OTLK - Earnings announcements

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. Financial Highlights for the Fiscal Year Ended September 30, 2025 For the fiscal year ended September 30, 2025, Outlook Therapeutics reported net loss attributable to common stockholders of $62.4 million, or $1.79 per basic and diluted share, and $1.4 million of revenue. This compares with net loss attributable to common stockholders of $75.4 million, or $4.06 per basic and diluted share, and no revenue for the prior year.

FDA issues Complete Response Letter (CRL) for resubmitted ONS-5010 BLAOutlook Therapeutics plans to work with FDA to address the Agency's issuesCompany to host a conference call and webcast today, August 28th at 8:30 AM ET 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 treat

First commercial sales of LYTENAVA™ (bevacizumab gamma) achieved in EuropeONS-5010/LYTENAVA™ (bevacizumab-vikg) Prescription Drug User Fee Act (PDUFA) goal date of August 27, 2025, in the United States ISELIN, N.J., Aug. 14, 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 reported financial results for the third quarter of fiscal year 2025 and provided a corporate update. Financial Highlights for the Fiscal Third Quarter Ended June 30, 2025For the fiscal third quarter ended June 30, 2025, Outlook Therapeutics reported net

LYTENAVA™ (bevacizumab gamma) on track for planned first commercial launches in Germany and the United Kingdom (UK) in Q2 CY2025Prescription Drug User Fee Act (PDUFA) goal date of August 27, 2025 in the United States ISELIN, N.J., May 15, 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 reported financial results for the second quarter of fiscal year 2025 and provided a corporate update. "Outlook Therapeutics remains on track in 2025 to transform into a commercial-stage company with the planned upcoming commercial launch of LYTENAVA™ (bevaciz

ONS-5010 / LYTENAVA™ (bevacizumab-vikg) Biologics License Application (BLA) resubmission on track to meet target of Q1 CY2025LYTENAVA™ (bevacizumab gamma) on track for first commercial launches in Germany and the United Kingdom (UK) planned for Q2 CY2025 ISELIN, N.J., Feb. 14, 2025 (GLOBE NEWSWIRE) -- Outlook Therapeutics, Inc. (NASDAQ:OTLK), a biopharmaceutical company that achieved regulatory approval in the European Union (EU) and the United Kingdom (UK) for the first authorized use of an ophthalmic formulation of bevacizumab for the treatment of wet age-related macular degeneration (wet AMD), today announced financial results for the first quarter of fiscal year 2025 and provided a co

LYTENAVA™ is the first and only approved ophthalmic formulation of bevacizumab for the treatment of wet AMD in the European Union (EU) and United Kingdom (UK); First commercial launch anticipated in H1 CY25Received NICE recommendation of LYTENAVA™ (bevacizumab gamma) for the treatment of wet AMD ISELIN, N.J., Dec. 27, 2024 (GLOBE NEWSWIRE) -- Outlook Therapeutics, Inc. (NASDAQ:OTLK), a biopharmaceutical company that achieved regulatory approval in the European Union and the United Kingdom earlier this year for the first authorized use of an ophthalmic formulation of bevacizumab for the treatment of wet age-related macular degeneration (wet AMD), today announced financial results for fisca

Received European Union (EU) and United Kingdom (UK) Marketing Authorization for LYTENAVA™ (bevacizumab gamma) for the treatment of wet AMDNORSE EIGHT current enrollment pace supports topline readout target of Q4 CY2024Resubmission of the ONS-5010 Biologics License Application (BLA) on track for Q1 CY2025Quarterly update conference call and webcast today, Wednesday, August 14th at 8:30 AM ET ISELIN, N.J., Aug. 14, 2024 (GLOBE NEWSWIRE) -- Outlook Therapeutics, Inc. (NASDAQ:OTLK), a biopharmaceutical company that has achieved regulatory approval in the EU and UK for the first authorized use of an ophthalmic formulation of bevacizumab for the treatment of wet age-related macular degenerati

ISELIN, N.J., Aug. 07, 2024 (GLOBE NEWSWIRE) -- Outlook Therapeutics, Inc. (NASDAQ:OTLK), a biopharmaceutical company that has achieved regulatory approval in the EU and UK for the first authorized use of an ophthalmic formulation of bevacizumab for the treatment of wet AMD, today announced that it will report its financial results for third quarter fiscal year 2024 on Wednesday, August 14, 2024. Outlook Therapeutics management will host its quarterly conference call and live audio webcast to discuss the operational and financial results at 8:30 AM ET that same day. The call will be led by Russell Trenary, President and Chief Executive Officer and Lawrence Kenyon, Chief Financial Officer

Positive opinion received from Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) for ONS-5010/LYTENAVA™ (bevacizumab gamma)United Kingdom (UK) Marketing Authorization Application (MAA) submitted NORSE EIGHT fully underway in the US; Topline readout expected in Q4 CY2024Resubmission of the ONS-5010 Biologics License Application (BLA) planned by the end of CY2024 Company to host inaugural quarterly update conference call and webcast on Thursday, May 16th at 8:30 AM ET ISELIN, N.J., May 15, 2024 (GLOBE NEWSWIRE) -- Outlook Therapeutics, Inc. (NASDAQ:OTLK), a biopharmaceutical company working to achieve regulatory approval for the first authorized

ISELIN, N.J., May 09, 2024 (GLOBE NEWSWIRE) -- Outlook Therapeutics, Inc. (NASDAQ:OTLK), a biopharmaceutical company working to achieve the first approval for an ophthalmic formulation of bevacizumab for the treatment of retinal diseases in the US and the EU, today announced that it will report its financial results for second quarter fiscal year 2024 on Thursday, May 16, 2024. Outlook Therapeutics management will host its inaugural quarterly conference call and live audio webcast to discuss the operational and financial results at 8:30 AM ET that same day. The call will be led by Russell Trenary, President and Chief Executive Officer and Lawrence Kenyon, Chief Financial Officer of Outloo

NORSE EIGHT underway with first subject dosed and additional clinical sites beginning enrollment Continue to expect planned resubmission of the ONS-5010 Biologics License Application (BLA) by the end of CY2024 Anticipate review decision from European regulators in the first half of CY2024 ISELIN, N.J., Feb. 14, 2024 (GLOBE NEWSWIRE) -- Outlook Therapeutics, Inc. (NASDAQ:OTLK), a biopharmaceutical company working to achieve regulatory approval for the first ophthalmic formulation of bevacizumab for the treatment of retinal diseases, today announced financial results for first quarter fiscal year 2024 and provided a corporate update. "We are proud of the recent progress our team has ma

Commencement of ONS-5010 NORSE EIGHT clinical trial targeted for first calendar quarter of 2024Company reaffirms potential for European approval for ONS-5010 with Marketing Authorization Application (MAA) decision date anticipated in the first half of 2024 Resubmission of the ONS-5010 Biologics License Application (BLA) expected by the end of calendar year 2024 ISELIN, N.J., Dec. 22, 2023 (GLOBE NEWSWIRE) -- Outlook Therapeutics, Inc. (NASDAQ:OTLK), a biopharmaceutical company working to achieve U.S. Food and Drug Administration (FDA) approval for the first ophthalmic formulation of bevacizumab for the treatment of retinal diseases, today announced recent corporate highlights and financia

FDA issues Complete Response Letter (CRL) for ONS-5010 BLA based on CMC and need for further confirmatory clinical evidence Outlook Therapeutics working with FDA to address the Agency's issues Company to host conference call and webcast, today, August 30 at 8:30 AM ET ISELIN, N.J., Aug. 30, 2023 (GLOBE NEWSWIRE) -- Outlook Therapeutics, Inc. (NASDAQ:OTLK), a biopharmaceutical company working to achieve FDA approval for the first ophthalmic formulation of bevacizumab for the treatment of retinal diseases, today announced the U.S. Food and Drug Administration (FDA) has issued a CRL to the Company's BLA for ONS-5010, an investigational ophthalmic formulation of bevacizumab under developmen

Prescription Drug User Fee Act (PDUFA) goal date of August 29, 2023 for ONS-5010, an investigational ophthalmic formulation of bevacizumab for the treatment of wet age-related macular degeneration (wet AMD) ISELIN, N.J., Aug. 14, 2023 (GLOBE NEWSWIRE) -- Outlook Therapeutics, Inc. (NASDAQ:OTLK), a biopharmaceutical company working to achieve FDA approval for the first ophthalmic formulation of bevacizumab for the treatment of wet AMD, today announced recent corporate highlights and financial results for its fiscal third quarter ended June 30, 2023. Russell Trenary, President and Chief Executive Officer of Outlook Therapeutics, commented, "We continue to be focused on our pre-launch activ

Upcoming Prescription Drug User Fee Act (PDUFA) goal date of August 29, 2023 for ONS-5010, an investigational ophthalmic formulation of bevacizumab for the treatment of wet age-related macular degeneration (wet AMD)Pre-launch commercial activities continue in preparation for potential approval and launch of ONS-5010 ISELIN, N.J., May 15, 2023 (GLOBE NEWSWIRE) -- Outlook Therapeutics, Inc. (NASDAQ:OTLK), a biopharmaceutical company working to develop and launch the first FDA-approved ophthalmic formulation of bevacizumab for use in retinal indications, today announced recent corporate highlights and financial results for its fiscal second quarter ended March 31, 2023.

Pre-launch commercial activities underway as Company advances toward U.S. Food and Drug Administration (FDA) Prescription Drug User Fee Act (PDUFA) goal date of August 29, 2023 for ONS-5010 / LYTENAVA™ (bevacizumab-vikg), an investigational ophthalmic formulation for the treatment of wet age-related macular degeneration (wet AMD)Cash runway through the anticipated FDA approval of ONS-5010 in the third calendar quarter of 2023 and into the fourth calendar quarter of 2023 ISELIN, N.J., Feb. 14, 2023 (GLOBE NEWSWIRE) -- Outlook Therapeutics, Inc. (NASDAQ:OTLK), a biopharmaceutical company working to develop and launch the first FDA-approved ophthalmic formulation of bevacizumab for use i

Planned re-submission of ONS-5010 / LYTENAVA™ (bevacizumab-vikg) Biologics License Application (BLA) to U.S. Food and Drug Administration (FDA) on track ISELIN, N.J., Aug. 10, 2022 (GLOBE NEWSWIRE) -- Outlook Therapeutics, Inc. (NASDAQ:OTLK), a pre-commercial biopharmaceutical company working to develop and launch the first FDA-approved ophthalmic formulation of bevacizumab for use in retinal indications, today announced its financial results for its fiscal third quarter ended June 30, 2022, provided recent corporate highlights, and reiterated its anticipated near-term milestones. Recent Corporate Highlights Announced the full cash pre-payment of its $12.3 million unsecured

ONS-5010 / LYTENAVA™ (bevacizumab-vikg) Biologics License Application (BLA) submitted to U.S. Food and Drug Administration (FDA); PDUFA date expected to be announced in June 2022Advancing ONS-5010 toward potential marketing approval in early 2023U.S. pre-launch commercial planning continues to ramp upOperations supported by access to funding expected to be sufficient to launch LYTENAVA, if approved ISELIN, N.J., May 13, 2022 (GLOBE NEWSWIRE) -- Outlook Therapeutics, Inc. (NASDAQ:OTLK), a pre-commercial biopharmaceutical company working to develop and launch the first FDA-approved ophthalmic formulation of bevacizumab for use in retinal indications, today announced recent corporate highlig

Outlook Therapeutics remains on track to submit new U.S. FDA Biologics License Application (BLA) for first ophthalmic formulation of bevacizumab Commercial launch planning underway Financed through the anticipated approval of the ONS-5010 BLA ISELIN, N.J., Feb. 14, 2022 (GLOBE NEWSWIRE) -- Outlook Therapeutics, Inc. (NASDAQ:OTLK), a biopharmaceutical company working to develop and launch the first FDA-approved ophthalmic formulation of bevacizumab for use in retinal indications, today announced recent corporate highlights and financial results for its fiscal first quarter ended December 31, 2021. Recent Corporate Highlights Expanded commercial team with appointment of SVP, Commercial

Positive clinical data reported for ONS-5010 / LYTENAVA™ (bevacizumab-vikg) in 2021 from multiple clinical trials, including statistically significant top-line efficacy and safety data from pivotal Phase 3 NORSE TWO trial for wet age-related macular degeneration (wet AMD)Recent financing activities expected to provide funding through the anticipated approval of the ONS-5010 biologics license application (BLA) expected in the first calendar quarter of 2023Pre-launch commercial planning underway in anticipation of ONS-5010 approval ISELIN, N.J., Dec. 22, 2021 (GLOBE NEWSWIRE) --  Outlook Therapeutics, Inc. (NASDAQ:OTLK), a biopharmaceutical company working to develop and launch the first FD

Reported positive, statistically significant top-line efficacy and safety data from pivotal Phase 3 NORSE TWO trial of ONS-5010 / LYTENAVA™ (bevacizumab-vikg) for the treatment of wet age-related macular degeneration (wet AMD) On track to submit new U.S. BLA for ONS-5010 in the first quarter of calendar 2022 and pre-commercial launch planning underway ISELIN, N.J., Aug. 13, 2021 (GLOBE NEWSWIRE) -- Outlook Therapeutics, Inc. (NASDAQ:OTLK), a biopharmaceutical company working to develop and launch the first FDA-approved ophthalmic formulation of bevacizumab for use in retinal indications, today announced recent corporate highlights and financial results for its fiscal third quarter ended

In NORSE TWO, ONS-5010 achieved statistically significant and clinically relevant primary (p = 0.0052) and key secondary (p = 0.0043) efficacy endpoints with 41% of subjects gaining at least 15 lettersIn NORSE TWO, ONS-5010 was safe and well tolerated Management to host conference call and webcast today at 8:00 a.m. ET ISELIN, N.J., Aug. 03, 2021 (GLOBE NEWSWIRE) -- Outlook Therapeutics, Inc. (NASDAQ:OTLK), a biopharmaceutical company working to develop and launch the first FDA-approved ophthalmic formulation of bevacizumab for use in retinal indications, today announced positive clinical and highly statistically significant top-line results from its pivotal Phase 3 NORSE TWO safety and e

Topline efficacy and safety data from pivotal Phase 3 NORSE TWO study on target to report in calendar Q3 2021Recently reported topline data from the NORSE THREE open-label safety study reinforce positive safety profile of ONS-5010 seen in the earlier clinical experience trial (NORSE ONE) ISELIN, N.J., May 14, 2021 (GLOBE NEWSWIRE) -- Outlook Therapeutics, Inc. (NASDAQ:OTLK), a late clinical-stage biopharmaceutical company working to develop the first FDA-approved ophthalmic formulation of bevacizumab for use in retinal indications, today announced recent corporate highlights and financial results for its fiscal second quarter ended March 31, 2021.Outlook Therapeutics also provided a cli

Topline data from pivotal Phase 3 safety and efficacy study (NORSE TWO) on target to report in Q3 2021Topline data from the open-label safety study (NORSE THREE) on target to report in Q2 2021Recent funding significantly enhances financial position, extends cash runway through BLA filing and provides strategic optionality to maximize stockholder value MONMOUTH JUNCTION, N.J., Feb. 16, 2021 (GLOBE NEWSWIRE) -- Outlook Therapeutics, Inc. (Nasdaq: OTLK), a late clinical-stage biopharmaceutical company working to develop the first FDA-approved ophthalmic formulation of bevacizumab-vikg for use in retinal indications, today announced recent corporate highlights and financial results for its

All planned clinical trials for ONS-5010 / LYTENAVA™ (bevacizumab-vikg) wet AMD BLA now fully enrolled or completedPivotal data expected in mid-2021 from ongoing, fully enrolled Phase 3 registration trial for ONS-5010 (NORSE TWO) with new BLA filing expected in second half of 2021 MONMOUTH JUNCTION, N.J., Dec. 23, 2020 (GLOBE NEWSWIRE) -- Outlook Therapeutics, Inc. (Nasdaq: OTLK), a late clinical-stage biopharmaceutical company working to develop the first FDA-approved ophthalmic formulation of bevacizumab-vikg for use in retinal indications, today announced its corporate highlights and financial results for its fiscal year ended September 30, 2020. Outlook Therapeutics also