24/7 Market News Snapshot 29 September, 2025 – Outlook Therapeutics, Inc. Common Stock (NASDAQ:OTLK)
DENVER, Colo., 29 September, 2025 (www.247marketnews.com) – (NASDAQ:OTLK) are discussed in this article.
Outlook Therapeutics, Inc. (NASDAQ:OTLK) is currently witnessing a significant surge in market activity, with shares rising over 24% to $1.206 in pre-market trading. The increased trading volume of 1.70 million shares underscores a growing wave of investor confidence, highlighting Outlook Therapeutics as a company to watch closely in the biotechnology sector.
This positive market movement coincides with the company’s recent engagement with the U.S. Food and Drug Administration (FDA). Outlook Therapeutics has concluded a productive Type A Meeting to address the complete response letter (CRL) received regarding its biologics license application (BLA) resubmission for ONS-5010, an investigational ophthalmic formulation of bevacizumab intended for the treatment of wet Age-related Macular Degeneration (AMD). The company aims to incorporate the insights gained from the FDA’s feedback and is targeting a BLA resubmission by the end of 2025.
Bob Jahr, Chief Executive Officer of Outlook Therapeutics, expressed optimism about the outcomes of the meeting, emphasizing their commitment to delivering a safe and effective treatment for patients. ONS-5010, also marketed under the name LYTENAVA™ (bevacizumab-vikg), has already received centralized Marketing Authorization in the European Union and clearance from health authorities in the United Kingdom, marking significant milestones in its development.
As Outlook Therapeutics continues to navigate the regulatory landscape and refine its approach based on feedback from the FDA, it remains dedicated to improving patient outcomes in retinal diseases. The ongoing advancements signal a promising horizon for ONS-5010, which has the potential to significantly enhance the treatment options available for individuals suffering from retinal conditions, positioning Outlook Therapeutics as a key player in biopharmaceutical innovation.