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Kyverna Sets Pace In Race For Autoimmune CAR-T Approval By 2026
Benzingaยท 2025-08-20 19:29
Core Insights - The biotechnology sector is witnessing significant innovation, particularly in advanced therapies for complex diseases, with a focus on autoimmune disorders and cell therapies [1] Company Overview - Kyverna Therapeutics Inc. is a small-cap biotechnology company specializing in cell therapies for autoimmune disorders [1] - The company has reported $211.7 million in cash, cash equivalents, and marketable securities as of June 30, 2025, which is expected to fund operations into 2027 [4] Clinical Development - Kyverna's lead CAR T-cell therapy candidate, KYV-101, is in late-stage clinical development, with registrational trials for stiff person syndrome (SPS) and myasthenia gravis (MG), along with ongoing Phase 1/2 trials for lupus nephritis [2] - Topline data for the registrational Phase 2 trial of KYV-101 in SPS and BLA submission is anticipated in the first half of 2026 [2] - The Phase 3 trial for KYV-101 in MG will include approximately 60 patients, with enrollment expected to start by the end of 2025, and interim Phase 2 data is anticipated in Q4 2025 [3] Market Position and Analyst Insights - William Blair analyst Sami Corwin believes Kyverna is on track to potentially have the first FDA-approved CAR-T therapy for an autoimmune disease, which could establish the company as a leader in this field [5][6] - The upcoming Phase 3 data readout for KYV-101 is considered de-risked based on positive outcomes from compassionate use cases [5] - William Blair initiated coverage with an Outperform rating and a fair value estimate of $27, primarily driven by the potential of KYV-101 [7] - Kyverna Therapeutics shares increased by 4.85% to $3.46 at the time of publication [7]