Kyverna Therapeutics’ KYV-101: Promising Developments and First-to-Market Potential in Autoimmune Diseases

Analyst Thomas Smith from Leerink Partners reiterated a Buy rating on Kyverna Therapeutics, Inc. (KYTX – Research Report) and keeping the price target at $25.00.

Thomas Smith’s rating is based on several promising developments at Kyverna Therapeutics, Inc. Firstly, the company’s lead asset, KYV-101, has shown significant clinical promise in treating a range of autoimmune diseases, including stiff person syndrome (SPS), myasthenia gravis (MG), and lupus nephritis (LN). The differentiated construct of KYV-101 has demonstrated compelling data in their compassionate-use program, which has been tested across more than 15 autoimmune diseases.
Furthermore, Kyverna has completed enrollment in the pivotal KYSA-8 trial for KYV-101 in SPS, with expectations for topline results and a Biologics License Application (BLA) filing in the first half of 2026. This positions the company for a first-to-market opportunity in a rare-disease setting. Additionally, the company has gained alignment with the FDA on their Chemistry, Manufacturing, and Controls (CMC) package, which is crucial for supporting the launch of KYV-101 in SPS and other indications. These factors, combined with ongoing clinical and regulatory progress, underpin Thomas Smith’s Buy rating for Kyverna Therapeutics.

Smith covers the Healthcare sector, focusing on stocks such as Viking Therapeutics, Tourmaline Bio, and Viridian Therapeutics. According to TipRanks, Smith has an average return of 32.5% and a 46.39% success rate on recommended stocks.

In another report released yesterday, H.C. Wainwright also upgraded the stock to a Buy with a $5.00 price target.