8-KAccepted Sep 24, 6:00 AM ET
Kyverna Therapeutics Reports Positive miv‑cel Trial Data
Accepted (ET)
6:00 AM
Sep 24, 2026
Filed
Sep 24, 2026
Documents
10
Size
230.8 KB
Summary
Kyverna Therapeutics Reports Positive miv‑cel Trial Data
What Happened
- On September 24, 2026 Kyverna Therapeutics, Inc. announced positive one‑year data from its registrational trial KYSA‑8 of miv‑cel (mivocabtagene autoleucel, KYV‑101) in patients with stiff person syndrome, and positive longer‑term follow‑up data from the Phase 2 portion of its registrational trial KYSA‑6 in patients with generalized myasthenia gravis (gMG). The company furnished a press release as Exhibit 99.1 to its Form 8‑K and scheduled a conference call for 8:00 a.m. Eastern Time on September 24, 2026 to review the results.
Key Details
- Filing date: Form 8‑K filed September 24, 2026; press release furnished as Exhibit 99.1.
- Trials: KYSA‑8 (registrational) — one‑year data in stiff person syndrome; KYSA‑6 (registrational trial’s Phase 2 portion) — longer‑term follow‑up in gMG.
- Conference call: 8:00 a.m. ET on September 24, 2026 to discuss results.
- Report signed by Gregory Martini, Chief Financial Officer, dated September 24, 2026.
Why It Matters
- The company reported positive registrational and longer‑term clinical data for its lead cell therapy candidate, miv‑cel, for two rare neuromuscular/autoimmune conditions. These results are material to Kyverna’s clinical development program and may inform next regulatory or development steps. Investors should review the company’s press release and the September 24 conference call for detailed efficacy, safety, and next‑step information disclosed by management.