Key Takeaways KYTX surged 23% after its registrational phase II KYSA-8 study met the primary endpoint in SPS.Kyverna Therapeutics reported a 46% median T25FW improvement, with 81% of patients exceeding a 20% gain.KYTX showed broad functional gains, 67% shed walking aids by Week 16 with a manageable safety profile.Shares of Kyverna Therapeutics (KYTX) surged 23.2% on Monday after the company reported positive top-line data from a registrational mid-stage study of its investigational candidate, mivocabtagene ...

Key Takeaways Five biotech stocks are highlighted for 2026 due to late-stage trials or upcoming FDA decisions.MindMed expects multiple phase III data readouts in 2026 for its lead program MM120.Ocugen, Kyverna and Celcuity face key inflection points tied to BLAs or pivotal clinical data.After a weak first half, the drug and biotech sector has recovered in the past 2-3 months with large drugmakers like Pfizer, AstraZeneca, Eli Lilly and Novo Nordisk signing drug pricing agreements with the Trump administrati ...

U.S. stock futures were lower this morning, with the Dow futures falling around 0.2% on Tuesday.Shares of Lightwave Logic Inc (NASDAQ:LWLG) fell sharply in pre-market trading after the company announced pricing of $35 million public offering of common stock.Lightwave Logic shares dipped 14.5% to $3.22 in pre-market trading.Here are some other stocks moving lower in pre-market trading.Ascent Solar Technologies, Inc. (NASDAQ:ASTI) shares dipped 15.1% to $3.54 in pre-market trading after jumping 34% on Monday. ...

U.S. stock futures were lower this morning, with the Dow futures falling around 0.2% on Tuesday.Shares of Lightwave Logic Inc (NASDAQ:LWLG) fell sharply in pre-market trading after the company announced pricing of $35 million public offering of common stock.Lightwave Logic shares dipped 14.5% to $3.22 in pre-market trading.Here are some other stocks moving lower in pre-market trading.Ascent Solar Technologies, Inc. (NASDAQ:ASTI) shares dipped 15.1% to $3.54 in pre-market trading after jumping 34% on Monday. ...

EMERYVILLE, Calif., Dec. 15, 2025 (GLOBE NEWSWIRE) -- Kyverna Therapeutics, Inc. (Nasdaq: KYTX) (“Kyverna”), a clinical-stage biopharmaceutical company focused on developing cell therapies for patients with autoimmune diseases, today announced that it has commenced an underwritten public offering of $100,000,000 of shares of its common stock. Kyverna intends to grant the underwriters a 30-day option to purchase up to an additional $15,000,000 of shares of common stock offered in the public offering, at the ...

Market Overview - U.S. stocks experienced a decline, with the Nasdaq Composite falling approximately 0.4% on Monday. The Dow decreased by 0.27% to 48,328.47, while the S&P 500 dropped 0.11% to 6,819.62 [1] - In the commodities market, oil prices fell by 1.5% to $56.58, while gold decreased by 0.1% to $4,366.60. Conversely, silver rose by 2.2% to $63.395, and copper increased by 1.1% to $5.4175 [5] Sector Performance - Health care shares saw an increase of 0.9% on Monday, indicating a positive trend in that sector [1] - Energy stocks, however, experienced a decline of 1.5% [1] International Markets - European shares showed positive performance, with the eurozone's STOXX 600 gaining 0.74%. Spain's IBEX 35 Index rose by 1.11%, and London's FTSE 100 jumped by 1.06% [6] - In contrast, Asian markets closed lower, with Japan's Nikkei falling by 1.31% and Hong Kong's Hang Seng dipping by 1.34% [7] Economic Indicators - The NAHB/Wells Fargo Housing Market Index increased to 39 in December, marking the highest reading in eight months, up from 38 in November and exceeding market estimates of 38 [2][10] - The NY Empire State Manufacturing Index fell to -3.9 in December, a significant drop from the previous month's one-year high of 18.7, and below market expectations of 10 [8] Company News - 3 E Network Technology Group Ltd (NASDAQ:MASK) shares surged by 47% to $0.44 following a master services agreement for an AI data center in Finland [9] - Kyverna Therapeutics Inc (NASDAQ:KYTX) shares rose by 28% to $11.22 after announcing topline data from KYSA-8 [9] - Artiva Biotherapeutics Inc (NASDAQ:ARTV) shares increased by 50% to $4.94 after reporting positive initial safety data [9] - iRobot Corp (NASDAQ:IRBT) shares plummeted by 72% to $1.20 after filing for Chapter 11 bankruptcy [9] - Argo Blockchain PLC – ADR (NASDAQ:ARBK) shares fell by 22% to $5.35 amid volatility in the cryptocurrency market [9] - Momentus Inc (NASDAQ:MNTS) shares dropped by 43% to $0.48 following a 1-for-17.85 reverse split announcement [9]

There was big news today for Kyverna Therapeutics, Inc. ( KYTX ) as they announced some very positive top line data on Miv-cel this morning. As a result, shares are up 35% pre-market. Because of the strengthI hold a Master’s degree in Cell Biology and began my career working for several years as a lab technician in a drug discovery clinic, where I gained extensive hands-on experience in cell culture, assay development, and therapeutic research. That scientific foundation gave me an appreciation for the rigo ...

Group 1 - U.S. stocks experienced a decline, with the Nasdaq Composite dropping over 100 points on Monday [1] - Kyverna Therapeutics Inc shares surged 31% to $11.49 following the announcement of topline data from the KYSA-8 Phase 2 trial [2][3] - The KYSA-8 trial involved mivocabtagene autoleucel (miv-cel), a CAR T-cell therapy targeting stiff person syndrome [1] Group 2 - Other notable stock gains included Beneficient, which increased by 29.3% to $6.21, and Immunome Inc, which rose 25.5% to $24.56 after positive results from its Phase 3 trial [3] - Falcon's Beyond Global Inc gained 14% to $12.83, while XBP Global Holdings Inc surged 11.5% to $6.39 [3] - Almonty Industries Inc announced a voluntary withdrawal of its base shelf prospectus, leading to a 9.1% increase in its stock price to $7.38 [3]

Kyverna Therapeutics Conference Call Summary Company Overview - **Company**: Kyverna Therapeutics (NasdaqGS:KYTX) - **Focus**: Development of CAR-T therapies for autoimmune diseases, specifically targeting stiff person syndrome (SPS) with their lead product MIVCEL (mevalcaptagene autolysel) Key Industry Insights - **Industry**: Autoimmune therapies, particularly CAR-T cell therapies - **Market Opportunity**: Significant unmet medical need in SPS with no FDA-approved therapies currently available Core Points and Arguments 1. **Top-Line Data from KYZA-8 Trial**: - The trial met primary and all secondary endpoints with high statistical significance, demonstrating MIVCEL's effectiveness in reversing disability in SPS patients after a single dose [4][12][25] - MIVCEL showed a 74% improvement in the Timed 25-Foot Walk test, with patients' times improving from an average of 17.3 seconds to 4.5 seconds [8][18] 2. **Regulatory Pathway**: - BLA submission to the FDA is on track for the first half of 2026, supported by the trial's results and designations such as RMAT and orphan drug status [4][13][25] 3. **Patient Population**: - The trial included 26 patients with a median age of 56, all of whom had previously inadequate responses to off-label immunotherapies [15][16] - 88% of patients were GAD65 positive, the most common autoantibody associated with SPS [16] 4. **Efficacy and Safety**: - MIVCEL demonstrated deep and broad B-cell depletion, with durable efficacy beyond 24 months in some patients [10][11][31] - The safety profile was well-tolerated, with no high-grade CRS or ICANS observed [21][22] 5. **Market Dynamics**: - Approximately 6,000 diagnosed patients in the U.S. with SPS, with 2,000 to 2,500 patients identified as having the highest unmet need [26][27] - The company aims to establish MIVCEL as the first FDA-approved therapy for SPS, targeting patients with inadequate responses to current treatments [27][29] 6. **Commercial Strategy**: - Focused commercialization strategy leveraging existing CAR-T ecosystem and targeting academic centers where patients are concentrated [29][30] - Plans to expand into broader indications, including myasthenia gravis, following the potential approval of MIVCEL [5][26] Additional Important Insights - **Patient Impact**: The psychological and physical burden of SPS is significant, with many patients experiencing severe mobility issues and requiring walking aids [9][10] - **Transformative Potential**: MIVCEL's ability to eliminate the need for chronic immunotherapies and improve quality of life is emphasized as a game changer for SPS patients [19][24] - **Future Directions**: Kyverna is also exploring other autoimmune diseases, with promising early data in multiple sclerosis and rheumatoid arthritis [31][54] Conclusion - Kyverna Therapeutics is positioned to potentially lead the CAR-T therapy market for autoimmune diseases, with MIVCEL showing promising results in treating stiff person syndrome and a clear path towards regulatory approval and commercialization.

Kyverna Therapeutics said on Monday its experimental cell therapy for treating patients with a rare movement disorder met the main goal of a mid-stage study, sending its shares surging 20% in premarke... ...