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Here’s What Hit Delcath Systems (DCTH) in Q3
Yahoo Finance· 2025-12-16 15:25
Riverwater Partners, an investment management company, released its “Micro Opportunities Strategy” Q3 2025 investor letter. A copy of the letter can be downloaded here. The strategy reported solid absolute returns in the quarter but lagged the benchmark as it did not keep pace with the strong rally. The strategy continues to focus on quality companies in the volatile environment. In addition, you can check the fund’s top 5 holdings to determine its best picks for 2025. In its third-quarter 2025 investor ...
GILD's Bictegravir and Lenacapavir Regimen for HIV Meets Primary Goal
ZACKS· 2025-12-16 14:56
Key Takeaways GILD's ARTISTRY-2 showed once-daily BIC/LEN was non-inferior to Biktarvy at week 48.GILD randomized virologically suppressed patients 2:1 to switch to BIC/LEN or stay on Biktarvy.GILD plans regulatory filings combining phase III results from ARTISTRY-1 and ARTISTRY-2.Gilead Sciences, Inc. (GILD) announced that the investigational single-tablet regimen of bictegravir and lenacapavir for the treatment of HIV met the primary endpoint in the late-stage ARTISTRY-2 study.ARTISTRY-2 is a multicenter, ...
意外BD,炸出新潜力靶点
Xin Lang Cai Jing· 2025-12-16 14:40
来源:市场资讯 (来源:抗体圈) 意料之外的惊喜来了!昨天收盘长春高新发布公告,其下属公司上海赛增医疗与Yarrow Bioscience签订 关于GenSci098管线的BD协议。根据协议,赛增医疗预计可获得1.2亿美元首付款及近期开发里程碑款 项(包括7000万美元不可退还、不可抵扣的首付款,及后续5000万美元的近期开发里程碑款项),后续里 程碑付款和销售额提成方面。赛增医疗将有权就本次独家许可至多获得13.65亿美元里程碑付款,后续 产品上市后并有权获得超过净销售额10%的销售提成。 这次BD是RTW Investments风投公司组的局,Yarrow Bioscience目前是一家还没有公司官网,员工人数 10-50人的小型biotech。而GenSci098则是一项还非常早期,目前还没有临床数据的管线。这场交易无论 怎么看,都显得过于早期,但是,笔者认为仍然有一些公开信息,可供我们串联。 但是7000万美金毕竟是不小的数字,笔者在这其中产生了强烈的好奇心,希望能够对它治疗的疾病与相 关管线格局进行整理。 01 靶点与前代药物 我们先从这个靶点开始解释,公告给它的名字是TSHR,它的全称是促甲状腺激 ...
Can-Fite Provides Update on Clinical and Financial Status
Globenewswire· 2025-12-16 14:19
Core Insights - Can-Fite BioPharma Ltd. is advancing its clinical development activities and financial status, focusing on proprietary small-molecule drugs for oncological and inflammatory diseases [1] Clinical Development - Can-Fite is enrolling patients in a pivotal Phase III clinical study for Namodenoson, targeting advanced hepatocellular carcinoma (HCC) in patients with Child-Pugh B7 liver function, addressing a significant unmet medical need [2] - An interim analysis for the Phase III study of Namodenoson is expected in Q4 2026, with potential eligibility for conditional regulatory approval from the FDA and EMA based on positive results [2] - A Phase IIb clinical study of Namodenoson for metabolic dysfunction-associated steatohepatitis (MASH) is ongoing, following positive Phase IIa trial results [3] - Namodenoson is also being evaluated in a Phase IIa study for pancreatic cancer, with data expected in Q2 2026 [4] - Can-Fite is conducting a pivotal Phase III clinical study for Piclidenoson in psoriasis, with interim analysis data anticipated in Q2 2026 [5] - The company has developed a Phase II study protocol for Lowe Syndrome, planning to submit it to regulatory authorities in Italy and EMA in Q1 2026 [5] Financial Status - As of June 30, 2025, Can-Fite had cash and cash equivalents of $6.45 million, and raised $5 million from a public offering in July 2025, followed by an additional $2.2 million through an ATM facility in November 2025 [6] Company Strategy - The company aims to address significant unmet medical needs with orally administered drug candidates, with ongoing pivotal studies in liver cancer and psoriasis, alongside mid-stage programs in MASH and pancreatic cancer [7] - Can-Fite's lead drug candidate, Piclidenoson, is positioned in multi-billion-dollar markets for cancer, liver, and inflammatory diseases, with a strong safety profile demonstrated in over 1,600 patients [8]
Here Are Tuesday’s Top Wall Street Analyst Research Calls: Allstate, Chubb Ltd., Eli Lilly, KLA Corp., Lockheed Martin, MongoDB, Roku, and More
Yahoo Finance· 2025-12-16 14:09
Thinkstock Quick Read The rotation trade had another run on Wall Street Monday, as tech stocks led the selling once again. While the move away from the AI/Data center trade has gained some strength, the reality is that with a likely third year of double-digit gains for the S&P 500, year-end profit taking is also coming in. With a slew of economic data set to come in this week, volatility could rise even further. If you’re thinking about retiring or know someone who is, there are three quick quest ...
Levi & Korsinsky Reminds Shareholders of a Lead Plaintiff Deadline of January 16, 2026 in Skye Bioscience, Inc. Lawsuit - SKYE
Prnewswire· 2025-12-16 14:00
NEW YORK, Dec. 16, 2025 /PRNewswire/ -- Levi & Korsinsky, LLP notifies investors in Skye Bioscience, Inc. ("Skye Bioscience, Inc." or the "Company") (NASDAQ: SKYE) of a class action securities lawsuit. CLASS DEFINITION: The lawsuit seeks to recover losses on behalf of Skye Bioscience, Inc. investors who were adversely affected by alleged securities fraud between November 4, 2024 and October 3, 2025. Follow the link below to get more information and be contacted by a member of our team: https://zlk.com/pslr ...
Monte Rosa Therapeutic (NasdaqGS:GLUE) Update / Briefing Transcript
2025-12-16 14:00
Summary of Monte Rosa Therapeutics Conference Call Company Overview - **Company**: Monte Rosa Therapeutics (NasdaqGS:GLUE) - **Focus**: Development of MRT-2359, a GSPT-1-directed molecular glue degrader for treating metastatic castration-resistant prostate cancer (CRPC) Key Industry Insights - **Target Market**: Heavily pretreated metastatic castration-resistant prostate cancer patients, particularly those with androgen receptor (AR) mutations - **Market Opportunity**: Up to 30% of metastatic CRPC patients in later lines of therapy carry AR mutations, indicating a substantial market potential for MRT-2359 [6][25] Core Findings from Clinical Trials - **Clinical Activity**: In a small phase II expansion arm, MRT-2359 combined with enzalutamide showed a 100% PSA response rate in four patients with AR mutations, with two patients achieving PSA 90 responses and two achieving PSA 50 responses [5][17] - **Disease Control Rate**: The overall disease control rate was 64% across 14 patients, with two RECIST partial responses and several patients showing stable disease [6][18] - **Safety Profile**: The combination was well tolerated, with mild to moderate gastrointestinal adverse events being the most common, suggesting a favorable safety profile compared to other therapies [6][17] Mechanism of Action - **MRT-2359 Mechanism**: Acts as a molecular glue degrader of GSPT-1, leading to the degradation of MYC and other oncoproteins, which is critical for the growth of prostate cancer cells [7][9] - **Preclinical Evidence**: Prostate cancer cell lines with high MYC expression showed greater sensitivity to MRT-2359, supporting its therapeutic rationale [10][11] Future Directions - **Next Steps**: Plans to initiate a signal-confirming phase II study in 2026, focusing on AR mutant patients and potentially expanding to earlier line settings [24][25] - **Study Design**: The upcoming study will utilize a Simon's two-stage design, enrolling up to 25 patients with metastatic CRPC and AR mutations, with endpoints including PSA response and safety [24] Pipeline Updates - **Other Programs**: Progress on MRT-6160, a VAV1-directed MGD program licensed to Novartis, and MRT-8102, a NEK7-directed MGD, with plans for multiple phase II studies in immune-mediated diseases and cardiovascular conditions, respectively [26][27] Additional Insights - **Comparative Analysis**: The PSA response rate of 29% in the overall population is comparable to other combination therapies, indicating competitive positioning in the market [17][25] - **Patient Demographics**: The study population was heavily pretreated, with 75% having prior treatment with second-generation AR inhibitors and 80% with chemotherapy, highlighting the challenging nature of the patient cohort [16][18] Conclusion - **Encouraging Data**: The results from the phase I-II study of MRT-2359 demonstrate compelling clinical activity in a high unmet need population, with plans for further studies to confirm its efficacy and safety in treating metastatic CRPC [25][26]
TMO Stock Set to Gain From the Expansion of Gibco Bacto Portfolio
ZACKS· 2025-12-16 13:51
Core Insights - Thermo Fisher Scientific (TMO) has expanded its Gibco Bacto CD portfolio with the introduction of Gibco Bacto CD Supreme FPM Plus and Gibco Bacto CD Supreme Feed (2X), aimed at enhancing plasmid DNA and recombinant protein production using E. coli [1][5] Company Developments - The new formulations represent a significant advancement in microbial bioprocessing technology, expected to strengthen TMO's Cell Culture and Cell Therapy business [2] - Following the announcement, TMO shares increased by 0.7%, closing at $575.91, indicating positive market reception [3] - TMO has a market capitalization of $215.01 billion and an earnings yield of 3.9%, outperforming the industry average of -3.5% [4] Product Features - The Gibco Bacto CD Supreme FPM Plus medium is hydrolysate-free and supports high-density E. coli cultures, designed for various strains, enhancing process development and growth performance [6] - When used with Bacto CD Supreme Feed (2X), customers can achieve up to 120% higher plasmid DNA production yield compared to traditional methods, ensuring consistent results from lab to commercial scale [8][9] Industry Context - The global plasmid DNA manufacturing market is projected to grow from $2.13 billion in 2024 at a CAGR of 21.4% through 2030, driven by increasing demand for gene therapy and mRNA vaccines [10] - TMO is expanding its bioprocessing capabilities in Asia, including a new Bioprocess Design Center in Hyderabad, India, to support the growing biopharmaceutical industry [11] Stock Performance - Over the past three months, TMO shares have risen by 21.8%, significantly outperforming the industry growth of 7.5% [12]
Top 2 Health Care Stocks That May Keep You Up At Night In December
Benzinga· 2025-12-16 13:30
As of Dec. 16, 2025, two stocks in the health care sector could be flashing a real warning to investors who value momentum as a key criteria in their trading decisions.The RSI is a momentum indicator, which compares a stock’s strength on days when prices go up to its strength on days when prices go down. When compared to a stock’s price action, it can give traders a better sense of how a stock may perform in the short term. An asset is typically considered overbought when the RSI is above 70, according to B ...
December 2025 Letter to Shareholders
Globenewswire· 2025-12-16 13:30
Core Insights - CytoDyn has made significant progress in 2025, particularly in demonstrating the potential of leronlimab in solid tumor oncology, especially for metastatic Triple-Negative Breast Cancer (mTNBC) [1][2][3] - The company is optimistic about 2026, anticipating important clinical and regulatory milestones that could enhance its position in the biotech industry [8][9] Operational Strengthening - In 2025, CytoDyn focused on regulatory preparations, clinical strategy refinement, and internal process improvements, including data integrity and trial oversight [4] - The company engaged more constructively with regulators and investigators to enhance operational efficiency [4] Clinical Program Advancement - CytoDyn's scientific team made foundational progress in therapeutic areas, improving study designs and aligning with clinical experts to create a realistic roadmap for future success [5] - The Phase II study for metastatic colorectal cancer (mCRC) was launched in July 2025, with early results showing promise [12][13] Financial Discipline - The company maintained prudent financial management in 2025, focusing on extending its financial runway and directing resources toward high-potential programs [6] Future Outlook - CytoDyn is preparing for several clinical and regulatory inflection points in 2026, including advancements in ongoing studies and data readouts to confirm the proposed mechanism of action for leronlimab [8][9] - The company plans to open an Expanded Access Program (EAP) for leronlimab in early 2026, pending FDA approval, to provide treatment options for patients who have exhausted other therapies [16] Collaborative Initiatives - CytoDyn is collaborating with various academic centers on multiple studies, including a pilot study for recurrent Glioblastoma and a project for Alzheimer's Disease, indicating a broadening of its research focus [17][18][19]