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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Outlook Therapeutics Inc (NASDAQ:OTLK) said the US Food and Drug Administration (FDA) has accepted its Biologics License Application (BLA) for its investigational ophthalmic formulation of bevacizumab for treating wet age-related macular degeneration (wet AMD).   The FDA set a Prescription Drug User Fee Act (PDUFA) goal date of 29 August 2023.

Outlook Therapeutics encouraged by FDA acceptance of application for drug to treat retinal eye disease wet AMD

ISELIN, N.J., Oct. 28, 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 the U.S. Food and Drug Administration (FDA) has accepted for filing a Biologics License Application (BLA) for ONS-5010 / LYTENAVA™ (bevacizumab-vikg), an investigational ophthalmic formulation of bevacizumab for the treatment of wet age-related macular degeneration (wet AMD). The FDA set a Prescription Drug User Fee Act (PDUFA) goal date of August 29, 2023. ONS-5010, if approved, is expected to receive 12 years of regulatory exclusivity in the United States.

Outlook Therapeutics® Announces Acceptance of Biologics License Application by U.S. FDA for ONS-5010 as a Treatment for Wet AMD

AmerisourceBergen

Outlook Therapeutics Inc (NASDAQ:OTLK) said it has entered into a strategic relationship with healthcare company AmerisourceBergen in preparation for the anticipated commercial launch in the United States of its ONS-5010 treatment for wet age-related macular degeneration (AMD).  ONS-5010 is an investigational ophthalmic formulation of bevacizumab under development to be administered as an intravitreal injection for the treatment of wet AMD and other retinal diseases.

Outlook Therapeutics enters into commercialization agreement with AmerisourceBergen

ISELIN, N.J. and CONSHOHOCKEN, Pa., Sept. 27, 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 AmerisourceBergen (NYSE: ABC), a global healthcare company and leader in specialty pharmaceutical distribution and services, announced today that they have entered into a strategic relationship in preparation for the anticipated commercial launch in the United States of ONS-5010 / LYTENAVA™ (bevacizumab-vikg), if approved by the U.S. Food and Drug Administration (FDA).

Outlook Therapeutics® and AmerisourceBergen Announce Strategic Commercialization Agreement for ONS-5010 for the Treatment of Wet AMD

ISELIN, N.J., Sept. 26, 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 it will present at Eyecelerator @ AAO 2022 taking place Thursday, September 29, 2022 in Chicago, Illinois.

Outlook Therapeutics® to Present at Eyecelerator @ AAO 2022

ISELIN, N.J., Sept. 07, 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 Russ Trenary, President and Chief Executive Officer of Outlook Therapeutics, will present at the H.C. Wainwright 24th Annual Global Investment Conference being held in New York, NY and virtually on September 12-14, 2022.

Outlook Therapeutics® to Present at the H.C. Wainwright 24th Annual Global Investment Conference

Outlook Therapeutics Inc (NASDAQ:OTLK) said it has re-submitted its biologics license application (BLA) to the US Food and Drug Administration (FDA) for ONS-5010, an investigational ophthalmic therapy which, if approved, will be branded as LYTENAVA (bevacizumab-vikg) for the treatment of wet age-related macular degeneration (wet AMD). Outlook Therapeutics CEO Russell Trenary said the company has worked diligently over the past three months to provide additional required information not included in its March 2022 submission.

Outlook Therapeutics re-submits biologics license application for ONS-5010 as a treatment for wet AMD to the FDA

ISELIN, N.J., Aug. 30, 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 re-submitted its Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for ONS-5010, an investigational ophthalmic therapy which, if approved, will be branded as LYTENAVA™ (bevacizumab-vikg) for the treatment of wet age-related macular degeneration (wet AMD).

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

Outlook Therapeutics (NASDAQ:OTLK) Inc, a pre-commercial biopharmaceutical company working to develop the first US Food and Drug Administration (FDA)-approved ophthalmic formulation of bevacizumab for use in retinal indications, said it has appointed Julia A Haller, MD, to the company's board of directors. "As one of the world's most accomplished professionals in ophthalmic education, research, and clinical ophthalmic practice, she will add tremendous value and insight to Outlook Therapeutics (NASDAQ:OTLK)," Randy Thurman, executive chair of Outlook Therapeutics said in a statement.

Outlook Therapeutics strengthens board with appointment of ophthalmologist Dr Julia Haller

ISELIN, N.J., Aug. 15, 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 the appointment of Julia A. Haller, MD, to the Company's Board of Directors.

Outlook Therapeutics Strengthens Board of Directors with Appointment of Julia A. Haller, MD

Outlook Therapeutics (NASDAQ:OTLK) Inc said it ended the fiscal third quarter with $26 million in cash and cash equivalents that are expected to fund its work into the first calendar quarter of 2023, including advancing the company's ophthalmic formulation of bevacizumab towards US Food and Drug Administration (FDA) approval. In reporting its financial results for the three months ended June 30, 2022, the company highlighted a number of recent corporate milestones, including confirming its plans to re-submit a Biologics License Application (BLA) for ONS-5010 for the treatment of wet age-related macular degeneration (wet AMD) to the US FDA by September 2022.

Outlook Therapeutics ends 3Q with $26 million in cash and cash equivalents; plans to re-submit ONS-5010 application by September

Outlook Therapeutics (NASDAQ:OTLK) Inc has ended the fiscal third quarter with $26 million in cash and cash equivalents that are expected to fund its work into the first calendar quarter of 2023, including advancing the company's ophthalmic formulation of bevacizumab towards US Food and Drug Administration (FDA) approval. In reporting its financial results for the three months ended June 30, 2022, the company highlighted a number of recent corporate milestones, including confirming its plans to re-submit a Biologics License Application (BLA) for ONS-5010 for the treatment of wet age-related macular degeneration (wet AMD) to the US FDA by September 2022.

Outlook Therapeutics ends 3Q with $26 million in cash and cash equivalents; plans to re-submit ONS-5010 license application by September

ISELIN, N.J., Aug. 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 its financial results for its fiscal third quarter ended June 30, 2022, provided recent corporate highlights, and reiterated its anticipated near-term milestones.

Outlook Therapeutics Reports Financial Results for Third Quarter Fiscal Year 2022 and Reiterates Key Anticipated Near-Term Milestones

ISELIN, N.J., Aug. 04, 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 Russ Trenary, President and Chief Executive Officer of Outlook Therapeutics, will present at the H.C. Wainwright 2nd Annual Ophthalmology Conference being held virtually on Wednesday, August 17.

Outlook to Present at the H.C. Wainwright 2nd Annual Ophthalmology Conference

ISELIN, N.J., July 05, 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, announced today the full cash pre-payment of its unsecured convertible promissory note dated November 4, 2020, as amended November 16, 2021 (the “Note”). All obligations under the Note have been repaid in cash and satisfied.

Outlook Therapeutics Announces Full Cash Pre-Payment of Convertible Promissory Note

Outlook Therapeutics (NASDAQ:OTLK) Inc has provided an update on its Biologics License Application (BLA) submission for ONS-5010/LYTENAVA (bevacizumab-vikg) for the treatment of wet age-related macular degeneration (wet AMD). The pre-commercial biopharmaceutical company said it has confirmed the additional information necessary to re-submit the BLA for ONS-5010 by September 2022 following receipt of additional correspondence from the US Food and Drug Administration (FDA).

Outlook Therapeutics confirms BLA re-submission date for its ONS-5010 wet AMD treatment

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ISELIN, N.J., June 14, 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, is providing an update on its Biologics License Application (BLA) submission for ONS-5010 / LYTENAVA™ (bevacizumab-vikg) for the treatment of wet age-related macular degeneration (wet AMD).

Outlook Therapeutics Confirms Status of Biologics License Application (BLA) Submission for ONS-5010

Today, we revisit Outlook Therapeutics for the first time since March 2021. The company recently temporarily withdrew its marketing application for its main asset, clouding the outlook on this small-cap name even further.

Outlook Therapeutics: A One-Buck Lottery Ticket

Outlook Therapeutics (NASDAQ:OTLK) Inc said it has voluntarily withdrawn the biologics license application (BLA) for its ophthalmic formulation of bevacizumab (ONS-5010 or Lytenava) after the US Food and Drug Administration (FDA) requested additional information.  The company added that it is actively working to respond to the FDA's request and plans to resubmit a revised BLA by September.

Outlook Therapeutics opts to resubmit BLA for wet AMD drug after FDA requests more info

ISELIN, N.J., May 31, 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 the U.S. Food and Drug Administration (FDA) has requested additional information in order to complete the filing of the Company's Biologics License Application (BLA) for ONS-5010/ LYTENAVA™ (bevacizumab-vikg) for the treatment of wet age-related macular degeneration (wet AMD). Outlook Therapeutics has voluntarily withdrawn its BLA for ONS-5010 and is actively working to respond to the FDA's request. The Company plans to re-submit a revised BLA by September 2022.

Outlook Therapeutics Provides Update on Biologics License Application (BLA) Submission for ONS-5010 as a Treatment for Wet AMD

ISELIN, N.J., May 18, 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 Lawrence Kenyon, Chief Financial Officer of Outlook Therapeutics, will present at the H.C. Wainwright Global Investment Conference being held May 23-26, 2022 in Miami, FL and virtually.

Outlook Therapeutics to Present at the H.C. Wainwright Global Investment Conference

Advanced Micro Devices

Outlook Therapeutics (NASDAQ:OTLK) Inc ended its fiscal second quarter with $58.4 million in cash – enough to launch its lead drug ONS-5010 without raising significant additional capital, it said. ONS-5010, which will be sold under the brand name Lytenava, is an investigational ophthalmic formulation of bevacizumab under development to be administered as an intravitreal injection for the treatment of wet age-related macular degeneration (AMD) and other retinal diseases.

Outlook Therapeutics ends fiscal 2Q with $58.4M in cash as it ramps up pre-commercial activities for wet AMD treatment Lytenava

ISELIN, N.J., May 13, 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 recent corporate highlights and financial results for its fiscal second quarter ended March 31, 2022.

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

Outlook Therapeutics (NASDAQ:OTLK) Inc has said its chief operations officer Terry Dagnon will discuss the company's wet age-related macular degeneration (AMD) drug Lytenava as part of a panel at the 2022 World Retina Conference later this month.  The conference is taking place from May 12-15, 2022, in Fort Lauderdale, Florida.

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