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 (ASX: OPT) generates frequent news as a clinical-stage biopharmaceutical company developing therapies for retinal diseases such as wet age-related macular degeneration (wet AMD) and diabetic macular edema (DME). Company announcements describe the progress of its lead product candidate, sozinibercept, a first-in-class VEGF-C/D ‘trap’ inhibitor studied in combination with standard-of-care anti-VEGF-A therapies.
News items for OPT commonly cover clinical milestones, including Phase 2b and Phase 3 trial updates in wet AMD, early-stage data in DME, and presentations of trial results and subgroup analyses at scientific meetings and in peer-reviewed journals. Opthea also releases updates on manufacturing activities, such as completion of drug substance and drug product Process Performance Qualification campaigns to support potential regulatory filings.
Investors following OPT news will also see corporate and capital markets developments. These include half-year financial reports, cash runway commentary, capital raising outcomes, and details of a Development Funding Agreement and its subsequent settlement. The company has reported that primary endpoints were not met in its COAST and ShORe Phase 3 wet AMD trials and has described the decision, together with its DFA investors, to discontinue development of sozinibercept in wet AMD, along with workforce reductions, management changes, and a planned strategic review.
Regulatory and listing updates also appear in Opthea’s news flow, such as announcements related to its intention to voluntarily delist American Depositary Shares from The Nasdaq Global Select Market. For readers interested in the intersection of ophthalmology, clinical trial data, and biotech corporate strategy, the OPT news feed provides ongoing context on Opthea’s programs and corporate actions.
Opthea (ASX/NASDAQ: OPT) has successfully completed its drug substance Process Performance Qualification (PPQ) campaign for sozinibercept, a potential treatment for wet age-related macular degeneration (wet AMD). The campaign involved producing three consecutive commercial-scale drug substance batches, validating Opthea's manufacturing process. This achievement is a significant milestone towards a potential Biologics License Application (BLA) filing for sozinibercept in wet AMD.
CEO Fred Guerard emphasized that this success demonstrates the company's ability to consistently manufacture quality drug substance at commercial scale, a important component for the BLA Chemistry, Manufacturing and Controls (CMC) module. Opthea is now well-positioned to supply its planned drug product PPQ campaign and initial launch materials. A progress update on the drug product PPQ campaign is expected in early 2025.
Opthea (ASX/NASDAQ: OPT) announced its participation in the 24th EURETINA Congress and EURETINA Innovation Spotlight in Barcelona, Spain. The company will present scientific data and host a non-CME educational lunch symposium highlighting sozinibercept's potential to improve visual outcomes in wet AMD patients. Key presentations include:
1. Sozinibercept in wet AMD: Potential for superior vision outcomes beyond anti-VEGF-A therapies
2. Intravitreal sozinibercept combined with ranibizumab for polypoidal choroidal vasculopathy treatment
3. VEGF-A/C/D inhibition with sozinibercept and ranibizumab combination therapy for nAMD
Opthea's Phase 3 pivotal program evaluating sozinibercept combination therapy in wet AMD has completed patient enrollment. Topline data for the COAST study is expected in early Q2 CY2025, and for the ShORe study in mid-year CY 2025.
Opthea (ASX/NASDAQ: OPT) announced executive leadership changes and senior hires to strengthen its expertise in retina, expand clinical capabilities, and advance commercial readiness. Key appointments include:
- Daniel Geffken as interim Chief Financial Officer
- Mike Campbell as Chief Commercial Officer
- Dayong Li as Senior Vice President, Biometrics
- Jen Watts as Vice President Global Clinical Operations
- Anthony Bonifazio as Vice President, Market Access
These changes come as Opthea prepares for its Phase 3 topline data readout of sozinibercept in wet AMD in 2025. The company recently raised US$150 million, extending its cash runway. Opthea is positioning itself for potential product launch and commercialization of sozinibercept in wet AMD.
Opthea (ASX/NASDAQ: OPT), a clinical-stage biopharmaceutical company focusing on retinal diseases, has announced its participation in two major investor conferences in September 2024. The company will present at the H.C. Wainwright 26th Annual Global Investment Conference on September 9 and the Cantor 2024 Global Healthcare Conference on September 17.
CEO Frederic Guerard, PharmD, will deliver presentations at both events, with the H.C. Wainwright presentation scheduled for 7:00 AM ET and the Cantor presentation at 8:35 AM ET. Investors can access live webcasts of both presentations through provided links or via the 'Events & Presentations' section of Opthea's website.
These conferences offer Opthea an opportunity to showcase its progress in developing novel therapies for prevalent retinal diseases, including wet age-related macular degeneration (wet AMD).
Opthea (ASX/NASDAQ: OPT) reported full-year financial results and business updates for the fiscal year ended June 30, 2024. Key highlights include:
- Completed enrollment in COAST and ShORe pivotal wet AMD trials
- Raised US$295.1 million to extend cash runway through topline data readouts in CY2025
- Strengthened leadership team with key appointments
- Net loss increased to US$220.2 million, with adjusted non-IFRS net loss of US$174.0 million
- Cash and cash equivalents totaled US$172.5 million as of June 30, 2024
Opthea expects topline results from COAST in early Q2 CY 2025 and ShORe by mid-CY 2025, as it prepares for potential launch of sozinibercept in wet AMD.
Opthea (ASX/NASDAQ: OPT), a clinical-stage biopharmaceutical company focused on developing therapies for retinal diseases, has announced its participation in the H.C. Wainwright 4th Annual Ophthalmology Virtual Conference on August 15, 2024. The company's management will present and engage in one-on-one investor meetings during the event.
Key details of the virtual conference include:
- Presentation available on August 15, 2024, at 7:00 am ET
- Presenter: Frederic Guerard, PharmD, CEO of Opthea
- Webcast accessible via a provided link and on Opthea's website
This participation highlights Opthea's ongoing efforts to engage with investors and showcase its progress in developing novel therapies for retinal diseases, particularly wet age-related macular degeneration (wet AMD).
Opthea (ASX/NASDAQ: OPT) has formed a Medical Advisory Board (MAB) comprising 10 international retina thought leaders. The MAB, chaired by Dr. Arshad M. Khanani, will advise on addressing unmet medical needs in retinal diseases and inform development efforts, particularly the sozinibercept clinical program in wet AMD. This formation comes as Opthea prepares for Phase 3 topline data read-out of its two pivotal trials (COAST in early Q2 2025 and ShORE in mid-2025) and advances BLA and go-to-market preparations. The MAB includes renowned experts from the US, Argentina, Australia, China, France, Germany, and Israel, bringing diverse expertise in retinal diseases, clinical research, and ophthalmology.
Opthea (ASX/NASDAQ: OPT) has successfully completed its A$55.9 million (US$36.9 million) Retail Entitlement Offer, marking the final stage of its approximately A$227.3 million (US$150.0 million) capital raising. The Retail Entitlement Offer saw eligible retail shareholders take up about 18.3 million New Shares, representing a 13.1% take-up rate.
This follows the successful Institutional Entitlement Offer and Placement, which raised approximately A$171.5 million (US$113.2 million). The capital raising included the issuance of New Shares and New Options, with one option offered for every three New Shares subscribed. A total of about 189.4 million New Options will be issued, exercisable at A$1.00 per option until June 30, 2026.
New Shares and New Options are expected to commence normal trading on July 18, 2024. Opthea, a clinical-stage biopharmaceutical company, is developing novel therapies for retinal diseases, including wet age-related macular degeneration (wet AMD) and diabetic macular edema (DME).
Opthea has announced the publication of a scientific review in the journal Ophthalmology and Therapy. The study supports sozinibercept (OPT-302) as a potential treatment for wet age-related macular degeneration (AMD), targeting VEGF-C and VEGF-D signaling pathways. This review underlines the importance of these pathways in retinal diseases and presents sozinibercept as a complementary therapy to standard anti-VEGF-A treatments. Opthea's Phase 3 clinical trials, COAST and ShORe, are currently assessing the safety and efficacy of sozinibercept, with results expected in early Q2 and mid-2025, respectively.
Opthea has launched a fully underwritten retail entitlement offer to raise approximately A$55.0 million (US$36.9 million). The offer opens on June 19, 2024, and closes on July 10, 2024. Eligible retail shareholders can purchase new shares on a 1-for-1.22 basis and will receive options to acquire additional shares on a 1-for-3 basis. This follows a successful institutional entitlement offer and placement that raised A$171.5 million (US$113.2 million). Funds will support the clinical development of sozinibercept for treating wet AMD, including Phase 3 trials COAST and ShORe, and other general corporate purposes.
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