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Outlook Therapeutics, Inc. - $OTLK STOCK NEWS

Welcome to our dedicated page for Outlook Therapeutics news (Ticker: $OTLK), a resource for investors and traders seeking the latest updates and insights on Outlook Therapeutics stock.

Our selection of high-quality news articles is accompanied by an expert summary from Rhea-AI, detailing the impact and sentiment surrounding the news at the time of release, providing a deeper understanding of how each news could potentially affect Outlook Therapeutics's stock performance. The page also features a concise end-of-day stock performance summary, highlighting the actual market reaction to each news event. The list of tags makes it easy to classify and navigate through different types of news, whether you're interested in earnings reports, stock offerings, stock splits, clinical trials, fda approvals, dividends or buybacks.

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Rhea-AI Summary

Outlook Therapeutics (Nasdaq: OTLK), a biopharmaceutical company focused on retinal disease treatments, announced its Q2 FY2024 financial results and provided a corporate update. The company reported a net loss of $114.3 million ($8.01 per share), up from $6.7 million ($0.52 per share) last year. Adjusted net loss was $22.1 million ($1.55 per share), influenced by warrant-related expenses. As of March 31, 2024, Outlook Therapeutics had $47.2 million in cash.

Key milestones include a CHMP positive opinion for ONS-5010 in the EU, UK MAA submission, NORSE EIGHT trial progress, and planned resubmission of the ONS-5010 BLA by end of CY2024. The company anticipates potential FDA approval and commercial launch of ONS-5010 in 2025.

Outlook Therapeutics hosted its inaugural quarterly update call on May 16, 2024, discussing these developments and future plans.

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Outlook Therapeutics® has submitted a Marketing Authorization Application (MAA) for ONS-5010/LYTENAVA™ for the treatment of wet age-related macular degeneration (AMD) in the UK. This move follows a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA). The positive CHMP opinion was for the authorization of ONS-5010/LYTENAVA™ in the EU. The submission to the Medicines and Healthcare products Regulatory Agency (MHRA) in the UK was made under the International Recognition Procedure (IRP), leveraging the CHMP opinion. The successful MAA submission would provide a new treatment option for wet AMD patients in the UK.

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Outlook Therapeutics, Inc. (Nasdaq: OTLK) will report its financial results for the second quarter fiscal year 2024 on May 16, 2024. The company aims to achieve the first approval for an ophthalmic formulation of bevacizumab for retinal diseases in the US and the EU. The management will host a quarterly conference call and webcast on the same day to discuss operational and financial results.

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Outlook Therapeutics, Inc. (OTLK) will present at the 2024 Retina World Congress to discuss their investigational ophthalmic formulation of bevacizumab for retinal diseases. The presentation will be led by Russell Trenary, the President and CEO, on May 9, 2024. This formulation aims to provide a safe and effective treatment option for wet AMD, addressing the current risks associated with using repackaged IV bevacizumab.

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Outlook Therapeutics, Inc. (OTLK) will present at the Ophthalmology Innovation Summit (OIS) Retina Innovation Showcase on May 4, 2024. The company aims to secure approval for an ophthalmic bevacizumab formulation for retinal disease treatment in the US and EU. Russell Trenary, President and CEO, will lead the company presentation at 8:35 AM PT.

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Outlook Therapeutics, Inc. (OTLK) has closed a private placement with Syntone Ventures, , securing $5.0 million in upfront gross proceeds. The company may receive up to $8 million more upon full cash exercise of warrants. This funding will support the development of an ophthalmic formulation of bevacizumab for retinal diseases in the US and the EU.
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Outlook Therapeutics (OTLK) receives positive opinion from CHMP for ONS-5010/LYTENAVA™ in the EU, a significant milestone in treating wet AMD.
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Outlook Therapeutics, Inc. (OTLK) closed a private placement, raising $60 million upfront with potential for $99 million more. Great Point Partners led the investment, joined by existing and new investors. BofA Securities and BTIG were co-placement agents.
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Outlook Therapeutics, Inc. (OTLK) announces a 1-for-20 reverse stock split to regain compliance with Nasdaq listing requirements. The reverse split will reduce outstanding shares from 260.3 million to 13.0 million, with no change in par value per share.
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Outlook Therapeutics, Inc. (OTLK) announces progress in NORSE EIGHT trial with first subject dosed and financial results for Q1 FY2024. Anticipates resubmission of ONS-5010 BLA by end of CY2024 and EU regulatory decision in first half of CY2024. Secures financing for regulatory efforts.
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Outlook Therapeutics, Inc.

Nasdaq:OTLK

OTLK Rankings

OTLK Stock Data

181.26M
6.07M
36.82%
23.53%
6.14%
Biological Product (except Diagnostic) Manufacturing
Manufacturing
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United States of America
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About OTLK

overview oncobiologics is a pure-play complex biosimilar company focused on technically challenging and commercially attractive monoclonal antibodies (mabs), in the therapeutic areas of immunology and oncology. our strategy is to cost-effectively develop technically challenging biosimilars on an accelerated timeline, which we believe is fundamental to our success and positions us to be a leading biosimilar company. we have leveraged our team’s biopharmaceutical expertise to establish fully integrated in-house development and manufacturing capabilities, which we refer to as our biosymphony™ platform. oncobiologics’ platform addresses the numerous complex technical and regulatory challenges in developing and commercializing mab biosimilars. pipeline oncobiologics is actively working on eight biosimilar candidates. the company’s most advanced assets, ons-3010 (a biosimilar of humira®) and ons-1045 (a biosimilar of avastin®) have both successfully completed phase i trials and phase 3 t