Kyverna Shares Rise After FDA Gives Special Designation to Stiff-Person Treatment

By Stephen Nakrosis

Shares of Kyverna Therapeutics rose after hours on Monday, following news that the company's treatment of refractory stiff-person syndrome got a regenerative medicine advanced therapy designation for the Food and Drug Administration.

The stock was recently up 8.9% at $10.80. Shares finished the day's regular session with a 1.2% gain and are down about 57% since listing on Nasdaq in February.

KYV-101's designation as regenerative medicine advanced therapy allows for accelerated approval based on intermediate endpoints. The designation is aimed at treating serious or life-threatening conditions.

Refractory stiff-person syndrome is a rare autoimmune disorder with symptoms including painful muscle rigidity and violent spasms. The National Organization for Rare Disorders said one estimate places the incidence at one in a million.

Kyverna said KYV-101 is being evaluated in trials in the U.S. and Germany across rheumatology and neurology, two broad areas of autoimmune disease.

Write to Stephen Nakrosis at stephen.nakrosis@wsj.com

(END) Dow Jones Newswires

July 15, 2024 18:57 ET (22:57 GMT)

Copyright (c) 2024 Dow Jones & Company, Inc.