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 (NASDAQ: ISEE), now a subsidiary of Astellas Pharma, remains a leader in developing innovative therapies for retinal diseases including age-related macular degeneration. This dedicated news hub provides investors and healthcare professionals with essential updates on clinical trials, regulatory milestones, and strategic developments following the company's acquisition.
Access timely updates on Avacincaptad Pegol and other pipeline candidates targeting Geographic Atrophy. Our curated news collection features official press releases, trial result analyses, and partnership announcements from trusted sources. Track progress in ophthalmology research through verified updates on therapeutic advancements and regulatory pathways.
Key content includes updates on late-stage clinical programs, manufacturing developments, and scientific collaborations. All information is vetted for accuracy and relevance to investor decision-making. Bookmark this page for streamlined access to critical updates about Iveric Bio's contributions to retinal disease treatment under Astellas' global infrastructure.
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.
