Kyverna Therapeutics Announces Completion of BLA Submission for Miv-cel in Stiff Person Syndrome and Reports Third Quarter 2026 Financial Results
Globe Newswire•12/11/2026•08:00 ET
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Key Highlights
- ➤BLA submission completed for miv-cel in SPS, seeking FDA priority review
- ➤$170.6 million cash and securities; operating runway expected into 2028
- ➤KYSA-6 Phase 3 gMG enrollment remains on track for mid-2027 completion
- ➤Third-quarter net loss $41.9 million, or $0.68 per share
- ➤KYV-102 program deprioritized as Kyverna focuses on miv-cel indications
Expert Statements
Warner Biddle, Chief Executive Officer of Kyverna Therapeutics
“Kyverna is very proud to submit the first BLA for a CAR T-cell therapy in autoimmune disease, paving the way for a potential new standard of care with a single dose, designed to reset the immune system and free patients from lifelong disease and chronic immunotherapies”
Warner Biddle, Chief Executive Officer of Kyverna Therapeutics
“We believe miv-cel’s clinical profile, differentiated construct design and established manufacturing process can support a strong launch in SPS, if approved.”
Warner Biddle, Chief Executive Officer of Kyverna Therapeutics
“We continue to advance our commercial readiness activities by hiring key commercial leaders with deep expertise in CAR T, neurology, and rare disease launches, initiating the critical field infrastructure, and working with treatment centers to prepare for potential patient access.”
Warner Biddle, Chief Executive Officer of Kyverna Therapeutics
“Our progress to date is a testament to the dedication of our employees, investigators, patients, and partners.”
Warner Biddle, Chief Executive Officer of Kyverna Therapeutics
“SPS is our lead indication, but we believe it is only the beginning of a much broader opportunity to transform the treatment paradigm for neurologic autoimmune diseases.”
BLA submission for miv-cel in SPS completed with request for priority review
Commercial readiness advancing for potential U.S. launch of miv-cel, which would become the first approved therapy for SPS and first approved CAR-T therapy in autoimmune disease
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