प्राथमिक स्रोत रिकॉर्ड
महत्वपूर्णआवेदन जमा
काइवेर्ना की miv-cel के लिए SPS BLA सबमिशन की योजना H1 2026 में
The company announced its intent to file the first BLA for miv-cel in stiff person syndrome in the first half of 2026, following positive registrational data from the KYSA-8 trial. Full registrational data are also expected to be reported in 1H 2026. The filing is fully funded by the recent $105 million follow-on offering that extends cash runway into 2028.
मुख्य तथ्य
- फाइल किया गया
- 12 जन॰ 2026, 01:00 pm
- घटना
- आवेदन जमा
- दिशा
- तटस्थ
- कंपनी
KYTXKyverna- संपत्ति
- mivocabtagene autoleucel
- स्रोत
- SEC 8-K
- विश्वसनीयता
- स्रोत सहित
स्रोत का अंश
EX-99.1 3 kytx-ex99_1.htm EX-99.1 EX-99.1 Exhibit 99.1 Kyverna Therapeutics Provides Corporate Update and Outlines 2026 Strategic Priorities at the J.P. Morgan Healthcare Conference Advancing valuable commercial opportunity in stiff person syndrome (SPS) following landmark registrational data; Biologics License Application (BLA) submission anticipated in 1H 2026 First patient enrolled in registrational Phase 3 trial in generalized myasthenia gravis (gMG) Completed follow-on offering extends cash runway into 2028, expected to fully fund SPS BLA filing, commercial launch, and Phase 3 gMG trial Kyverna Board member, Christi Shaw, appointed as Executive Chairperson, further bolstering Company’s CAR T commercialization experience; Ian Clark, former Chairperson, to remain on Board EMERYV
इस संपत्ति पर और
उल्लेखनीय
27 जुल॰ 2026
12:00 pm
KYTXKyvernaKyverna ने ElevateBio के साथ miv-cel के लिए वाणिज्यिक विनिर्माण समझौता किया
महत्वपूर्ण
26 मार्च 2026
08:06 pm
KYTXKyvernaनिर्णायक
15 दिस॰ 2025
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KYTXKyverna