Shares of Inhibikase Therapeutics surged in premarket trading on Wednesday following the company’s recent acquisition of orphan-drug designation from the U.S. Food and Drug Administration (FDA) for its flagship program, risvodetinib. This medical breakthrough is specifically aimed at treating multiple system atrophy (MSA), a rare and incurable neurological disease known for its degenerative effect on certain brain regions.
At present, there are no FDA-approved therapeutic interventions available to address the symptoms or modify the progression of MSA. The orphan-drug program by the FDA grants special recognition to drugs and biologics designed to tackle diseases and disorders that impact fewer than 200,000 individuals in the United States. Moreover, this designation provides the drugs with an extended period of marketing exclusivity, protecting them against potential competitors.
Inhibikase Therapeutics is currently focused on advancing its animal-model studies to explore the therapeutic potential of risvodetinib in blocking the progression of MSA as well as potentially reversing functional loss associated with this debilitating neurological condition.
The shares of Inhibikase skyrocketed by 22% in premarket trading, reaching $1.71 per share from their previous closing price of $1.40.