On Tuesday, H.C. Wainwright maintained its Neutral stance on shares of Kyverna Therapeutics Inc (NASDAQ: KYTX) with an unchanged price target of $8.00. The firm's position follows Kyverna's announcement on Monday that the U.S. Food and Drug Administration (FDA) granted Regenerative Medicine Advanced Therapy (RMAT) Designation to its KYV-101, a CD19 CAR-T therapy, for the treatment of refractory stiff-person syndrome (SPS).
Kyverna Therapeutics had previously reported the clearance of an Investigational New Drug (IND) application last month, which allows the company to move forward with the Phase 2 trial of KYV-101 in the treatment of SPS that is resistant to current therapies.
Despite this regulatory progress, H.C. Wainwright expressed reservations about the potential of KYV-101 to effectively tackle autoimmune disorders for the long term, citing the inherent limitations of DNA-based CAR-T therapies.
The firm highlighted concerns regarding the preliminary data on KYV-101, suggesting it may not be indicative of the therapy's ability to generate sustained and profound responses in autoimmune diseases.
The skepticism extends to the broader category of DNA-based CAR-T treatments, especially when compared to alternative approaches such as mRNA-modified CAR-T therapies, which may offer superior results.
H.C. Wainwright's cautious outlook is also informed by the competitive landscape in the CAR-T therapy space. The firm indicated it is awaiting clinical data that demonstrates significant and lasting responses before adopting a more optimistic view on Kyverna's prospects.
In summary, H.C. Wainwright reiterated its Neutral rating on Kyverna Therapeutics, with a price target of $8.00 over the next 12 months. The firm's position remains unchanged despite the recent FDA RMAT Designation for KYV-101, as it calls for more conclusive evidence of the therapy's efficacy in the treatment of autoimmune conditions.
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