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Outlook Therapeutics Inc - OTLK STOCK NEWS

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

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.

Designed with both novice traders and seasoned investors in mind, our page aims to simplify the complex world of stock market news. By combining real-time updates, Rhea-AI's analytical insights, and historical stock performance data, we provide a holistic view of Outlook Therapeutics's position in the market.

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%
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none
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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
management
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News
OUTLOOK INVESTOR DEADLINE APPROACHING
Rhea-AI Summary
Outlook Therapeutics, Inc. (NASDAQ: OTLK) Faces Securities Class Action Lawsuit Due to FDA Issues with Lead Product Candidate
Rhea-AI Impact
Rhea-AI Sentiment
End-of-Day
1%
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none
News
Outlook Therapeutics® Provides Update on Type A Meetings with FDA
Rhea-AI Summary
Outlook Therapeutics has completed Type A Meetings with the FDA to discuss the Complete Response Letter for ONS-5010, their ophthalmic formulation of bevacizumab for the treatment of retinal diseases. The FDA has requested an additional clinical trial for the approval of ONS-5010 for the treatment of wet AMD. Outlook Therapeutics has reached an agreement in principle with the FDA on a clinical trial design and aims to resubmit the BLA by the end of 2024, with approval expected in mid-2025.
Rhea-AI Impact
Rhea-AI Sentiment
End-of-Day
-46.2%
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none
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News
Outlook Therapeutics® to Present at Guggenheim’s 5th Annual Inflammation, Neurology & Immunology (INI) Conference
Rhea-AI Summary
Outlook Therapeutics, Inc. (Nasdaq: OTLK) announced that its President and CEO, Russell Trenary, will participate in a fireside chat at Guggenheim’s 5th Annual Inflammation, Neurology & Immunology Conference on November 7th. The company is working towards FDA approval for the first ophthalmic formulation of bevacizumab for the treatment of retinal diseases. The fireside chat will be accessible via a live audio webcast on the company's website.
Rhea-AI Impact
Rhea-AI Sentiment
End-of-Day
5.33%
Tags
conferences
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News
Outlook Therapeutics® Requests Type A Meeting With FDA
Rhea-AI Summary
Outlook Therapeutics submits Type A Meeting request to FDA to discuss Complete Response Letter (CRL) for ONS-5010, an ophthalmic formulation of bevacizumab. FDA acknowledged trial success but cited CMC issues, open observations, and lack of evidence. Company committed to addressing concerns.
Rhea-AI Impact
Rhea-AI Sentiment
End-of-Day
1.38%
Tags
none
News
Outlook Therapeutics® to Present at the 2023 Cantor Fitzgerald Global Healthcare Conference
Rhea-AI Summary
Outlook Therapeutics CEO to participate in panel presentation at Cantor Fitzgerald Global Healthcare Conference on September 26th.
Rhea-AI Impact
Rhea-AI Sentiment
End-of-Day
-2.33%
Tags
conferences
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News
Outlook Therapeutics® to Present at the H.C. Wainwright 25th Annual Global Investment Conference
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
conferences
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News
Outlook Therapeutics® Provides Regulatory Update on FDA Review of ONS-5010 / LYTENAVA™ (bevacizumab-vikg) for the Treatment of Wet AMD
Rhea-AI Summary
FDA issues Complete Response Letter (CRL) for ONS-5010 BLA based on CMC and need for further confirmatory clinical evidence
Rhea-AI Impact
Rhea-AI Sentiment
End-of-Day
-80.92%
Tags
none
News
Outlook Therapeutics® Reports Financial Results for Third Quarter Fiscal Year 2023 and Reiterates Key Anticipated Near-Term Milestones
Rhea-AI Summary
Outlook Therapeutics announces recent corporate highlights and financial results. The Prescription Drug User Fee Act (PDUFA) goal date for ONS-5010 is August 29, 2023. ONS-5010 is an investigational ophthalmic formulation of bevacizumab for the treatment of wet age-related macular degeneration (wet AMD). Outlook Therapeutics is focused on pre-launch activities and positioning itself as an innovative leader in the anti-VEGF space. The use of unapproved repackaged IV bevacizumab from compounding pharmacies is estimated to account for approximately 50% of all wet AMD injections in the United States each year. ONS-5010 has been developed to address concerns related to safety and potency issues associated with using off-label, repackaged bevacizumab. Outlook Therapeutics has upcoming milestones including the completion of the NORSE SEVEN clinical trial in 2024 and the MAA decision date from the EMA’s CHMP in the EU expected in the first half of 2024.
Rhea-AI Impact
Rhea-AI Sentiment
End-of-Day
-1.88%
Tags
earnings
Stock OTLK logo
Outlook Therapeutics Inc

Nasdaq:OTLK

OTLK Rankings

#3812 Ranked by Market Cap
#4841 Ranked by Stock Gains
N/A Ranked by Dividends

OTLK Stock Data

187.78M
6.07M
36.82%
23.53%
6.14%
Biological Product (except Diagnostic) Manufacturing
Manufacturing
Link
United States
Iselin

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