[ad_1]
What happened
Ivéric Bio (NASDAQ: ISEE) the stock exploded as the company had no news to share today. At 11:07 a.m. EDT, shares of the clinical-stage biopharmaceutical company were up 56.8% on poor results from a potential competitor.
So what
Iveric Bio has not said anything about Zimura, its primary candidate for the treatment of geographic atrophy secondary to age-related macular degeneration. The stock is skyrocketing today in response to mixed results from pivotal trials which Apellis Pharmaceuticals (NASDAQ: APLS) reported today.
Image source: Getty Images.
Iveric Bio has previously reported on Zimura’s success in the Gather1 pivotal trial, but we are still awaiting the results of the Gather2 study. Today, Apellis Pharmaceuticals published the results of two pivotal geographic atrophy studies with pegcetacoplan, and only one reached statistical significance on its primary endpoint. This means that Zumira could be the first geographic atrophy drug to gain FDA approval.
Now what
Apellis Pharmaceuticals will not let mixed pivotal trial data prevent it from submitting a pegcetacoplan application later this year. With varying results from clinical trials designed to be identical, there’s a good chance the FDA will ask for more data that is delaying biotechnology by more than a year.
The Gather2 trial with Zimura completed recruitment in July and the study protocol provides for 12 months of treatment and observation. If Gather2 is read as successfully as Gather1, Iveric Bio could submit an application for its first new drug by the end of next year.
This article represents the opinion of the author, who may disagree with the “official” recommendation position of a premium Motley Fool consulting service. We are heterogeneous! Challenging an investment thesis – even one of our own – helps us all to think critically about investing and make decisions that help us become smarter, happier, and richer.
[ad_2]
Source link