“.Kyverna Therapeutics to Announce Topline Results of Phase 2 KYSA‑8 Trial of KYV‑101 in Stiff‑Person Syndrome

Kyverna Therapeutics (NASDAQ: KYTX) will host a live webcast and conference call on Dec 15, 2025 at 8:00 a.m. ET to present topline data from its registrational Phase 2 KYSA‑8 trial of the CD19 CAR‑T therapy KYV‑101 in stiff‑person syndrome. Registration is required for dial‑in details; the webcast and slides will be available on the investor‑relations site afterward. Ahead of the call, KYTX shares closed at $8.78, rose 5.0% on elevated volume, and the company cites a $150 M non‑dilutive loan and $171 M cash runway supporting a planned BLA filing in early 2026.

Kyverna Therapeutics (Nasdaq: KYTX) will host a live webcast and conference call on Monday, December 15, 2025 at 8:00 a.m. ET to present topline data from its registrational Phase 2 KYSA‑8 trial of KYV‑101 in stiff‑person syndrome (SPS).

Registration is required to receive a dial‑in number and PIN; the event can also be viewed via live webcast. Presentation slides will be posted in the Events & Presentations section of Kyverna’s investor‑relations site, with a replay available afterward.

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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 moving average 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% (TLSA flagged in the momentum scan as –16.85% intraday). With only one peer in the scanner moving down and one moving up, the setup appears 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 $150 M 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 produced muted or negative next‑day moves, even when data were positive, while the latest Q3 update with clear timelines generated a positive reaction.

Recent Company History

Over the past several months, Kyverna has advanced KYV‑101 across multiple autoimmune indications while bolstering its balance sheet. The Q3 2025 earnings release on Nov 12 disclosed $171.1 M in cash and access to a $150 M loan facility, supporting a planned Biologics License Application for SPS in the first half of 2026. Interim Phase 2 gMG data from KYSA‑6 (Oct 29) and prior enrollment updates for KYSA‑8 set the stage for today’s registrational topline call.

Market Pulse Summary

The upcoming call on Dec 15, 2025 at 8:00 a.m. ET will disclose topline results from the registrational Phase 2 KYSA‑8 trial of KYV‑101 in stiff‑person syndrome. If the data demonstrate robust efficacy, durable response, and an acceptable safety profile, Kyverna could move its SPS program toward a Biologics License Application in H1 2026, accelerating its entry into a market with limited therapeutic options. Investors will scrutinize response rates, time‑to‑response, and any autoimmune‑related adverse events, comparing them to the earlier KYSA‑6 gMG outcomes. Updated regulatory timelines will also be a key focus.

Key Terms

registrational
medical

Used as an adjective, ‘registrational’ describes data, studies, or trials designed specifically to convince health regulators to approve a drug, device, or treatment. Successful registrational results are the most direct path to market authorization and revenue.

phase 2
medical

Phase 2 is the mid‑stage clinical trial where a drug is tested in a larger patient cohort to confirm efficacy and continue safety monitoring. Results heavily influence a product’s likelihood of reaching market and its valuation.

clinical trial
medical

A clinical trial is a controlled study that evaluates a new therapy’s safety and efficacy in humans. Positive or negative outcomes can sharply affect a company’s prospects and stock price.

stiff person syndrome
medical

A rare neurological disorder characterized by muscle rigidity and painful spasms, often driven by an autoimmune process. The disease presents a high‑unmet‑need market, making any effective therapy a potentially lucrative niche.

topline results
financial

Topline results are the initial, high‑level summary of a trial’s primary outcomes and safety snapshot. They act as a headline that can trigger immediate market reactions before full data release.

AI-generated analysis. Not financial advice.

Kyverna Therapeutics, Inc. (Nasdaq: KYTX), a clinical‑stage biopharma focused on cell‑based therapies for autoimmune disease, announced today that it will host a live webcast and conference call on Monday, Dec 15, 2025 at 8:00 a.m. ET to review topline data from the registrational Phase 2 KYSA‑8 trial of its CD19 CAR‑T candidate KYV‑101 in stiff‑person syndrome.

KYV‑101 is a fully human, autologous CD19 CAR‑T therapy with CD28 co‑stimulation, engineered for potent B‑cell depletion and a favorable safety profile. The single‑dose approach aims to reset the immune system and achieve durable, drug‑free remission in B‑cell‑driven autoimmunity.

Kyverna’s broader pipeline includes additional late‑stage trials in myasthenia gravis (KYSA‑6) and lupus nephritis, as well as next‑generation CAR‑T candidates in both autologous and allogeneic formats. The company’s recent $150 M non‑dilutive term loan, combined with $171 M of cash on hand, provides runway through the anticipated Biologics License Application filing for SPS in the first half of 2026.

FAQ

When will Kyverna present KYSA‑8 topline results?

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

How can investors join the webcast?

Investors must register online to receive a dial‑in number and PIN; the call is also accessible through the live webcast on the company’s investor‑relations site.

Where will the presentation materials and replay be posted?

Materials and an archived replay will be available in the Events & Presentations section of Kyverna’s investor‑relations website (ir.kyvernatx.com).

What is the clinical context of the KYSA‑8 trial?

KYSA‑8 is a registrational Phase 2 study evaluating KYV‑101 in patients with stiff‑person syndrome.

Will an archived replay be provided?

Yes, an archived replay will be posted after the live event.

Original article, Author: Jam. If you wish to reprint this article, please indicate the source:https://aicnbc.com/14519.html

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