Kyverna Wins RMAT for Miv-Cel in Progressive MS

The Tip Desk · August 12, 2026 · 3 min read

Cash, cash equivalents and marketable securities were $199.4 million as of June 30, 2026, with operating runway still expected into 2028.

Kyverna Therapeutics (KYTX), a late-stage clinical immunology company developing CAR T-cell therapies for neurologic autoimmune diseases, said the Food and Drug Administration granted Regenerative Medicine Advanced Therapy designation for miv-cel in non-active secondary progressive multiple sclerosis, a designation that was not present in the company’s two prior quarterly updates.

The Emeryville, Calif.-based company said the FDA granted the RMAT designation based on compelling clinical data from investigator-initiated trials at Stanford University and the University of California, San Francisco. The designation provides the opportunity for increased FDA engagement and eligibility for priority and rolling reviews, as well as accelerated approval pathways. Kyverna expects to provide an update on its PMS development strategy by early 2027, as well as additional data from the Stanford Phase 1 investigator-initiated trial in the fourth quarter of 2026.

Chief Medical and Development Officer Naji Gehchan said miv-cel’s potential to stabilize or improve disability status with a single dose could represent a transformative treatment advance in progressive multiple sclerosis, given the steady progression patients face despite available therapies.

The company also said it had submitted the Chemistry, Manufacturing and Controls module of its rolling biologic license application for miv-cel in stiff person syndrome and remained on track to complete the submission in the fourth quarter of 2026, after initiating the rolling BLA in the first-quarter update. Kyverna plans to seek priority review under the SPS RMAT designation, positioning miv-cel for potential commercial launch in 2027. The company plans to report 12-month topline data from KYSA-8 in the third quarter of 2026.

Enrollment in the KYSA-6 Phase 3 trial in generalized myasthenia gravis is expected to be completed in mid-2027, and longer-term follow-up Phase 2 topline data are expected in the third quarter of 2026, consistent with the first-quarter timeline. Kyverna continues to explore miv-cel with alternative or no preconditioning regimens and the potential for outpatient administration.

In the second quarter, Kyverna appointed Greg Martini as Chief Financial Officer, Nadia Dac as Chief Commercial Officer, and Ritesh Srivastava as Chief Legal and Compliance Officer. Dac’s commercial appointment had already been announced with first-quarter results. The company is hiring key commercial leadership roles, activating commercial sites, and pursuing a commercial supply agreement, payer and patient advocacy engagement, and healthcare professional education in preparation for a rare-disease launch in SPS upon approval.

Research and development expenses were $24.8 million for the three months ended June 30, 2026, down from $35.8 million in the year-ago quarter. General and administrative expenses were $14.8 million, up from $8.6 million a year earlier. The company reported a net loss of $38.3 million, or $0.63 a share, versus a $42.1 million, or $0.97 a share, loss a year earlier. Weighted-average shares outstanding rose to 60.9 million from 43.2 million a year earlier.

Interest expense was $0.7 million in the three months ended June 30, 2026, versus $14 thousand a year earlier, as loan payable, net, stood at $24.9 million at June 30, 2026. Cash, cash equivalents, and marketable securities were $199.4 million as of June 30, 2026, down from $279.3 million at December 31, 2025. That amount, in addition to amounts available for draw from the Oxford Finance amended loan facility, is expected to provide operating runway into 2028.

Chief Executive Officer Warner Biddle said Kyverna continues to advance the rolling BLA submission for stiff person syndrome, progress commercial launch readiness activities, and accelerate enrollment in the registrational trial in generalized myasthenia gravis. The company has three RMAT indications and the potential to deliver the first approved CAR T-cell therapy for autoimmune diseases.