MB-07811

Study is Evaluating Monthly Subcutaneous, Weekly Oral, and Daily Oral Regimens Designed to Explore Maintenance Dosing Regimens Following Initial Weight Loss with VK2735 SAN DIEGO, Jan. 8, 2026 /PRNewswire/ -- Viking Therapeutics, Inc. (Viking) (NASDAQ: VKTX), a clinical-stage biopharmaceutical company focused on the development of novel therapies for metabolic and endocrine disorders, today announced the completion of patient enrollment in its exploratory maintenance dosing study of VK2735, the company's dual agonist of the glucagon-like peptide 1 (GLP-1) and glucose-dependent insulinotropic polypeptide (GIP) receptors. VK2375 is being developed in both oral and subcutaneous formulations for the potential treatment of various metabolic disorders such as obesity. The maintenance dosing study is a Phase 1, randomized, double-blind, placebo-controlled trial designed to evaluate various dosing regimens, following initial weight loss achieved with weekly VK2735 treatment. The trial enrolled approximately 180 adults with BMI ≥30 kg/m2 but who are otherwise healthy. All enrolled participants receive initial weekly subcutaneous doses of VK2735 or placebo for 19 weeks. Following Week 19, participants are transitioned to a range of VK2735 maintenance dosing regimens including weekly, every other week, or monthly subcutaneous dosing, as well as daily oral dosing, weekly oral dosing, or placebo. The objectives of the study are to evaluate the safety, tolerability, and pharmacokinetic profile of VK2735 under these various dosing regimens. Exploratory endpoints are assessing change in body weight from baseline, as well as change in body weight from Week 19 to the end of the study at Week 31. "The successful development of maintenance dosing regimens is critical to realizing the long-term health benefits from weight loss and may provide an opportunity to further differentiate VK2735 from currently available obesity treatments," said Brian Lian Ph.D., chief executive officer of Viking. "Importantly, the same dual-acting GLP-1/GIP agonist molecule is used in both our subcutaneous and oral formulations, which may uniquely enable treatment flexibility with VK2735. Remaining on the same active compound offers the potential for long-term dosing with either tablets or injections with potentially reduced side effects compared with options that require switching between different therapeutic agents. This may improve adherence to treatment, a key factor in achieving the long-term benefits of weight loss such as improved cardiovascular health, enhanced physical function, and increased quality of life. We look forward to reporting the results of this important study later this year." In addition to the maintenance dosing study, Viking is currently conducting two Phase 3 studies evaluating subcutaneous VK2735 (VANQUISH-1 and VANQUISH-2). These trials are randomized, double-blind, placebo-controlled, multicenter trials designed to assess the efficacy and safety of subcutaneous VK2735 dosed weekly for 78 weeks. The VANQUISH-1 study has completed enrollment of approximately 4,650 adults with obesity (BMI ≥30 kg/m2) or who are overweight (BMI ≥27 kg/m2) with at least one weight-related co-morbid condition. The VANQUISH-2 study is enrolling approximately 1,100 adults with type 2 diabetes who have obesity or are overweight. Patients in both trials are being randomized to one of four weekly treatment arms: VK2735 7.5 mg; VK2735 12.5 mg; VK2735 17.5 mg; and placebo. About GLP-1 and Dual GLP-1/GIP Agonists Activation of the glucagon-like peptide 1 (GLP-1) receptor has been shown to decrease glucose, reduce appetite, lower body weight, and improve insulin sensitivity in patients with type 2 diabetes, obesity, or both. Semaglutide is a GLP-1 receptor agonist that has been approved by the U.S. Food and Drug Administration and is currently marketed in various dosage strengths and forms as Ozempic®, Rybelsus®, and Wegovy®. More recently, research efforts have explored the potential co-activation of the glucose-dependent insulinotropic peptide (GIP) receptor as a means of enhancing the therapeutic benefits of GLP-1 receptor activation. Tirzepatide is a dual GLP-1/GIP receptor agonist that has been approved by the U.S. Food and Drug Administration and is currently marketed in various dosage strengths and forms as Mounjaro® and Zepbound®. About Viking Therapeutics, Inc. Viking Therapeutics, Inc. is a clinical-stage biopharmaceutical company focused on the development of novel first-in-class or best-in-class therapies for the treatment of metabolic and endocrine disorders. Viking's research and development activities leverage its expertise in metabolism to develop innovative therapeutics designed to improve patients' lives. Viking's clinical programs include VK2735, a novel dual agonist of the glucagon-like peptide 1 (GLP-1) and glucose-dependent insulinotropic polypeptide (GIP) receptors for the potential treatment of various metabolic disorders. The company is evaluating its subcutaneous formulation of VK2735 in a Phase 3 obesity program that includes two Phase 3 clinical trials (VANQUISH-1 and VANQUISH-2). Data from a Phase 1 and a Phase 2 trial evaluating subcutaneous VK2735 demonstrated an encouraging safety and tolerability profile as well as positive signs of clinical benefit. Concurrently, the company is evaluating an oral formulation of VK2735 in obesity. Viking is also developing VK2809, a novel, orally available, small molecule selective thyroid hormone receptor beta agonist for the treatment of lipid and metabolic disorders. The compound successfully achieved both the primary and secondary endpoints in a Phase 2b study for the treatment of biopsy-confirmed non-alcoholic steatohepatitis (NASH) and fibrosis. In a Phase 2a trial for the treatment of non-alcoholic fatty liver disease (NAFLD) and elevated LDL-C, patients who received VK2809 demonstrated statistically significant reductions in LDL-C and liver fat content compared with patients who received placebo. The company's newest program is evaluating a series of internally developed dual amylin and calcitonin receptor agonists (or DACRAs) for the treatment of obesity and other metabolic disorders. In the rare disease space, Viking is developing VK0214, a novel, orally available, small molecule selective thyroid hormone receptor beta agonist for the potential treatment of X-linked adrenoleukodystrophy (X-ALD). In a Phase 1b clinical trial in patients with the adrenomyeloneuropathy (AMN) form of X-ALD, VK0214 was shown to be safe and well-tolerated, while driving significant reductions in plasma levels of very long-chain fatty acids (VLCFAs) and other lipids, as compared to placebo. For more information about Viking Therapeutics, please visit . Forward-Looking Statements This press release contains forward-looking statements regarding Viking Therapeutics, Inc., under the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995, including statements about Viking's expectations regarding its clinical and preclinical development programs, anticipated timing for reporting clinical data and cash resources. Forward-looking statements are subject to risks and uncertainties that could cause actual results to differ materially and adversely and reported results should not be considered as an indication of future performance. These risks and uncertainties include, but are not limited to: risks associated with the success, cost and timing of Viking's product candidate development activities and clinical trials, including those for VK2735, VK0214, VK2809, and the company's other incretin receptor agonists; risks that prior clinical and preclinical results may not be replicated; risks regarding regulatory requirements; and other risks that are described in Viking's most recent periodic reports filed with the Securities and Exchange Commission, including Viking's Annual Report on Form 10-K for the year ended December 31, 2024, and subsequent Quarterly Reports on Form 10-Q, including the risk factors set forth in those filings. These forward-looking statements speak only as of the date hereof. Viking disclaims any obligation to update these forward-looking statements except as required by law. SOURCE Viking Therapeutics, Inc. 21% more press release views with Request a Demo

毫无疑问的是在2025年上半年一轮波澜壮阔的中国创新药资产在二级市场的爆发之后，当下已经调整数月。中国创新药资产多在资金自由流动的香港市场上市，其走势与全球资金流动密切相关。 创新药资产，留给有准备的人。恒生生物科技指数自2025年1月中旬至9月中旬累计上涨幅度超过125%，自9月的高点以来至今调整大约20%。而在2025年以前的两年多时间中无数上市于港股的创新药公司一度市值跌至破现的尴尬境地，而正是在2022年下半年开始持续收集筹码的投资者在这轮创新药牛市中候得数倍的投资回报。 对于整个板块而言，虽有过去三个月的调整，但是2025年至今依旧涨幅颇高。而三个月的调整时间与20%的调整幅度或许并不足以支持下一轮创新药牛市的快速到来。 把市场交给时间的同时，中国创新药创新实力的持续提升并在逐渐被全世界所认知的事实也毋庸置疑。回顾2025年全球生物医药并购以及BD合作的报道中，知名媒体Fierce Pharma在报道中也认为当下欧美企业并购/合作对象中，来自中国的资产数量正在增加，而中国也正在成为全球创新中心。而背后的原因则是中国的创业活力令人震惊且拥有巨量的高级技术人员以及大规模投资和快速向前推动的意愿。 美股创新药资产亦是如此，不过当下处于不同的阶段。根据美国生物技术股指数XBI，生物技术行业在2025年春季触底，准确地说是4月初。特朗普在四月初公布解放日关税后，XBI跌至18个月来最低点。但到12月，该指数上涨了75%，达到自2021年以来的最高水平。 相较于回调中的港股创新药，或许XBI短期的赢率更高。而当XBI指数见顶之后港股创新药或能迎来更加全面的反转。 减重世界第三极 Viking Therapeutics 目前被市场视为继诺和诺德和礼来之后，减肥药（GLP-1）赛道最具竞争力的“第三极”潜力股。 截至 2025 年 9 月 30 日，公司持有约 7.15 亿美元 的现金及等价物。按目前的烧钱速度，足以支撑其运营至 2027 年之后，覆盖核心项目 VK2735 的关键临床开支。但是随着Q3临床开支的加大，Q3 净亏损为 9080 万美元，去年同期为 2490 万美元。 Viking 的核心价值由 VK2735和 VK2809（MASH/NASH 药物）两部分组成。VK2735，一款GLP-1/GIP 双重激动剂，是 Viking 的核心管线，具有注射剂和口服片剂两种剂型，对标礼来的替尔泊肽。 最受期待的口服片剂。2025 年 8 月公布了 Phase 2 VENTURE-Oral 临床数据。 每日一次口服 13 周后，最高剂量组减重达 12.2%。但市场对其 28% 的高停药率（主要因呕吐等胃肠道副作用）存有疑虑，导致当时股价出现剧烈波动。 第一梯队的口服数据。礼来的奥福格鲁肽在72周内（III期临床）减重约11%。诺和诺德的口服司美格鲁肽在64周内（III期临床）减重约14%。 VK2735的13周12.2%，在目前临床中后期的口服减重管线中处于第一梯队。在试验进行到13周时并未出现平台期，暗示未来随着时间的推移或许会取得更有效的减重数据。 安全性之外的长期有效性担忧。VK2735在短期实验中的数据鼓舞人心，但是长期有效性是否能达到和礼来或诺和诺德相同的水准却缺乏数据。当下也只能从已经公布的II期数据的体重随时间下降趋势上窥得一二。 皮下注射制剂。Phase 2 VENTURE 研究显示，13 周减重达 14.7%。更重要的是，在 2025 年 11 月的肥胖周（ObesityWeek）上，数据显示 78% 的前期糖尿病患者在治疗 13 周后恢复了正常血糖。 2025 年 11 月，公司宣布已完成 Phase 3 VANQUISH-1 临床试验的患者入组，规模约 4,650 人。预计 2027 年 获得III期临床顶线数据。 预期与梦想 创新药买预期的最优秀案例。对于Viking而言，拥有一款有望在口服剂型的有效性上与礼来以及诺和诺德一搏的药物，美股市场当下寄予的估值为42亿美元。而当下全球细胞治疗的王者传奇生物的美股市值也在42亿美元左右，尤其是强生旗下“最强TCE”的临床数据公布之后，作为直接竞争对后传奇生物股价剧烈波动。 一个是处于“纯预期”的减重药新星，一个是已经拥有重磅炸弹、营收快速增长的细胞治疗领军者。 Viking代表更高的天花板。Viking的42亿美元市值买的是万能减重药这个史诗级赛道的入场券。如果VK2735最终获批并在口服市场占据5-10%的市场，其年销售额有望达到50-100亿美元，按照5倍PS计算其预期市值为250-500亿美元。而根据相关研究报告，一款药物从III期临床至成功申报BLA的概率约为70%，按照这个获批概率当下的市值依旧被低估。 回到现实，对于Viking而言纵然有着不错的临床数据，但是诺和诺德和礼来拥有极强的产能优势和医保覆盖能力，身为“光杆司令”的 Viking 在商业化阶段可能面临巨大阻力。 传奇生物代表的是所见即所得。每年有超过10亿美元的现金流进入，但是随着TCE的快速推进以及相对小分子药物和抗体药物较低的利润率需要对其业务做出部分折扣。但是预期2025年传奇生物营收接近20亿美元，当下市值41亿美元，PS仅为2倍。 For future 更多创新药内容尽在辰小飞的log~ 欢迎添加Murphy微信，备注公司/姓名。Base上海，欢迎线下交流。