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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. (Nasdaq: ISEE) announced an underwritten public offering of common stock, with underwriters given a 30-day option to purchase an additional 15% of shares. The offering is subject to market conditions, and there is no guarantee on its completion or terms. Cowen, Credit Suisse, and Stifel are serving as book-running managers, with Wedbush PacGrow as lead manager. The shares are part of an effective shelf registration statement. IVERIC bio focuses on developing treatments for retinal diseases with unmet medical needs.
IVERIC bio received FDA agreement under a Special Protocol Assessment for its pivotal GATHER2 trial of Zimura® (avacincaptad pegol) targeting geographic atrophy from age-related macular degeneration. Enrollment completion is expected by late July 2022, with topline data anticipated in the latter half of 2022. The FDA endorsed a revision of the primary efficacy endpoint for GATHER2, allowing for a more accurate analysis of data collected. Successful outcomes in GATHER2 could support a New Drug Application for Zimura.
Iveric Bio (Nasdaq: ISEE) announced an accelerated enrollment timeline for its pivotal GATHER2 clinical trial of Zimura (avacincaptad pegol), targeting geographic atrophy secondary to age-related macular degeneration. Enrollment is expected to complete by late July 2021, with topline data anticipated in the second half of 2022. The trial is currently exceeding patient retention goals, aiming for an injection fidelity rate over 90%. Key presentations at the symposium included analyses indicating Zimura's potential in earlier stages of dry AMD, highlighting its significance in combating this leading cause of blindness.
Iveric Bio (Nasdaq: ISEE) announced a virtual symposium on June 18, 2021, focusing on its Zimura® (avacincaptad pegol) program aimed at treating geographic atrophy from age-related macular degeneration (AMD). The event will feature updates on patient enrollment in the GATHER2 clinical trial and discussions on the current landscape of dry AMD. Key opinion leaders, including retinal specialists, will present findings, including new analyses from the GATHER1 trial. A live webcast will be available on Iveric Bio's investor website, with replays accessible for 30 days.
Iveric Bio reported its financial results for Q1 2021, highlighting a net loss of $26.8 million ($0.29 per diluted share), compared to a loss of $15.1 million ($0.28 per share) in Q1 2020. The company is focused on executing the GATHER2 clinical trial for Zimura, with patient recruitment expected to complete in Q3 2021. Cash, cash equivalents, and securities totaled $180.2 million as of March 31, 2021, with guidance estimating a year-end range of $125 to $135 million. R&D expenses rose to $18.5 million due to trial initiation and increased manufacturing activities.
Iveric Bio (NASDAQ: ISEE) announced the granting of equity-based awards on May 3, 2021, to four newly hired non-executive employees. This move complies with Nasdaq Listing Rule 5635(c)(4) and serves as a material inducement for employment acceptance. The grants include 95,450 stock options with an exercise price of $7.17 per share and 7,000 restricted stock units. The options vest over four years while the restricted units vest fully on May 3, 2022, contingent upon continued employment. Iveric Bio focuses on developing treatments for retinal diseases.
Iveric Bio, Inc. (Nasdaq: ISEE) will release its Q1 2021 financial and operational results on May 5, 2021. A conference call is scheduled for 8:00 a.m. Eastern Time to discuss these results and provide a business update. Participants can dial 1-888-317-6003 (USA) or 1-412-317-6061 (International) with passcode 5841649. The call will also be accessible via a live audio webcast on the Iveric Bio website, with a replay available for two weeks. Iveric Bio focuses on developing treatments for retinal diseases.
IVERIC bio, Inc. (Nasdaq: ISEE) announced the resignation of co-founder and Executive Chairman, David R. Guyer, MD, effective after the 2021 Annual Stockholder Meeting on May 19. Guyer has been integral to the company since its founding and will transition to a Senior Advisor role. He will rejoin SV Health Investors as a Venture Partner. Iveric bio focuses on developing treatments for retinal diseases, including the Phase 3 program of Zimura® for geographic atrophy related to age-related macular degeneration. Guyer's departure marks a significant leadership change for the company.
Iveric Bio (NASDAQ:ISEE) announced the granting of equity-based awards on April 1, 2021, as part of its 2019 Inducement Stock Incentive Plan to a newly hired non-executive employee. The inducement includes a non-statutory option to purchase 60,000 shares at an exercise price of $6.49, which vests over four years, along with two grants of 10,000 restricted stock units. These awards are intended to incentivize the employee's acceptance of employment and are compliant with Nasdaq Listing Rule 5635(c)(4).
IVERIC bio granted equity awards to a new non-executive employee under its 2019 Inducement Stock Incentive Plan on March 15, 2021. The awards include a non-statutory option to purchase 125,000 shares and two sets of restricted stock units totaling 70,000 shares, aimed at incentivizing the new hire. The stock option has an exercise price of $6.425, vesting over four years, while the restricted stock units vest in staggered periods. These grants are part of Iveric's strategy to attract talent in the biopharmaceutical sector focused on retinal diseases.
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