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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The stock price of Outlook Therapeutics Inc (NASDAQ: OTLK) fell by over 20% pre-market today. This is why it happened.

Outlook Therapeutics (OTLK) Stock: Why The Price Dropped Today

ISELIN, N.J., Nov. 23, 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, announced today that, due to demand, the underwriter has agreed to increase the size of the previously announced public offering and purchase on a firm commitment basis 40,000,000 shares of common stock of Outlook Therapeutics, at a price to the public of $1.25 per share, less underwriting discounts and commissions. The closing of the offering is expected to occur on or about November 29, 2021, subject to satisfaction of customary closing conditions.

Outlook Therapeutics Increases Previously Announced Bought Deal Offering of Common Stock to $50 Million

ISELIN, N.J., Nov. 23, 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 8,000,000 shares of common stock of Outlook Therapeutics, at a price to the public of $1.25 per share, less underwriting discounts and commissions. The closing of the offering is expected to occur on or about November 29, 2021, subject to satisfaction of customary closing conditions.

Outlook Therapeutics Announces $10 Million Bought Deal Offering of Common Stock

- NORSE TWO showed highly statistically significant, clinically relevant results consistent with historical ophthalmic bevacizumab data

Outlook Therapeutics Presents NORSE TWO Phase 3 Pivotal Safety and Efficacy Data for ONS-5010 / LYTENAVA™ (bevacizumab-vikg) at the Retina Subspecialty Day, American Academy of Ophthalmology (AAO) 2021 Annual Conference

Live moderated video webcast discussion among members of management and Thought Leaders Firas M. Rahhal, MD and Robert L. Avery, MD on Tuesday, November 16th at 9:00 AM ET Live moderated video webcast discussion among members of management and Thought Leaders Firas M. Rahhal, MD and Robert L. Avery, MD on Tuesday, November 16th at 9:00 AM ET

Outlook Therapeutics to Present at the Virtual Investor Roundtable Event

Firas M. Rahhal, MD, will present Phase 3 pivotal data from the NORSE TWO registration trial on Saturday, November 13, 2021 Firas M. Rahhal, MD, will present Phase 3 pivotal data from the NORSE TWO registration trial on Saturday, November 13, 2021

Outlook Therapeutics to Present at the Retina Subspecialty Day, American Academy of Ophthalmology 2021 Annual Conference

Outlook Therapeutics management to present on Thursday, November 11, 2021 Outlook Therapeutics management to present on Thursday, November 11, 2021

Outlook Therapeutics to Present at the Eyecelerator@AAO 2021 Conference Retina Showcases

Strong safety data from NORSE THREE registration trial consistent with other trials for ONS-5010 and in prior published research Strong safety data from NORSE THREE registration trial consistent with other trials for ONS-5010 and in prior published research

Outlook Therapeutics' Positive NORSE THREE Safety Data Presented at 2021 American Society of Retina Specialists for ONS-5010 Ophthalmic Bevacizumab

Suber Huang, MD, MBA, FASRS, will present safety data from Outlook Therapeutics' NORSE THREE registration trial on Tuesday, October 12, 2021 Suber Huang, MD, MBA, FASRS, will present safety data from Outlook Therapeutics' NORSE THREE registration trial on Tuesday, October 12, 2021

Outlook Therapeutics to Present at the 2021 American Society of Retina Specialists (ASRS) Annual Meeting

Outlook Therapeutics senior leadership team to provide a company overview and participate on industry panel on Thursday, October 7, 2021 Outlook Therapeutics senior leadership team to provide a company overview and participate on industry panel on Thursday, October 7, 2021

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

ISELIN, N.J., Sept. 28, 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 new 12-month safety data from the pivotal Phase 3 NORSE TWO trial that further confirm the strong safety profile in this study of ONS-5010 / LYTENAVA™ (bevacizumab-vikg) for treatment of neovascular age-related macular degeneration (wet AMD). In August 2021, Outlook Therapeutics announced the topline readout of pivotal data from its NORSE TWO trial, which included 11 months of safety data. The topline data previously reported from NORSE TWO demonstrated clinically relevant and highly statistically significant results as well as a robust safety profile indicating that in the trial ONS-5010 was well tolerated and showed no unanticipated safety signals.

Outlook Therapeutics Reports New Positive 12-Month Safety Data from Pivotal Phase 3 NORSE TWO Trial

Live fireside chat with C. Russell Trenary, President and CEO of Outlook Therapeutics on Tuesday, September 28 at 2:00 PM ET Live fireside chat with C. Russell Trenary, President and CEO of Outlook Therapeutics on Tuesday, September 28 at 2:00 PM ET

Outlook Therapeutics to Present at the Cantor Fitzgerald Virtual Global Healthcare Conference

ISELIN, N.J., Sept. 13, 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 the presentation of safety data from the NORSE THREE trial evaluating ONS-5010 / LYTENAVA™ (bevacizumab-vikg) at the EURETINA Virtual 2021 conference on September 12, 2021. The previously announced topline results from the open-label safety study demonstrated that ONS-5010 ophthalmic bevacizumab, under evaluation for the treatment of wet AMD, showed no unexpected safety trends and had a safety profile consistent with that of prior published data undertaken by the National Eye Institute (2011 CATT trial).

Outlook Therapeutics Presents Positive NORSE THREE Safety Data for ONS-5010 / LYTENAVA™ (bevacizumab-vikg) at EURETINA Virtual 2021 Medical Conference

ISELIN, N.J., Sept. 08, 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 that C. Russell Trenary, President and Chief Executive Officer of Outlook Therapeutics, will participate in a fireside chat during the virtual H.C. Wainwright 23 rd Annual Global Investment Conference being held September 13 – 15, 2021.

Outlook Therapeutics to Present at H.C. Wainwright 23rd Annual Global Investment Conference

Shares of Outlook Therapeutics (NASDAQ:OTLK) moved higher by 2.8% in pre-market trading after the company reported Q3 results. Quarterly Results Earnings per share were down 133.33% year over year to ($0.07), which were in line with the estimate of ($0.07).

Outlook Therapeutics: Q3 Earnings Insights

ISELIN, N.J., Aug. 13, 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 third quarter ended June 30, 2021.

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

ISELIN, N.J., Aug. 11, 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 that C. Russell Trenary III, President and Chief Executive Officer of Outlook Therapeutics, will participate in the H.C. Wainwright Ophthalmology Virtual Conference being held Tuesday, August 17, 2021 from 9:00 – 10:00 a.m. ET .

Outlook Therapeutics to Participate at the H.C. Wainwright Ophthalmology Virtual Conference

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Investors are excited about the potential of the drugmaker's experimental wet AMD treatment.

Why Outlook Therapeutics Stock Surged Today

H.C. Wainwright raised the price target on Outlook Therapeutics Inc (NASDAQ:OTLK) to $6 from $5 and reiterated a Buy rating. The Company announced "exceptionally strong" data that showed Lytenava's statistically significant superiority over Lucentis, analyst Douglas Tsao tells investors in a research note.

HC Wainwright Raises Price Target On Outlook Therapeutics After Wet AMD Trial Data

OTLK stock is on the move today. The company is coming forth with promising data on its treatment of a damaging eye disease.

OTLK Stock: The Huge Trial News Lifting Outlook Therapeutics

The stock price of Outlook Therapeutics Inc (NASDAQ: OTLK) increased by over 30% pre-market. This is why it happened.

OTLK Stock Price Increases Over 30% Pre-Market: Why It Happened

Outlook Therapeutics Inc (NASDAQ: OTLK) stock is trading higher in premarket session in reaction to positive top-line results from Phase 3 NORSE TWO trial evaluating ONS-5010 / LYTENAVA (bevacizumab) for neovascular age-related macular degeneration (wet AMD).  The primary endpoint for the study was the proportion of patients who gain at least 15 letters in the best-corrected visual acuity (BCVA) at 11 months.

Outlook Therapeutics Stock Surges Positive ONS-5010 Data In Wet AMD Patients

ISELIN, N.J., Aug. 03, 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 positive clinical and highly statistically significant top-line results from its pivotal Phase 3 NORSE TWO safety and efficacy trial evaluating ONS-5010 / LYTENAVA™ (bevacizumab) for treatment of neovascular age-related macular degeneration (wet AMD). Outlook Therapeutics will host a conference call and webcast today, August 3, 2021, at 8:00 a.m. ET (details below) to discuss the results of the study.

Outlook Therapeutics Reports Positive Efficacy and Safety Data from Pivotal Phase 3 NORSE TWO Trial of ONS-5010 / LYTENAVA™ (bevacizumab-vikg) for the Treatment of Wet AMD

News for Outlook Therapeutics Inc Stock (OTLK)