NASH 新药上市带来 Fibrsocan 需求爆发，预计持续时间 5 年以上｡ 全球有 NASH (MASH) 患者 3~4 亿，诺和诺 德､礼来､默沙东､辉瑞､BI 等多家医药巨头均在布局 NASH 新药｡2025~2030 年有多个 NASH 新药上市，而这些新药 进行推广的前提是把患者找出来 (NASH 无症状)， 这就需要大量使用 Fibroscan (福瑞控股子公司 EchoSens 的核心 产品)，Fibroscan 是 NASH 的流量入口。在治疗的患者需要进行评估疗效 (例如 3 个月一次)， 也需要大量用到 Fibroscan。预计未来 3~5 年，欧美在治疗的 NASH 患者达千万量级，大规模筛查加疗效评估带来的检测需求可能上 亿人次每年｡如果都是按次收费，单次平均 40 欧元，则 EchoSens 未来收入可达 40 亿欧元，净利润 16 亿欧元｡保守 预测，只有一半是按次收费，净利润也达 8 亿欧元，归母 4 亿欧元 (仅欧美市场)｡ 今年三季度迎来 NASH 产业巨大拐点｡ 诺和诺德一季报显示，已在今年一季度提交司美格鲁肽 NASH 适应症上市申 请，并获得美国优先审批资格，将在今 ...

Core Insights - Madrigal Pharmaceuticals has successfully launched Rezdiffra (resmetirom) for nonalcoholic steatohepatitis (NASH) in April 2024, achieving net sales of $137.3 million in Q1, surpassing the $100 million per quarter threshold [1] Company Performance - The drug Rezdiffra has shown strong market performance shortly after its launch, indicating a robust demand in the NASH treatment space [1] Market Context - The success of Rezdiffra reflects the growing interest and investment in biotech stocks, particularly those focused on FDA-regulated industries and significant health conditions like NASH [1]

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Topline CATT1 Phase 3 data is expected in 2H 2026 Protocol amendment shortens trial duration from 12 to 6 months, expediting time to topline data HIGH POINT, N.C., May 15, 2025 (GLOBE NEWSWIRE) -- vTv Therapeutics Inc. (Nasdaq: VTVT), a late-stage biopharmaceutical company with an innovative clinical portfolio of small molecules and lead program in diabetes, today announced that screening has been reinitiated in the Company’s CATT1 Phase 3 trial investigating cadisegliatin as an adjunctive treatment of type ...

89Bio (ETNB) 2025 Conference May 14, 2025 01:40 PM ET Speaker0 This joining us on this, our second day of Bank of America's twenty twenty five health care conference here in Las Vegas. My name is Jason Zemanski. I'm one of SMID cap analysts here at the bank, And I'm so pleased to have join me on stage, Rohan Palakkar. Thank you so much for joining us. Speaker1 Great to be here, Jason. Thanks for having us. Well, Speaker0 maybe let's start broadly, especially for those newer to the story. What about FGF21 ma ...

Core Insights - Agios Pharmaceuticals is presenting new data on its pyruvate kinase (PK) activators, mitapivat and tebapivat, at the upcoming European Hematology Association (EHA) Congress in Milan, Italy, from June 12-15, 2025 [1][2] Company Overview - Agios Pharmaceuticals is a leader in cellular metabolism and PK activation, focusing on therapies for rare diseases [1][17] - The company has developed PYRUKYND (mitapivat), a first-in-class pyruvate kinase activator for treating hemolytic anemia in adults with PK deficiency [9][17] Clinical Data Presentation - A total of 14 presentations and publications will be shared at EHA 2025, highlighting the efficacy and safety of PK activation in treating rare blood disorders [3][2] - Key presentations include: - Results from the ACTIVATE-KidsT Phase 3 study of mitapivat in children with PK deficiency, showing a clinically meaningful reduction in transfusion burden [6] - Long-term data from the ESTIMATE Phase 2 trial of mitapivat in sickle cell disease, demonstrating sustained efficacy and tolerability over three years [6] - Preclinical data on tebapivat's potential in reducing red blood cell sickling in sickle cell disease patients [6] Research Focus Areas - The presentations will cover serious conditions with limited treatment options, including sickle cell disease, thalassemia, PK deficiency, and myelodysplastic syndromes [2][6] - Ongoing investigations include the expression patterns of PKM2 in patients with myelodysplastic syndromes, supporting the potential of tebapivat in lower-risk MDS [6] Collaboration and Community Engagement - Agios aims to strengthen its collaboration with the global hematology community through these presentations at EHA [2]

Akero Therapeutics (AKRO) 2025 Conference May 13, 2025 04:40 PM ET Speaker0 And I'm very pleased to have joined me in our first slot of the afternoon session, Andrew Chang, CEO of Vaccaro. Thank you so much for joining us. Speaker1 Thank you for having us, Jason. Well, perfect. Speaker0 Maybe just to start broadly to provide a little context for those newer to the story, Can you describe the role of FGF21 in the pathogenesis of liver fibrosis? Kind of acknowledging that it is somewhat early, but what are so ...

Financial Data and Key Metrics Changes - The company ended Q1 2025 with $150 million in cash, cash equivalents, and short-term investments, an increase from $132 million at the end of 2024, primarily due to $35 million raised from the ATM facility [22][20] - R&D expenses for Q1 2025 were $15.8 million, down from $21.5 million in the same period of 2024, with $9.2 million specifically related to pemidutide development [22][24] - General and administrative expenses rose to $6 million from $5.3 million in Q1 2024, mainly due to increased non-cash stock compensation [23] Business Line Data and Key Metrics Changes - The company is focused on the development of pemidutide, with significant progress in the NASH program, including the upcoming readout of the IMPACT Phase 2b MATCH trial [8][12] - The trial enrolled 212 participants with biopsy-confirmed F2F3 NASH, enhancing the study's power [12] Market Data and Key Metrics Changes - The company is expanding into alcohol use disorder (AUD) and alcohol liver disease (ALD), with plans for Phase II trials in these areas [9][10] - The market research indicates that a drug like pemidutide, which reduces alcohol consumption and liver inflammation, would be well-received by patients and physicians [18] Company Strategy and Development Direction - The company aims to establish pemidutide as a foundational treatment across multiple fibrotic liver diseases, focusing on NASH, AUD, and ALD [10][19] - The strategic partnership with Hercules Capital for a $100 million credit facility is intended to support the ongoing development of pemidutide [9][20] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in achieving the trial's key efficacy and safety objectives for pemidutide, which could become the first therapy to achieve statistical significance on NASH endpoints at 24 weeks [8][13] - The company anticipates 2025 to be a transformative year, with significant milestones expected from the IMPACT trial and the initiation of Phase II trials for AUD and ALD [19][24] Other Important Information - The company is preparing for an end-of-Phase II meeting with the FDA in Q4 2025, which will discuss the potential for accelerated approval in F4 cirrhosis [78][79] - The company has a large safety database for pemidutide, which may allow for more efficient trial designs in Phase III [73] Q&A Session Summary Question: Can you provide commentary on the distribution of F2 and F3 in the Phase 2b population? - Management indicated that the demographics of the final qualifying population are similar to other studies, but precise numbers will be presented later [28][29] Question: What is the ideal population for pemidutide post-IMPACT? - The focus is on treating NASH with obesity, as a significant percentage of NASH patients are obese, which is a key factor in the treatment strategy [30][31] Question: How are you handling study discontinuations? - Management reported satisfaction with the discontinuation rates and stated that data will be available at the time of the readout [36] Question: How important is weight loss in this study? - Weight loss is crucial, as it addresses comorbidities associated with NASH, and the company aims to achieve clinically meaningful weight loss [40][41] Question: What are the expected placebo responses for fibrosis and NASH resolution endpoints? - Management noted that placebo responses have varied historically, but they expect to control the placebo response effectively in their trial [87][88] Question: Will you discuss NASH F4 cirrhosis with the FDA? - The company intends to discuss F4 with the FDA and believes they will be successful in this area [78][79] Question: Can you confirm the cash runway with the Hercules facility? - The facility will provide $15 million upfront, with additional tranches available, potentially extending the cash runway into Q3 2026 [81][82]

Altimmune (ALT) Q1 2025 Earnings Call May 13, 2025 08:30 AM ET Speaker0 Good morning, ladies and gentlemen, and welcome to the Altimmune First Quarter twenty twenty five Financial Results Conference Call. After the speakers' presentation, there will be a question and answer session. To ask a question during the session, you will need to press 11 on your telephone. You will then hear an automated message advising your hand is raised. To withdraw your question, please press 11 again. As a reminder, this call ...

Core Viewpoint - BON Natural Life Limited has launched a new sleep health product series utilizing a proprietary delivery system aimed at enhancing the bio-activity of glucoraphanin, a compound found in broccoli, to improve health benefits [1][3][4] Group 1: Product Development - The new product series is developed using the "Glucoraphanin-Myrosinase" delivery system, which is patent-pending and designed to enhance the absorption and utilization of glucoraphanin in the body [1][3] - The delivery system aims to improve the conversion efficiency of glucoraphanin to sulforaphane, addressing challenges related to bio-availability [3][4] Group 2: Health Benefits - Glucoraphanin is linked to various health benefits, including anti-cancer properties, sleep regulation, neuro-protective effects, digestive health support, anti-inflammatory, antioxidant, and anti-aging effects [2] - The enzymatic conversion of glucoraphanin to sulforaphane is typically inefficient, which limits the health benefits derived from broccoli [2] Group 3: Market Potential - The company anticipates that the new sleep health products will achieve market expansion and significantly impact the sleep health market dynamics [4] - The innovative delivery system is expected to combine scientific rigor with commercial potential, addressing unmet needs in sleep health [4]