Pursuing a rare autoimmune disease accelerated Kyverna’s path to BLA

Kyverna is targeting a BLA submission for next half that would mark a first for autoimmune CAR Ts, and highlight the advantages of pursuing an initial niche indication strategy in a drug class that’s competing for patients and other clinical resources. 

On Monday, Emeryville, Calif.-based Kyverna Therapeutics Inc. (NASDAQ:KYTX) reported that its lead autoimmune CAR T cell therapy, mivocabtagene autoleucel (“miv-cel,” formerly KYV-101), met the primary and secondary endpoints in a registrational Phase II trial in patients with stiff person syndrome. With its stock rising, the company moved to raise money on the back of the readout, proposing to raise $100 million in a follow-on. Last week, clinical data fueled the best week for biotech follow-ons this year.  ...