Outlook Therapeutics Inc Stock Price, News & Analysis

Outlook Therapeutics (NASDAQ: OTLK) has received Scottish Medicines Consortium (SMC) recommendation for LYTENAVA (bevacizumab gamma) to treat wet age-related macular degeneration (wet AMD) within NHS Scotland. LYTENAVA is the first licensed ophthalmic formulation of bevacizumab for wet AMD in the UK, with 10 years of market exclusivity. The recommendation follows successful clinical trials (NORSE ONE, TWO, and THREE) and the recent commercial launch in the UK. Outlook has partnered with Cencora for global distribution support, aiming to enhance market access in the EU, UK, and potentially the US pending approval.

Outlook Therapeutics (NASDAQ: OTLK) has launched LYTENAVA (bevacizumab gamma), the first and only approved ophthalmic formulation of bevacizumab for wet AMD treatment, in Germany and the UK. This marks a significant milestone as the drug addresses the current practice of using off-label repackaged bevacizumab, which accounts for approximately 2.8 million injections annually in Europe. The company has partnered with Cencora (formerly AmerisourceBergen) for global commercial distribution and plans additional European launches throughout 2025 and 2026. LYTENAVA aims to mitigate risks associated with current off-label bevacizumab use while maintaining the standard of care for retinal diseases.

Outlook Therapeutics (OTLK) has announced the pricing of a $13.0 million public offering of common stock and warrants. The offering consists of 9,285,714 shares of common stock priced at $1.40 per share, with each share accompanied by warrants to purchase two additional shares. The warrants have an exercise price of $1.40 per share, are immediately exercisable, and will expire in five years. The offering is expected to close on May 27, 2025. BTIG, LLC serves as the sole book-running manager. The company plans to use the proceeds for working capital and general corporate purposes.

Outlook Therapeutics (OTLK), a biopharmaceutical company specializing in bevacizumab treatments for retina diseases, has announced a proposed public offering of common stock and warrants. The offering will be managed by BTIG, LLC as the sole book-running manager. The company plans to use the proceeds for working capital and general corporate purposes.

The securities will be offered under a previously effective shelf registration statement (Form S-3, No. 333-278340). The final size, terms, and completion of the offering are subject to market conditions and cannot be guaranteed. A preliminary prospectus supplement and accompanying prospectus will be filed with the SEC.

Outlook Therapeutics (OTLK) reported its Q2 FY2025 financial results and provided key updates. The company is preparing for the commercial launch of LYTENAVA™ (bevacizumab gamma) in Germany and the UK in Q2 CY2025, following Marketing Authorization approvals in both regions. In the US, OTLK awaits FDA decision for ONS-5010 with a PDUFA date of August 27, 2025. The company reported a net loss of $46.4 million ($1.50 per share) and had cash reserves of $7.6 million as of March 31, 2025. LYTENAVA™ is positioned as the first authorized ophthalmic formulation of bevacizumab for wet AMD treatment, targeting a market where approximately 2.8 million off-label injections are administered annually in Europe and 2.7 million in the US. The company has partnered with Cencora for global commercial distribution.

Outlook Therapeutics (Nasdaq: OTLK) announced the FDA's acceptance of their resubmitted Biologics License Application (BLA) for ONS-5010, their ophthalmic formulation of bevacizumab for treating wet age-related macular degeneration (wet AMD). The FDA designated it as a Class 2 review with a PDUFA goal date of August 27, 2025.

If approved, ONS-5010 will be marketed as LYTENAVA™ in the United States and is expected to receive 12 years of regulatory exclusivity. The resubmission includes efficacy and safety data from the NORSE EIGHT trial, along with additional chemistry, manufacturing, and controls information requested by the FDA.

The company has already secured regulatory approval for this treatment in the European Union and United Kingdom, marking it as the first authorized ophthalmic formulation of bevacizumab for wet AMD in these regions.

Outlook Therapeutics (OTLK) has re-submitted its Biologics License Application (BLA) to the FDA for ONS-5010, branded as LYTENAVA™ (bevacizumab-vikg), for treating wet age-related macular degeneration (wet AMD). The resubmission follows the company's recent regulatory approvals in the EU and UK.

The BLA includes data from the NORSE EIGHT trial, a randomized study of 400 wet AMD patients comparing ONS-5010 to ranibizumab. While ONS-5010 showed clinical improvements with 3.3 to 5.5 letter improvement in vision across timepoints, it did not meet the pre-specified non-inferiority endpoint at week 8. However, anatomical response was comparable between treatments, with ONS-5010 achieving a -123.9 micron reduction in central retinal thickness versus -127.3 microns for ranibizumab.

An FDA decision is expected within six months.

Outlook Therapeutics (OTLK) announced its participation in the Virtual Investor 'Top 5 for '25' On-Demand Conference. The company's CFO and Interim CEO, Lawrence A. Kenyon, presented the top five reasons why investors should focus on Outlook Therapeutics in 2025. The presentation is now available for viewing online.

Notably, OTLK is a biopharmaceutical company that has achieved regulatory approval in the European Union and the United Kingdom for its ophthalmic formulation of bevacizumab, marking the first authorized use of such treatment for wet age-related macular degeneration (wet AMD).

Outlook Therapeutics (OTLK) reported financial results for Q1 FY2025 and provided key updates. The company plans to resubmit its ONS-5010 BLA in Q1 2025, with potential FDA approval expected in Q3 2025. Commercial launches of LYTENAVA™ (bevacizumab gamma) are planned for Germany and UK in Q2 2025, marking the first authorized ophthalmic formulation of bevacizumab for wet AMD treatment in these regions.

For Q1 FY2025, OTLK reported net income of $17.4 million ($0.72 per share), compared to a net loss of $11.2 million ($0.86 per share) in the same period last year. The company had cash and cash equivalents of $5.7 million as of December 31, 2024, with additional $17.8 million received in January 2025 from warrant exercises.

In the NORSE EIGHT trial, while ONS-5010 missed the primary endpoint at week 8, it met non-inferiority margins at week 12, showing mean visual acuity improvements and similar anatomical response compared to ranibizumab.