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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Traeger

Holley

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ISELIN, N.J., Nov. 02, 2023 (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 completed the requested Type A Meetings with the U.S. Food and Drug Administration (FDA) to discuss the Complete Response Letter (CRL) dated August 29, 2023 regarding the Biologics License Application (BLA) for ONS-5010, an investigational ophthalmic formulation of bevacizumab under development to treat wet AMD.

Outlook Therapeutics® Provides Update on Type A Meetings with FDA

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Outlook Therapeutics® to Present at Guggenheim's 5th Annual Inflammation, Neurology & Immunology (INI) Conference

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ISELIN, N.J., Sept. 29, 2023 (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 a Type A Meeting request has been submitted to the U.S. Food and Drug Administration (FDA) to discuss the Complete Response Letter (CRL) dated August 29, 2023 regarding the Biologics License Application (BLA) for ONS-5010, an investigational ophthalmic formulation of bevacizumab under development to treat wet AMD.

Outlook Therapeutics® Requests Type A Meeting With FDA

LOS ANGELES, CA / ACCESSWIRE / September 27, 2023 / The Schall Law Firm, a national shareholder rights litigation firm, announces that it is investigating claims on behalf of investors of Outlook Therapeutics, Inc. ("Outlook" or "the Company") (NASDAQ:OTLK) for violations of the securities laws. The investigation focuses on whether the Company issued false and/or misleading statements and/or failed to disclose information pertinent to investors.

INVESTOR ACTION ALERT: The Schall Law Firm Announces it is Investigating Claims Against Outlook Therapeutics, Inc. Corporation and Encourages Investors with Losses to Contact the Firm

LOS ANGELES, CA / ACCESSWIRE / September 25, 2023 / The Schall Law Firm, a national shareholder rights litigation firm, announces that it is investigating claims on behalf of investors of Outlook Therapeutics, Inc. ("Outlook" or "the Company") (NASDAQ:OTLK) for violations of the securities laws. The investigation focuses on whether the Company issued false and/or misleading statements and/or failed to disclose information pertinent to investors.

INVESTIGATION ALERT: The Schall Law Firm Announces it is Investigating Claims Against Outlook Therapeutics, Inc. Corporation and Encourages Investors with Losses to Contact the Firm

Live video webcast panel presentation on Tuesday, September 26th at 1:35 PM ET Live video webcast panel presentation on Tuesday, September 26th at 1:35 PM ET

Outlook Therapeutics® to Present at the 2023 Cantor Fitzgerald Global Healthcare Conference

LOS ANGELES, CA / ACCESSWIRE / September 18, 2023 / The Schall Law Firm, a national shareholder rights litigation firm, announces that it is investigating claims on behalf of investors of Outlook Therapeutics, Inc. ("Outlook" or "the Company") (NASDAQ:OTLK) for violations of the securities laws. The investigation focuses on whether the Company issued false and/or misleading statements and/or failed to disclose information pertinent to investors.

SHAREHOLDER ACTION ALERT: The Schall Law Firm Announces it is Investigating Claims Against Outlook Therapeutics, Inc. Corporation and Encourages Investors with Losses to Contact the Firm

LOS ANGELES, CA / ACCESSWIRE / September 14, 2023 / The Schall Law Firm, a national shareholder rights litigation firm, announces that it is investigating claims on behalf of investors of Outlook Therapeutics, Inc. ("Outlook" or "the Company") (NASDAQ:OTLK) for violations of the securities laws. The investigation focuses on whether the Company issued false and/or misleading statements and/or failed to disclose information pertinent to investors.

SHAREHOLDER ALERT: The Schall Law Firm Announces it is Investigating Claims Against Outlook Therapeutics, Inc. Corporation and Encourages Investors with Losses to Contact the Firm

LOS ANGELES, CA / ACCESSWIRE / September 13, 2023 / The Schall Law Firm, a national shareholder rights litigation firm, announces that it is investigating claims on behalf of investors of Outlook Therapeutics, Inc. ("Outlook" or "the Company") (NASDAQ:OTLK) for violations of the securities laws. The investigation focuses on whether the Company issued false and/or misleading statements and/or failed to disclose information pertinent to investors.

INVESTIGATION ACTION ALERT: The Schall Law Firm Announces it is Investigating Claims Against Outlook Therapeutics, Inc. Corporation and Encourages Investors with Losses to Contact the Firm

LOS ANGELES, CA / ACCESSWIRE / September 8, 2023 / The Schall Law Firm, a national shareholder rights litigation firm, announces that it is investigating claims on behalf of investors of Outlook Therapeutics, Inc. ("Outlook" or "the Company") (NASDAQ:OTLK) for violations of the securities laws. The investigation focuses on whether the Company issued false and/or misleading statements and/or failed to disclose information pertinent to investors.

INVESTOR ACTION ALERT: The Schall Law Firm Announces it is Investigating Claims Against Outlook Therapeutics, Inc. Corporation and Encourages Investors with Losses In Excess of $500,000 to Contact the Firm

Live video webcast presentation on Wednesday, September 13th at 9:30 AM ET Live video webcast presentation on Wednesday, September 13th at 9:30 AM ET

Outlook Therapeutics® to Present at the H.C. Wainwright 25th Annual Global Investment Conference

LOS ANGELES, CA / ACCESSWIRE / September 2, 2023 / The Schall Law Firm, a national shareholder rights litigation firm, announces that it is investigating claims on behalf of investors of Outlook Therapeutics, Inc. ("Outlook" or "the Company") (NASDAQ: OTLK) for violations of the securities laws. The investigation focuses on whether the Company issued false and/or misleading statements and/or failed to disclose information pertinent to investors.

SHAREHOLDER ACTION NOTICE: The Schall Law Firm Announces it is Investigating Claims Against Outlook Therapeutics, Inc. Corporation and Encourages Investors with Losses In Excess of $500,000 to Contact the Firm

NEW YORK , Aug. 31, 2023 /PRNewswire/ -- Attorney Advertising -- Bronstein, Gewirtz & Grossman, LLC is investigating potential claims on behalf of purchasers of Outlook Therapeutics, Inc. ("Outlook" or "the Company") (NASDAQ: OTLK). Investors who purchased Outlook securities are encouraged to obtain additional information and assist the investigation by visiting the firm's site: www.bgandg.com/otlk.

Outlook Therapeutics, Inc. (OTLK) Investigation: Bronstein, Gewirtz & Grossman, LLC Encourages Investors to Contact the Firm

Outlook's (OTLK) shares decline as it receives a complete response letter for Lytenava (ONS-5010), treating wet age-related macular degeneration.

Outlook's (OTLK) Shares Decline on CRL for Wet AMD Candidate

Outlook Therapeutics (NASDAQ: OTLK ) stock is taking a beating on Wednesday after getting a rejection letter from the FDA. That letter has to do with its biologics license application (BLA) for ONS-5010.

Why Is Outlook Therapeutics (OTLK) Stock Down 78% Today?

Outlook Therapeutics Inc (NASDAQ:OTLK) stock collapsed, losing some 70% of its value in premarket, after the drug discovery firm's potential treatment for eye disease was rejected by the US Food and Drug Administration. The FDA denied the company's license application for a treatment for wet age-related macular degeneration (AMD), telling the company that its unable to approve the drug in its current form and further clinical evidence would be required.

Outlook Therapeutics collapses as FDA rejects application for eye drug

Outlook Therapeutics said on Wednesday the U.S. Food and Drug Administration declined to approve its experimental eye disease drug, in part due to manufacturing issues observed during pre-approval inspections.

US FDA declines to approve Outlook Therapeutics' eye disease drug

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Outlook Therapeutics Inc.'s stock OTLK, +10.16% tumbled 71% in premarket trade Wednesday, after the company said the U.S. Food and Drug Administration has issued a Control Response Letter for the company's Biologics License Application for a treatment for wet age-related macular degeneration. The FDA issues a CRL when it's unable to approve a drug in its current form, and is seeking further confirmatory clinical evidence.

Outlook Therapeutics' stock tumbles 71% premarket after FDA rejects treatment for wet AMD

FDA issues Complete Response Letter (CRL) for ONS-5010 BLA based on CMC and need for further confirmatory clinical evidence

Outlook Therapeutics® Provides Regulatory Update on FDA Review of ONS-5010 / LYTENAVA™ (bevacizumab-vikg) for the Treatment of Wet AMD

Outlook Therapeutics (OTLK) is seeing favorable earnings estimate revision activity and has a positive Zacks Earnings ESP heading into earnings season.

Should You Buy Outlook Therapeutics (OTLK) Ahead of Earnings?

ISELIN, N.J., Aug. 14, 2023 (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 wet AMD, today announced recent corporate highlights and financial results for its fiscal third quarter ended June 30, 2023.

News for Outlook Therapeutics Inc Stock (OTLK)