Outlook Therapeutics Inc Stock Price, News & Analysis

Suber Huang, MD, MBA, FASRS will present safety data from Outlook Therapeutics’ NORSE THREE registration trial on October 12, 2021. The study focuses on ONS-5010 / LYTENAVA™ (bevacizumab-vikg), an investigational formulation for retinal indications. The presentation will occur at the 2021 Annual Meeting of the American Society of Retina Specialists in San Antonio, Texas, highlighting safety results in patients with wet AMD, DME, and BRVO. If approved, ONS-5010 is expected to be the first FDA-approved ophthalmic formulation of bevacizumab.

Outlook Therapeutics will showcase its innovations at the OIS Retina Innovation Showcase on October 7, 2021. C. Russell Trenary, President and CEO, will present the company's mission to introduce the first FDA-approved ophthalmic formulation of bevacizumab for retinal conditions. The presentation is set for 8:55 AM CT, followed by a panel with Jeff Evanson, Chief Commercial Officer, at 4:35 PM CT. Their product, ONS-5010/LYTENAVA™, aims to treat wet AMD, DME, and BRVO, targeting U.S. and international markets.

Outlook Therapeutics announced new 12-month safety data from the pivotal Phase 3 NORSE TWO trial for its investigational ophthalmic formulation ONS-5010 (bevacizumab-vikg) targeting wet age-related macular degeneration (AMD). The results confirm a strong safety profile consistent with previous trials. Topline findings reveal 41% of patients treated with ONS-5010 gained at least 15 letters in visual acuity compared to 23% with ranibizumab. Plans for a Biologics License Application submission to the FDA are set for Q1 2022, aiming for ONS-5010 to be the first FDA-approved ophthalmic bevacizumab.

Outlook Therapeutics fireside chat details

On September 28, 2021, at 2:00 PM ET, C. Russell Trenary, President and CEO of Outlook Therapeutics (Nasdaq: OTLK), will participate in a live fireside chat during the Cantor Fitzgerald Virtual Global Healthcare Conference. This event includes opportunities for virtual one-on-one meetings with the investor community. The chat will be accessible via a live webcast on the company's Investors page and available for 90 days post-event.

Outlook Therapeutics aims to develop ONS-5010 as the first FDA-approved ophthalmic formulation of bevacizumab.

Outlook Therapeutics (Nasdaq: OTLK) announced the presentation of safety data from the NORSE THREE trial for ONS-5010 (LYTENAVA™), an ophthalmic formulation of bevacizumab, at the EURETINA Virtual 2021 conference. The study, involving 197 subjects with retinal diseases like wet AMD, showed no unexpected safety trends. It aims to support a biologics license application (BLA) submission in early 2022, potentially granting ONS-5010 12 years of market exclusivity if approved. The company also reported positive results from the NORSE TWO trial, indicating significant efficacy.

Outlook Therapeutics, Inc. (Nasdaq: OTLK) announced that C. Russell Trenary, its CEO, will participate in a fireside chat at the H.C. Wainwright 23rd Annual Global Investment Conference from September 13-15, 2021. The company is focusing on developing ONS-5010/LYTENAVA™, the first FDA-approved ophthalmic formulation of bevacizumab for retinal diseases. A video webcast of the chat will be available on-demand starting September 13 at 7:00 AM ET. The company aims to submit its BLA for ONS-5010 to the FDA, positioning itself as a leader in treating retinal indications.

Outlook Therapeutics, Inc. (Nasdaq: OTLK) reported positive results from its pivotal Phase 3 NORSE TWO trial of ONS-5010 (bevacizumab-vikg) for treating wet age-related macular degeneration (wet AMD). The trial achieved statistically significant primary (p = 0.0052) and secondary (p = 0.0043) endpoints, with 41% of subjects gaining at least 15 letters of Best Visual Acuity Change (BVCA). The company plans to submit a Biologics License Application (BLA) in Q1 2022, aiming for FDA approval and 12 years of exclusivity. Financially, Outlook reported a net loss of $12.2 million for Q3 2021.

Outlook Therapeutics announced that President and CEO Russell Trenary will participate in the panel The Greatest Unmet Needs Facing Ophthalmology Today at the H.C. Wainwright Ophthalmology Virtual Conference on August 17, 2021. This event highlights Outlook's progress in developing ONS-5010 / LYTENAVA™, the first FDA-approved ophthalmic formulation of bevacizumab for retinal diseases. Recent clinical trials for ONS-5010 show promising results for treating wet AMD, addressing the absence of approved formulations and the risks associated with repackaged IV bevacizumab.

Outlook Therapeutics announced positive results from the pivotal Phase 3 NORSE TWO trial for ONS-5010 (bevacizumab-vikg) in treating wet AMD. The study met its primary efficacy endpoint, with 41% of patients gaining at least 15 letters in visual acuity (p = 0.0052). ONS-5010 demonstrated a favorable safety profile, consistent with earlier trials. The company plans to submit a Biologics License Application to the FDA in the first quarter of 2022, aiming to offer an FDA-approved alternative to off-label bevacizumab injections widely used for retinal diseases.