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 10, 2022 (GLOBE NEWSWIRE) -- Outlook Therapeutics, Inc. (Nasdaq: OTLK), a pre-commercial biopharmaceutical company working to develop and launch the first FDA-approved ophthalmic formulation of bevacizumab for use in retinal indications, today announced that Terry Dagnon, Chief Operations Officer of Outlook Therapeutics, will be a panelist at the Retina World Congress 2022 taking place May 12-15, 2022 in Fort Lauderdale, Florida.

Outlook Therapeutics to Participate in Retina World Congress 2022

Live moderated video webcast on Wednesday, May 11th at 1:00 PM ET Live moderated video webcast on Wednesday, May 11th at 1:00 PM ET

Outlook Therapeutics to Participate at the Virtual Investor 2022 CEO Spotlight

Outlook Therapeutics (NASDAQ:OTLK) Inc revealed that BioLexis Private Limited, a strategic shareholder in the pre-commercial biopharmaceutical company, is being reorganized and has resulted in GMS Holdings emerging as its largest shareholder. The Singapore and Iselin, New Jersey-based biopharma company noted that the BioLexis reorganization, which does not entail any changes in the indirect ownership of Outlook Therapeutics (NASDAQ:OTLK), provides GMS Holdings with “increased flexibility” to support Outlook's growth as its largest shareholder.

Outlook Therapeutics says BioLexis reorganization results in GMS Holdings becoming its largest shareholder

SINGAPORE and ISELIN, N.J., April 22, 2022 (GLOBE NEWSWIRE) -- Outlook Therapeutics, Inc. (Nasdaq: OTLK), a pre-commercial biopharmaceutical company working to develop and launch the first FDA-approved ophthalmic formulation of bevacizumab for use in retinal indications, and BioLexis Pte Ltd. (“BioLexis”), a strategic shareholder in Outlook Therapeutics, today announced that BioLexis is being reorganized. The BioLexis reorganization, which does not entail any changes in the indirect ownership of Outlook Therapeutics, provides GMS Holdings with increased flexibility to support the future growth of Outlook Therapeutics as its largest shareholder.

BioLexis Reorganization Results in GMS Holdings as Largest Shareholder in Outlook Therapeutics

ISELIN, N.J., April 05, 2022 (GLOBE NEWSWIRE) -- Outlook Therapeutics, Inc. (Nasdaq: OTLK), a biopharmaceutical company working to develop and launch the first FDA-approved ophthalmic formulation of bevacizumab for use in retinal indications, today announced that Russ Trenary, President and Chief Executive Officer of Outlook Therapeutics, will be presenting at the Wet AMD and DME Drug Development Summit taking place April 5-7, 2022 in Boston, Massachusetts.

Outlook Therapeutics to Present at Wet AMD and DME Drug Development Summit

Outlook Therapeutics (NASDAQ:OTLK) Inc said it has submitted its Biologics License Application (BLA) to the US Food and Drug Administration (FDA) for ONS-5010, an investigational therapy for the treatment of wet age-related macular degeneration (wet AMD). If approved, the treatment will be branded as LYTENAVA (bevacizumab-vikg) and could replace the current practice of using unapproved repackaged IV bevacizumab sourced from compounding pharmacies, products that have known risks of contamination and inconsistent potency and availability.

Outlook Therapeutics submits Biologics License Application to US FDA for its investigational therapy to treat wet age-related macular degeneration

ISELIN, N.J., March 31, 2022 (GLOBE NEWSWIRE) -- Outlook Therapeutics, Inc. (Nasdaq: OTLK), a biopharmaceutical company working to develop and launch the first FDA-approved ophthalmic formulation of bevacizumab for use in retinal indications, today announced it has submitted its Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for ONS-5010, an investigational therapy which, if approved, will be branded as LYTENAVA™ (bevacizumab-vikg), for the treatment of wet age-related macular degeneration (wet AMD). If approved, LYTENAVA™ (bevacizumab-vikg) could replace the current practice of using unapproved repackaged IV bevacizumab sourced from compounding pharmacies for the treatment of wet AMD. “This BLA submission for our investigational ONS-5010 not only marks a very significant moment for Outlook Therapeutics, but represents a real step forward for potentially providing an on-label, FDA-approved alternative for the most frequently used anti-VEGF treatment in wet AMD patients in the United States,” said Russ Trenary, President and Chief Executive Officer, Outlook Therapeutics. “If approved for marketing, we hope to see our ophthalmic bevacizumab become a valuable on-label therapy offering clinicians and their patients a safe and effective ophthalmic formulation of a treatment whose value has been proven over many years of clinical practice. We are excited for the potential to offer an ophthalmic bevacizumab formulation that ships straight from our factory partners to distribution centers while avoiding the risks of using unapproved repackaged IV bevacizumab that is approved for intravenous use but not for intravitreal administration.”

Outlook Therapeutics Submits Biologics License Application to the U.S. Food and Drug Administration for ONS-5010 as a Treatment for Wet AMD

ISELIN, N.J., March 03, 2022 (GLOBE NEWSWIRE) -- Outlook Therapeutics, Inc. (Nasdaq: OTLK), a biopharmaceutical company working to develop and launch the first FDA-approved ophthalmic formulation of bevacizumab for use in retinal indications, today announced that Alicia Tozier has been appointed as Senior Vice President, Marketing and Market Access.

Outlook Therapeutics Bolsters Commercialization Expertise with Appointment of Alicia Tozier as Senior Vice President of Marketing and Market Access

Pivotal Phase 3 data from the NORSE TWO registration trial to be presented by Lawrence Lee, MD, MBBS, FRANZCO, FRACS Pivotal Phase 3 data from the NORSE TWO registration trial to be presented by Lawrence Lee, MD, MBBS, FRANZCO, FRACS

Outlook Therapeutics to Present at the RANZCO 52nd Annual Scientific Congress

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ISELIN, N.J., Feb. 14, 2022 (GLOBE NEWSWIRE) -- Outlook Therapeutics, Inc. (Nasdaq: OTLK), a biopharmaceutical company working to develop and launch the first FDA-approved ophthalmic formulation of bevacizumab for use in retinal indications, today announced recent corporate highlights and financial results for its fiscal first quarter ended December 31, 2021.

Outlook Therapeutics Reports Financial Results for First Quarter Fiscal Year 2022 and Provides Corporate Update

Live video webcast presentation on Friday, February 18th at 10:40 AM ET Live video webcast presentation on Friday, February 18th at 10:40 AM ET

Outlook Therapeutics to Present at the 11th Annual SVB Leerink Global Healthcare Conference

ISELIN, N.J., Feb. 08, 2022 (GLOBE NEWSWIRE) -- Outlook Therapeutics, Inc. (Nasdaq: OTLK), a biopharmaceutical company working to develop and launch the first FDA-approved ophthalmic formulation of bevacizumab for use in retinal indications, today announced the appointment of Joel Prieve as Senior Vice President, Commercial Operations.

Outlook Therapeutics Expands Commercial Team with Appointment of Senior Vice President of Commercial Operations

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ISELIN, N.J., Jan. 25, 2022 (GLOBE NEWSWIRE) -- Outlook Therapeutics, Inc. (Nasdaq: OTLK), a biopharmaceutical company working to develop and launch the first FDA-approved ophthalmic formulation of bevacizumab for use in retinal indications, today provided a business outlook for 2022.

Outlook Therapeutics Provides a Corporate Update and Business Outlook

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Outlook's drug ONS-5010 has a unique value prop that will set it apart in the wet AMD landscape.

Outlook Therapeutics: Likely FDA Approval, Possible Buyout

Live video webcast presentation on Tuesday, January 25th at 3:00 PM ET Live video webcast presentation on Tuesday, January 25th at 3:00 PM ET

Outlook Therapeutics to Present at the Virtual Investor 2022 Top Picks Conference

ISELIN, N.J., Jan. 04, 2022 (GLOBE NEWSWIRE) -- Outlook Therapeutics, Inc. (Nasdaq: OTLK), a biopharmaceutical company working to develop and launch the first FDA-approved ophthalmic formulation of bevacizumab for use in retinal indications, today announced that C. Russell Trenary III, President and Chief Executive Officer of Outlook Therapeutics, will participate in a fireside chat at the virtual H.C. Wainwright BioConnect Conference taking place January 10-13, 2022.

Outlook Therapeutics to Present at the H.C. Wainwright BioConnect Conference

ISELIN, N.J., Dec. 22, 2021 (GLOBE NEWSWIRE) --  Outlook Therapeutics, Inc. (Nasdaq: OTLK), a biopharmaceutical company working to develop and launch the first FDA-approved ophthalmic formulation of bevacizumab for use in retinal indications, today announced recent corporate highlights and financial results for its fiscal year ended September 30, 2021. Outlook Therapeutics also provided a clinical development and pre-commercialization update on ONS-5010 / LYTENAVA™ (bevacizumab-vikg), its investigational ophthalmic formulation of bevacizumab for the treatment of wet age-related macular degeneration (wet AMD) and other retinal indications.

Outlook Therapeutics Reports Financial Results for Fiscal Year 2021 and Provides Corporate Update

Francesco Bandello, MD, FEBO, will present Phase 3 pivotal safety and efficacy data from the NORSE TWO registration trial Francesco Bandello, MD, FEBO, will present Phase 3 pivotal safety and efficacy data from the NORSE TWO registration trial

Outlook Therapeutics to Present Pivotal Data from NORSE TWO Trial at the 9th International Congress on OCT and OCT Angiography in Rome (ICOOR)/ FLORetina Symposia

Suber Huang, MD, MBA, FASRS will present data from the Phase 3 pivotal NORSE TWO registration trial Suber Huang, MD, MBA, FASRS will present data from the Phase 3 pivotal NORSE TWO registration trial

Outlook Therapeutics to Present at the 14th Asia-Pacific Vitreo-Retina Society (APVRS) Congress

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ISELIN, N.J., Nov. 29, 2021 (GLOBE NEWSWIRE) -- Outlook Therapeutics, Inc. (Nasdaq: OTLK) (“Outlook Therapeutics”), a late clinical-stage biopharmaceutical company working to develop and launch the first FDA-approved ophthalmic formulation of bevacizumab-vikg for use in retinal indications, today announced the closing of its previously announced underwritten public offering of 46,000,000 shares of common stock of the Company at a price to the public of $1.25 per share, which includes the exercise in full of the underwriter's option to purchase additional shares.

Outlook Therapeutics Announces Closing of $57.5 Million Bought Deal, Including Full Exercise of Underwriter's Option to Purchase Additional Shares

Outlook Therapeutics Inc (NASDAQ: OTLK) has increased the size of the previously announced public offering to 40 million shares at $1.25 per share, for gross proceeds of $50 million. The offer price represents a discount of almost 20% from the last close price of $1.56 on Tuesday.

News for Outlook Therapeutics Inc Stock (OTLK)