Welcome to our dedicated page for Opthea news (Ticker: OPT), a resource for investors and traders seeking the latest updates and insights on Opthea stock.
Opthea Limited develops novel therapies for vision-threatening retinal diseases, including wet age-related macular degeneration and diabetic macular edema. Its updates center on sozinibercept, a first-in-class VEGF-C/D trap inhibitor evaluated with standard-of-care anti-VEGF-A therapies for wet AMD, along with clinical publications, conference presentations, and development-program disclosures.
Recurring announcements also cover manufacturing and CMC preparation for sozinibercept, operating and financial results, cash runway commentary, material agreements, shareholder voting matters, capital-structure disclosures, and governance changes for the foreign issuer and its American depositary security program.
Opthea Limited (ASX:OPT; Nasdaq:OPT) has received an initial Pediatric Study Plan (iPSP) waiver from the FDA for OPT-302, its leading candidate for wet age-related macular degeneration treatment. This waiver eliminates the need for additional pediatric studies, streamlining the pathway to a marketing application. CEO Dr. Megan Baldwin highlighted this milestone as vital for ongoing Phase 3 trials in adults, aiming for potential regulatory approval. The company focuses on unmet needs in retinal diseases, combining OPT-302 with anti-VEGF-A therapies for improved efficacy.
Opthea Limited has announced the treatment of the first patient in its Phase 3 pivotal studies for OPT-302, targeting treatment-naïve wet age-related macular degeneration (AMD). Conducting two global trials (ShORe and COAST), Opthea aims to assess the efficacy of OPT-302 combined with anti-VEGF-A therapies compared to monotherapy. The ShORe trial involves 990 patients, focusing on improving visual acuity over 52 weeks. The promising results from the Phase 2b trial, showing significant visual gains, support this new phase. Top-line data is expected in 2023, paving the way for potential FDA and EMA applications.
Opthea Limited (ASX:OPT, Nasdaq:OPT) announces a virtual presentation by CEO Dr. Megan Baldwin at the Oppenheimer 31st Annual Healthcare Conference on March 16, 2021, at 3:50 PM ET. The presentation will focus on their leading product candidate, OPT-302, designed to treat retinal diseases like wet age-related macular degeneration and diabetic macular edema. The live webcast will be available on Opthea’s website. The company acknowledges inherent risks in biotechnology investments due to the complex nature of drug development and regulatory approval processes.
Opthea Limited (ASX:OPT; Nasdaq: OPT) has finalized the designs for two pivotal Phase 3 clinical trials, ShORe and COAST, to assess its drug OPT-302 for treating wet age-related macular degeneration (AMD). Both trials will evaluate OPT-302 in combination with Lucentis® and Eylea®, involving approximately 990 treatment-naive patients each. Initiation is on track for Q1 2021, with top-line data expected in late 2023. Successful outcomes may lead to marketing approvals in the US and EU, potentially tapping into the $11.9 billion market for retinal diseases.
Opthea Limited (ASX:OPT, Nasdaq: OPT) announced that CEO Dr. Megan Baldwin will present a corporate update at the 10th Annual SVB Leerink Global Healthcare Conference on Feb 24, 2021, at 3:40pm ET. The presentation will focus on Opthea's novel therapy for retinal diseases, particularly wet age-related macular degeneration and diabetic macular edema. A live webcast will be accessible via their Investors page. Investors are cautioned about the inherent risks in biotechnology investments, including lengthy clinical trials and regulatory approvals.
Opthea Limited (ASX:OPT, Nasdaq: OPT) announced the pricing of its initial public offering in the U.S., offering 8,563,300 American Depositary Shares (ADS) at $13.50 each. The offering aims to raise approximately $128.2 million in gross proceeds. Additionally, the company offered pre-funded warrants for 936,700 ADSs at an effective price of $13.49999 per warrant. An option for underwriters to purchase an additional 1,425,000 ADSs exists. The ADSs are expected to begin trading on October 16, 2020, with the offering closing on or around October 20, 2020.