IVERIC Bio Inc. (NASDAQ:ISEE) Stock Gains Momentum: More to Come This Week?
IVERIC Bio Inc. (NASDAQ:ISEE) Jumped 8% after the company announced that the FDA had issued it with a written agreement under the Special Protocol Assessment (SPA) to design the pivotal Zimura clinical study, GATHER2.
Zimura is an experimental drug the company is developing for geographic atrophy secondary it age-related macular degeneration treatment. The company had previously announced that it expects enrolment for the study to commence in late July. However, data from the trial will be available in 2H 2022, a year after the last subject’s enrollment, plus the time required for database lock and analysis.
Pravin U Dugel, the company’s president, said they are delighted to receive the SPA agreement from the FDA. He said they are thanking the agency for the collaborative engagement and valuable input on the GATHER2 study’s primary efficacy outcome, which the company feels reflects the thinking of the FDA. So, in the coming months, ISEE is a stock worth watching.
Market Reaction:
On Tuesday, ISEE stock jumped 8.20% at $8.59 with more than 20.38 million shares, compared to its average volume of 860k shares. The stock had moved within a range of $7.55 – 9.37 after opening the trade at $8.30. Over the past 52-week, the stock has been trading within a range of $3.97 – 9.37.
