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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 (NASDAQ: ISEE) announces participation in investor conferences in November 2022. Key events include the Credit Suisse 31st Annual Healthcare Conference on November 9 at 6:15 PM ET, Guggenheim's 4th Annual Neuro/Immunology Conference on November 14 at 2:45 PM ET, and the Stifel Healthcare Conference on November 15 at 11:30 AM ET. Live webcasts will be available on Iveric Bio's website, with archived replays accessible for 30 days. The company focuses on developing treatments for retinal diseases.
Iveric Bio (ISEE) announced the submission of the first part of its New Drug Application (NDA) to the FDA for avacincaptad pegol (ACP), a novel treatment for geographic atrophy due to age-related macular degeneration (AMD). This follows the completion of pivotal clinical trials, GATHER1 and GATHER2, both showing significant efficacy in slowing GA progression. The FDA has granted Fast Track designation for ACP, which underscores the drug’s potential to address unmet medical needs in this area.
IVERIC bio reported positive GATHER2 results for avacincaptad pegol (ACP) in treating geographic atrophy (GA), achieving its primary endpoint in two Phase 3 trials. The company plans to submit a New Drug Application (NDA) by year-end 2022, ahead of schedule, and is preparing for commercialization.
As of September 30, 2022, the company had $321 million in cash and expects to maintain sufficient liquidity through at least mid-2024. Q3 net loss was $42.4 million, or ($0.35) per share, vs. a $24.6 million loss in Q3 2021.
Iveric Bio (NASDAQ: ISEE) announced the granting of equity-based awards to eight new non-executive employees as part of its 2019 Inducement Stock Incentive Plan on November 1, 2022. The awards include non-statutory stock options for 122,800 shares with an exercise price of $23.95 and 15,500 restricted stock units. The stock options vest over four years, beginning November 1, 2023. Iveric Bio focuses on developing novel treatments for retinal diseases, aiming to enhance patients' quality of life.
Iveric Bio (NASDAQ: ISEE) will report its Q3 2022 financial results on November 3, 2022, at 8:00 a.m. ET. Following the results, management will host a live conference call and webcast for a comprehensive discussion of the financial outcomes and business updates. Investors can participate by calling 1-888-317-6003 (USA) or 1-412-317-6061 (International), with a passcode of 8170771. A replay will be available for two weeks post-call.
Iveric Bio, Inc. (NASDAQ: ISEE) announced on October 3, 2022, the granting of equity-based awards as part of its 2019 Inducement Stock Incentive Plan to two new non-executive employees. The inducement grants include non-statutory stock options to purchase 67,000 shares and 16,000 restricted stock units. The stock options have an exercise price of $18.26 per share and vest over four years. The plan aims to attract talent to support the company's focus on developing treatments for retinal diseases.
Iveric Bio (Nasdaq: ISEE) announced that top-line efficacy and safety results from its GATHER2 Phase 3 clinical trial of avacincaptad pegol (Zimura) will be presented at the American Academy of Ophthalmology 2022 annual meeting from September 30 to October 3 in Chicago. This marks the first public presentation of GATHER2 results, which demonstrated meeting the pre-specified primary endpoint of slowing geographic atrophy (GA) progression at 12 months. The company plans to submit a new drug application to the FDA by the end of Q1 2023.
Iveric Bio (NASDAQ: ISEE) announced its executives, Glenn P. Sblendorio and Pravin U. Dugel, M.D., will participate in two investor conferences this September. The Wells Fargo 2022 Healthcare Conference is scheduled for September 9 at 10:25 a.m. ET, and the Morgan Stanley 20th Annual Global Healthcare Conference on September 12 at 2:50 p.m. ET. Investors can access live webcasts on the Iveric Bio website, with replays available for 30 days post-conference. Iveric Bio focuses on developing treatments for retinal diseases.
IVERIC bio announced positive topline results from the GATHER2 Phase 3 trial of Zimura, a complement C5 inhibitor for geographic atrophy (GA). GATHER2 met its primary endpoint with a 14.3% reduction in mean GA growth rate (p=0.0064) over 12 months. A significant 17.7% reduction was noted using observed GA area (p=0.0039). A New Drug Application (NDA) is planned for submission to the FDA by Q1 2023. The safety profile was favorable, with no significant ocular complications reported. These results follow GATHER1, solidifying Zimura's potential impact on treating GA.
Iveric Bio (NASDAQ: ISEE) announced on September 1, 2022, the granting of equity-based awards to two newly hired non-executive employees as part of its 2019 Inducement Stock Incentive Plan. This included 38,600 stock options priced at $9.89 per share and 8,000 restricted stock units. The stock options vest over four years, with partial vesting starting on September 1, 2023, while the restricted stock units will have staggered vesting dates in 2022 and 2023. These grants are intended as a material inducement for the employees to join the company.
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