After receiving approval for its innovative medication, Iveric Bio Inc. (Nasdaq: ISEE) saw a 25.87% increase to $21.70 in current market value on Friday.
For what therapy did ISEE receive approval?
A new investigational complement C5 inhibitor for the treatment of geographic atrophy (GA) secondary to age-related macular degeneration (AMD), avacincaptad pegol (ACP, also known as Zimura), has received Breakthrough Therapy designation from the U.S. Food and Drug Administration (FDA), according to a report from Iveric Bio (ISEE). Based on the 12-month pre-specified main endpoint data from the pivotal GATHER1 and GATHER2 clinical trials, ACP is now the first and only experimental medication to obtain Breakthrough Therapy designation status for this indication.
3 Tiny Stocks Primed to Explode
The world's greatest investor — Warren Buffett — has a simple formula for making big money in the markets. He buys up valuable assets when they are very cheap. For stock market investors that means buying up cheap small cap stocks like these with huge upside potential.
We've set up an alert service to help smart investors take full advantage of the small cap stocks primed for big returns.
Click here for full details and to join for free
Sponsored
A possible new drug’s development and regulatory assessment are expedited when it receives the breakthrough therapy designation because it will treat a severe ailment and fill a critical medical need. The novel therapy must offer preliminary clinical evidence that it may significantly outperform competing treatments in terms of efficacy or safety for a clinically relevant endpoint, as well as generally indicate a clear advantage.
The fact that GATHER1 and GATHER2 both achieved their major endpoints and helped Iveric Bio satisfy the demanding requirements is reflected in the Breakthrough designation. The execution of its complete NDA filing and launch planning will be the main priorities for ISEE, with the goal of becoming the first to market. In order to speed up the review process for avacincaptad pegol and maybe provide a novel medication for AMD patients affected by GA, ISEE will collaborate with the FDA.
How will ISEE advance further?
Iveric Bio (ISEE) recently announced the rolling evaluation of the first portion of its New Drug Application (NDA), which includes the complete clinical data package from the key GATHER1 and GATHER2 studies. By the end of the year, ISEE expects to have finished the last component of the NDA filing.
