Kyverna Sets Pace In Race For Autoimmune CAR-T Approval By 2026

The biotechnology sector is experiencing a surge in innovation as companies develop advanced therapies to address complex diseases. This wave of progress is particularly evident in the development of novel treatments for autoimmune disorders, where cutting-edge cell therapies hold promise to transform patient care.

On Wednesday, William Blair initiated coverage on Kyverna Therapeutics Inc. (NASDAQ:KYTX), a small-cap biotechnology company focused on cell therapies for autoimmune disorders.

Kyverna’s lead CAR T-cell therapy candidate, KYV-101, is advancing through late-stage clinical development with registrational trials for stiff person syndrome and myasthenia gravis, and two ongoing multi-center Phase 1/2 trials for patients with lupus nephritis.

Topline data for the registrational Phase 2 trial of KYV-101 in stiff person syndrome (SPS) and BLA submission anticipated in the first half of 2026.

Registrational Phase 3 KYV-101 trial in myasthenia gravis (MG) to include ~60 patients, with enrollment to initiate by year-end 2025; interim Phase 2 data expected in the fourth quarter of 2025.

Also Read: AstraZeneca Prepares Showdown With JNJ, Amgen With Phase 3 Win For Myasthenia Gravis Drug Candidate

Kyverna reported $211.7 million in cash, cash equivalents, and marketable securities as of June 30, 2025, which the company expects will provide a cash runway into 2027.

William Blair analyst Sami Corwin wrote, “We believe Kyverna is poised to have the first FDA-approved CAR-T for the treatment of an autoimmune disease, which could secure the company's position as a leader in the field and enable it to rapidly advance additional indications.”

Corwin sees the upcoming Phase 3 KYV-101 data readout as de-risked based on data from two SPS patients treated with KYV-101 under compassionate use, who demonstrated durable reductions in autoantibodies and significant improvements in mobility.

The analyst adds that if approved in late 2026 or early 2027, KYV-101 will not only be the first approved therapy for SPS, but also could be the first approved CAR-T therapy for an autoimmune indication, which would be a milestone for the company and the space more broadly.

William Blair initiated coverage with an Outperform rating and a fair value estimate of $27, with the majority of the current valuation attributed to KYV-101. The generation of data across its clinical pipeline is expected to drive the stock price over the next 12-18 months.

KYTX Price Action: Kyverna Therapeutics shares were up 4.85% at $3.46 at the time of publication on Wednesday, according to Benzinga Pro data.

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