Welcome to our dedicated page for Iveric Bio news (Ticker: ISEE), a resource for investors and traders seeking the latest updates and insights on Iveric Bio stock.
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, a biopharmaceutical company focused on retinal disease treatments, announced that CEO Glenn P. Sblendorio and President Pravin U. Dugel, M.D., will speak at the Cowen 43rd Annual Health Care Conference on March 7, 2023, at 2:50 p.m. Eastern Time. Investors and the public can access the live webcast through the Investor / Events & Presentations section of Iveric Bio's website. An archived replay will be available for at least 30 days post-conference. Iveric Bio aims to provide innovative solutions to address significant unmet medical needs in retinal health.
Iveric Bio, Inc. (ISEE) is set to announce its fourth quarter and full-year 2022 financial results on March 1, 2023. A live conference call and webcast will follow at 8:00 a.m. Eastern Time to discuss these results and provide a business update. Interested participants can join the call via dial-in numbers or access the webcast on the company's website, with a replay available for two weeks thereafter.
The company focuses on developing treatments for retinal diseases with significant unmet medical needs, particularly age-related macular degeneration.
Iveric Bio has announced that the U.S. FDA has accepted its New Drug Application (NDA) for avacincaptad pegol (ACP), a complement C5 inhibitor aimed at treating geographic atrophy (GA) due to Age-Related Macular Degeneration (AMD).
The NDA is under Priority Review, with a PDUFA goal date of
No review issues have been identified, and no Advisory Committee meeting is planned. ACP has shown efficacy in two pivotal Phase 3 trials, achieving a primary endpoint in both, with observed efficacy rates up to 35%.
Iveric Bio (NASDAQ: ISEE) announced on
IVERIC bio, Inc. announced the election of Pravin U. Dugel, MD, as a Board Member effective January 1, 2023. Dr. Dugel, instrumental in developing avacincaptad pegol (ACP), an investigational drug for geographic atrophy, aims to enhance the company's strategy ahead of potential FDA approval. The GATHER clinical trials showed promising results, meeting primary endpoints for ACP. With Doug's extensive experience, IVERIC bio positions itself strongly for future advancements in treating age-related macular degeneration.
Iveric Bio has submitted the third and final part of its New Drug Application (NDA) for avacincaptad pegol (ACP) to the FDA for geographic atrophy (GA) related to age-related macular degeneration (AMD). This submission follows successful efficacy results from the GATHER1 and GATHER2 clinical trials, where ACP demonstrated up to 35% efficacy. The company seeks priority review due to its Breakthrough Therapy designation, aiming to expedite the treatment availability for AMD patients suffering from GA.
IVERIC bio, Inc. (NASDAQ: ISEE) announced on December 1, 2022, the granting of equity-based awards to nine newly-hired, non-executive employees. These awards include non-statutory stock options for 199,500 shares and 35,400 restricted stock units. The options have an exercise price of $22.76, aligning with the closing price on the grant date, and will vest over four years. Additionally, various tranches of restricted stock units will vest between January 2023 and December 2025. This move aims to incentivize new hires and enhance the company's talent strategy.
Iveric bio, Inc. (Nasdaq: ISEE) has announced the pricing of an upsized public offering of
IVERIC bio, Inc. (ISEE) has announced a public offering of $250 million in common stock, with an option for underwriters to purchase an additional 15% of shares. The offering is subject to market conditions and is being managed by Morgan Stanley, BofA Securities, Cowen, and Stifel. This follows an automatically effective registration statement filed with the SEC on October 21, 2021. The proceeds aim to support the Company’s ongoing development of novel treatments for retinal diseases.
Iveric Bio (Nasdaq: ISEE) announced that the FDA granted Breakthrough Therapy designation for avacincaptad pegol (ACP), an investigational treatment for geographic atrophy (GA) due to Age-Related Macular Degeneration (AMD). This designation, based on 12-month data from pivotal GATHER trials, recognizes ACP as the first investigational therapy achieving statistically significant results in two phase 3 trials. With observed efficacy rates reaching 35% and a focus on NDA submission, Iveric aims to expedite approval and bring this crucial therapy to market for AMD patients suffering from GA.
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