Kyverna reports Q2 2026 results and RMAT nod for miv-cel in progressive MS

Kyverna Therapeutics said on August 11, 2026 that the FDA granted RMAT designation to miv-cel for non-active secondary progressive multiple sclerosis (naSPMS), based on compelling clinical data from investigator-initiated trials at Stanford University and the University of California, San Francisco in patients with PMS.¹ The designation gives Kyverna increased FDA engagement and eligibility for priority and rolling reviews, as well as accelerated approval pathways.¹ The company said it plans to lay out its PMS development strategy in early 2027 and to release further data from the Stanford Phase 1 trial in the fourth quarter of 2026.

On the lead program, Kyverna said its rolling BLA for stiff person syndrome is underway, with the CMC module submitted and completion targeted for the fourth quarter of 2026, with plans to seek priority review under RMAT designation.¹ It said it expects to report 12-month topline data from the KYSA-8 trial in the third quarter of 2026.¹

In generalized myasthenia gravis, Kyverna said enrollment in the Phase 3 KYSA-6 trial is expected to be completed by mid-2027, with longer-term follow-up Phase 2 topline data expected in the third quarter of 2026.¹

The company also disclosed new executive hires during the quarter, naming Greg Martini as chief financial officer, Nadia Dac as chief commercial officer, and Ritesh Srivastava as chief legal and compliance officer.

On finances, Kyverna reported $199.4 million in cash, cash equivalents, and marketable securities as of June 30, 2026, and said that amount, along with funds available under its amended Oxford Finance loan facility, is expected to support operations into 2028.¹ Net loss for the quarter was $38.3 million, or $0.63 per share.¹