Kyverna (KYTX) Gets RMAT Designation for CAR T-Cell Product
Kyverna Therapeutics, Inc. KYTX announced that the FDA has granted the Regenerative Medicine Advanced Therapy ("RMAT") designation to its lead pipeline candidate KYV-101.
KYV-101 is an autologous, fully human CD19 chimeric antigen receptor (CAR) T-cell product candidate for use in B cell-driven autoimmune diseases.
The FDA granted the RMAT designation to KYV-101 for the treatment of patients suffering from refractory stiff-person syndrome (SPS).
SPS is a rare, progressive neurological autoimmune disorder causing debilitating muscle stiffness in the torso, arms and legs, thereby affecting the ability to walk or move.
The RMAT designation will allow Kyverna to receive expert guidance on efficient drug development and use of surrogate endpoints from senior FDA officials.
Kyverna’s shares rose 7.5% in after-market trading hours on July 15 but lost 51.5% in the past three months against the industry’s growth of 9.7%.
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Last month, the FDA cleared the company’s investigational new drug (IND) application for KYV-101, to be used for the treatment of SPS in Kyverna's trial, named KYSA-8.
Kyverna is evaluating KYV-101 in two broad areas of autoimmune diseases, namely rheumatology and neurology.
The initial focus in the rheumatology space is on lupus nephritis (LN) and systemic sclerosis (SSc). The company is conducting two phase I/II trials of KYV-101 in patients with LN. KYTX received the IND application clearance in October 2023 for a phase I/II study in SSc.
In the neurology space, the company intends to initially focus on myasthenia gravis (MG) and multiple sclerosis (MS) diseases.
Kyverna received the IND clearance in November 2023 for a phase II trial in MG. It also obtained the same clearance in December 2023 for a phase II study in MS. The FDA granted orphan drug designation to KYV-101 for the treatment of MG.
The company also partnered with Intellia Therapeutics, Inc. NTLA to develop KYV-201, an allogeneic CD19 CAR T-cell product candidate (CRISPR) using the same underlying CAR construct in KYV-101.
Per the terms, NTLA granted KYMR an exclusive, worldwide royalty bearing license (under certain of Intellia’s intellectual property) to research, develop and sell the CRISPR candidate.
As of Mar 31, 2024, Kyverna had $369.8 million in cash, cash equivalents, and available-for-sale marketable securities. The cash balance included approximately $336.2 million in net proceeds raised from its initial public offering that was completed in February 2024.
Zacks Rank & Stocks to Consider
KYTX currently carries a Zacks Rank #3 (Hold).
A couple of better-ranked stocks in the healthcare sector are Entrada Therapeutics TRDA and Corcept Therapeutics CORT, both carrying a Zacks #1 Rank (Strong Buy) at present. You can see the complete list of today’s Zacks #1 Rank stocks here.
Entrada’s loss per share estimate for 2024 has narrowed from 27 cents to 13 cents in the past 60 days, and the same for 2025 has narrowed from $3.44 to $3.21 in the past 30 days.
In the past 60 days, estimates for CORT’s 2024 earnings per share have improved from 90 to 95 cents. Shares of CORT have rallied 40.7% in the past three months.
CORT’s earnings beat estimates in each of the trailing four quarters, delivering an average surprise of 33.7%.
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