and initial sales validate its regulatory and commercial path, providing a strong foundation for US launch. Financials are tight, cash burn is high, and revenue is minimal, but US approval could rapidly shift the outlook, unlocking a much larger market.

Oncobiologics, Inc. (OTLK) came out with a quarterly loss of $0.44 per share versus the Zacks Consensus Estimate of a loss of $0.42. This compares to a loss of $0.83 per share a year ago.