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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.

Outlook Therapeutics, Inc. (OTLK) is a clinical-stage biopharmaceutical company dedicated to developing and commercializing innovative monoclonal antibody (mAb) therapies for ocular diseases. The cornerstone of their pipeline is ONS-5010, also known as Lytenava™, which targets various ophthalmic indications, including wet age-related macular degeneration (wet AMD), diabetic macular edema (DME), and branch retinal vein occlusion (BRVO).

Outlook Therapeutics aims to address the unmet needs in ophthalmology with cost-effective and accessible treatment options. The company leverages its proprietary BioSymphony™ platform to expedite the development of these complex biologics, ensuring high standards of quality and compliance with regulatory requirements.

Recent achievements include the successful completion of Phase 3 clinical trials for ONS-5010. These promising results bring Outlook Therapeutics a step closer to FDA approval and commercialization. The company is also exploring strategic partnerships to enhance its market reach and streamline its operations.

Financially, Outlook Therapeutics shows a robust commitment to R&D, as evidenced by their investment in clinical trials and manufacturing capabilities. Their integrated approach, combining in-house development and scalable production, positions them as a competitive player in the biosimilar market.

For investors, Outlook Therapeutics represents a unique opportunity in the biopharmaceutical sector focused on ophthalmology. The company’s strategic direction and ongoing projects highlight its potential for significant growth and market impact.

News

Outlook Therapeutics® to Present at the Retina World Congress 2024

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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® to Present at the Ophthalmology Innovation Summit (OIS) Retina Innovation Showcase

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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® Announces Closing of Private Placement of $5.0 Million

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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® Receives European Union Positive CHMP Opinion for ONS-5010 as a Treatment for Wet AMD

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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® Announces Closing of Private Placement of up to $159 Million

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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® Announces Effective Date for 1-for-20 Reverse Stock Split

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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® Reports Financial Results for First Quarter Fiscal Year 2024 and Provides Corporate Update

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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® Doses First Subject in NORSE EIGHT

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Outlook Therapeutics, Inc. (OTLK) announced the start of patient enrollment in the NORSE EIGHT clinical trial for ONS-5010, a potential treatment for neovascular age-related macular degeneration. The trial aims to support the resubmission of the Biologics License Application (BLA) by the end of 2024. If successful, it would fulfill FDA's requirements for approval. The company also received written agreement from the FDA under a Special Protocol Assessment (SPA) for NORSE EIGHT, indicating positive progress in the development pathway. Outlook Therapeutics is optimistic about the potential FDA approval and launch of ONS-5010, with the primary endpoint being the mean change in Best Corrected Visual Acuity (BCVA) from baseline to Week 8.
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Outlook Therapeutics® Receives FDA Agreement Under Special Protocol Assessment (SPA) for 90 Day Non-Inferiority Study, NORSE EIGHT, and Announces Private Placement of Up to $172 Million to Advance ONS-5010

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Outlook Therapeutics, Inc. has received FDA agreement for the NORSE EIGHT clinical trial protocol evaluating ONS-5010 in neovascular age-related macular degeneration subjects. The company also entered into securities purchase agreements to raise up to $172 million to fund the development of ONS-5010. The financing is expected to take ONS-5010 through potential FDA approval and fund commercial launch. The company has also reached an agreement to extend the maturity of its outstanding convertible promissory note until July 1, 2025.
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Outlook Therapeutics® Reports Financial Results for Fiscal Year 2023 and Reiterates ONS-5010 Clinical and Regulatory Path Forward in the U.S. and EU

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Outlook Therapeutics, Inc. (Nasdaq: OTLK) announced the commencement of ONS-5010 NORSE EIGHT clinical trial in the first quarter of 2024, reaffirming potential European approval for ONS-5010 with the MAA decision date expected in the first half of 2024. The resubmission of the ONS-5010 BLA is anticipated by the end of 2024. The company reported a net loss attributable to common stockholders of $59.0 million for the fiscal year ended September 30, 2023, with cash and cash equivalents of $23.4 million as of that date.
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FAQ

What is the current stock price of Outlook Therapeutics (OTLK)?

The current stock price of Outlook Therapeutics (OTLK) is $1.44 as of December 20, 2024.

What is the market cap of Outlook Therapeutics (OTLK)?

The market cap of Outlook Therapeutics (OTLK) is approximately 32.5M.

What does Outlook Therapeutics, Inc. specialize in?

Outlook Therapeutics specializes in developing and commercializing monoclonal antibody therapies for ocular diseases.

What is ONS-5010?

ONS-5010, also known as Lytenava™, is a monoclonal antibody therapy being developed by Outlook Therapeutics for several ophthalmic conditions.

What are the key therapeutic areas for Outlook Therapeutics?

The key therapeutic areas include wet age-related macular degeneration (wet AMD), diabetic macular edema (DME), and branch retinal vein occlusion (BRVO).

Has ONS-5010 completed clinical trials?

Yes, ONS-5010 has successfully completed Phase 3 clinical trials and is awaiting regulatory approval.

What is the BioSymphony™ platform?

The BioSymphony™ platform is Outlook Therapeutics' proprietary system for developing and manufacturing complex biologics efficiently and in compliance with regulatory standards.

Is Outlook Therapeutics involved in any partnerships?

Yes, Outlook Therapeutics is exploring strategic partnerships to enhance market reach and streamline operations.

What opportunities does Outlook Therapeutics offer to investors?

Outlook Therapeutics offers a unique investment opportunity in the biopharmaceutical sector, with a focus on innovative treatments for ocular diseases and potential for significant market growth.

What is the financial condition of Outlook Therapeutics?

Outlook Therapeutics demonstrates a strong commitment to R&D, investing heavily in clinical trials and manufacturing capabilities to ensure high-quality product development.

What recent achievements has Outlook Therapeutics made?

Recent achievements include the successful completion of Phase 3 trials for ONS-5010, bringing the company closer to FDA approval and commercialization.

How does Outlook Therapeutics ensure the quality of its products?

Outlook Therapeutics uses its BioSymphony™ platform to maintain high standards of quality and regulatory compliance throughout the development and manufacturing process.

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Outlook Therapeutics, Inc.

Nasdaq:OTLK

OTLK Rankings

#5093 Ranked by Market Cap
N/A Ranked by Dividends

OTLK Stock Data

32.53M
15.23M
35.58%
35.65%
14.37%
Biotechnology
Biological Products, (no Disgnostic Substances)
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United States of America
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