By Colin Kellaher


Shares of Inhibikase Therapeutics rose sharply in premarket trading Wednesday after the clinical-stage pharmaceutical company won U.S. Food and Drug Administration orphan-drug designation for its lead program risvodetinib in multiple system atrophy.

The Atlanta company said there are currently no approved symptomatic or disease-modifying therapies for multiple system atrophy, a rare and ultimately fatal neurological disease that causes certain brain areas to deteriorate.

The FDA's orphan-drug program gives special status to drugs and biologics for diseases and disorders that affect fewer than 200,000 people in the U.S. and provides for an extended marketing exclusivity period against competition.

Inhibikase said it is advancing its animal-model studies of risvodetinib to determine its therapeutic potential to block progression and correct functional loss in multiple system atrophy.

Inhibikase shares, which closed Tuesday at $1.40, were recently up 22% to $1.71 in premarket trading.


Write to Colin Kellaher at colin.kellaher@wsj.com


(END) Dow Jones Newswires

10-04-23 0900ET