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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.
Outlook Therapeutics' stock fell to a new low due to FDA rejection of its Lytenava filing for wet AMD. Efficacy evidence remains key issue.
U.S. stock futures rose on the first trading day of the year on Friday after missing the Santa Claus rally over the truncated week. Futures of major benchmark indices were higher. The Santa Claus trading period, which began on Dec. 24 last week, did not materialize as the S&P 500 declined for the fourth straight session, despite recording gains for 2025.
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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.
Oncobiologics (NASDAQ: OTLK - Get Free Report) and Barinthus Biotherapeutics (NASDAQ: BRNS - Get Free Report) are both small-cap medical companies, but which is the superior stock? We will compare the two companies based on the strength of their analyst recommendations, valuation, dividends, institutional ownership, profitability, earnings and risk. Valuation and Earnings This table compares Oncobiologics and
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.
ISELIN, N.J., Nov. 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 it has re-submitted its Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for ONS-5010, after receiving the official minutes from the FDA Type A meeting conducted in September 2025.
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).