Opthea Ltd. (OPT) stock prices were up by a massive 33.06% shortly after market trading commenced on June 16th, 2021, bringing the price per share up to USD$11.44 early on in the trading day.
Contextualizing the Surge in Stock Price
This massive overnight surge comes despite there being an absence of news coverage on any recent developments that would explain the fortuitous change in equity value. While meme stocks have been all the rage in the stock markets as of late, it seems unlikely that the movement in the price of company shares is due to the meme stock phenomenon. More likely is the case that the company has seen fundamental or market developments that have not yet reached the media.
The end of March 2021 saw the company announce the receipt of an initial Pediatric Study Plan (iPSP) waiver from the U.S. Food and Drug Administration for OPT-302. The company’s leading product candidate is currently in Phase 3 clinical development for the treatment of neovascular (wet) age-related macular degeneration.
Marketing Application for OPT-302
With the intention of submitting a marketing application of the new treatment, the regulatory review process dictates that OPT provide the FDA with a proposed strategy for the investigation the new treatment in the pediatric population. Notably, the FDA has previously agreed to waive the iPSP requirement.
Receipt of iPSP Waiver
The company received such an official, agreed waiver from the FDA for OPT-302 across all subsets of the pediatric population. This includes the full pediatric age group under the age of 17 years. The waiver is for the treatment of wet AMD in conjunction with intravitreal anti-VEGF-A therapy. Due to the receipt of this iPSP waiver, OPT will not have to conduct further studies in the pediatric population.
The agreed iPSP will serve as a crucially significant regulatory milestone in the US, the completion of which will facilitate the submission of a marketing application for OPT-302 to the FDA. The company is committed to continuing the process to fulfill the regulatory requirements stemming from their focus on the pivotal Phase 3 clinical trial. These trials in adult patients are designed to support potential marketing approval of OPT-302 as a viable and effective treatment of wet AMD.
Future Outlook for OPT
Armed with the fortuitous surge in value of their equity, OPT is poised to capitalize on the opportunities presented to it. The company is keen to continue its trajectory of success and usher in more organic growth over the long-term. Current and potential investors are hopeful that the management will leverage the resources at their disposal to facilitate significant and sustained increases in shareholder value.