Kyverna Therapeutics GAAP EPS of -$0.68 beats by $0.01

Kyverna Therapeutics (NASDAQ:KYTX) submitted a Biologics License Application for miv-cel in stiff person syndrome, seeking priority review. The company reported a Q3 2026 net loss of $41.9 million and $170.6 million in cash. It expects operating runway into 2028 and is focusing on late-stage neurologic indications with miv-cel.

Kyverna Therapeutics reported a 14% wider net loss YoY in 3Q 2026, with total operating expenses rising 11%. R&D expenses fell 11%, while general and administrative expenses increased 92%. The company completed a rolling BLA submission for miv-cel in SPS and expects to finish patient enrollment in a Phase 3 trial by mid-2027.

Kyverna Therapeutics, Inc. (KYTX) filed an SEC Form 8-K — Results of Operations and Financial Condition. Exhibit 99.1 Kyverna Therapeutics Announces Completion of BLA Submission for Miv-cel in Stiff Person Syndrome and Reports Third Quarter 2026 Financial Results BLA submission for miv-cel in SPS completed with request for priority review Commercial readiness advancing for potential

Kyverna Therapeutics reported phase 2 results for KYSA-8, showing 67% of 12 patients no longer needed walking aids after 16 weeks. All 26 patients discontinued chronic immunotherapies. No prior-period comparison was provided. The next catalyst is regulatory progress for potential approval in SPS, with no timeline specified.

Kyverna Therapeutics presented updated Phase 1 trial data for miv-cel in progressive multiple sclerosis at MS Toronto 2026. Five patients showed stable or improved EDSS scores, with four sustaining benefits for over a year. The therapy demonstrated robust CAR T-cell expansion and a well-tolerated safety profile. Miv-cel is being investigated for autoimmune diseases, with over 100 patients treated to date.

Kyverna Therapeutics (NASDAQ:KYTX) reported Phase 1 trial data for miv-cel in progressive MS patients. Five of six showed stable or improved disability scores, with four sustaining benefits for over a year. The treatment showed CAR T-cell expansion and B-cell depletion, with no high-grade safety issues. Stanford's Jeffrey Dunn noted the unmet need for progressive MS therapies. Kyverna aims to update its strategy by early 2027.