Outlook Therapeutics Reports Financial Results for Second Quarter Fiscal Year 2025 and Provides Corporate Update |
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. |
globenewswire.com |
2025-05-15 20:01:00 |
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Outlook Therapeutics® Announces Acceptance of Biologics License Application by U.S. FDA for ONS-5010 as a Treatment for Wet AMD |
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. |
globenewswire.com |
2025-04-08 12:45:00 |
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Outlook Therapeutics® Re-Submits Biologics License Application for ONS-5010 as a Treatment for Wet AMD to the U.S. Food and Drug Administration |
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). |
globenewswire.com |
2025-02-28 10:05:00 |
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Outlook Therapeutics® Participates in the Virtual Investor “Top 5 for ‘25” On-Demand Conference |
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. |
globenewswire.com |
2025-02-19 11:00:00 |
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Outlook Therapeutics® Reports Financial Results for First Quarter Fiscal Year 2025 and Provides Corporate Update |
ONS-5010 / LYTENAVA™ (bevacizumab-vikg) Biologics License Application (BLA) resubmission on track to meet target of Q1 CY2025 LYTENAVA™ (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 corporate update. |
globenewswire.com |
2025-02-14 10:05:00 |
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Outlook Therapeutics® Participates in Virtual Investor “What This Means” Segment |
Dr. Jennifer Kissner, SVP Clinical Development, discusses the 12-week safety and efficacy results for NORSE EIGHT clinical trial |
globenewswire.com |
2025-02-04 11:05:00 |
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Outlook Therapeutics® Appoints Faisal G. Sukhtian as Chairman of the Board of Directors |
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. |
globenewswire.com |
2025-01-31 10:05:00 |
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Outlook Therapeutics® Announces Presentation of Efficacy and Safety Results from NORSE EIGHT Clinical Trial Evaluating ONS-5010 for the Treatment of Wet AMD |
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), today announced the presentation of data from NORSE EIGHT at the Hawaiian Eye and Retina 2025 Meeting being held January 18-24, 2025 in Kauai, HI. |
globenewswire.com |
2025-01-23 11:05:00 |
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Outlook Therapeutics® to Present at LIVE! with Webull Corporate Connect: Healthcare Investment Webinar |
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. |
globenewswire.com |
2025-01-22 11:05:00 |
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Outlook Therapeutics Vision Loss Drug At Par With Novartis Drug |
On Thursday, Outlook Therapeutics, Inc. OTLK completed the analysis of the complete 12-week safety and efficacy results for NORSE EIGHT evaluating ONS-5010 in wet age-related macular degeneration (wet AMD) patients. |
benzinga.com |
2025-01-16 14:09:50 |
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Outlook Therapeutics® Announces Complete Twelve Week Efficacy and Safety Results of NORSE EIGHT Clinical Trial |
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 results for NORSE EIGHT, the second of two adequate and well controlled clinical trials evaluating ONS-5010 in wet AMD patients. ONS-5010 demonstrated noninferiority to ranibizumab at week 12 in the NORSE EIGHT trial. Based on the completed analysis of the 12-week results, Outlook Therapeutics plans to resubmit the Biologics License Application (BLA) for ONS-5010 in the first quarter of calendar 2025. |
globenewswire.com |
2025-01-16 08:00:00 |
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Outlook Therapeutics® Participates in Virtual Investor “What This Means” Segment |
Jedd Comiskey, Senior Vice President, Head of Europe, highlights the recent NICE recommendation of LYTENAVA™ (bevacizumab gamma) for the treatment of wet AMD |
globenewswire.com |
2025-01-08 11:15:00 |
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Outlook Therapeutics® Reports Financial Results for Fiscal Year 2024 and Provides Corporate Update |
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 fiscal year 2024 and provided a corporate update. |
globenewswire.com |
2024-12-27 10:05:00 |
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Outlook Therapeutics® Streamlines Operations |
ISELIN, N.J., Dec. 13, 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 that following an internal strategic review, the management team and Board of Directors have implemented initiatives to streamline the organization, reduce operating expenses and preserve capital, with the goal of maximizing its efforts to commercially launch LYTENAVA™ (bevacizumab gamma) for the treatment of wet AMD in the European Union (EU) and United Kingdom (UK) and supporting the resubmission of the Biologics License Application (BLA) for ONS-5010/LYTENAVA™ to the U.S. Food and Drug Administration (FDA). |
globenewswire.com |
2024-12-13 18:30:00 |
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Outlook Therapeutics® Announces NICE Recommendation of LYTENAVA™ (bevacizumab gamma) for the Treatment of Wet AMD |
First positive reimbursement decision worldwide for LYTENAVA™; First launch anticipated in H1 2025 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) 40,000 new wet AMD patients each year in the UK who could benefit from treatment 1 ISELIN, N.J., Dec. 04, 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 the National Institute for Health and Care Excellence (NICE) has recommended LYTENAVA™ (bevacizumab gamma), as an option for the treatment of wet AMD. |
globenewswire.com |
2024-12-04 10:05:00 |
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Outlook Therapeutics® Announces Executive Leadership Transition |
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. |
globenewswire.com |
2024-12-03 18:30:00 |
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SHAREHOLDER ALERT: Pomerantz Law Firm Investigates Claims On Behalf of Investors of Outlook Therapeutics, Inc. - OTLK |
NEW YORK , Dec. 2, 2024 /PRNewswire/ -- Pomerantz LLP is investigating claims on behalf of investors of Outlook Therapeutics, Inc. ("Outlook" or the "Company") (NASDAQ: OTLK). Such investors are advised to contact Danielle Peyton at newaction@pomlaw.com or 646-581-9980, ext. |
prnewswire.com |
2024-12-02 16:31:00 |
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OTLK Stock Falls on Failure to Meet Non-Inferiority Goal in AMD Study |
Outlook Therapeutics stock tanks 65% as ONS-5010 fails to meet the pre-specified non-inferiority endpoint at week 8 in the 90-day NORSE EIGHT study for wet AMD. |
zacks.com |
2024-11-28 13:31:08 |
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Why Is Eye Disease-Focused Outlook Therapeutics Stock Trading Lower On Wednesday? |
Outlook Therapeutics Inc. OTLK revealed preliminary topline results of NORSE EIGHT, the second of two clinical trials evaluating ONS-5010 in wet AMD patients. |
benzinga.com |
2024-11-27 11:27:39 |
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Outlook Therapeutics® Announces Preliminary Topline Results of NORSE EIGHT Clinical Trial |
ISELIN, N.J., Nov. 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 preliminary topline results of NORSE EIGHT, the second of two adequate and well controlled clinical trials evaluating ONS-5010 in wet AMD patients. Upon the completion of analysis of the final results of NORSE EIGHT, Outlook Therapeutics plans to resubmit the Biologics License Application (BLA) application for ONS-5010 in the first quarter of calendar 2025. |
globenewswire.com |
2024-11-27 08:50:00 |
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Outlook Therapeutics® to Present at the Guggenheim Healthcare Innovation Conference |
Live fireside chat with CEO, Russ Trenary, on November 12th at 2:30 PM ET Live fireside chat with CEO, Russ Trenary, on November 12th at 2:30 PM ET |
globenewswire.com |
2024-11-06 10:05:00 |
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OUTLOOK ALERT: Bragar Eagel & Squire, P.C. is Investigating Outlook Therapeutics, Inc. on Behalf of Long-Term Stockholders and Encourages Investors to Contact the Firm |
NEW YORK, Oct. 11, 2024 (GLOBE NEWSWIRE) -- Bragar Eagel & Squire, P.C., a nationally recognized shareholder rights law firm, is investigating potential claims against Outlook Therapeutics, Inc. (NASDAQ: OTLK) on behalf of long-term stockholders following a class action complaint that was filed against Outlook on November 3, 2023 with a Class Period from December 29, 2022 to August 29, 2023. Our investigation concerns whether the board of directors of Outlook have breached their fiduciary duties to the company. |
globenewswire.com |
2024-10-12 01:00:00 |
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Outlook Therapeutics® to Participate in the Virtual Investor Closing Bell Series |
Live video webcast with Russell Trenary, President and CEO of Outlook Therapeutics on Thursday, September 19th at 4:00 PM ET Live video webcast with Russell Trenary, President and CEO of Outlook Therapeutics on Thursday, September 19th at 4:00 PM ET |
globenewswire.com |
2024-09-16 12:05:00 |
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Outlook Therapeutics® Participates in the 2nd Annual Chardan Virtual Ophthalmology Conference Series |
Webcast replay of fireside chat now available |
globenewswire.com |
2024-09-13 13:05:00 |
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Outlook Therapeutics® Announces Completion of Enrollment in NORSE EIGHT Clinical Trial |
ISELIN, N.J., Sept. 04, 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 the completion of enrollment for its NORSE EIGHT clinical trial evaluating ONS-5010 in wet AMD patients. NORSE EIGHT is the subject of a Special Protocol Assessment (SPA) agreement with the FDA, and, if successful, is the final anticipated clinical trial required before expected resubmission of the Outlook Therapeutics' Biologics License Application (BLA) for ONS-5010. |
globenewswire.com |
2024-09-04 12:35:00 |
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Outlook Therapeutics® to Present at the H.C. Wainwright 26th Annual Global Investment Conference |
ISELIN, N.J., Sept. 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 the first authorized use of an ophthalmic formulation of bevacizumab for the treatment of wet age-related macular degeneration (wet AMD), today announced that Russell Trenary, President and CEO of Outlook Therapeutics will present at the H.C. Wainwright 26th Annual Global Investment Conference being held September 9-11, 2024 in New York, NY. |
globenewswire.com |
2024-09-03 12:45:00 |
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Outlook Therapeutics: Poised To Jump With Wet AMD Treatment If It Can Overcome FDA Hurdles |
Outlook Therapeutics faces liquidity issues and delays in FDA approval for its Wet AMD therapy, leading to a downgrade from Strong Buy to Buy. The potential blockbuster market for LYTENAVA in treating Wet AMD is significant, but FDA hurdles and financial constraints pose risks. Despite high upside potential, investors face the risk of losing their entire stake due to Outlook's financial and regulatory challenges. |
seekingalpha.com |
2024-08-26 08:11:43 |
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Outlook Therapeutics® Reports Financial Results for Third Quarter Fiscal Year 2024 and Provides Corporate Update |
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 degeneration (wet AMD), today announced financial results for the third quarter of fiscal year 2024 and provided a corporate update. As previously announced, Outlook Therapeutics will host its quarterly conference call and live audio webcast, today, Wednesday, August 14, 2024, at 8:30 AM ET (details below). |
globenewswire.com |
2024-08-14 11:05:00 |
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Outlook Therapeutics® to Present at the H.C. Wainwright 4th Annual Ophthalmology Virtual Conference |
ISELIN, N.J., Aug. 12, 2024 (GLOBE NEWSWIRE) -- Outlook Therapeutics, Inc. (Nasdaq: OTLK), a biopharmaceutical company focused on development and commercialization of ONS-5010/LYTENAVA™ (bevacizumab-vikg; bevacizumab gamma) for the treatment of retina diseases, today announced that Russell Trenary, President and CEO of Outlook Therapeutics will participate in a fireside chat at the H.C. Wainwright 4 th Annual Ophthalmology Virtual Conference being held on Thursday, August 15, 2024. |
globenewswire.com |
2024-08-12 13:05:00 |
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Outlook Therapeutics® to Report Financial Results for Third Quarter Fiscal Year 2024 on August 14, 2024 and Host Quarterly Conference Call and Webcast |
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. |
globenewswire.com |
2024-08-07 12:35:00 |
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Outlook Therapeutics® to Present at the BTIG Virtual Biotechnology Conference 2024 |
Company to participate in a fireside chat on Monday, August 5 th at 8:00 AM ET |
globenewswire.com |
2024-07-30 13:10:00 |
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3 Beaten Down Pharmaceuticals With Catalysts for Higher Prices |
Trading volume spikes in beaten-down stocks often signal a bottom for prices investors can bank on. The problem is that beaten-down stocks are usually in that position for a good reason, so it helps if there is a catalyst for higher share prices in addition to the trading volume. |
marketbeat.com |
2024-07-11 11:12:55 |
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