Outlook Therapeutics Inc Stock Price, News & Analysis

Outlook Therapeutics (OTLK) has announced complete 12-week efficacy and safety results for its NORSE EIGHT clinical trial evaluating ONS-5010 in wet AMD patients. The trial demonstrated non-inferiority to ranibizumab at week 12, with ONS-5010 showing a mean 5.5 letter improvement in BCVA compared to 6.5 letters for ranibizumab.

The company plans to resubmit its Biologics License Application (BLA) in Q1 2025. While the trial didn't meet its week 8 primary endpoint, the 12-week data showed consistent improvement and comparable safety to ranibizumab. ONS-5010 has already received marketing authorization in the EU and UK, with European launch planned for first half of 2025.

Additionally, OTLK has entered into warrant inducement transactions expected to generate up to $20.4 million in gross proceeds, which will fund clinical development programs, European commercial launch, and working capital.

Outlook Therapeutics (OTLK) announced that Jedd Comiskey, Senior Vice President and Head of Europe, participated in a Virtual Investor segment discussing the recent NICE recommendation of LYTENAVA™ (bevacizumab gamma) for treating wet age-related macular degeneration (wet AMD).

LYTENAVA™ is significant as it represents the first and only authorized ophthalmic formulation of bevacizumab for wet AMD treatment in adults in both the EU and UK. The company has secured regulatory approvals in these regions earlier this year, with an initial 10-year market exclusivity period.

Outlook Therapeutics (OTLK) reported financial results for fiscal year 2024, highlighting the approval of LYTENAVA™ as the first authorized ophthalmic formulation of bevacizumab for wet AMD treatment in the EU and UK. The company plans its first commercial launch in H1 2025, following NICE recommendation. Key developments include upcoming NORSE EIGHT efficacy data expected in January 2025 and BLA resubmission planned for Q1 2025.

Financial results show a net loss of $75.4 million ($4.06 per share) compared to $59.0 million ($4.72 per share) in the previous year. Cash position stands at $14.9 million as of September 30, 2024.

Outlook Therapeutics (OTLK) announced operational streamlining initiatives following internal strategic review. The company will implement a 23% workforce reduction, expecting annual savings of $1.4 million. This decision follows the recent EU and UK regulatory approvals of LYTENAVA™ (bevacizumab gamma) for wet AMD treatment.

LYTENAVA™ received NICE recommendation and has secured 10 years of market exclusivity in the EU and UK as the first authorized ophthalmic formulation of bevacizumab. The company plans to resubmit its BLA application to the FDA in Q1 2025, following the full NORSE EIGHT trial results expected in January 2025.

Outlook Therapeutics (OTLK) has received a positive recommendation from the National Institute for Health and Care Excellence (NICE) for LYTENAVA™ (bevacizumab gamma) in treating wet age-related macular degeneration (wet AMD). This marks the first positive reimbursement decision worldwide for LYTENAVA™.

The drug, which received regulatory approval in the EU and UK earlier this year, is the first and only approved ophthalmic formulation of bevacizumab for wet AMD treatment in these regions. It has secured 10 years of market exclusivity. The company anticipates its first commercial launch in H1 2025, with potential to benefit approximately 40,000 new wet AMD patients annually in the UK.

The recommendation applies to England and Wales, and follows LYTENAVA™'s Marketing Authorization by the UK MHRA. Outlook Therapeutics has partnered with Cencora for global commercial launch support.

Outlook Therapeutics (OTLK) announced an immediate executive leadership change as Russell Trenary steps down from his position as President and CEO. Lawrence Kenyon, the current Executive Vice President, CFO, and board member, has been appointed as Interim CEO.

The company, which recently received regulatory approval in the EU and UK for LYTENAVA™ (bevacizumab gamma) - the first ophthalmic formulation of bevacizumab for wet AMD treatment - maintains its plans to resubmit the BLA for ONS-5010 in Q1 2025 and commence LYTENAVA™ sales in Europe in H1 2025. The board has initiated a search for a permanent CEO through an executive search firm.

Outlook Therapeutics announced preliminary topline results of NORSE EIGHT trial for ONS-5010 in wet AMD patients. The trial did not meet its pre-specified non-inferiority endpoint at week 8 compared to ranibizumab. The ONS-5010 arm showed +4.2 letter improvement in BCVA versus +6.3 letters for ranibizumab. Despite not meeting the endpoint, the drug demonstrated vision improvement, biologic activity, and favorable safety profile. Final efficacy data is expected in January 2025, with BLA resubmission planned for Q1 2025. The company maintains European and UK marketing authorization for LYTENAVA™, with potential launch in these markets in 2025.

Outlook Therapeutics (OTLK), which recently secured regulatory approval in the EU and UK for its ophthalmic bevacizumab formulation treating wet AMD, announces its participation in the Guggenheim Healthcare Innovation Conference. CEO Russell Trenary will engage in a fireside chat on November 12, 2024, at 2:30 PM ET in Boston, MA. The management team will also conduct one-on-one meetings with qualified investors attending the conference. A live webcast will be available on the company's website, with the replay accessible for 90 days post-event.

Outlook Therapeutics (Nasdaq: OTLK), a biopharmaceutical company, announced that its President and CEO, Russell Trenary, participated in a Virtual Investor CEO Connect segment. The segment, now available for viewing, provided an overview of the company's recent achievements and upcoming milestones. Outlook Therapeutics recently gained regulatory approval in the European Union and the United Kingdom for the first authorized use of an ophthalmic formulation of bevacizumab to treat wet age-related macular degeneration (wet AMD). The company is working towards becoming the first and only approved ophthalmic formulation of bevacizumab for wet AMD treatment.