Prescription Drug User Fee Act (PDUFA) goal date of August 27, 2025 ISELIN, N.J., April 08, 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 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 AMD. The

ISELIN, N.J., Feb. 28, 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 it has re-submitted its Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for ONS-5010, an investigational ophthalmic product which, if approved, will be branded as LYTENAVA™ (bevacizumab-vikg) for the treatment of wet age-related macular degeneration (wet AMD). "We remain committed to bringing

On-demand video webcast now available here ISELIN, N.J., Feb. 19, 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 it participated in the Virtual Investor "Top 5 for ‘25" On-Demand Conference. As part of the event, Lawrence A. Kenyon, Chief Financial Officer and Interim Chief Executive Officer of Outlook Therapeutics, presented the top five reasons of why he believes the investment community and

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

Dr. Jennifer Kissner, SVP Clinical Development, discusses the 12-week safety and efficacy results for NORSE EIGHT clinical trial Watch the "What This Means" segment here ISELIN, N.J., Feb. 04, 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 that Jennifer Kissner, Ph.D., SVP Clinical Development of Outlook Therapeutics participated in a Virtual Investor "What This Means" segment. As part of the segm

ISELIN, N.J., Jan. 31, 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 Faisal G. Sukhtian has been appointed as Chairman of the Board of Directors, effective immediately. Mr. Sukhtian will assume the role from Randy Thurman, who will remain on the Board as Lead Independent Director. "On behalf of the Board of Directors, management, and employees of Outlook Therapeutics, I want to extend my deepest

Data presented at Hawaiian Eye and Retina 2025 MeetingResults confirmed that intravitreal ONS-5010 provided early and sustained anatomic improvements, with steady gains in BCVA and reliable, consistent safetyONS-5010 demonstrated to be non-inferior to Lucentis at 4 and 12 weeksCompany on track for anticipated BLA resubmission in calendar Q1 2025 ISELIN, N.J., Jan. 23, 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)

ISELIN, N.J., Jan. 22, 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) 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 that Lawrence A. Kenyon, Executive Vice President, CFO and Interim CEO of Outlook Therapeutics will present at LIVE! with Webull Corporate Connect: Healthcare Investment Webinar being held on January 29, 2025. Conference Details: Conference: LIVE! with Webull Corporate Connect: Virtual Biotech Investment Webinar

ONS-5010 demonstrated to be non-inferior to Lucentis at 12 weeksBLA resubmission on track for calendar Q1 2025Entered into agreements for warrant inducement transaction expected to result in up to $20.4 million in gross proceeds ISELIN, N.J., Jan. 16, 2025 (GLOBE NEWSWIRE) -- Outlook Therapeutics, Inc. (Outlook Therapeutics, or the Company) (NASDAQ:OTLK), a biopharmaceutical company that achieved regulatory approval in the European Union and the United Kingdom for the first authorized use of an ophthalmic formulation of bevacizumab for the treatment of wet age-related macular degeneration (wet AMD), today announced it has completed the analysis of the complete 12-week safety and efficacy

Jedd Comiskey, Senior Vice President, Head of Europe, highlights the recent NICE recommendation of LYTENAVA™ (bevacizumab gamma) for the treatment of wet AMD Access the segment here ISELIN, N.J., Jan. 08, 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) 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 that Jedd Comiskey, Senior Vice President, Head of Europe of Outlook Therapeutics, participated in a Virtual Investor "What This Me

ISELIN, N.J., Jan. 31, 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 Faisal G. Sukhtian has been appointed as Chairman of the Board of Directors, effective immediately. Mr. Sukhtian will assume the role from Randy Thurman, who will remain on the Board as Lead Independent Director. "On behalf of the Board of Directors, management, and employees of Outlook Therapeutics, I want to extend my deepest

ISELIN, N.J., Dec. 03, 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 LYTENAVA™ (bevacizumab gamma), the first ophthalmic formulation of bevacizumab authorized for the treatment of wet age-related macular degeneration (wet AMD) in adults, today announced that Russell Trenary has stepped down as the Company's President and Chief Executive Officer (CEO), effective immediately. Lawrence Kenyon, Executive Vice President, Chief Financial Officer and member of the board of directors, has been appointed Interim CEO. "On behalf of our management team

ISELIN, N.J., Nov. 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 retinal diseases, today announced the appointment of Jedd Comiskey as Senior VP – Head of Europe. Mr. Comiskey has a successful track record in the planning, organization and execution of product launches. Over the course of his career, he has demonstrated innovative, solution-focused results, navigating the highly complex European pharmaceutical landscape. "We believe in the potential of ONS-5010 to address the global need for an approved bevacizumab that meets ophtha

ISELIN, N.J., Aug. 15, 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 the appointment of Julia A. Haller, MD, to the Company's Board of Directors. "We are pleased to welcome Dr. Haller to Outlook Therapeutics' Board of Directors. As one of the world's most accomplished professionals in ophthalmic education, research, and clinical ophthalmic practice, she will add tremendous value and insight to Outlook Therapeutics," said Randy Thurman, Executive Chairman of the Outlook Therapeutics Board o

Ms. Tozier has held commercial leadership positions across the full product lifecycle and exceeded goals for 14 launches across 70-plus global markets, with deep experience in ophthalmology and leadership for launching wet AMD/DME therapies. ISELIN, N.J., March 03, 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 that Alicia Tozier has been appointed as Senior Vice President, Marketing and Market Access. "We are pleased to strengthen our commercialization expertise with the addition of Alicia to our leader

Joel Prieve brings nearly 20 years of commercial operations expertise and proven track record in sales and account management ISELIN, N.J., Feb. 08, 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 the appointment of Joel Prieve as Senior Vice President, Commercial Operations. "Outlook Therapeutics is thrilled to welcome Joel to our executive leadership team. We believe his background and expertise in commercialization and specialty biopharmaceutical distribution will be invaluable as we continue advan

Experienced executive with a track-record of successful eye care product launchesAppointment reflects Outlook Therapeutics' dedication to transition to commercial-stage company ISELIN, N.J., July 07, 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 the appointment of C. Russell Trenary III as President, Chief Executive Officer and a member of the Board of Directors. Lawrence A. Kenyon, who has served as Outlook Therapeutics' President, CEO and CFO since June 2018, will continue serving as CFO and as a me

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