Arrowhead Pharmaceuticals Conference Call Summary Company Overview - **Company**: Arrowhead Pharmaceuticals (NasdaqGS:ARWR) - **Focus**: Development of obesity therapeutics, specifically targeting the activin E ALK7 pathway and its implications for metabolic diseases Key Points from the Call Industry and Market Context - **Obesity Treatment Landscape**: The call highlighted the evolving understanding of obesity as a multifaceted disease requiring diverse treatment approaches, including pharmacotherapy, surgical options, and lifestyle changes [2][4][5] - **Unmet Needs**: There is a significant unmet need in treating obesity, particularly in patients with Type 2 diabetes, who often do not respond well to existing therapies [5][14][24] Clinical Trials and Results - **ARO-INHBE and ARO-ALK7**: The call presented interim results from Phase I and II studies of two obesity candidates, ARO-INHBE and ARO-ALK7, focusing on their efficacy and safety [2][3][30] - **Interim Results**: - ARO-INHBE demonstrated a mean maximal reduction of activin E by 85% at a 400 mg dose, leading to a 10% reduction in visceral fat and a 38% reduction in liver fat after a single dose [20][34] - In combination with tirzepatide, ARO-INHBE achieved a 9.4% weight loss in obese diabetic patients, compared to 4.8% with tirzepatide alone [25][35] - ARO-ALK7 showed an 88% mean reduction in ALK7 mRNA after a single dose, with a 14.1% placebo-adjusted reduction in visceral fat observed at week eight [32][36] Mechanism of Action - **Activin E ALK7 Pathway**: The pathway is implicated in regulating visceral adiposity, and silencing its expression may lead to improved metabolic outcomes [17][18][27] - **Combination Therapy**: The combination of ARO-INHBE with tirzepatide is seen as a promising approach to enhance weight loss and metabolic health in patients with obesity and Type 2 diabetes [24][35] Safety and Tolerability - **Safety Profile**: ARO-INHBE and ARO-ALK7 were reported to be well tolerated, with most treatment-emergent adverse events (TEAEs) being mild and no significant adverse trends in laboratory values [27][33] Future Directions - **Next Steps**: Arrowhead plans to expand its studies, including increasing patient numbers and exploring combination therapies with other GLP-1 drugs [38][39] - **Regulatory Pathway**: Discussions regarding the regulatory pathway for ARO-INHBE and ARO-ALK7 are ongoing, with a focus on combination therapies for diabetic patients [51][52] Additional Insights - **Research and Development**: Arrowhead is exploring additional targets in obesity and metabolic disorders, including liver and adipose dimers capable of silencing multiple genes with a single drug [39][40] - **Commercialization Plans**: The company is transitioning to a commercial stage with its first sales expected in the FCS patient population, with further studies planned to support label expansion [40][41] Conclusion Arrowhead Pharmaceuticals is making significant strides in the development of innovative obesity therapeutics, with promising interim results from its clinical trials. The focus on the activin E ALK7 pathway and combination therapies positions the company well in addressing the unmet needs in obesity treatment, particularly for patients with Type 2 diabetes. The safety and efficacy data presented suggest a strong potential for these candidates in future therapeutic paradigms.

证券代码：600998 证券简称：九州通 公告编号：临2026-003 九州通医药集团股份有限公司 关于盐酸布比卡因注射液获得药品注册证书的公告 本公司董事会及全体董事保证本公告内容不存在任何虚假记载、误导性陈述或者重大遗漏，并对其内容 的真实性、准确性和完整性承担法律责任。 2026年1月5日，九州通医药集团股份有限公司（以下简称"公司"或"九州通"）子公司北京京丰制药集团 有限公司（以下简称"京丰制药"）的下属公司汇禹远和（海南）药业有限公司（以下简称"汇禹远和"） 收到国家药品监督管理局核准签发的盐酸布比卡因注射液《药品注册证书》。现将相关情况公告如下： 一、药品注册证书主要信息 药品名称：盐酸布比卡因注射液 剂型：注射剂 规格：按C18H28N2O·HCl计，5ml:37.5mg；10ml:75mg 注册分类：化学药品3类 证书编号：2025S04058；2025S04059 药品批准文号：国药准字H20256484；国药准字H20256485 申请事项：药品注册（境内生产） 盐酸布比卡因注射液是一款酰胺类长效局部麻醉药，主要用于局部浸润麻醉、外周神经阻滞和椎管内阻 滞。该药品为国家医保甲类、国家基本 ...

Key Takeaways ZBIO shares plunged 51.9% on Jan. 5, even after its phase III INDIGO study met the primary endpoint.Obexelimab cut IgG4-RD flare risk by 56% vs. placebo over 52 weeks and met key secondary endpoints.ZBIO plans FDA BLA filing for obexelimab in Q2 2026 and an EMA application in 2H 2026 for IgG4-RD.Zenas BioPharma (ZBIO) announced that the phase III INDIGO study, which evaluated its lead pipeline candidate, obexelimab, for treating patients with immunoglobulin G4-related disease (IgG4-RD), has me ...

Key Takeaways Moderna filed for approval of its seasonal flu vaccine mRNA-1010 in the US, EU, Canada and Australia.MRNA said late-stage data show mRNA-1010 immune responses match standard and high-dose flu shots.The filings could also support a potential future resubmission of its COVID-flu combo vaccine.Moderna (MRNA) announced that it submitted regulatory filings seeking approval for its seasonal influenza vaccine mRNA-1010 across the United States, European Union, Canada and Australia.These filings seek ...

Key Takeaways Galafold raked in $371.5M in the first nine months of 2025, accounting for over 80% of FOLD's product sales.Galafold benefits from broad global approvals and U.S. patent protection extending through 2038.FOLD's Pombiliti Opfolda delivered $77.5M sales in the first nine months of 2025, up 61% Y/Y.Amicus Therapeutics (FOLD) has made solid progress with its lead marketed product, Galafold (migalastat), which generates the majority of the company’s revenues.Galafold is approved for treating Fabry ...

The Tel Aviv Stock Exchange rose strongly today. The Tel Aviv 35 Index rose 2.86% to 3,845.39 points - a new record, the Tel Aviv 125 Index rose 2.55% to 3,8980.80 points; and the BlueTech Global Index rose 2.48% to 675.31 points. The All Bond corporate bond index rose 0.12% to 424.03 points. Turnover totalled NIS 5.44 billion in equities and NIS 8.35 billion in bonds. On the foreign exchange market, the representative shekel-dollar rate was set 0.19% higher from Monday, at NIS 3.164/$, and the representa ...

Corcept has also repeatedly assured investors that "[o]ur new drug application for relacorilant is progressing toward approval by the end of" 2025 and "[r]elacorilant's strong efficacy and safety profile gives us the potential to become the new standard of care for patients with hypercortisolism." Critically, Corcept's management also expressed confidence that "we're [more] confident than ever that we're on track to grow our hypercortisolism business from $3 billion to $5 billion in annual revenues in three ...

Key Takeaways Incyte's phase III study of Monjuvi combo met key goals versus R-CHOP alone in first-line DLBCL.INCY's Monjuvi/Minjuvi plus Revlimid with R-CHOP improved outcomes with no new or unexpected safety signals.Incyte plans an FDA filing seeking the label expansion of Monjuvi for first-line DLBCL treatment in H1 2026.Incyte (INCY) announced positive top-line results from a late-stage lymphoma study of Monjuvi/Minjuvi (tafasitamab), a humanized Fc-modified cytolytic CD19 targeting monoclonal antibody, ...

The Stock Exchange of Hong Kong Limited and the Securities and Futures Commission take no responsibility for the contents of this announcement, make no representation as to its accuracy or completeness and expressly disclaim any liability whatsoever for any loss howsoever arising from or in reliance upon the whole or any part of the contents of this announcement. 廣州新濟醫藥股份有限公司 Guangzhou Novaken Pharm Co., Ltd. (A joint stock company incorporated in the People's Republic of China with limited liability) WARNI ...

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