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.

12/19/2023 08:05 AM

News

Outlook Therapeutics® Submits Special Protocol Assessment (SPA) to FDA for Non-Inferiority Study of ONS-5010

Rhea-AI Summary

Outlook Therapeutics, Inc. (Nasdaq: OTLK) announced the submission of a Special Protocol Assessment (SPA) request for the NORSE EIGHT study, with plans to commence in Q1 2024. The company expects to resubmit the ONS-5010 Biologics License Application (BLA) in the U.S. by the end of 2024, based on the results of the study and additional work to address FDA concerns.

Rhea-AI Impact

Rhea-AI Sentiment

End-of-Day

9.81%

Tags

12/06/2023 08:05 AM

News

Outlook Therapeutics® Announces Strategic Organizational Realignment

Rhea-AI Summary

Outlook Therapeutics, Inc. (OTLK) announces realignment to support ONS-5010 U.S. and EU regulatory and commercial priorities. The company continues progress toward additional clinical trials for the ONS-5010 Biologics License Application in the U.S. and expects approval in Europe by the first half of 2024. The realignment includes the appointment of Joel Prieve as Senior Vice President of Licensing and M&A and Terry Dagnon as Senior Advisor. Additionally, Jedd Comiskey was added as Senior Vice President – Head of Europe to focus on potential commercial launch and partnership opportunities for ONS-5010 in the EU.

Rhea-AI Impact

Rhea-AI Sentiment

End-of-Day

-0.89%

Tags

11/27/2023 08:05 AM

News

Outlook Therapeutics® Announces Receipt of Type A Meeting Minutes and Reiterates Regulatory Path Forward for ONS-5010

Rhea-AI Summary

Outlook Therapeutics, Inc. (OTLK) plans to resubmit the ONS-5010 Biologics License Application (BLA) to the FDA by the end of 2024 pending final agreement on a clinical trial protocol and successful completion of the required additional clinical trial. The planned clinical trial is expected to be a 3-month non-inferiority study with a 60-day efficacy endpoint. The company received official minutes from the Type A meeting with the FDA regarding the Complete Response Letter (CRL) for the BLA, and is working to design an appropriate study to satisfy the FDA’s requirements. The company is encouraged by the productive discussions with the FDA and continues to believe in the potential of ONS-5010 to address the need for an approved ophthalmic bevacizumab for the treatment of wet AMD.

Rhea-AI Impact

Rhea-AI Sentiment

End-of-Day

2.61%

Tags

11/14/2023 08:05 AM

News

Outlook Therapeutics® Adds Global Commercial Expertise with Appointment of Jedd Comiskey as Senior VP - Head of Europe

Rhea-AI Summary

Outlook Therapeutics, Inc. (Nasdaq: OTLK) announced the appointment of Jedd Comiskey as Senior VP – Head of Europe. Mr. Comiskey brings a successful track record in product launches and navigating the European pharmaceutical landscape. The company is preparing for the potential European launch of ONS-5010, with an expected Marketing Authorization Application (MAA) decision date in the first half of 2024. The appointment aims to strengthen the company's global launch strategy and potential European partnership for ONS-5010.

Rhea-AI Impact

Rhea-AI Sentiment

End-of-Day

8.91%

Tags

11/13/2023 08:00 AM

News

Rhea-AI Summary

Outlook Therapeutics to present at H.C. Wainwright 25th Annual Global Investment Conference

Rhea-AI Impact

Rhea-AI Sentiment

End-of-Day

1.77%

Tags

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.

Outlook Therapeutics, Inc.

Nasdaq:OTLK

OTLK Rankings

#5093 Ranked by Market Cap

N/A Ranked by Dividends

OTLK Stock Data

Market Cap 32.53M

Float 15.23M

Insiders Ownership 35.58%

Institutions Ownership 35.65%

Short Percent 14.37%

Industry Biotechnology

Sector Biological Products, (no Disgnostic Substances)

Website Link

Country United States of America

City ISELIN