Iveric Bio Inc Stock Price, News & Analysis

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 August 19, 2023.

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 February 1, 2023 the granting of equity-based awards to 16 newly-hired, non-executive employees as per its 2019 Inducement Stock Incentive Plan. The awards include non-statutory stock options for 368,000 shares and 40,550 restricted stock units. Stock options have an exercise price of $23.70 per share, vesting over four years. The plan follows Nasdaq rules and aims to assist in recruitment by offering competitive compensation. The company's focus lies in developing treatments for retinal diseases.

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 13,350,000 shares of common stock at $22.50 per share, aiming for gross proceeds of approximately $300.4 million. The underwriters have a 30-day option to purchase an additional 2,002,500 shares. The offering is expected to close on or around December 5, 2022. This capital raise is intended to support the company’s ongoing programs in retinal diseases.

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.