Kyverna Therapeutics, Inc. (Nasdaq: KYTX) announced on November 12, 2026, that it has completed the submission of a rolling Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for mivocabtagene autoleucel (miv-cel, KYV-101) in stiff person syndrome (SPS). The company submitted the application under the Regenerative Medicine Advanced Therapy (RMAT) designation, seeking priority review of the therapy.
The BLA is supported by positive data from the KYSA-8 registrational trial. The filing marks a significant milestone as Kyverna positions miv-cel to become the first approved therapy for SPS and the first approved CAR-T therapy for an autoimmune disease. The company is actively advancing commercial readiness activities, including hiring key commercial leaders and building field infrastructure, in anticipation of a potential U.S. launch in 2027.
Regarding its broader pipeline, Kyverna reported that enrollment in the Phase 3 KYSA-6 trial for generalized myasthenia gravis is on track to be completed in mid-2027. Additionally, the company updated on its Progressive Multiple Sclerosis (PMS) program, noting that the FDA granted RMAT designation for miv-cel in non-active secondary progressive multiple sclerosis (naSPMS). Kyverna elected to deprioritize its KYV-102 program to focus resources on its late-stage neurologic indications.
In financial results for the third quarter ended September 30, 2026, Kyverna reported $170.6 million in cash, cash equivalents, and marketable securities. The company expects this cash balance, combined with funds available from an amended loan facility with Oxford Finance, to provide operating runway into 2028. Research and Development (R&D) expenses for the quarter were $27.0 million, while General and Administrative (G&A) expenses were $15.9 million. The company reported a net loss of $41.9 million, or $0.68 per share, for the quarter.
