Welcome to our dedicated page for Outlook Therapeutics news (Ticker: OTLKW), a resource for investors and traders seeking the latest updates and insights on Outlook Therapeutics stock.
Outlook Therapeutics Inc (OTLKW) is a biopharmaceutical innovator advancing ophthalmic treatments for conditions like wet age-related macular degeneration (wet AMD). This page serves as the definitive source for verified company updates, offering investors and healthcare professionals timely access to critical developments.
Find curated press releases covering regulatory milestones, clinical trial progress, and strategic partnerships. Our repository includes updates on the company’s EU/UK-approved bevacizumab formulation, financial filings, and research breakthroughs—all organized for efficient tracking of this clinical-stage leader.
Regularly refreshed with official announcements, this resource helps stakeholders monitor OTLKW’s progress in addressing unmet ophthalmic needs. Bookmark this page to stay informed about pipeline advancements and market expansions directly from the source.
Outlook Therapeutics (NASDAQ: OTLK) announced that the FDA has issued a Complete Response Letter (CRL) for ONS-5010/LYTENAVA™ (bevacizumab-vikg), their wet AMD treatment candidate. The FDA cannot approve the application in its current form due to lack of substantial evidence of effectiveness.
The CRL highlighted that while the NORSE TWO trial met its primary endpoint, the NORSE EIGHT trial did not, leading to the FDA's recommendation for additional confirmatory efficacy evidence. Despite this setback in the U.S., LYTENAVA™ has already received Marketing Authorization in the European Union and UK, and has been commercially available in Germany and UK since June 2025 as the first authorized ophthalmic formulation of bevacizumab for wet AMD treatment.
Outlook Therapeutics (NASDAQ: OTLK) reported its Q3 FY2025 financial results and achieved significant milestones. The company recorded its first commercial sales of LYTENAVA™ (bevacizumab gamma) in Europe, marking its transition to a commercial-stage company. For Q3, OTLK reported revenue of $1.5 million and a net loss of $20.2 million ($0.55 per share).
The company has a crucial PDUFA date of August 27, 2025, for ONS-5010/LYTENAVA™ FDA approval in the United States. LYTENAVA™ is now commercially available in Germany and UK for wet AMD treatment, with first patients already dosed. The company ended the quarter with cash and equivalents of $8.9 million.
Outlook Therapeutics (NASDAQ: OTLK), a biopharmaceutical company specializing in bevacizumab treatments for retina diseases, announced its participation in the 8th Annual OIS Retina Innovation Summit. The company's CEO, Bob Jahr, will present during the Innovation Showcase session on July 29, 2025, from 8:35 – 9:35 AM PT in Long Beach, California.
Outlook Therapeutics (NASDAQ:OTLK), a biopharmaceutical company developing bevacizumab treatments for retina diseases, announced its participation in the Virtual Investor "What's Your Story" Summer Spotlight On-Demand Conference. Bob Jahr, the company's newly appointed CEO, shared his professional journey and vision for the company's future in a video presentation.
The presentation is now accessible to investors through the Virtual Investor website and Outlook Therapeutics' investor relations page.
Outlook Therapeutics (NASDAQ: OTLK) has appointed Bob Jahr as its new Chief Executive Officer and Board member. Jahr brings over 20 years of biopharmaceutical industry experience specializing in building and leading commercial teams across various therapeutic areas including rare disease, oncology, and neuroscience.
The appointment comes at a strategic time as Outlook Therapeutics is launching LYTENAVA™ (bevacizumab-vikg) in Europe and awaiting potential FDA approval in the United States. Lawrence A. Kenyon, who served as interim CEO, will continue as Chief Financial Officer and Board member.
As part of his employment agreement, Jahr will receive an inducement grant of options to purchase 800,000 shares of common stock, vesting over four years with 25% vesting in the first year and the remainder monthly over three years.
[ "Strategic timing of CEO appointment coincides with European launch of LYTENAVA™ and pending FDA approval", "New CEO brings extensive commercial leadership experience with multiple billion-dollar assets", "Continued stability with CFO Lawrence Kenyon remaining in his role" ]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.
