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Fractyl Health Announces Groundbreaking Data from REMAIN-1 Midpoint Cohort Showing Revita® Maintained Weight Loss After GLP-1 Discontinuation
Globenewswire· 2025-09-26 19:00
Pilot study met key 3-month efficacy endpoint with strong statistical significance (p=0.014); Revita-treated patients lost an additional 2.5% total body weight after stopping GLP-1 drugs vs. 10% regain in sham-treated patients Revita procedure demonstrated excellent safety and tolerability to date, consistent with prior clinical studies Results validate pivotal study design and reinforce Revita’s potential to be the first therapy for post-GLP-1 weight maintenance Company to host investor call and webcast to ...
Fractyl Health (NasdaqGM:GUTS) Earnings Call Presentation
2025-09-26 19:00
Developing Durable Therapies to Break the Pattern of Obesity Corporate Presentation | September 2025 NASDAQ:GUTS Legal Disclaimer The study database has not been locked as this is an ongoing study, and the data are subject to further cleaning and validation. Forward-Looking Statements This presentation contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. All statements contained in this presentation that do not relate to matters of historical fact a ...
Evkeeza® (evinacumab-dgnb) ANGPTL3 Antibody Approved in the U.S. for Children as Young as 1 Year Old with Ultra-Rare Form of High Cholesterol
Globenewswire· 2025-09-26 19:00
FDA approval extends the indication of Evkeeza to treat younger patients with homozygous hypercholesterolemia (HoFH) HoFH is an inherited condition characterized by extremely high levels of low-density lipoprotein cholesterol (LDL-C) Initial Evkeeza approval based on placebo-controlled trial showing Evkeeza, when added to standard lipid-lowering therapies, could lower LDL-C by about 50% compared to placebo in this high unmet need population TARRYTOWN, N.Y., Sept. 26, 2025 (GLOBE NEWSWIRE) -- Regeneron Phar ...
Soligenix Announces Pricing of $7.5 Million Public Offering
Prnewswire· 2025-09-26 18:33
About Soligenix Soligenix is a late-stage biopharmaceutical company focused on developing and commercializing products to treat rare diseases where there is an unmet medical need. The Company's Specialized BioTherapeutics business segment is developing and moving toward potential commercialization of HyBryteâ"¢ (SGX301 or synthetic hypericin sodium) as a novel photodynamic therapy utilizing safe visible light for the treatment of cutaneous T- cell lymphoma (CTCL). With successful completion of the second Ph ...
Bio-Techne Advances Spatial Biology Solutions Bridging Translational Research to Clinical Applications
Prnewswire· 2025-09-26 18:30
Accessibility StatementSkip Navigation MINNEAPOLIS, Sept. 26, 2025 /PRNewswire/ -- Bio-Techne Corporation (NASDAQ: TECH), a global provider of life science tools, reagents and diagnostic products, today announced new advancements in its spatial biology portfolio for the RNAscopeâ"¢ ISH technology and the Lunaphore COMETâ"¢. These solutions help researchers and pathologists bridge the gap between translational research and clinical applications by enabling the detection of RNA and protein biomarkers on the s ...
uniQure(QURE.US)因基因疗法AMT-130大涨 高盛唱多:峰值销售额有望达25亿美元
智通财经网· 2025-09-26 16:44
智通财经APP获悉,高盛最新深度分析报告聚焦uniQure NV(QURE.US)基因疗法AMT-130在亨廷顿病治 疗中的突破性进展及商业前景。据披露,该疗法已在两项剂量组临床试验中展现显著疗效——高剂量组 17例患者完成36个月随访后,复合亨廷顿病评定量表显示疾病进展较自然病史减缓75%,总功能能力评 分变化减缓60%,脑脊液神经丝轻链蛋白水平平均下降8.2%;低剂量组12例患者虽未直接给出对比数 据,但整体趋势与高剂量组一致。生物标志物及多项次要终点指标均支持AMT-130的神经保护作用。近 日,该股已因为该疗法消息出现大涨。 在FDA加速批准路径下,uniQure计划于2026年第一季度提交生物制品许可申请,基于高剂量组三年期 的复合亨廷顿病评定量表(CUHDRS)变化数据,并采用ENROLL-HD自然病史数据集作为外部对照进行 倾向评分匹配分析。FDA已认可其制造工艺验证路径,要求补充全规模良好生产规范批次及单个工艺性 能确认批次以支持生物制品许可申请(BLA)提交。 安全性方面,自2022年12月起未新增严重不良事件,给药相关不良反应均已解决;第三队列联合免疫抑 制方案试验中,三例严重不良事件通过 ...
BioPorto Sponsors Conferences on Pediatric Critical Care with New NGAL Scientific Data Presented
Globenewswire· 2025-09-26 16:13
September 26, 2025News Release BioPorto Sponsors Conferences on Pediatric Critical Care with New NGAL Scientific Data Presented COPENHAGEN, DENMARK and BOSTON, MA, USA, September 26 – BioPorto A/S (“BioPorto” or the “Company”) (CPH:BIOPOR), is pleased to support conferences focused on pediatric solid organ transplants and critical care nephrology. Clinical researchers present posters, abstracts and new publications using NGAL in their patients, leading to better identification for risk of Acute Kidney Injur ...
CSL Vifor and Travere Therapeutics Recognize Updated KDIGO Clinical Practice Guidelines for IgA Nephropathy
Prnewswire· 2025-09-26 14:30
ST. GALLEN, Switzerland, and SAN DIEGO, Sept. 26, 2025 /PRNewswire/ -- CSL Vifor and Travere Therapeutics, Inc., (NASDAQ: TVTX) support the recent publication of the updated clinical practice guidelines for the treatment of IgA Nephropathy (IgAN), Kidney Disease: Improving Global Outcomes (KDIGO) 2025 clinical practice guideline for the management of IgA Nephropathy and Immunoglobulin A vasculitis. The updated guidelines define diagnostic criteria, treatment goals and treatment approaches, aiming for progre ...
Mesoblast Cell Therapy Products are Designated U.S. Origin and Not Subject to Tariffs
Globenewswire· 2025-09-26 13:49
NEW YORK, Sept. 26, 2025 (GLOBE NEWSWIRE) -- Mesoblast Limited (Nasdaq:MESO; ASX:MSB), global leader in allogeneic cellular medicines for inflammatory diseases, today reiterated that its allogeneic cell therapy products are manufactured from U.S. donors in the U.S. and designated as U.S. origin products not subject to tariffs on imported branded or patented pharmaceutical products. Ryoncil® (remestemcel-L) is the only allogeneic mesenchymal stromal cell therapy approved by U.S. Food and Drug Administration ...
Mesoblast Cell Therapy Products are Designated U.S. Origin and Not Subject to Tariffs
Globenewswire· 2025-09-26 13:49
NEW YORK, Sept. 26, 2025 (GLOBE NEWSWIRE) -- Mesoblast Limited (Nasdaq:MESO; ASX:MSB), global leader in allogeneic cellular medicines for inflammatory diseases, today reiterated that its allogeneic cell therapy products are manufactured from U.S. donors in the U.S. and designated as U.S. origin products not subject to tariffs on imported branded or patented pharmaceutical products. Ryoncil® (remestemcel-L) is the only allogeneic mesenchymal stromal cell therapy approved by U.S. Food and Drug Administration ...