Every material Form 8-K Kyverna Therapeutics, Inc. has filed with the SEC since July 27, 2026, read and summarized by AI: what happened, the key figures, whether it reads positive or negative for shareholders, and how big a deal it is (impact 1-5). Newest first; each brief links to its own page and to the filing on SEC.gov.
Kyverna Therapeutics said one-year topline data from its KYSA-8 registrational trial in stiff person syndrome (SPS) and longer-term Phase 2 follow-up data from KYSA-6 in generalized myasthenia gravis (gMG) were positive. The company said it remains on track to complete its rolling BLA submission in Q4 2026, and the filing contains no financial results, guidance, or deal terms.
KYSA-8: median timed 25-Foot Walk improvement of 49% at month 12 among 26 SPS patients (p < 0.0001)
KYSA-6 Phase 2: all 7 gMG patients reached clinically meaningful improvement at 24 weeks; 57% maintained minimal symptom expression at last follow-up
Rolling BLA submission for miv-cel in SPS is on track for completion in Q4 2026; full data at MS Toronto, October 21-23, 2026
Conference call set for 8:00 a.m. Eastern Time on September 24, 2026
Kyverna Therapeutics reported a second-quarter 2026 net loss of $38.3 million, or $0.63 per share, compared with a net loss of $42.1 million, or $0.97 per share, in the same quarter of 2025. The company had $199.4 million in cash, cash equivalents, and marketable securities at June 30, 2026, and reiterated that its operating runway extends into 2028.
Q2 2026 net loss of $38.3 million, or $0.63 per share, versus $42.1 million, or $0.97 per share, in Q2 2025
R&D expenses were $24.8 million and G&A expenses were $14.8 million in the quarter
Cash, cash equivalents, and marketable securities of $199.4 million at June 30, 2026; runway into 2028
FDA granted RMAT designation for miv-cel in non-active secondary progressive multiple sclerosis; rolling BLA for stiff person syndrome expected to be completed in Q4 2026
Kyverna Therapeutics and ElevateBio signed a Clinical and Commercial Supply Agreement on July 23, 2026, replacing their prior manufacturing agreement in its entirety. The deal covers clinical and commercial supply of Kyverna's lead candidate, miv-cel, and requires Kyverna to order minimum quantities in certain years and/or after FDA approval. The filing does not disclose dollar values, so shareholders cannot yet gauge the financial scale of the commitment.
Agreement signed July 23, 2026, and replaces the prior agreement with ElevateBio in its entirety.
Initial term of five years, with automatic one-year renewals unless terminated under the agreement's terms.
Prices and fees are subject to an annual inflation adjustment up to a maximum percentage, tied to the PPI for Pharmaceutical Preparation Manufacturing.
Full agreement to be filed with the Form 10-Q for the quarter ending September 30, 2026; certain terms will be confidential.
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