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MOONLAKE DECEMBER 15th DEADLINE: Bragar Eagel & Squire, P.C. Urgently Reminds MoonLake Immunotherapeutics Investors to Contact the Firm
Globenewswire· 2025-12-15 15:46
Bragar Eagel & Squire, P.C. Litigation Partner Brandon Walker Encourages Investors Who Suffered Losses In MoonLake (MLTX) To Contact Him Directly To Discuss Their Options If you purchased or acquired MoonLake Immunotherapeutics common stock between March 10, 2024 through September 29, 2025 and would like to discuss your legal rights, call Bragar Eagel & Squire partner Brandon Walker or Melissa Fortunato directly at (212) 355-4648. Click here to participate in the action. NEW YORK, Dec. 15, 2025 (GLOBE NEWSW ...
BMY Gains 13.1% in Three Months: Buy, Sell or Hold the Stock?
ZACKS· 2025-12-15 15:36
Key Takeaways BMY posted better-than-expected Q3 results and raised revenue guidance on strong demand for key growth drugs.Growth portfolio momentum from Opdivo, Reblozyl and Breyanzi is helping stabilize revenues amid generics.Generic competition continues to pressure legacy drugs, which BMY expects to decline 15-17% in 2025.Bristol Myers Squibb Company (BMY) has been performing well recently. Shares of this biotech giant have gained 13.1% in the past three months compared with the industry’s growth of 15. ...
Take the Zacks Approach to Beat the Markets: Liquidia, Western Digital & Johnson & Johnson in Focus
ZACKS· 2025-12-15 15:11
Key Takeaways Liquidia Corporation shares have gained 43.9% since an October upgrade, far outpacing the S&P 500's rise.Shares of WDC have climbed 52.8% since its October Outperform upgrade, beating the S&P 500 by a wide margin.JNJ has returned 19.3% over 12 weeks, benefiting from investor demand for quality dividend stocks.The U.S. stock markets ended the week mostly lower, with the tech-heavy Nasdaq Composite and the S&P 500 slipping by 1.49% and 0.28%, respectively, due to a sharp selloff in tech stocks. ...
Oncotelic Therapeutics and Brush and Key Foundation Announce Publication in International Journal of Molecular Sciences Highlighting Context-Dependent Biomarkers in Liver and Pancreatic Cancer
Globenewswire· 2025-12-15 15:00
AGOURA HILLS, Calif., Dec. 15, 2025 (GLOBE NEWSWIRE) -- Oncotelic Therapeutics, Inc. (OTCQB: OTLC) in collaboration with the Brush and Key Foundation, today announced the publication of a peer-reviewed research article in the International Journal of Molecular Sciences titled “Comparative Tumor Microenvironment Analysis for HCC and PDAC Using KMplotter.” Chang, W.-H.; Shah, D.; Myers, S.; Potts, M.; Qazi, S.; Trieu, V. International Journal of Molecular Sciences 2025, 26, 11920. The study presents a compreh ...
Kyverna Therapeutics (NasdaqGS:KYTX) Update / Briefing Transcript
2025-12-15 14:02
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.
The Gross Law Firm Reminds Skye Bioscience, Inc. Investors of the Pending Class Action Lawsuit with a Lead Plaintiff Deadline of January 16, 2026 - SKYE
Prnewswire· 2025-12-15 14:00
NEW YORK, Dec. 15, 2025 /PRNewswire/ -- The Gross Law Firm issues the following notice to shareholders of Skye Bioscience, Inc. (NASDAQ: SKYE). Shareholders who purchased shares of SKYE during the class period listed are encouraged to contact the firm regarding possible lead plaintiff appointment. Appointment as lead plaintiff is not required to partake in any recovery. CONTACT US HERE: https://securitiesclasslaw.com/securities/skye-bioscience-inc-loss-submission-form/?id=180162&from=4 CLASS PERIOD: Novem ...
Anixa Biosciences Announces Transfer of IND for Breast Cancer Vaccine from Cleveland Clinic
Prnewswire· 2025-12-15 13:45
Core Insights - Anixa Biosciences has completed the transfer of the Investigational New Drug application for its breast cancer vaccine from Cleveland Clinic, becoming the trial sponsor for its future development [1][2] - The company plans to advance the vaccine into a Phase 2 clinical trial after completing enrollment and observing encouraging immune response and safety data in the Phase 1 trial [2][4] - The breast cancer vaccine targets -lactalbumin, a protein that re-emerges in many forms of breast cancer, potentially offering therapeutic and preventive benefits [3] Company Overview - Anixa is a clinical-stage biotechnology company focused on cancer treatment and prevention, with a portfolio that includes an ovarian cancer immunotherapy program developed in collaboration with Moffitt Cancer Center [5] - The company’s vaccine portfolio includes vaccines for breast and ovarian cancer, developed in collaboration with Cleveland Clinic, and aims to address various cancers by immunizing against "retired" proteins expressed in certain cancer forms [5] - Anixa's business model involves partnering with renowned research institutions to explore emerging technologies for further development and commercialization [5]
MindWalk Reports Record Growth and Announces Strategic Progress on Its AI Asset Pipeline
Businesswire· 2025-12-15 13:30
VICTORIA, British Columbia--(BUSINESS WIRE)--MindWalk (NASDAQ: HYFT), a BioNative AI biotherapeutic research and technology company combining in silico and wet lab operations for biologics discovery and development, today announced financial results for the second quarter of fiscal 2026 and provided updates on its AI driven asset pipeline and strategic initiatives. MindWalk operates a proprietary BioNative AI platform built on patented HYFT patterns—evolution shaped subsequence codes that link sequence, str ...
Adaptive Biotechnologies signs non-exclusive deals with Pfizer worth up to $890 million
Reuters· 2025-12-15 13:24
Adaptive Biotechnologies said on Monday it has signed two non-exclusive deals with Pfizer to support research in rheumatoid arthritis and other immune-related diseases. ...
Dren Bio to collaborate with Sanofi to develop autoimmune disease therapies for up to $1.7 billion
Reuters· 2025-12-15 13:21
Core Insights - Dren Bio has entered into a strategic collaboration with Sanofi to develop therapies for autoimmune diseases, with a deal valued at up to $1.7 billion [1] Company Summary - Dren Bio is a private biotech company focused on developing therapies for autoimmune diseases [1] - Sanofi is a global healthcare leader collaborating with Dren Bio for the development of these therapies [1] Financial Summary - The collaboration deal is worth up to $1.7 billion, indicating significant financial commitment from both companies [1]