Outlook Therapeutics Inc

Outlook Therapeutics, Inc. is a clinical-stage biopharmaceutical company, which engages in the development of ONS-5010/LYTENAVA. Its pipeline includes unmet patient needs, repackaged IV bevacizumab, and anti-VEGF. The company was founded by Pankaj Mohan on January 5, 2010 and is headquartered in Iselin, NJ.

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Outlook Therapeutics progresses well with ONS-5010, eyes global expansion

Outlook Therapeutics is well-positioned for potential approvals in Europe and the US in 2024 and 2025.
Strong financial backing and progress in key studies indicate a positive trajectory.
Challenges include addressing FDA queries and ensuring smart approval processes.
Opportunities lie in leveraging existing infrastructure, pricing discussions, and FDA agreements.

Outlook Therapeutics advances clinical trials and secures EU market entry

Outlook Therapeutics made significant progress with marketing authorization and clinical trial advancements.
Financial stability improved with reduced convertible notes and ample cash reserves.
Challenges lie in managing expenses, addressing analyst inquiries, and preparing for commercial launch.

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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).

Outlook Therapeutics® Streamlines Operations

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.

Outlook Therapeutics® Announces NICE Recommendation of LYTENAVA™ (bevacizumab gamma) for the Treatment of Wet AMD

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.

Outlook Therapeutics® Announces Executive Leadership Transition

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.

SHAREHOLDER ALERT: Pomerantz Law Firm Investigates Claims On Behalf of Investors of Outlook Therapeutics, Inc. - OTLK

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.

OTLK Stock Falls on Failure to Meet Non-Inferiority Goal in AMD Study

Outlook Therapeutics Inc. OTLK revealed preliminary topline results of NORSE EIGHT, the second of two clinical trials evaluating ONS-5010 in wet AMD patients.

Why Is Eye Disease-Focused Outlook Therapeutics Stock Trading Lower On Wednesday?

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.

Outlook Therapeutics® Announces Preliminary Topline Results of NORSE EIGHT Clinical Trial

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

Outlook Therapeutics® to Present at the Guggenheim Healthcare Innovation Conference

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.

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

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

Outlook Therapeutics® to Participate in the Virtual Investor Closing Bell Series

Webcast replay of fireside chat now available

Outlook Therapeutics® Participates in the 2nd Annual Chardan Virtual Ophthalmology Conference Series

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.

Outlook Therapeutics® Announces Completion of Enrollment in NORSE EIGHT Clinical Trial

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.

Outlook Therapeutics® to Present at the H.C. Wainwright 26th Annual Global Investment Conference

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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.

Outlook Therapeutics: Poised To Jump With Wet AMD Treatment If It Can Overcome FDA Hurdles

Outlook Therapeutics, Inc. Q3 2024 Earnings Conference Call August 14, 2024 8:30 AM ET Company Participants Jenene Thomas - JTC Team, LLC, Investor Relations Russell Trenary - President and Chief Executive Officer Lawrence Kenyon - Chief Financial Officer Conference Call Participants Julian Harrison - BTIG Will Hidell - Brookline Capital Markets Tim Chiang - Capital One Douglas Tsao - HC Wainwright Daniil Gataulin - Chardan Capital Markets Operator Greetings. And welcome to the Outlook Therapeutics Corporate Third Quarter Fiscal Year 2024 Update Conference Call and Webcast.

Outlook Therapeutics, Inc. (OTLK) Q3 2024 Earnings Call Transcript

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).

Outlook Therapeutics® Reports Financial Results for Third Quarter Fiscal Year 2024 and Provides Corporate Update

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.

Outlook Therapeutics® to Present at the H.C. Wainwright 4th Annual Ophthalmology Virtual Conference

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.

Outlook Therapeutics® to Report Financial Results for Third Quarter Fiscal Year 2024 on August 14, 2024 and Host Quarterly Conference Call and Webcast

Company to participate in a fireside chat on Monday, August 5 th at 8:00 AM ET

Outlook Therapeutics® to Present at the BTIG Virtual Biotechnology Conference 2024

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ISELIN, N.J., July 08, 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 the United Kingdom (UK) Medicines and Healthcare products Regulatory Agency (MHRA) has granted marketing authorization for LYTENAVA™ (bevacizumab gamma), an ophthalmic formulation of bevacizumab for the treatment of wet AMD in the UK. LYTENAVA™ (bevacizumab gamma) is the first and only authorized ophthalmic formulation of bevacizumab for use in treating wet AMD in the EU and UK.

Outlook Therapeutics® Announces UK MHRA Marketing Authorization of LYTENAVA™ (bevacizumab gamma) for the Treatment of Wet AMD

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Outlook Therapeutics: Analysts Forecast Over 500% Stock Upside

Outlook Therapeutics received a Complete Response Letter from the FDA in August 2023, causing a 74% drop in share price. Following a Type A meeting with the FDA in November 2023, Outlook agreed to conduct an additional clinical trial for ONS-5010. Its recent Special Protocol Assessment with the FDA sets it up for filing a BLA if the trial is successful in Q4, 2024.

Outlook Therapeutics: Worth A Good Strong Look After CRL

Outlook Therapeutics is resubmitting a BLA for ONS-5010 by 2024, with top-line data expected in Q4, 2024. ONS-5010 received European Commission Marketing Authorization for treating wet AMD in May 2024, and it is preparing for a commercial launch in early 2025. The anti-VEGF retina market is estimated at $15.9 billion globally, with substantial market opportunities in the US, EU, and UK.

News for Outlook Therapeutics Inc Stock (OTLK)