more_reports

Get the Latest Investment Ideas Delivered Straight to Your Inbox. Subscribe

TICKERS: KYTX

New Remission Data on MG Patients Compelling
Research Report

View Important Disclosures for this Article
Share on Stocktwits

Source:

Kyverna Therapeutics Inc.'s (KYTX:NASDAQ) KYV-101 cell therapy drives a 15-month and longer remission in three patients treated on a compassionate use basis, noted an H.C. Wainwright & Co. report.

Kyverna Therapeutics Inc. (KYTX:NASDAQ), developer of cell therapies, disclosed that all three compassionate use myasthenia gravis patients treated with KYV-101 remain in a drug-free, disease-free remission at or beyond 15 months, reported Mitchell Kapoor, analyst at H.C. Wainwright & Co., in an August 29 research note.

On the news, H.C. Wainwright raised its target price on the cell therapy developer to US$10 per share from US$5 previously.

"This data strengthens our conviction in KYV-101's long-term prospects, leading us to raise our probability of approval in myasthenia gravis to 25% (from the prior 20%)," Kapoor wrote.

KYV-101 is Kyverna's investigational, autologous CD19 chimeric antigen receptor (CAR) T-cell therapy, currently being evaluated in Phase 2 of the KYSA-6 clinical trial as a treatment for myasthenia gravis.

170% Return Potential

Compared to H.C. Wainwright's new US$10 per share target price, the California-based biopharma was trading at about US$3.70 per share at the time of Kapoor's report, the analyst noted. From this price, the return to target is 170%.

Kyverna is still a Buy.

The company has 43.2 million shares outstanding. Its market cap is US$160 million. Its 52-week range is US$1.78–8.28 per share.

Remission Duration Significant

Kyverna announced the remission results for the three compassionate use myasthenia gravis patients at its recent Neuroimmunology key opinion leader (KOL) event, noted Kapoor. Results show that for Patients 1, 2 and 3 treated with KYV-101, they remain in remission at 24 months, 22 months and 15 months, respectively, reported Kapoor. What is new in Kyverna's announcement is the remission duration for Patients 2 and 3 beyond about six months.

This is the first time all three patients were in remission past the one-year target. This is a significant milestone and particularly meaningful for patients and caregivers, the KOLs at Kyverna's event said.

"Durability is now extended across multiple patients, reinforcing the credibility of KYV-101's clinical profile and the case for CAR-T usage in autoimmune disease," noted Kapoor.

The data highlight that durability is what primarily differentiates KYV-101 from FcRn inhibitors and from complement inhibitors. With these other therapies, patients remain symptomatic despite expensive, continuous treatment and background immunosuppressants. Further, the just announced durability outcomes of KYV-101 meet the threshold for commercialization, according to H.C. Wainwright, which is also important, especially since FcRn therapy costs US$400,000–500,000 per year.

Interim results from KYSA-6, follow-up of six patients out to nine months, are expected in Q4/25. In those, H.C. Wainwright will be looking specifically at three key outcomes, the analyst pointed out. One is early trajectories, to see if they are trending toward durability of one year or longer. Another is background therapies, to see if they could be eliminated. A third is safety, to see if the profile continues to be favorable.  

"Even without full 12-month data, interim results paired with compassionate use follow-up [data] should provide strong validation," Kapoor noted.

How KYV-101 Differs

Slides shown at the KOL event highlight the shortfalls of noncurative treatment modalities in terms of the disease remaining symptomatic and thus continuing to impair patients' ability to perform activities of daily living (ADLs). This is quantified by the Myasthenia Gravis ADL (MG-ADL) scale, a patient-reported questionnaire. The lower the patients' score on it, the better.

FcRn inhibitors efgartigimod, rozanolixizumab, and nipocalimab produce mean reductions on the MG-ADL scale of about 4–5 at their primary endpoints but require repeat treatment cycles. Complement inhibitors eculizumab and ravulizumab yield 3–4-point improvements in MG-ADL, but chronic dosing is required to achieve this. CD19 monoclonal antibody inebilizumab improves MG-ADL but leaves residual disease. Investigational mRNA CAR-T lowers MG-ADL by about 4 points, but patients relapse and need re-dosing.

In contrast, with KYV-101 therapy, as shown in the compassionate-use cases, MG-ADL scores were 0, background treatment could be eliminated, and durability was 24, 22, and 15 months. These outcomes suggest a level of remission with KYV-101 not seen before with approved drugs or other investigational agents. KYV-101 appears to differ from all of these therapies with respect to depth of response, freedom from chronic dosing, and durability.

"KOLs noted that if safety is maintained, CAR-T could move up in the myasthenia gravis treatment continuum, with applicability beyond the late-line refractory segment," reported Kapoor.

More Clinical Trials

At the KOL event, Kyverna shared the design of the upcoming KYSA-6 Phase 2/3 trial, approved by the U.S. Food and Drug Administration (FDA). The study calls for about 60 myasthenia gravis patients to be randomized on a 1:1 basis versus standard of care. Primary endpoints will be MG-ADL and Quantitative Myasthenia Gravis scores at 24 weeks. Crossover is allowed, but FcRn and anti-CD19/20 background therapies are excluded. The trial is more than 90% powered to show superiority at week 24.

"The design provides a rapid path to a biologics license application submission to the FDA, though its 24-week primary window requires clean execution, with longer-term durability captured in 18-month follow-up," noted Kapoor.

Kyverna is also assessing KYV-101 in stiff person syndrome. That trial, KYSA-8 Phase 2, is fully enrolled. Topline data are expected in H1/26.

At this point, Kapoor noted, stiff person syndrome remains a call option to H.C. Wainwright's valuation of Kyverna.


Want to be the first to know about interesting Regenerative Medicine investment ideas? Sign up to receive the FREE Streetwise Reports' newsletter. Subscribe

Important Disclosures:

  1. Doresa Banning wrote this article for Streetwise Reports LLC and provides services to Streetwise Reports as an independent contractor.
  2.  This article does not constitute investment advice and is not a solicitation for any investment. Streetwise Reports does not render general or specific investment advice and the information on Streetwise Reports should not be considered a recommendation to buy or sell any security. Each reader is encouraged to consult with his or her personal financial adviser and perform their own comprehensive investment research. By opening this page, each reader accepts and agrees to Streetwise Reports' terms of use and full legal disclaimer. Streetwise Reports does not endorse or recommend the business, products, services or securities of any company. 
  3. This article does not constitute medical advice. Officers, employees and contributors to Streetwise Reports are not licensed medical professionals. Readers should always contact their healthcare professionals for medical advice.

For additional disclosures, please click here.

Disclosures for H.C. Wainwright & Co., Kyverna Therapeutics Inc., August 29, 2025

Important Disclaimers This material is confidential and intended for use by Institutional Accounts as defined in FINRA Rule 4512(c). It may also be privileged or otherwise protected by work product immunity or other legal rules. If you have received it by mistake, please let us know by e-mail reply to [email protected] and delete it from your system; you may not copy this message or disclose its contents to anyone. The integrity and security of this message cannot be guaranteed on the Internet. H.C. WAINWRIGHT & CO, LLC RATING SYSTEM: H.C. Wainwright employs a three tier rating system for evaluating both the potential return and risk associated with owning common equity shares of rated firms. The expected return of any given equity is measured on a RELATIVE basis of other companies in the same sector. The price objective is calculated to estimate the potential movements in price that a given equity could reach provided certain targets are met over a defined time horizon. Price objectives are subject to external factors including industry events and market volatility. RETURN ASSESSMENT Market Outperform (Buy): The common stock of the company is expected to outperform a passive index comprised of all the common stock of companies within the same sector. Market Perform (Neutral): The common stock of the company is expected to mimic the performance of a passive index comprised of all the common stock of companies within the same sector. Market Underperform (Sell): The common stock of the company is expected to underperform a passive index comprised of all the common stock of companies within the same sector. Rating and Price Target History for: Kyverna Therapeutics, Inc (KYTX-US) as of 08-28-2025 35 30 25 20 15 10 5 0 Q2 Q3 2023 Q1 Q2 Q3 2024 Q1 Q2 Q3 2025 Q1 Q2 Q3 I:NEUTRAL:$8.00 07/03/24 NEUTRAL:$7.00 08/15/24 NEUTRAL:$6.00 11/20/24 NEUTRAL:$4.00 04/03/25 BUY:$5.00 05/27/25 Investment Banking Services include, but are not limited to, acting as a manager/co-manager in the underwriting or placement of securities, acting as financial advisor, and/or providing corporate finance or capital markets-related services to a company or one of its affiliates or subsidiaries within the past 12 months. Distribution of Ratings Table as of August 28, 2025 IB Service/Past 12 Months Ratings Count Percent Count Percent Buy 555 82.47% 112 20.18% Neutral 73 10.85% 11 15.07% Sell 2 0.30% 0 0.00% Under Review 43 6.39% 12 27.91% H.C. Wainwright & Co, LLC (the “Firm”) is a member of FINRA and SIPC and a registered U.S. Broker-Dealer. I, Mitchell S. Kapoor and Raghuram Selvaraju, Ph.D. , certify that 1) all of the views expressed in this report accurately reflect my personal views about any and all subject securities or issuers discussed; and 2) no part of my compensation was, is, or will be directly or indirectly related to the specific recommendation or views expressed in this research report; and 3) neither myself nor any members of my household is an officer, director or advisory board member of these companies. None of the research analysts or the research analyst’s household has a financial interest in the securities of Kyverna Therapeutics, Inc (including, without limitation, any option, right, warrant, future, long or short position). As of July 31, 2025 neither the Firm nor its affiliates beneficially own 1% or more of any class of common equity securities of Kyverna Therapeutics, Inc. Neither the research analyst nor the Firm knows or has reason to know of any other material conflict of interest at the time of publication of this research report.

The research analyst principally responsible for preparation of the report does not receive compensation that is based upon any specific investment banking services or transaction but is compensated based on factors including total revenue and profitability of the Firm, a substantial portion of which is derived from investment banking services. Mr. Selvaraju, who is [the][an] author of this report, is the Chairman of and receives compensation from Relief Therapeutics Holding SA, a Swiss, commercial-stage biopharmaceutical company identifying, developing and commercializing novel, patent protected products in selected specialty, rare and ultra-rare disease areas on a global basis ("Relief"). You should consider Mr. Selvaraju's position with Relief when reading this research report. The Firm or its affiliates did not receive compensation from Kyverna Therapeutics, Inc for investment banking services within twelve months before, but will seek compensation from the companies mentioned in this report for investment banking services within three months following publication of the research report. The Firm does not make a market in Kyverna Therapeutics, Inc as of the date of this research report. The securities of the company discussed in this report may be unsuitable for investors depending on their specific investment objectives and financial position. Past performance is no guarantee of future results. This report is offered for informational purposes only, and does not constitute an offer or solicitation to buy or sell any securities discussed herein in any jurisdiction where such would be prohibited. This research report is not intended to provide tax advice or to be used to provide tax advice to any person. Electronic versions of H.C. Wainwright & Co., LLC research reports are made available to all clients simultaneously. No part of this report may be reproduced in any form without the expressed permission of H.C. Wainwright & Co., LLC. Additional information available upon request. H.C. Wainwright & Co., LLC does not provide individually tailored investment advice in research reports. This research report is not intended to provide personal investment advice and it does not take into account the specific investment objectives, financial situation and the particular needs of any specific person. Investors should seek financial advice regarding the appropriateness of investing in financial instruments and implementing investment strategies discussed or recommended in this research report. H.C. Wainwright & Co., LLC’s and its affiliates’ salespeople, traders, and other professionals may provide oral or written market commentary or trading strategies that reflect opinions that are contrary to the opinions expressed in this research report. H.C. Wainwright & Co., LLC and its affiliates, officers, directors, and employees, excluding its analysts, will from time to time have long or short positions in, act as principal in, and buy or sell, the securities or derivatives (including options and warrants) thereof of covered companies referred to in this research report. The information contained herein is based on sources which we believe to be reliable but is not guaranteed by us as being accurate and does not purport to be a complete statement or summary of the available data on the company, industry or security discussed in the report. All opinions and estimates included in this report constitute the analyst’s judgment as of the date of this report and are subject to change without notice. Securities and other financial instruments discussed in this research report: may lose value; are not insured by the Federal Deposit Insurance Corporation; and are subject to investment risks, including possible loss of the principal amount invested.





Want to read more about Regenerative Medicine investment ideas?
Get Our Streetwise Reports Newsletter Free and be the first to know!

A valid email address is required to subscribe