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FARMINGTON HILLS, Mich. - Opus Genetics, Inc. (NASDAQ: IRD), a biotech firm specializing in ophthalmic treatments with a current market capitalization of $26.2 million, has announced a Special Protocol Assessment (SPA) agreement with the U.S. Food and Drug Administration (FDA) for a Phase 3 clinical trial of APX3330. According to InvestingPro data, the company's stock has experienced significant volatility, declining 25% in the past week alone. This oral medication is being tested as a treatment for moderate to severe non-proliferative diabetic retinopathy (NPDR).
The SPA is a significant milestone, confirming that the Phase 3 trial design and primary endpoint – a reduction in worsening on the diabetic retinopathy severity scale – are sufficient for a New Drug Application, contingent on positive trial results and a thorough review of the data.
APX3330 aims to address the underlying factors of NPDR, a leading cause of blindness in adults with diabetes, affecting around 10 million patients in the U.S. The drug, which has passed through 12 clinical trials, functions by inhibiting Ref-1, a transcription factor regulator. While InvestingPro analysis indicates the company maintains strong liquidity with a current ratio of 6.63, suggesting adequate resources for clinical development, their financial health score stands at 1.9, rated as 'Fair' by InvestingPro analysts. This inhibition is expected to manage angiogenesis, oxidative stress, and inflammation – all factors in ocular diseases.
Opus Genetics CEO George Magrath expressed confidence in the Phase 3 trial design, highlighting the potential of APX3330 to be a transformative treatment for NPDR patients. The company is seeking partners to fund further development, as it continues to concentrate on advancing gene therapy candidates for inherited retinal diseases (IRDs).
The company's pipeline includes gene therapies targeting various forms of bestrophinopathy, Leber congenital amaurosis (LCA), retinitis pigmentosa, and other ophthalmologic disorders. A Phase 1/2 study for BEST1 gene therapy is expected to begin in 2025, while their Phentolamine Ophthalmic Solution 0.75% is currently in Phase 3 trials for presbyopia and reduced dim light vision post-surgery. Despite current challenges reflected in negative earnings per share of $1.09, analyst price targets range from $8 to $15, suggesting potential upside. Unlock additional insights and 12 more exclusive ProTips with InvestingPro.
This press release includes forward-looking statements, and readers are advised that actual results could differ due to various risks and uncertainties. The information provided is based on a press release statement from Opus Genetics, Inc.
In other recent news, Opus Genetics has been assigned a Buy rating by H.C. Wainwright, which set an $8.00 price target for the company. The analyst cited the potential of Opus Genetics' inherited retinal disease (IRD) platform and the 2025 catalysts for ongoing innovation. The company's Leber Congenital Amaurosis (LCA) and Best Vitelliform Macular Dystrophy (BEST1) developments were particularly noted.
Meanwhile, Ocuphire Pharma acquired Opus Genetics in an all-stock deal, forming a new entity focused on inherited retinal diseases. This merger is expected to enhance their pipeline, including the OPGx-LCA5 gene therapy candidate and the Phentolamine Ophthalmic Solution 0.75%.
Furthermore, Ocuphire reported positive results from two pivotal Phase 3 clinical trials for its eye treatment RYZUMVI. The company also initiated the VEGA-3 Phase 3 clinical trial for the treatment of presbyopia and the LYNX-2 Phase 3 trial for decreased visual acuity under low light conditions. Additionally, the ZETA-2 Phase 2/3 trial for APX3330, a treatment for non-proliferative diabetic retinopathy, is set to begin in 2025. These developments highlight the company's commitment to advancing eye condition treatments.
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