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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MONMOUTH JUNCTION, N.J., Jan. 28, 2021 (GLOBE NEWSWIRE) -- Outlook Therapeutics, Inc. (Nasdaq: OTLK) (“Outlook Therapeutics”), a late clinical-stage biopharmaceutical company working to develop the first FDA-approved ophthalmic formulation of bevacizumab-vikg for use in retinal indications, today announced that it has entered into an underwriting agreement with H.C. Wainwright & Co., LLC under which the underwriter has agreed to purchase on a firm commitment basis 10,000,000 shares of common stock of Outlook Therapeutics, at a price to the public of $1.00 per share, less underwriting discounts and commissions. The closing of the offering is expected to occur on or about February 2, 2021, subject to satisfaction of customary closing conditions.

Outlook Therapeutics Announces $10.0 Million Bought Deal Offering of Common Stock

MONMOUTH JUNCTION, N.J., Jan. 12, 2021 (GLOBE NEWSWIRE) -- Outlook Therapeutics, Inc. (Nasdaq: OTLK), a late clinical-stage biopharmaceutical company working to develop the first FDA-approved ophthalmic formulation of bevacizumab-vikg for use in retinal indications, announces the release of a podcast video produced by the Ophthalmology Innovation Summit (OIS) featuring Firas Rahhal, MD, a partner at Retina-Vitreous Associates Medical Group and Associate Clinical Professor of Ophthalmology at the UCLA School of Medicine and two members of Outlook Therapeutics' management team, Terry Dagnon, Chief Operating Officer, and Jeff Evanson, Chief Commercial Officer. The interview, led by Dr. Rahhal, discusses how and why Outlook Therapeutics is advancing its investigational compound ONS-5010, now in Phase 3 clinical trials, towards filing with the Food and Drug Administration (FDA) as the first approved and cGMP-manufactured ophthalmic formulation of bevacizumab designed to meet the needs of the retina community.

Leading Ophthalmology Organization Launches Podcast Video with Firas Rahhal, MD, to Explore the Genesis and Promise of Outlook Therapeutics' ONS-5010/LYTENAVA™ (bevacizumab-vikg)

MONMOUTH JUNCTION, N.J., Dec. 23, 2020 (GLOBE NEWSWIRE) -- Outlook Therapeutics, Inc. (Nasdaq: OTLK), a late clinical-stage biopharmaceutical company working to develop the first FDA-approved ophthalmic formulation of bevacizumab-vikg for use in retinal indications, today announced its corporate highlights and financial results for its fiscal year ended September 30, 2020.

Outlook Therapeutics Reports Financial Results for Fiscal Year 2020 and Provides Corporate Update

MONMOUTH JUNCTION, N.J., Dec. 01, 2020 (GLOBE NEWSWIRE) -- Outlook Therapeutics, Inc. (Nasdaq: OTLK), a late clinical-stage biopharmaceutical company working to develop the first FDA-approved ophthalmic formulation of bevacizumab for use in retinal indications, announced today that it has received notification from Nasdaq that it has regained compliance with the minimum bid price for continued listing on the Nasdaq Capital Market, as the closing bid price of Outlook Therapeutics' common stock has been at $1.00 or greater for 10 consecutive trading days. Accordingly, this matter is now closed.

Outlook Therapeutics Regains Compliance with Nasdaq Minimum Bid Price Requirement

MONMOUTH JUNCTION, N.J., Nov. 19, 2020 (GLOBE NEWSWIRE) -- Outlook Therapeutics, Inc. (Nasdaq: OTLK), a late clinical-stage biopharmaceutical company working to develop the first FDA-approved ophthalmic formulation of bevacizumab-vikg for use in retinal indications, today announced the creation of its Global Retina Advisory Council. Mark Humayun, MD, PhD, has agreed to act as Chairman of the Advisory Council and Firas Rahhal, MD, has agreed to join him as an inaugural member.

Outlook Therapeutics Announces Creation of Global Retina Advisory Council

MONMOUTH JUNCTION, N.J., Nov. 11, 2020 (GLOBE NEWSWIRE) -- Outlook Therapeutics, Inc. (Nasdaq: OTLK), a late clinical-stage biopharmaceutical company working to develop the first FDA-approved ophthalmic formulation of bevacizumab-vikg for use in retinal indications, held its previously announced virtual KOL Roundtable on October 29, 2020 featuring Firas Rahhal, MD, a partner at Retina-Vitreous Associates Medical Group and Associate Clinical Professor of Ophthalmology at the UCLA School of Medicine, and Outlook Therapeutics' management team – Lawrence Kenyon, President, CEO and CFO, Terry Dagnon, COO, and Jeff Evanson, CCO.

Virtual KOL Roundtable Recap: Outlook Therapeutics and Firas Rahhal, MD, Discussed wet AMD Treatment Landscape and ONS-5010/LYTENAVA™

MONMOUTH JUNCTION, N.J., Nov. 05, 2020 (GLOBE NEWSWIRE) -- Outlook Therapeutics, Inc. (Nasdaq: OTLK), a late clinical-stage biopharmaceutical company working to develop the first FDA-approved ophthalmic formulation of bevacizumab-vikg for use in retinal indications, today announced the issuance of a $10.2 million unsecured promissory note (the “Note”) to an accredited investor for $10.0 million cash proceeds, which will be used to pay off existing demand notes and to provide additional working capital.

Outlook Therapeutics Secures $10 Million in Additional Working Capital

MONMOUTH JUNCTION, N.J., Nov. 03, 2020 (GLOBE NEWSWIRE) -- Outlook Therapeutics, Inc. (Nasdaq: OTLK), a late clinical-stage biopharmaceutical company working to develop the first FDA-approved ophthalmic formulation of bevacizumab-vikg for use in retinal indications, today announced the completion of patient enrollment for its planned open-label safety study evaluating ONS-5010/LYTENAVA™ (NORSE THREE). Patient enrollment for the study was completed in less than one month, significantly ahead of the planned four-month enrollment schedule.

Outlook Therapeutics Completes Patient Enrollment of Open-Label Safety Study for ONS-5010/LYTENAVA™ (bevacizumab-vikg)

Live moderated video webcast discussion among members of management and Key Opinion Leader Firas M. Rahhal, MD on Thursday, October 29th at 10:00 AM ET Live moderated video webcast discussion among members of management and Key Opinion Leader Firas M. Rahhal, MD on Thursday, October 29th at 10:00 AM ET

Outlook Therapeutics to Present at the Virtual Investor KOL Roundtable

MONMOUTH JUNCTION, N.J., Oct. 13, 2020 (GLOBE NEWSWIRE) -- Outlook Therapeutics, Inc. (Nasdaq: OTLK), a late clinical-stage biopharmaceutical company working to develop the first FDA-approved ophthalmic formulation of bevacizumab-vikg for use in retinal indications, today announced the initiation and enrollment of the first patients in its planned supplemental open-label safety study evaluating ONS-5010 / LYTENAVA™ (bevacizumab-vikg) for the treatment of wet age-related macular degeneration (AMD) (NORSE THREE).

Outlook Therapeutics Announces Initiation of Supplemental Open-Label Safety Study for ONS-5010 / LYTENAVA™ (bevacizumab-vikg)

MONMOUTH JUNCTION, N.J., Oct. 07, 2020 (GLOBE NEWSWIRE) -- Outlook Therapeutics, Inc. (Nasdaq: OTLK), a late clinical-stage biopharmaceutical company working to develop the first FDA-approved ophthalmic formulation of bevacizumab-vikg for use in retinal indications, today announced that Lawrence Kenyon, President, CEO and CFO of Outlook Therapeutics, will participate at the BIO Investor Forum Digital taking place on October 13-15, 2020.

Outlook Therapeutics to Present at the Virtual BIO Investor Forum Digital

MONMOUTH JUNCTION, N.J., Sept. 30, 2020 (GLOBE NEWSWIRE) -- Outlook Therapeutics, Inc. (Nasdaq: OTLK) is a late clinical-stage biopharmaceutical company developing the first FDA-approved ophthalmic formulation of bevacizumab-vikg (LYTENAVA™) for use in retinal indications (known as ONS-5010). Outlook Therapeutics is advancing on multiple fronts, including: progress on its Phase 3 clinical program, manufacturing and regulatory activities, and global strategic partnering negotiations, all leading to the planned commercial launch of ONS-5010 anticipated in 2022. In addition, Outlook Therapeutics recently completed a strategic partnership for commercialization in Greater China and is in discussions with other strategic partners for commercial launches in the United States, Asia and Europe.

Outlook Therapeutics Provides Update on Progress Towards First Approved Ophthalmic Formulation of Bevacizumab-vikg for Advanced Macular Degeneration

MONMOUTH JUNCTION, N.J., Sept.  08, 2020  (GLOBE NEWSWIRE) -- Outlook Therapeutics, Inc. (Nasdaq: OTLK), a late clinical-stage biopharmaceutical company working to develop the first FDA-approved ophthalmic formulation of bevacizumab-vikg for use in retinal indications, today announced that Lawrence Kenyon, President, CEO and CFO of Outlook Therapeutics, will present at two upcoming investor conferences in September.

Outlook Therapeutics to Present at Two Upcoming Investor Conferences

The share price of Outlook Therapeutics fell sharply due to the anticipated differentiation between LYTENAVA and LUCENTIS.

Outlook Therapeutics: Interpreting The New Phase 3 Trial Results

MONMOUTH JUNCTION, N.J., Aug.  26, 2020  (GLOBE NEWSWIRE) -- Outlook Therapeutics, Inc. (Nasdaq: OTLK), a late clinical-stage biopharmaceutical company working to develop the first FDA-approved ophthalmic formulation of bevacizumab-vikg for use in retinal indications, today announced topline results demonstrating anticipated safety and efficacy and positive proof-of-concept of ONS-5010 / LYTENAVA™ (bevacizumab-vikg) for the treatment of wet age-related macular degeneration (wet AMD) from its NORSE 1 clinical study, the first of two registration clinical trials.  ONS-5010 is the first injectable ophthalmic formulation of bevacizumab-vikg seeking U.S. Food and Drug Administration (FDA) approval for the treatment of wet AMD under a new Biologics License Application (BLA).

Outlook Therapeutics Reports Topline Results and Positive Proof-of-Concept for ONS-5010 / LYTENAVA™ (bevacizumab-vikg) from NORSE 1

Oncobiologics, Inc. (OTLK) delivered earnings and revenue surprises of -83.33% and -100.00%, respectively, for the quarter ended June 2020.

Oncobiologics, Inc. (OTLK) Reports Q3 Loss, Lags Revenue Estimates

MONMOUTH JUNCTION, N.J., Aug.  14, 2020  (GLOBE NEWSWIRE) -- Outlook Therapeutics, Inc. (Nasdaq: OTLK), a late clinical-stage biopharmaceutical company working to develop the first FDA-approved ophthalmic formulation of bevacizumab-vikg for use in retinal indications, today announced its corporate highlights and financial results for its fiscal third quarter ended June 30, 2020.   Outlook Therapeutics also provided a clinical development update on  ONS-5010 / LYTENAVA™  (bevacizumab-vikg), its investigational ophthalmic formulation of bevacizumab-vikg for the treatment of wet age-related macular degeneration (wet AMD) and other retinal indications.

Outlook Therapeutics Reports Financial Results for the Third Quarter of Fiscal Year 2020 and Provides Corporate Update

Oncobiologics, Inc. (OTLK) doesn't possess the right combination of the two key ingredients for a likely earnings beat in its upcoming report.

Oncobiologics, Inc. (OTLK) May Report Negative Earnings: Know the Trend Ahead of Q3 Release

MONMOUTH JUNCTION, N.J., July  17, 2020  (GLOBE NEWSWIRE) --  Outlook Therapeutics, Inc.  (Nasdaq: OTLK), a late clinical-stage biopharmaceutical company working to develop the first FDA-approved ophthalmic formulation of bevacizumab-vikg for use in retinal indications, today announced the successful closing of its previously announced private placement of 823,045 shares of common stock at a purchase price of $1.215 per share, for aggregate gross proceeds of approximately $1.0 million, to Syntone Ventures LLC, a U.S.-based affiliate of Syntone Technologies Group Co. Ltd.  The securities were priced at-the-market under Nasdaq rules.

Outlook Therapeutics Announces Closing of $1.0 Million Private Placement Priced At-The-Market Under Nasdaq Rules

MONMOUTH JUNCTION, N.J., July  07, 2020  (GLOBE NEWSWIRE) --  Outlook Therapeutics, Inc.  (Nasdaq: OTLK), a late clinical-stage biopharmaceutical company working to develop the first FDA-approved ophthalmic formulation of bevacizumab for use in retinal indications, today announced the completion of patient enrollment in its NORSE 2 clinical trial for  ONS-5010 / LYTENAVA™  (bevacizumab-vikg), an investigational ophthalmic formulation of bevacizumab for use in retinal indications.

Outlook Therapeutics Completes Patient Enrollment for NORSE 2 Study of ONS-5010 / LYTENAVA™ (bevacizumab-vikg)

Outlook Therapeutics (OTLK) saw a big move last session, as its shares jumped 7% on the day, amid huge volumes.

Outlook Therapeutics (OTLK) Catches Eye: Stock Jumps 7%

MONMOUTH JUNCTION, N.J., June  25, 2020  (GLOBE NEWSWIRE) --  Outlook Therapeutics, Inc.  (Nasdaq: OTLK) (“the Company”), a late clinical-stage biopharmaceutical company working to develop the first FDA-approved ophthalmic formulation of bevacizumab for use in retinal indications, today announced that it has closed its previously announced registered direct offering priced at-the-market under Nasdaq rules of 8,407,411 shares of its common stock, at a purchase price of $1.215 per share, for aggregate gross proceeds of approximately $10.2 million.

Outlook Therapeutics Announces Closing of $10.2 Million Financing Priced At-The-Market Under Nasdaq Rules

MONMOUTH JUNCTION, N.J., June  17, 2020  (GLOBE NEWSWIRE) --  Outlook Therapeutics, Inc.  (Nasdaq: OTLK) (the Company), a late clinical-stage biopharmaceutical company working to develop the first FDA-approved ophthalmic formulation of bevacizumab for use in retinal indications, today provided a clinical update for  ONS-5010 / LYTENAVA™  (bevacizumab-vikg), the Company’s investigational ophthalmic formulation of bevacizumab.

Outlook Therapeutics Provides Clinical Update on ONS-5010 / LYTENAVA™ (bevacizumab-vikg)

Live moderated video webcast discussion with President, CEO and CFO Lawrence Kenyon, on Wednesday, June 17th at 2:00 PM ET, immediately followed by an interactive Q&A session Live moderated video webcast discussion with President, CEO and CFO Lawrence Kenyon, on Wednesday, June 17th at 2:00 PM ET, immediately followed by an interactive Q&A session

Outlook Therapeutics to Present at the Virtual Investor Fireside Chat Series

MONMOUTH JUNCTION, N.J., June  03, 2020  (GLOBE NEWSWIRE) --  Outlook Therapeutics, Inc.  (Nasdaq: OTLK) (the Company), a late clinical-stage biopharmaceutical company working to develop the first FDA-approved ophthalmic formulation of bevacizumab for use in retinal indications, today announced the successful closing of its previously announced private placement of $16.0 million of common stock at a price of $1.00 per share (representing a 34% premium at signing) to Syntone Ventures LLC, a U.S.-based affiliate of Syntone Technologies Group Co. Ltd.

News for Outlook Therapeutics Inc Stock (OTLK)