Core Viewpoint - The company has established a fundraising management system to regulate the management and use of funds raised in the A-share market, ensuring compliance with the intended purposes outlined in the prospectus [1] Group 1 - The fundraising management system mandates that raised funds must be deposited in a designated account, and the company must sign a supervision agreement with relevant parties [1] - Funds raised should be used for the main business as specified in the prospectus and are prohibited from being used for financial investments [1] - If specific circumstances arise regarding the investment projects, a re-evaluation is required [1] Group 2 - Idle funds can be managed in cash or used to supplement working capital, subject to review and disclosure [1] - Any changes to the investment projects must follow legal procedures, and the company is required to disclose the actual use of funds accurately [1] - The company will conduct biannual checks on the progress of fund usage and disclose reports accordingly [1] - The system will take effect from the date of approval by the board of directors [1]

Core Insights - Imugene Ltd has received full support from the US FDA for its Phase 1B study data regarding its CAR-T cell therapy, azer-cel, validating the proposed dosing regimen, lymphodepletion schedule, and manufacturing process [1][2] - The FDA's feedback allows the company to proceed with its pivotal study design, confirming the efficacy, safety, and process standards of azer-cel [2][8] - The company reported an 82% overall response rate from its Phase 1B trial, indicating strong potential for the therapy [4][10] FDA Support and Study Progress - The FDA has not requested further data or dosing adjustments, which is considered a rare outcome at this stage of development [2][8] - The CEO emphasized that the FDA's affirmation provides a clear path for the pivotal study, as all aspects of the proposed plan have been approved [8][10] - Imugene is currently dosing its CAR-T naïve cohort, which has no approved CAR-T therapies, representing a rapid opportunity for data generation and regulatory engagement [3][9] Future Plans and Data Collection - The company is actively presenting azer-cel at the ASH conference and plans to continue collecting clinical data while preparing for pivotal manufacturing steps in the upcoming year [3][10] - The strategy includes gathering data in both DLBCL and the CAR-T naïve cohort, aiming for a fast-to-market approach [10]

Core Insights - Robbins Geller Rudman & Dowd LLP is investigating potential violations of U.S. federal securities laws involving ALT5 Sigma Corporation, focusing on whether the company and its executives made false or misleading statements or failed to disclose material information to investors [1][2] Company Overview - ALT5 Sigma provides blockchain-powered technologies through its Fintech and Biotechnology segments [2] - On August 11, 2025, ALT5 Sigma announced plans to raise approximately $1.5 billion before fees through a registered direct offering and a private placement offering [2] Recent Developments - On August 29, 2025, ALT5 Sigma disclosed a judgment from the Intermediate Court of Nyarugenge, Rwanda, finding its subsidiary criminally liable for offenses including illicit enrichment and money laundering [3] - An independent committee was appointed by the Board to investigate potential misstatements or omissions in the financial statements [3] - On October 22, 2025, Peter Tassiopoulos was suspended as CEO, effective immediately, with pay [3] - ALT5 Sigma announced on November 18, 2025, that it would not file its Quarterly Report on Form 10-Q for that quarter in a timely manner [3] - A leadership overhaul occurred on November 27, 2025, with the rapid departures of the CFO, Acting CEO, and COO, alongside the appointment of a new Acting CEO and an experienced CFO [3] - On November 28, 2025, ALT5 Sigma's independent registered public accounting firm resigned due to the retirement of its sole partner [3] - On December 3, 2025, ALT5 Sigma received a notice from Nasdaq regarding non-compliance with listing requirements due to the resignation of a Board member [3]

中新网上海12月11日电 (记者 许婧)上财浦发金融创新研究院与上海科创银行联合主办的"科创金融 研究中心成立暨(潮涌东方论坛)科创新格局下的金融创新"活动10日在上海举办。活动上，科创金融研 究中心(以下简称"中心")正式落成。 当天的论坛上，上海财经大学商学院教授、国际文化交流学院院长董静以"创投视角下的科创金 融"为主题，详细解读了当前科创投资的最新动态与未来发展趋势。 信诺维首席战略官周智敏、矩量光启创始人于文龙、国盛证券具身智能研究院院长张一鸣分别就生 物医药、量子计算、具身智能等前沿科技领域的发展趋势进行了精彩分享，通过独家深度洞察展现了前 沿科技领域的无限潜力。 圆桌论坛上，科创伙伴联盟成员单位代表围绕"科创新格局下的金融创新"展开了深入探讨。与会嘉 宾一致认为，当前科技创新呈现出多学科交叉融合、应用场景不断拓展等显著特点，这对金融行业提出 了更高的要求。金融行业需要不断创新服务模式和产品，以满足科创企业多样化的融资需求。 上海财经大学方面表示，未来，上财浦发金融创新研究院依托科创金融研究中心这一优质平台，深 化双方紧密合作；同时，不断整合各方资源，优化金融服务流程，提升金融服务科技创新的能力与 ...

NEW YORK, Dec. 11, 2025 (GLOBE NEWSWIRE) -- WHY: Rosen Law Firm, a global investor rights law firm, reminds purchasers of common stock of MoonLake Immunotherapeutics (NASDAQ: MLTX) between March 10, 2024 and September 29, 2025, both dates inclusive (the “Class Period”), of the important December 15, 2025 lead plaintiff deadline. SO WHAT: If you purchased MoonLake common stock during the Class Period you may be entitled to compensation without payment of any out of pocket fees or costs through a contingency ...

NEW YORK, Dec. 11, 2025 (GLOBE NEWSWIRE) -- Mesoblast Limited (Nasdaq:MESO; ASX:MSB), global leader in allogeneic cellular medicines for inflammatory diseases, today announced that an independent peer-reviewed comparative analysis of efficacy and safety between remestemcel-L and ruxolitinib for treatment of steroid-refractory acute graft versus host disease (SR-aGvHD) was presented at the 67th ASH Annual meeting in Florida this past week. The independent study authors concluded that remestemcel-L showed sup ...

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Core Insights - Amgen has received FDA approval for UPLIZNA (inebilizumab-cdon) as the first CD19-targeted B cell therapy for treating generalized myasthenia gravis (gMG) in adults who are positive for anti-acetylcholine receptor (AChR) and anti-muscle specific tyrosine kinase (MuSK) antibodies, offering a new treatment option with the potential for long-term disease control through biannual dosing after initial loading doses [1][7][20] Group 1: Treatment Efficacy and Approval - The approval is based on the Myasthenia Gravis Inebilizumab Trial (MINT), which is the largest Phase 3 study for gMG, demonstrating significant efficacy in reducing symptoms and steroid dependency among patients [4][5] - At Week 26, UPLIZNA showed a 1.9-point improvement in the Myasthenia Gravis Activities of Daily Living (MG-ADL) score compared to placebo, with a statistically significant p-value of <0.0001 [6][11] - The trial included 238 adults, with 87.4% of UPLIZNA patients reducing their steroid dose to 5 mg or less per day by Week 26, indicating a reduction in steroid dependency [4][14] Group 2: Patient Impact and Market Potential - UPLIZNA offers a convenient dosing schedule of twice a year, which is expected to improve patient adherence and quality of life by providing six months of treatment-free time between doses [2][7] - The prevalence of gMG in the U.S. is estimated to be between 80,000 and 100,000 patients, with a growing global incidence, highlighting a significant market opportunity for UPLIZNA [3][17] - This approval marks the third indication for UPLIZNA, previously approved for anti-AQP4 antibody positive neuromyelitis optica spectrum disorder (NMOSD) and Immunoglobulin G4-related disease (IgG4-RD), showcasing the drug's versatility [7][20] Group 3: Safety and Adverse Reactions - Common adverse reactions reported in gMG patients include headache and infusion-related reactions, with a noted incidence of 10.1% during the clinical trials [8][30] - Amgen emphasizes its commitment to patient support and access to UPLIZNA, indicating a proactive approach to managing treatment-related challenges [8][39]

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Summary of Cardiff Oncology Conference Call Company Overview - **Company**: Cardiff Oncology (NasdaqCM: CRDF) - **Focus**: Development of onvansertib, a first-in-class PLK1 inhibitor targeting RAS-mutated metastatic colorectal cancer [2][35] Key Points and Arguments Product and Mechanism - **Onvansertib**: A highly selective PLK1 inhibitor designed for first-line treatment of RAS-mutated metastatic colorectal cancer [2][4] - **Mechanism**: PLK1 is an enzyme that drives tumor cell division and survival; onvansertib inhibits this enzyme, leading to reduced tumor growth and metastasis [3][4] Clinical Trials and Efficacy - **Clinical Trials**: Initial trials showed strong efficacy signals in RAS-mutated metastatic colorectal cancer, particularly in BEV-naive patients [3][11] - **Response Rates**: In a second-line trial, onvansertib combined with standard care showed a 73% response rate in BEV-naive patients compared to 16% in BEV-exposed patients [11] - **Progression-Free Survival (PFS)**: Nearly doubled in BEV-naive patients compared to historical controls [11] Market Opportunity - **Unmet Need**: Colorectal cancer has a low five-year survival rate of only 15%, with no new therapies introduced in over 20 years for RAS-mutated patients [5][6] - **Target Population**: Approximately 50% of newly diagnosed colorectal cancer patients have RAS mutations, indicating a significant market opportunity [6][35] Regulatory and Development Path - **FDA Alignment**: Received clear guidance from the FDA to pivot from second-line to first-line clinical development, addressing a larger patient population [4][18] - **Ongoing Trials**: The ongoing first-line trial is designed to assess the efficacy of onvansertib in combination with standard chemotherapy [19][20] Safety and Tolerability - **Safety Profile**: Onvansertib is well tolerated, with no significant increase in neutropenia compared to control groups [30][31] - **Combination Therapy**: The drug can be combined with existing chemotherapies without compromising safety, allowing for longer treatment durations [40][41] Financial and Strategic Partnerships - **Partnership with Pfizer**: Pfizer holds a 3% equity stake in Cardiff Oncology and is involved in trial execution through its Pfizer Ignite program, providing high-quality data without strings attached [33][34] Future Outlook - **Next Steps**: Plans to update on trial progress in Q1 of the following year, with a focus on durability data and potential registrational trials [36] - **Investment Opportunity**: The company is positioned to make a significant impact in the treatment of colorectal cancer, presenting a compelling investment opportunity [42][43] Additional Important Information - **Patents**: Two new patents were issued, extending the intellectual property protection for onvansertib until at least 2043 [17] - **Clinical Data Publication**: Findings have been published in the Journal of Clinical Oncology, highlighting the significance of the research [16] This summary encapsulates the critical insights from the conference call, emphasizing Cardiff Oncology's innovative approach to treating colorectal cancer and the potential for significant market impact.