Outlook Therapeutics Inc

Outlook Therapeutics, Inc. is a clinical-stage biopharmaceutical company, which engages in the development of ONS-5010/LYTENAVA. Its pipeline includes unmet patient needs, repackaged IV bevacizumab, and anti-VEGF. The company was founded by Pankaj Mohan on January 5, 2010 and is headquartered in Iselin, NJ.

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Outlook Therapeutics progresses well with ONS-5010, eyes global expansion

Outlook Therapeutics is well-positioned for potential approvals in Europe and the US in 2024 and 2025.
Strong financial backing and progress in key studies indicate a positive trajectory.
Challenges include addressing FDA queries and ensuring smart approval processes.
Opportunities lie in leveraging existing infrastructure, pricing discussions, and FDA agreements.

Outlook Therapeutics advances clinical trials and secures EU market entry

Outlook Therapeutics made significant progress with marketing authorization and clinical trial advancements.
Financial stability improved with reduced convertible notes and ample cash reserves.
Challenges lie in managing expenses, addressing analyst inquiries, and preparing for commercial launch.

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ISELIN, N.J., May 09, 2024 (GLOBE NEWSWIRE) -- Outlook Therapeutics, Inc. (Nasdaq: OTLK), a biopharmaceutical company working to achieve the first approval for an ophthalmic formulation of bevacizumab for the treatment of retinal diseases in the US and the EU, today announced that it will report its financial results for second quarter fiscal year 2024 on Thursday, May 16, 2024. Outlook Therapeutics management will host its inaugural quarterly conference call and live audio webcast to discuss the operational and financial results at 8:30 AM ET that same day.

Outlook Therapeutics® to Report Financial Results for Second Quarter Fiscal Year 2024 on May 16, 2024 and Host Inaugural Quarterly Conference Call and Webcast

ISELIN, N.J., May 02, 2024 (GLOBE NEWSWIRE) -- Outlook Therapeutics, Inc. (Nasdaq: OTLK), a biopharmaceutical company working to achieve the first approval for an ophthalmic formulation of bevacizumab for the treatment of retinal diseases in the US and the EU, today announced it will present at the 2024 Retina World Congress being held May 9-12, 2024 in Fort Lauderdale, FL.

Outlook Therapeutics® to Present at the Retina World Congress 2024

ISELIN, N.J., April 29, 2024 (GLOBE NEWSWIRE) -- Outlook Therapeutics, Inc. (Nasdaq: OTLK), a biopharmaceutical company working to achieve the first approval for an ophthalmic formulation of bevacizumab for the treatment of retinal diseases in the US and the EU, today announced it will present at the OIS Retina Innovation Showcase being held May 4, 2024 in Seattle, WA.

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

ISELIN, N.J., April 15, 2024 (GLOBE NEWSWIRE) -- Outlook Therapeutics, Inc. (Nasdaq: OTLK), a biopharmaceutical company working to achieve the first approval for an ophthalmic formulation of bevacizumab for the treatment of retinal diseases in the US and the EU, today announced that it has closed its previously announced private placement with Syntone Ventures, LLC, an existing stockholder, for upfront gross proceeds of approximately $5.0 million from the issuance and sale of shares of the Company's common stock and accompanying warrants, before deducting offering expenses. In addition, Outlook Therapeutics has the potential to receive additional gross proceeds of up to $8 million upon the full cash exercise of the warrants issued in the private placement, before deducting offering expenses.

Outlook Therapeutics® Announces Closing of Private Placement of $5.0 Million

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The positive CHMP opinion could mean possible European Approval; European Commission expected to decide upon approval for this in the next few months. Phase 3 NORSE EIGHT study underway using ONS-5010 for the treatment of patients with Wet-AMD; Data expected to be released in Q4 of 2024. Pending the primary endpoint of BCVA in NORSE EIGHT being met with statistical significance, BLA filing of ONS-5010 for Wet-AMD expected in 2024.

Outlook Therapeutics: De-Risked Regulatory Tracks Are Lining Up For Possible ONS-5010 Approval

ISELIN, N.J., March 22, 2024 (GLOBE NEWSWIRE) -- Outlook Therapeutics, Inc. (Nasdaq: OTLK), a biopharmaceutical company working to achieve the first approval for an ophthalmic formulation of bevacizumab for the treatment of retinal diseases in the US and the EU, today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has issued a positive opinion concerning the authorization of ONS-5010/LYTENAVA™ (bevacizumab gamma), an investigational ophthalmic formulation of bevacizumab for the treatment of wet age-related macular degeneration (wet AMD) in the EU. Outlook Therapeutics is assessing both direct commercialization of the product and partnering in Europe on a country-by-country basis.

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

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ISELIN, N.J., March 18, 2024 (GLOBE NEWSWIRE) -- Outlook Therapeutics, Inc. (Nasdaq: OTLK), a biopharmaceutical company working to achieve the first approval for an ophthalmic formulation of bevacizumab for the treatment of retinal diseases in the US and the EU, today announced that it has closed its previously announced private placement, for upfront gross proceeds of approximately $60 million from the issuance and sale of shares of the Company's common stock and accompanying warrants, before deducting placement agent fees and offering expenses. Outlook Therapeutics has the potential to receive additional gross proceeds of up to $99 million upon the full cash exercise of the warrants issued in the private placement, before deducting placement agent fees and offering expenses.

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

ISELIN, N.J., March 12, 2024 (GLOBE NEWSWIRE) -- Outlook Therapeutics, Inc. (Nasdaq: OTLK) (the “Company”), a biopharmaceutical company working to achieve FDA approval for the first ophthalmic formulation of bevacizumab for the treatment of retinal diseases, today announced that a 1-for-20 reverse stock split of its outstanding shares of common stock will be effective on March 14, 2024.

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

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ISELIN, N.J., Feb. 14, 2024 (GLOBE NEWSWIRE) -- Outlook Therapeutics, Inc. (Nasdaq: OTLK), a biopharmaceutical company working to achieve regulatory approval for the first ophthalmic formulation of bevacizumab for the treatment of retinal diseases, today announced financial results for first quarter fiscal year 2024 and provided a corporate update.

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

ISELIN, N.J., Jan. 31, 2024 (GLOBE NEWSWIRE) -- Outlook Therapeutics, Inc. (Nasdaq: OTLK), a biopharmaceutical company working to achieve FDA approval for the first ophthalmic formulation of bevacizumab for the treatment of retinal diseases, today announced that the first subject has been dosed in the NORSE EIGHT clinical trial evaluating ONS-5010 in neovascular age-related macular degeneration (wet AMD) patients.

Outlook Therapeutics® Doses First Subject in NORSE EIGHT

Outlook (OTLK) stock rises after aligning with the FDA regarding the protocols of a non-inferiority study of ONS-5010 for AMD. The study is set to become the basis for BLA resubmission by 2024-end.

Outlook (OTLK) Surges 31% on Regulatory Update for AMD Study

ISELIN, N.J., Jan. 23, 2024 (GLOBE NEWSWIRE) -- Outlook Therapeutics, Inc. (Nasdaq: OTLK), a biopharmaceutical company working to achieve FDA approval for the first ophthalmic formulation of bevacizumab for the treatment of retinal diseases, today announced that it has received written agreement from the FDA under an SPA for the NORSE EIGHT clinical trial protocol evaluating ONS-5010 in neovascular age-related macular degeneration (AMD) subjects. Additionally, Outlook Therapeutics entered into securities purchase agreements with certain institutional and accredited investors for up to $172 million in gross proceeds to fund the advancement of ONS-5010.

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

NEW YORK , Jan. 2, 2024 /PRNewswire/ -- WHY: Rosen Law Firm, a global investor rights law firm, reminds purchasers of securities of Outlook Therapeutics, Inc. (NASDAQ: OTLK) between December 29, 2022 and August 29, 2023, both dates inclusive (the "Class Period"), of the important January 2, 2024 lead plaintiff deadline. SO WHAT: If you purchased Outlook securities during the Class Period you may be entitled to compensation without payment of any out of pocket fees or costs through a contingency fee arrangement.

OTLK FINAL DEADLINE: ROSEN, NATIONAL INVESTOR COUNSEL, Encourages Outlook Therapeutics, Inc. Investors to Secure Counsel Before Important January 2 Deadline in Securities Class Action - OTLK

NEW YORK , Jan. 2, 2024 /PRNewswire/ -- Levi & Korsinsky, LLP notifies investors in Outlook Therapeutics, Inc. ("Outlook" or the "Company") (NASDAQ: OTLK) of a class action securities lawsuit. CLASS DEFINITION: The lawsuit seeks to recover losses on behalf of Outlook investors who were adversely affected by alleged securities fraud between August 3, 2021 and August 29, 2023.

SHAREHOLDER ALERT: Levi & Korsinsky Notifies Outlook Therapeutics, Inc.(OTLK) Investors of a Class Action Lawsuit and Upcoming Deadline

NEW YORK--(BUSINESS WIRE)--WHY: Rosen Law Firm, a global investor rights law firm, reminds purchasers of securities of Outlook Therapeutics, Inc. (NASDAQ: OTLK) between December 29, 2022 and August 29, 2023, both dates inclusive (the “Class Period”), of the important January 2, 2024 lead plaintiff deadline. SO WHAT: If you purchased Outlook securities during the Class Period you may be entitled to compensation without payment of any out of pocket fees or costs through a contingency fee arrangem.

OTLK DEADLINE TOMORROW: ROSEN, TRUSTED INVESTOR COUNSEL, Encourages Outlook Therapeutics, Inc. Investors to Secure Counsel Before Important January 2 Deadline in Securities Class Action – OTLK

NEW YORK , Dec. 28, 2023 /PRNewswire/ -- Pomerantz LLP announces that a class action lawsuit has been filed against Outlook Therapeutics, Inc. ("Outlook" or the "Company") (NASDAQ: OTLK) and certain officers.  The class action, filed in the United States District Court for the District of New Jersey, and docketed under 23-cv-21862, is on behalf of a class consisting of all persons and entities other than Defendants that purchased or otherwise acquired Outlook securities between December 29, 2022 and August 29, 2023, both dates inclusive (the "Class Period"), seeking to recover damages caused by Defendants' violations of the federal securities laws and to pursue remedies under Sections 10(b) and 20(a) of the Securities Exchange Act of 1934 ("Exchange Act") and Rule 10b-5 promulgated thereunder, against the Company and certain of its top officials.

SHAREHOLDER ALERT: Pomerantz Law Firm Reminds Shareholders with Losses on their Investment in Outlook Therapeutics, Inc. of Class Action Lawsuit and Upcoming Deadline - OTLK

LOS ANGELES , Dec. 28, 2023 /PRNewswire/ -- Glancy Prongay & Murray LLP ("GPM") announces that investors with substantial losses have opportunity to lead the securities fraud class action lawsuit against Outlook Therapeutics, Inc. ("Outlook" or the "Company") (NASDAQ: OTLK). Class Period: August 3, 2021 – August 29, 2023 Lead Plaintiff Deadline: January 2, 2024 If you wish to serve as lead plaintiff of the Outlook lawsuit, you can submit your contact information at www.glancylaw.com/cases/Outlook-Therapeutics-Inc/.

OTLK Investors Have Opportunity to Lead Outlook Therapeutics, Inc. Securities Fraud Lawsuit

LOS ANGELES--(BUSINESS WIRE)--The Law Offices of Frank R. Cruz reminds investors of the upcoming January 2, 2024 deadline to file a lead plaintiff motion in the class action filed on behalf of investors who acquired Outlook Therapeutics, Inc. (“Outlook” or the “Company”) (NASDAQ: OTLK) securities between August 3, 2021 and August 29, 2023, inclusive (the “Class Period”). If you are a shareholder who suffered a loss, click here to participate. On August 30, 2023, Outlook disclosed that the FDA h.

The Law Offices of Frank R. Cruz Reminds Investors of Looming Deadline in the Class Action Lawsuit Against Outlook Therapeutics, Inc. (OTLK)

If you suffered losses exceeding $50,000 investing in Outlook securities between August 3, 2021 and August 29, 2023 and would like to discuss your legal rights, call Faruqi & Faruqi partner Josh Wilson directly at 877-247-4292 or 212-983-9330  (Ext. 1310). You may also click here for additional information: www.faruqilaw.com/OTLK.

OUTLOOK INVESTOR DEADLINE APPROACHING: Securities Litigation Partner James (Josh) Wilson Encourages Investors Who Suffered Losses Exceeding $50,000 In Outlook To Contact Him Directly To Discuss Their Options

LOS ANGELES, CA / ACCESSWIRE / December 26, 2023 / The Schall Law Firm, a national shareholder rights litigation firm, reminds investors of a class action lawsuit against Outlook Therapeutics, Inc. ("Outlook" or "the Company") (NASDAQ:OTLK) for violations of 10(b) and 20(a) of the Securities Exchange Act of 1934 and Rule 10b-5 promulgated thereunder by the U.S. Securities and Exchange Commission. Investors who purchased the Company's securities between December 29, 2022 and August 29, 2023, inclusive (the "Class Period"), are encouraged to contact the firm before January 2, 2024.

INVESTOR ACTION ALERT: The Schall Law Firm Encourages Investors in Outlook Therapeutics, Inc. with Losses In Excess of $100,000 to Contact the Firm

NEW YORK , Dec. 26, 2023 /PRNewswire/ -- WHY: Rosen Law Firm, a global investor rights law firm, reminds purchasers of securities of Outlook Therapeutics, Inc. (NASDAQ: OTLK) between December 29, 2022 and August 29, 2023, both dates inclusive (the "Class Period"), of the important January 2, 2024 lead plaintiff deadline. SO WHAT: If you purchased Outlook securities during the Class Period you may be entitled to compensation without payment of any out of pocket fees or costs through a contingency fee arrangement.

ROSEN, RESPECTED INVESTOR COUNSEL, Encourages Outlook Therapeutics, Inc. Investors With Losses to Secure Counsel Before Important January 2 Deadline in Securities Class Action - OTLK

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