Common Stock, par value $0.00001 per share
- Symbol
- KYTX
- Exchange
- NASDAQ
- Classification
- COMMON
- Status
- Current
Current Report · Items 7.01, 9.01 · 8-K
Kyverna Therapeutics, Inc.
KYTXNASDAQEQUITYCurrent
Regulation FD Disclosure
Item 7.01 Regulation FD Disclosure. On September 24, 2026, Kyverna Therapeutics, Inc. (the “Company”) issued a press release announcing positive one-year data from its registrational trial, KYSA-8, of miv-cel (mivocabtagene autoleucel, KYV-101) in patients with stiff person syndrome, and positive longer-term follow-up data from the Phase 2 portion of its registrational trial, KYSA-6, of miv-cel in…
Company context
Kyverna Therapeutics, Inc. (Nasdaq: KYTX) is a late-stage clinical immunology company pioneering differentiated therapies with curative potential for neurologic autoimmune diseases. Kyverna’s lead autologous CD19-targeting CAR T-cell therapy candidate, miv-cel (mivocabtagene autoleucel, KYV-101), has demonstrated the potential to fundamentally change the treatment paradigm across multiple B-cell-driven autoimmune diseases. Kyverna is advancing its potentially first-in-class neuroimmunology franchise with its recently completed registrational trial in stiff person syndrome (SPS) and an ongoing registrational trial for generalized myasthenia gravis (gMG).
Current securities
Registered securities in this filing
Kyverna Therapeutics, Inc. · 8-K · Filed 2026-09-24
Disclosure sections
Item 7.01Item 7.01 - Regulation FD Disclosure
Item 7.01 Regulation FD Disclosure.
On September 24, 2026, Kyverna Therapeutics, Inc. (the “Company”) issued a press release announcing positive one-year data from its registrational trial, KYSA-8, of miv-cel (mivocabtagene autoleucel, KYV-101) in patients with stiff person syndrome, and positive longer-term follow-up data from the Phase 2 portion of its registrational trial, KYSA-6, of miv-cel in patients with generalized myasthenia gravis (gMG). The Company will host a conference call at 8:00 a.m. Eastern Time on September 24, 2026 to review the results. A copy of the press release is furnished as Exhibit 99.1 to this Current Report on Form 8-K and is incorporated herein by reference.
The information contained in Item 7.01 of this Current Report on Form 8-K (including Exhibit 99.1 attached hereto) shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended, or the Exchange Act, except as expressly provided by specific reference in such a filing.
Filed exhibits (1)
Exhibit 99.1 Kyverna Therapeutics Reports Positive One-Year Data Demonstrating Durable Clinical Responses and Favorable Safety Profile for Miv-cel in Stiff Person Syndrome and Generalized Myasthenia Gravis Topline durability data reinforce potential for single-dose miv-cel to free patients from life-long disease burden and chronic immunotherapies, further highlighting miv-cel’s differentiated construct Sustained clinical benefit and reversal of disability through one year support the potential to be the first approved therapy in SPS and first approved CAR T-cell therapy for autoimmune disease; rolling BLA submission on track for completion in Q4 2026 Longer-term Phase 2 follow-up in gMG demonstrate robust and durable effects sustained for up to 1.5 years, with majority of patients maintaining MSE; Phase 3 enrollment expected to be completed in mid-2027 Consistent, well-tolerated safety profile with no high-grade CRS or ICANS, and no cases of IEC-HS in one-year follow-up Company to host conference call on September 24, 2026 at 8 am ET EMERYVILLE, Calif., Sept. 24, 2026 -- Kyverna Therapeutics, Inc. (Nasdaq: KYTX), a late-stage clinical immunology company pioneering transforma…
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