Kyverna Therapeutics to Report Topline Results from Registrational Phase 2 KYSA-8 Trial of KYV-101 in Stiff Person Syndrome

Rhea-AI Summary

Kyverna Therapeutics (Nasdaq: KYTX) will host a live webcast and conference call on Monday, December 15, 2025 at 8:00 AM ET to review topline results from the registrational Phase 2 KYSA-8 clinical trial evaluating KYV-101 in stiff person syndrome (SPS).

Registration is required to receive a dial-in number and unique PIN; the event can also be accessed via live webcast. Presentation materials will be posted in the Events & Presentations section of Kyverna's investor relations website and an archived replay will be available after the call.

Key Figures

Share price $8.78 Last close before KYSA-8 topline call announcement

1-day move 5.02% Price change over prior 24 hours

Today’s volume 1,103,084 shares Trading volume vs 20-day average

Volume vs avg 2.12x Relative to 20-day average volume of 519,572

52-week high $9.75 52-week trading range high

52-week low $1.78 52-week trading range low

Market Reality Check

$8.78 Last Close

Volume Volume 1,103,084 is 2.12x the 20‑day average of 519,572, signaling elevated interest ahead of the KYSA‑8 topline call. high

Technical Shares at $8.78 are trading above the 200‑day MA of $4.16 and sit 9.95% below the 52‑week high of $9.75.

Peers on Argus 1 Up 1 Down

KYTX is up 5.02% on strong volume while close peers show mixed moves: CABA -0.42%, CRBU -3.76%, ELTX -2.09%, NTHI +11.34%, TLSA +4.09% (but flagged in momentum scan as -16.85% intraday). With only 1 peer in the scanner moving down and 1 up, the setup looks stock‑specific ahead of KYSA‑8 results.

Historical Context

Date	Event	Sentiment	Move	Catalyst
Nov 12	Earnings & update	Positive	+4.7%	Q3 2025 results plus progress on SPS and gMG programs and financing.
Nov 10	Conference appearance	Neutral	-2.9%	Announcement of CEO presentation at Jefferies London Healthcare Conference.
Nov 03	Debt financing	Positive	-1.3%	Up to <b>$150M</b> non‑dilutive term loan to fund late‑stage programs.
Oct 29	Clinical data update	Positive	-5.8%	Positive interim Phase 2 KYSA‑6 gMG data with strong response and safety.
Oct 22	Data call setup	Neutral	-6.6%	Scheduling of KYSA‑6 interim data call and AANEM presentation details.

Pattern Detected

Recent clinically focused and financing updates often saw muted or negative next‑day moves, even on positive data, while the latest Q3 update with clear timelines drew a positive reaction.

Recent Company History

Over the past few months, Kyverna has advanced KYV‑101 across multiple autoimmune indications while strengthening its balance sheet. The company reported Q3 2025 results on Nov 12 with cash of $171.1M and access to a loan facility up to $150M, supporting a planned BLA for SPS in 1H 2026. Positive interim Phase 2 gMG data from KYSA‑6 on Oct 29 and prior updates on KYSA‑8 enrollment framed today’s announcement of an upcoming registrational KYSA‑8 topline call as the next key milestone in SPS.

Market Pulse Summary

This announcement schedules a conference call on December 15, 2025 at 8:00 a.m. ET to discuss topline results from the registrational Phase 2 KYSA‑8 trial of KYV‑101 in stiff person syndrome. It marks the transition of SPS into a potential registration event following earlier guidance toward a BLA filing in 1H 2026. Investors may focus on efficacy, durability, and safety data versus prior KYSA‑6 gMG results and on any updated timelines for regulatory submissions.

Key Terms

registrational medical

"topline results from the registrational Phase 2 KYSA-8 clinical trial"

Used as an adjective, 'registrational' describes data, studies, or trials designed specifically to convince health regulators to approve a drug, device, or treatment. Investors care because successful registrational results are the most direct path to market authorization and revenue; think of them as the final exam or blueprint that regulators use to decide whether a product can be sold widely, so passing them can materially change a company’s value.

phase 2 medical

"topline results from the registrational Phase 2 KYSA-8 clinical trial"

Phase 2 is the mid-stage clinical trial where a new drug or treatment is tested in a larger group of patients to see if it works and to keep checking safety after initial human testing. Think of it as a field test that proves whether a product actually delivers its promised benefit. Investors watch Phase 2 closely because its results strongly influence a medicine’s chances of reaching the market, the size of its potential sales, and the company’s valuation.

clinical trial medical

"Phase 2 KYSA-8 clinical trial evaluating KYV-101 in stiff person syndrome"

A clinical trial is a carefully controlled study in which a new medicine, medical device, or treatment is tested on people to see if it is safe and effective. For investors it matters because trial results determine whether a product can win regulatory approval and reach patients, much like a road test decides if a new car can be sold; positive or negative results can sharply change a company’s prospects and stock value.

stiff person syndrome medical

"KYSA-8 clinical trial evaluating KYV-101 in stiff person syndrome (SPS)"

A rare neurological disorder in which muscles become abnormally stiff and prone to painful spasms, often triggered by movement, noise, or emotional stress; it is usually caused by an immune system problem that interferes with normal nerve signals to muscles. Investors care because the condition creates demand for specialized diagnostics, long-term therapies, and clinical research; progress or setbacks in treatments, approvals, or trial results can materially affect companies developing drugs, medical devices, or diagnostic tests, similar to how a breakthrough in a small but underserved market can change a company’s prospects.

topline results financial

"to review topline results from the registrational Phase 2 KYSA-8 clinical trial"

Topline results are the initial, high-level summary of the most important outcomes from an event such as a clinical trial or a company reporting period — for a drug study this means whether the main goals were met and basic safety info, and for a company it often means headline revenue and profit figures. Investors care because these summaries act like a headline that quickly signals whether prospects have improved or worsened, often driving immediate market reactions before the full details are released.

AI-generated analysis. Not financial advice.

– Company to host live webcast and conference call Monday, December 15, 2025 at 8:00 am ET –

EMERYVILLE, Calif., Dec. 14, 2025 (GLOBE NEWSWIRE) -- Kyverna Therapeutics, Inc. (Nasdaq: KYTX), a clinical-stage biopharmaceutical company focused on developing cell therapies for patients with autoimmune diseases, announced it will host a live webcast and conference call on Monday, December 15, 2025 at 8:00 am ET to review topline results from the registrational Phase 2 KYSA-8 clinical trial evaluating KYV-101 in stiff person syndrome (SPS).

Conference Call Details

Participants will need to register at the below-noted URL in order to listen and participate in the call. Once registered, participants will receive a dial-in phone number and unique PIN number which will be needed to join the call. The call can also be accessed via live webcast. The webcast and supporting presentation materials will be available on the "Events & Presentations" section of Kyverna's Investor Relations webpage at ir.kyvernatx.com. An archived replay will also be available on the website.

Dial-In Registration Link:
Conference Call Registration

Webcast Link:
Kyverna Topline Results for SPS Conference Call

About KYV-101

KYV-101 is a fully human, autologous, CD19 CAR T-cell therapy with CD28 co-stimulation, designed for potency and tolerability, which is under investigation for B-cell-driven autoimmune diseases. With a single administration, KYV-101 has potential to achieve deep B-cell depletion and immune system reset to deliver durable drug-free, disease-free remission in autoimmune diseases. 

About Kyverna Therapeutics

Kyverna Therapeutics, Inc. (Nasdaq: KYTX) is a clinical-stage biopharmaceutical company focused on liberating patients through the curative potential of cell therapy. 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. The Company is also harnessing other KYSA trials and investigator-initiated trials, including in multiple sclerosis and rheumatoid arthritis, to inform the next priority indications for the Company to advance into late-stage development. Additionally, its pipeline includes next-generation CAR T-cell therapies in both autologous and allogeneic formats, including efficiently expanding into broader autoimmune indications and the potential to increase patient reach with KYV-102 using its proprietary whole blood rapid manufacturing process. For more information, please visit https://kyvernatx.com.

Forward-Looking Statements

Statements in this press release about future expectations, plans and prospects, as well as any other statements regarding matters that are not historical facts, may constitute “forward-looking statements.” The words, without limitation, “anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,” “intend,” “may,” “plan,” “potential,” “predict,” “project,” “should,” “target,” “will,” “would” and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these or similar identifying words. Forward-looking statements in this press release include, without limitation, those related to Kyverna’s anticipated timing for its live webcast reporting its trial data and results and the topics expected to be discussed on the webcast and Kyverna’s next priority indications. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including: uncertainties related to market conditions, the possibility that results from prior clinical trials, named-patient access activities and preclinical studies may not necessarily be predictive of future results; and other factors discussed in the “Risk Factors” section of Kyverna’s most recent Annual Report on Form 10-K and Quarterly Reports on Form 10-Q that Kyverna has filed or may subsequently file with the U.S. Securities and Exchange Commission. Any forward-looking statements contained in this press release are based on the current expectations of Kyverna’s management team and speak only as of the date hereof, and Kyverna specifically disclaims any obligation to update any forward-looking statement, whether as a result of new information, future events or otherwise.

Contacts: 

Investors: InvestorRelations@kyvernatx.com 
Media: media@kyvernatx.com 

FAQ

When will Kyverna (KYTX) present KYSA-8 topline results for KYV-101?

Kyverna will present topline results on December 15, 2025 at 8:00 AM ET via webcast and conference call.

How can investors join the Kyverna (KYTX) December 15, 2025 webcast and conference call?

Investors must register online to receive a dial-in number and unique PIN; the call is also accessible via live webcast on the company IR site.

Where will Kyverna (KYTX) post the KYSA-8 presentation materials and replay?

Presentation materials and an archived replay will be available in the Events & Presentations section of Kyverna's investor relations website at ir.kyvernatx.com.

What is the clinical context of Kyverna's KYSA-8 trial for KYV-101?

KYSA-8 is a registrational Phase 2 clinical trial evaluating KYV-101 in patients with stiff person syndrome.

Will there be an archived replay of Kyverna's December 15, 2025 KYSA-8 topline call?

Yes, an archived replay will be posted on Kyverna's investor relations website after the live event.