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 Limited has commenced patient enrollment at the first clinical trial sites in the Asia-Pacific for the OPT-302 Phase 3 program, targeting wet age-related macular degeneration (AMD). This milestone follows successful patient recruitment in the U.S., Canada, and Europe. The ShORe and COAST trials aim to assess the efficacy of OPT-302 in combination with existing therapies, with results expected by late 2023. The FDA has granted Fast Track status to OPT-302, facilitating quicker development for this unmet medical need.
Opthea Limited (ASX:OPT; Nasdaq:OPT) has opened enrollment for its Phase 3 clinical trials of OPT-302 in Europe, targeting wet age-related macular degeneration (AMD). The ShORe and COAST trials aim to enroll approximately 990 patients each and assess OPT-302's efficacy in combination with existing therapies. The FDA has granted OPT-302 Fast Track designation, facilitating expedited development. Top-line data is expected in late 2023, with plans for regulatory submissions to the FDA and EMA to follow. This expansion highlights Opthea's commitment to addressing retinal diseases globally.
Opthea Limited (ASX:OPT) announced that CEO Dr. Megan Baldwin will participate in three investor conferences in September 2021. These events include Citi's 16th Annual BioPharma Virtual Conference on September 9, H.C. Wainwright Annual Healthcare Conference on September 13, and Oppenheimer Healthcare Fall Summit on September 20. Opthea is focused on developing therapies for retinal diseases, particularly its lead product candidate, OPT-302, currently in Phase 3 trials. The firm emphasizes the speculative nature of biotech investments due to various inherent risks.
Opthea Limited (ASX:OPT; Nasdaq:OPT) has made significant strides in advancing its lead product OPT-302 for wet age-related macular degeneration (AMD). The company reported the treatment of its first patient in Phase 3 trials (ShORe and COAST) and received FDA Fast Track designation, expediting its development. Opthea's cash reserves stand at US$118.2 million, with R&D expenses increasing to US$25.9 million due to ongoing trials. Notably, the fiscal year ended June 30, 2021, resulted in a net loss of US$45.3 million, up from US$11.1 million the previous year.
Opthea Limited (ASX:OPT), a biopharmaceutical company focused on retinal diseases, announced that CEO Dr. Megan Baldwin will present at the H.C. Wainwright Ophthalmology Virtual Conference on August 17, 2021. The presentation will be available on-demand starting at 7:00 AM ET. Opthea is developing OPT-302, a leading product candidate in Phase 3 trials aimed at treating conditions like wet age-related macular degeneration and diabetic macular edema. The company emphasizes the inherent risks associated with biotechnology investments and advises seeking professional investment advice.
Opthea Limited (ASX:OPT; Nasdaq:OPT) has commenced patient recruitment in Canada for its Phase 3 clinical trials of OPT-302, aimed at treating wet age-related macular degeneration (AMD). Following Health Canada's approval, the ShORe and COAST trials will evaluate the efficacy of OPT-302 alongside existing therapies. The FDA has awarded OPT-302 Fast Track status due to positive previous trial outcomes, which could accelerate its approval process. Results from these trials are expected in the second half of 2023, potentially leading to global marketing authorizations.
Opthea Limited (ASX:OPT; Nasdaq:OPT) announced that the FDA granted Fast Track designation for its VEGF-C/-D trap inhibitor, OPT-302, aimed at treating neovascular (wet) age-related macular degeneration (AMD). This designation facilitates expedited clinical development, allowing for more frequent communications with the FDA and a Rolling Review of the Biologic Drug Application. OPT-302 holds potential as a differentiated treatment option, possibly improving vision outcomes for patients with unresolved responses to traditional therapies.
Opthea Limited (ASX:OPT; Nasdaq:OPT) announced the appointment of Mrs. Karen Adams as Vice President of Finance and Company Secretary, effective June 12, 2021. With extensive experience in finance, including her role as Chief Financial Officer at Victor Smorgon Group and prior experience at Nexvet Biopharma, Mrs. Adams brings valuable expertise in corporate governance and financial reporting. This leadership change occurs as Opthea advances its product OPT-302 through pivotal Phase 3 clinical trials for wet age-related macular degeneration, marking a significant phase in the company's growth.
Opthea Limited (ASX:OPT; Nasdaq:OPT) has appointed Dr. Julia Haller and Ms. Judith Robertson as independent Non-Executive Directors as of June 1, 2021. Their extensive backgrounds in ophthalmology and commercial life sciences aim to enhance Opthea's clinical and commercialization strategies. The company is focused on advancing its lead product candidate, OPT-302, which is undergoing pivotal Phase 3 trials for wet age-related macular degeneration (AMD), with top-line data expected in 2023. The new board members are expected to provide significant expertise in navigating these developments.
Opthea Limited (ASX:OPT; Nasdaq:OPT) has announced the resignation of Mr. Michael Tonroe as Company Secretary and CFO, effective June 24, 2021. The company is in search of a qualified replacement to manage financial reporting for its dual listings on ASX and Nasdaq. Mr. Tonroe departs as Opthea prepares for its global Phase 3 clinical development for OPT-302 targeting wet age-related macular degeneration. CEO Dr. Megan Baldwin acknowledged Mr. Tonroe's significant contributions since 2014, highlighting his role in the company’s growth and recent Nasdaq listing.
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