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Outlook Therapeutics

Outlook Therapeutics logo
🇺🇸United States
Ownership
Public
Established
2011-01-01
Employees
24
Market Cap
$176.7M
Website
http://www.outlooktherapeutics.com
Introduction

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.

msn.com
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Outlook Therapeutics stock craters as the wet AMD drug fails Phase III trial

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Outlook Therapeutics stock craters as wet AMD drug fails Phase III trial

Outlook Therapeutics' Lytenava failed to meet a key endpoint in Phase III NORSE EIGHT trial for wet AMD, leading to a stock drop of over 79%. Despite this, Outlook plans to resubmit the biologics licence application in Q1 2025, with full three-month trial results expected in January 2025. The company also aims to launch Lytenava in the UK and Germany in 2025 and is exploring global partnerships excluding the US.
stocktitan.net
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Outlook Therapeutics® Announces Preliminary Topline Results of NORSE EIGHT Clinical Trial

Outlook Therapeutics announced preliminary NORSE EIGHT trial results for ONS-5010 in wet AMD patients, showing +4.2 letter improvement in BCVA versus +6.3 letters for ranibizumab, not meeting the non-inferiority endpoint. Despite this, ONS-5010 demonstrated vision improvement, biologic activity, and a favorable safety profile. Final efficacy data is expected in January 2025, with BLA resubmission planned for Q1 2025. The company maintains European and UK marketing authorization for LYTENAVA™, with potential launch in these markets in 2025.
biospace.com
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Outlook Therapeutics Announces Preliminary Topline Results of NORSE EIGHT Clinical Trial

Outlook Therapeutics announced preliminary results of NORSE EIGHT, a trial evaluating ONS-5010 for wet AMD, showing an improvement in vision and favorable safety profile. The trial did not meet the non-inferiority endpoint at week 8. Full month 3 data expected in January 2025, with plans to resubmit the BLA in Q1 2025. The company also plans a potential 2025 launch in the UK and Germany.
quantisnow.com
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Outlook Therapeutics® to Present at the Guggenheim Healthcare Innovation Conference

Outlook Therapeutics, Inc. announced that Russell Trenary, President and CEO, will participate in a fireside chat on November 12, 2024, at the Guggenheim Healthcare Innovation Conference in Boston, MA. The event will include a live webcast accessible on the company's website, with a replay archived for 90 days. Outlook Therapeutics is focused on the development and commercialization of ONS-5010/LYTENAVA™ (bevacizumab-vikg) for retina diseases, including wet AMD, with plans to launch in the EU and UK in the first half of 2025.
quantisnow.com
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Outlook Therapeutics® Participates in the 2nd Annual Chardan Virtual Ophthalmology

Outlook Therapeutics participated in Chardan's 2nd Annual Virtual Ophthalmology Summit, discussing wet AMD treatment with ONS-5010/LYTENAVA™. The fireside chat is available for viewing.
biospace.com
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Outlook Therapeutics® Announces Completion of Enrollment in NORSE EIGHT Clinical Trial

Outlook Therapeutics completes enrollment for NORSE EIGHT trial, evaluating ONS-5010 in wet AMD patients. NORSE EIGHT, under an FDA SPA, is the final trial before resubmitting the BLA for ONS-5010. Topline results expected in Q4 CY2024, with BLA resubmission planned for Q1 CY2025.
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