Kyverna Therapeutics Reports Positive Phase 2 Results for Miv-cel in Stiff Person Syndrome

Kyverna Therapeutics, Inc. +1.14%

Kyverna Therapeutics, Inc.

KYTX

8.87

+1.14%

Kyverna Therapeutics Inc. has announced topline results from the KYSA-8 clinical trial, a single-arm registrational Phase 2 study evaluating miv-cel in patients with stiff person syndrome (SPS) who had an inadequate response to non-approved treatment options. A total of 26 patients received a single dose of miv-cel and were followed through the primary analysis time point at Week 16, with additional follow-up continuing. Kyverna plans to submit a Biologics License Application (BLA) to the FDA for SPS in the first half of 2026. The company has received both Regenerative Medicine Advanced Therapy and Orphan Drug designations for miv-cel in this indication. Kyverna intends to present the full SPS data set at a medical conference in 2026. The topline results were reviewed during a live investor webcast on December 15, 2025, with materials available on the company's Investor Relations website.

Disclaimer: This news brief was created by Public Technologies (PUBT) using generative artificial intelligence. While PUBT strives to provide accurate and timely information, this AI-generated content is for informational purposes only and should not be interpreted as financial, investment, or legal advice. Kyverna Therapeutics Inc. published the original content used to generate this news brief via GlobeNewswire (Ref. ID: GNW9602097-en) on December 15, 2025, and is solely responsible for the information contained therein.
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