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Iveric Bio, Inc. (NASDAQ: ISEE) is a prominent biopharmaceutical company dedicated to the development of innovative therapeutics targeted at diseases affecting the back of the eye. The company's primary focus is on age-related macular degeneration (AMD), a significant cause of vision loss among older adults. Iveric Bio is at the forefront of ophthalmology research, advancing drugs that could potentially transform the treatment landscape for retinal diseases.
One of the company's notable projects is the development of Avacincaptad Pegol, aimed at treating Geographic Atrophy secondary to AMD, a condition that leads to irreversible blindness. This drug is currently in advanced stages of clinical trials, poised to make a substantial impact upon receiving regulatory approval.
In a significant development, on July 11, 2023, Iveric Bio was acquired by Astellas Pharma Inc. (TSE: 4503). This acquisition, valued at approximately $5.9 billion, marks a strategic expansion for Astellas into the ophthalmology sector. The merger combines Iveric Bio's extensive expertise and promising drug pipeline with Astellas' robust global presence and resources, setting the stage for accelerated progress in developing and commercializing treatments for retinal diseases.
Following the acquisition, Iveric Bio's common stock was delisted from NASDAQ. The successful completion of this acquisition signifies a new chapter for Iveric Bio, with enhanced capabilities to bring groundbreaking ophthalmic therapies to market.
Iveric Bio remains committed to its mission of addressing unmet medical needs in eye care through pioneering research and development. As a subsidiary of Astellas, it is well-positioned to leverage combined strengths, promising a future where advancements in treatment for retinal diseases can significantly improve patient outcomes globally.
For more detailed and up-to-date information, investors and stakeholders are encouraged to follow the latest news releases and updates from both Iveric Bio and Astellas Pharma.
Iveric bio, Inc. (ISEE) has announced significant findings from the GATHER clinical trials regarding avacincaptad pegol (ACP) for treating geographic atrophy (GA) linked to age-related macular degeneration. The post-hoc analysis indicated a 56% reduction in persistent vision loss in patients receiving ACP compared to sham treatments over 12 months. Notably, this analysis established a connection between decreased GA growth and lower rates of vision loss for the first time. The company aims to demonstrate the efficacy and safety of ACP as it seeks FDA approval. These results were presented at the 2023 ARVO annual meeting, highlighting ACP's potential to address a critical unmet need in retinal disease treatment.
Iveric Bio, Inc. (NASDAQ: ISEE) announced on April 3, 2023, the grant of equity-based awards to nine new non-executive employees. These inducement grants were made under the Company’s 2019 Inducement Stock Incentive Plan and consist of non-statutory stock options for 166,000 shares and 27,000 restricted stock units. The stock options have an exercise price of $26.49 per share and a vesting schedule spanning four years, with 25% vesting on April 3, 2024. Iveric Bio focuses on developing treatments for retinal diseases and aims to improve patient outcomes in this area.
Iveric Bio (NASDAQ: ISEE) announced on
IVERIC bio, Inc. (ISEE) announced the FDA's acceptance of its New Drug Application (NDA) for avacincaptad pegol (ACP) for treating geographic atrophy (GA) associated with age-related macular degeneration (AMD), granting priority review with a PDUFA date of August 19, 2023. A post-hoc analysis from GATHER trials indicated up to a 59% reduction in vision loss at 12 months. The company's commercial launch preparations are accelerating, with a full U.S. sales team expected by April. Financially, IVERIC reported a net loss of $185.2 million for 2022, with R&D expenses increasing to $117.0 million as the company progresses in developing treatments for retinal diseases.
Iveric Bio (Nasdaq: ISEE) announced significant results from a post-hoc time-to-event analysis of its GATHER clinical trials, demonstrating up to a 59% reduction in the rate of vision loss at 12 months when treated with avacincaptad pegol (ACP) 2 mg compared to sham treatment. The GATHER1 and GATHER2 trials focused on patients with geographic atrophy (GA) secondary to age-related macular degeneration (AMD). This analysis, to be presented at the ARVO Annual Meeting from April 23-27, 2023, indicates a strong clinical relevance and supports the efficacy of ACP 2 mg. Iveric Bio continues to investigate ACP under FDA evaluation, targeting a critical unmet need in retinal diseases.
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