Kyverna merencanakan BLA pertama untuk miv-cel pada stiff person syndrome pada 1H 2026

The company announced its registrational KYSA-8 Phase 2 trial for miv-cel in SPS met all primary and secondary endpoints with statistically significant clinical benefit and a favorable safety profile. Kyverna now expects to file its first BLA for miv-cel in stiff person syndrome in the first half of 2026.

Fakta utama

Diajukan: 26 Mar 2026, 20.06
Peristiwa: Permohonan diajukan
Arah: Netral
Perusahaan: KYTXKyverna
Aset: mivocabtagene autoleucel
Sumber: SEC 8-K
Keyakinan: Bersumber

Kutipan sumber

EX-99.1 2 kytx-ex99_1.htm EX-99.1 EX-99.1 Exhibit 99.1 Kyverna Therapeutics Provides Business Update and Reports Fourth Quarter and Full Year 2025 Financial Results Advancing first-to-market autoimmune CAR T opportunity in stiff person syndrome (SPS) with key launch preparation activities underway; BLA submission anticipated in 1H 2026 Progressing enrollment for FDA-aligned Phase 3 trial in generalized myasthenia gravis (gMG) Positive progressive multiple sclerosis data underscore valuable pipeline-in-a-product opportunity with miv-cel Cash and cash equivalents of $279 million provide expected runway into 2028, funding SPS BLA filing, commercial launch, and Phase 3 gMG trial EMERYVILLE, Calif., March 26, 2026 – Kyverna Therapeutics, Inc. (Nasdaq: KYTX), a late-stage clinical biopha

SEC 8-K