IVERIC bio, Inc. ISEE announced positive top-line data from the phase III GATHER2 study evaluating its investigational complement C5 inhibitor, Zimura for the treatment of geographic atrophy (“GA”).
GATHER2 is the second phase III study evaluating Zimura for the given indication. The study met its primary endpoint with a 14.3% reduction in the mean rate of growth in the GA area over 12 months of treatment using square root transformation and a 17.7% reduction using the observed GA area.
The study also demonstrated statistically significant results with favorable safety profiles in treatment with Zimura.
Per the company, a post-hoc analysis of patients receiving Zimura in the United States witnessed a 25.5% reduction using square root transformation and a reduction of 32% using the observed GA area.
Shares of IVERIC bio were up 66.3% on Tuesday following the announcement of the news. The stock has decreased 6.1% this year compared with the industry’s decline of 24.7%.
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The company is also evaluating Zimura in another pivotal study – GATHER1 – IVERIC bio’s first phase III study on Zimura in GA.
The data from GATHER1 and GATHER2 studies and IVERIC bio’s Special Protocol Assessment with the FDA will form the basis for an NDA for Zimura. The company plans to file the NDA in the first quarter of 2023.
After interactions with the FDA and other regulatory bodies across the world, the company plans to begin a study investigating Zimura in patients with intermediate AMD in the fourth quarter of 2022.
This apart, IVERIC bio also has several other candidates in its pipeline, most of which are in pre-clinical development for various diseases.
IVERIC bio has no approved product in its portfolio at the moment. Therefore, pipeline development remains in key focus for the company.
Zacks Rank & Stocks to Consider
IVERIC bio currently carries a Zacks Rank #3 (Hold). Some better-ranked stocks in the biotech sector include Achilles Therapeutics plc ACHL, Atara Biotherapeutics, Inc. ATRA and ORIC Pharmaceuticals, Inc. ORIC, all carrying a Zacks Rank #2 (Buy) at present. You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
Achilles Therapeutics’ loss per share estimates have narrowed 6.4% for 2022 and 9.6% for 2023 in the past 60 days.
Earnings of Achilles Therapeutics surpassed estimates in three of the trailing four quarters and missed on the remaining occasion. ACHL delivered an earnings surprise of 12.45%, on average.
Atara Biotherapeutics’ loss per share estimates have narrowed 43.2% for 2022 and 31.8% for 2023 in the past 60 days.
Earnings of Atara Biotherapeutics surpassed estimates in three of the trailing four quarters and missed on the other occasion. ATRA delivered an earnings surprise of 4.83%, on average.
ORIC Pharmaceuticals’ loss per share estimates have narrowed 8.6% for 2022 and 22% for 2023 in the past 60 days.
Earnings of ORIC Pharmaceuticals surpassed estimates in three of the trailing four quarters and missed on the remaining occasion. ORIC delivered an earnings surprise of 8.85%, on average.
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