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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 Closing of Private Placement of $5.0 Million
Rhea-AI Summary
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.
Rhea-AI Impact
Rhea-AI Sentiment
End-of-Day
1.51%
Tags
none
-
News
Outlook Therapeutics® Receives European Union Positive CHMP Opinion for ONS-5010 as a Treatment for Wet AMD
Rhea-AI Summary
Outlook Therapeutics (OTLK) receives positive opinion from CHMP for ONS-5010/LYTENAVA™ in the EU, a significant milestone in treating wet AMD.
Rhea-AI Impact
Rhea-AI Sentiment
End-of-Day
22.59%
Tags
none
-
News
Outlook Therapeutics® Announces Closing of Private Placement of up to $159 Million
Rhea-AI Summary
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.
Rhea-AI Impact
Rhea-AI Sentiment
End-of-Day
-4.88%
Tags
none
News
Outlook Therapeutics® Announces Effective Date for 1-for-20 Reverse Stock Split
Rhea-AI Summary
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.
Rhea-AI Impact
Rhea-AI Sentiment
End-of-Day
-10.57%
Tags
stock split
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News
Outlook Therapeutics® Reports Financial Results for First Quarter Fiscal Year 2024 and Provides Corporate Update
Rhea-AI Summary
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.
Rhea-AI Impact
Rhea-AI Sentiment
End-of-Day
5%
Tags
earnings
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News
Outlook Therapeutics® Doses First Subject in NORSE EIGHT
Rhea-AI Summary
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.
Rhea-AI Impact
Rhea-AI Sentiment
End-of-Day
-6.99%
Tags
none
News
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
Rhea-AI Summary
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.
Rhea-AI Impact
Rhea-AI Sentiment
End-of-Day
30.59%
Tags
none
-
News
Outlook Therapeutics® Reports Financial Results for Fiscal Year 2023 and Reiterates ONS-5010 Clinical and Regulatory Path Forward in the U.S. and EU
Rhea-AI Summary
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.
Rhea-AI Impact
Rhea-AI Sentiment
End-of-Day
-1.17%
Tags
earnings
-
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
none
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
none
Stock OTLK logo
Outlook Therapeutics Inc

Nasdaq:OTLK

OTLK Rankings

#3785 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