KYTX: KYSA-8 topline ay nagpapakita na natugunan ng miv-cel ang lahat ng endpoints sa SPS

Ang KYSA-8 registrational trial ay natugunan ang primary endpoint nito (T25FW, p=0.0002) at lahat ng secondary endpoints (p<0.0001) na may 81% ng mga pasyente na nakamit ang clinically meaningful improvement. Lahat ng pasyente ay nanatiling walang immunotherapies hanggang sa huling follow-up, at 67% ng mga gumagamit ng ambulatory aids ay hindi na nangangailangan ng mga ito. Ang data ay sumusuporta sa BLA submission na binalak para sa 1H 2026.

Mahahalagang fact

Na-file: Dis 15, 2025, 01:00 PM
Kaganapan: Topline na resulta
Direksyon: Positibo
Kumpanya: KYTXKyverna
Asset: mivocabtagene autoleucel
Pinagmulan: SEC 8-K
Kumpiyansa: May source
Kalendaryo: Resulta ng trial · Okt 1, 2026 · Positibo
Rate ng mse: 67% (n=3 na may >=24w f/u)
Walang NSIST: 100%
Pagbawas ng qmg sa w24: -7.7
Pagbawas ng mg adl sa w24: -8.0

Sipi mula sa source

EX-99.1 2 d33692dex991.htm EX-99.1 EX-99.1 Exhibit 99.1 Topline Data: KYSA-8 Registrational Trial of Miv-cel (KYV-101) in Stiff Person Syndrome (SPS) December 15, 2025 ©2025 Kyverna Therapeutics, Inc. Disclaimer and Forward-Looking Statements This presentation contains forward-looking statements that are based on management’s beliefs and assumptions and information currently available to management of Kyverna Therapeutics, Inc. (“Kyverna”, “we”, “our,” or the “Company”). All statements other than statements of historical facts contained in this presentation are forward-looking statements. Forward looking statements include, but are not limited to, statements concerning: the Company’s future results of operations and financial position, business strategy, drug candidates, planned preclin

SEC 8-K