Key Takeaways ALT received FDA Breakthrough Therapy Designation for pemvidutide in MASH, boosting shares by 16.52%.The tag is backed by IMPACT data, showing MASH resolution without worsening fibrosis & improved liver markers.ALT plans to begin a phase III MASH study in 2026.Altimmune (ALT) announced that the FDA has granted Breakthrough Therapy Designation to its lead pipeline candidate, pemvidutide, a novel, investigational GLP-1/glucagon dual receptor agonist, for the treatment of patients with metabolic ...

Key Takeaways CELC filed an NDA for gedatolisib in HR , HER2- advanced breast cancer, with an FDA decision due in 2026.Phase III VIKTORIA-1 data showed strong PFS gains, supporting gedatolisib as a second-line option.Celcuity completed enrollment in another VIKTORIA-1 cohort, with more cancer studies underway.Celcuity (CELC) has made significant clinical and regulatory progress in the past few months. In November, Celcuity submitted a new drug application (“NDA”) to the FDA seeking approval for its lead pip ...

Key Takeaways ANIP stock gained 21% in six months, supported by Q3 beats and higher full-year 2025 sales and EPS guidance.ANI Pharmaceuticals' rare disease segment more than doubled sales, led by strong demand for Cortrophin Gel.ANIP's generics unit grew in 2025 but faces rising competition and pricing pressure heading into late 2025.ANI Pharmaceuticals’ (ANIP) stock has risen 21% in the past six months, all thanks to the encouraging financial performance of the company during the first nine months of 2025. ...

NEW YORK, Jan. 06, 2026 (GLOBE NEWSWIRE) -- Pomerantz LLP is investigating claims on behalf of investors of Ultragenyx Pharmaceutical Inc. (“Ultragenyx” or the “Company”) (NASDAQ: RARE). Such investors are advised to contact Danielle Peyton at newaction@pomlaw.com or 646-581-9980, ext. 7980. The investigation concerns whether Ultragenyx and certain of its officers and/or directors have engaged in securities fraud or other unlawful business practices.  [Click here for information about joining the class acti ...

Eli Lilly and Nimbus Therapeutics have entered into a multiyear collaboration and exclusive licensing agreement to develop an oral treatment for obesity and other metabolic diseases. ...

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 ...

Core Insights - Moderna has submitted regulatory filings for its seasonal influenza vaccine mRNA-1010 in the US, EU, Canada, and Australia, targeting adults aged 50 and above, with plans to commercialize by next year [1][7] - The submissions are supported by late-stage study data indicating that mRNA-1010 generates immune responses comparable to existing flu vaccines from GSK and Sanofi [2][7] - Following the announcement, Moderna's stock rose over 4%, reflecting investor optimism regarding the potential product launch [3] Regulatory and Development Updates - The recent filings may also facilitate a future resubmission of Moderna's investigational COVID-19 and influenza combination vaccine, mRNA-1083, which had previously been withdrawn due to requests for additional efficacy data [4][7] - Moderna has faced challenges, including a 32% decline in stock over the past year, contrasting with a 15% growth in the industry [5][9] - The company has experienced setbacks, including the termination of a $766 million contract for a bird flu vaccine and the failure of its CMV vaccine in a late-stage study [9][10] Market Sentiment - The latest developments are seen as part of Moderna's strategy to improve negative market sentiment surrounding its stock [8]

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 ...