VK2809
Search documents
Viking Therapeutics Announces Completion of Enrollment in Phase 3 VANQUISH-2 Trial of VK2735
Prnewswire· 2026-03-26 11:05
Core Viewpoint - Viking Therapeutics has completed patient enrollment in its Phase 3 VANQUISH-2 clinical trial for VK2735, a dual agonist targeting GLP-1 and GIP receptors, aimed at treating obesity and type 2 diabetes [1][4]. Group 1: Trial Details - The Phase 3 VANQUISH-2 study is a randomized, double-blind, placebo-controlled trial involving approximately 1,000 adults with type 2 diabetes and obesity or overweight [2]. - Participants are randomized into four treatment arms receiving VK2735 at doses of 7.5 mg, 12.5 mg, 17.5 mg, or placebo, administered weekly for 78 weeks [2]. - The primary endpoint is the percent change in body weight from baseline after 78 weeks, with secondary endpoints assessing various safety and efficacy measures [3]. Group 2: Company Milestones - Completing enrollment in the VANQUISH-2 study is a significant milestone for Viking, marking the full enrollment of its two registration studies [4]. - The company also completed enrollment in the Phase 3 VANQUISH-1 study in November 2025, which focuses on similar patient demographics [4]. - Viking anticipates reporting results from the Phase 1 study on maintenance dosing regimens in the third quarter of 2026 [4]. Group 3: Previous Study Results - In 2024, Viking reported positive results from the Phase 2 VENTURE study, where VK2735 showed statistically significant reductions in body weight, with reductions up to 14.7% after 13 weekly doses [5]. - The VENTURE study also indicated a favorable safety and tolerability profile, with most adverse events being mild or moderate [5]. Group 4: Product Overview - VK2735 is being developed in both oral and subcutaneous formulations for metabolic disorders, with a focus on obesity treatment [1][8]. - The drug acts as a dual agonist for GLP-1 and GIP receptors, which are known to help reduce appetite and improve insulin sensitivity [6][8].
What to Know About This Obesity Drug Developer That Just Drew a New $7 Million Investment
Yahoo Finance· 2026-03-16 20:20
Company Overview - Viking Therapeutics is a clinical-stage biopharmaceutical company based in San Diego, California, focusing on developing novel therapies for metabolic and endocrine disorders [5] - The company has a market capitalization of $4.2 billion and reported a net income loss of $359.64 million over the trailing twelve months [4] - Viking's lead candidates include VK2809 for non-alcoholic steatohepatitis and VK5211 for hip fracture recovery, with a business model centered on advancing proprietary drug candidates through clinical trials [8] Recent Developments - On February 17, 2026, ACT Capital Management disclosed a new position in Viking Therapeutics, acquiring 206,100 shares valued at $7.25 million [1][2] - This new position represents 5.86% of ACT Capital Management's reportable assets under management as of December 31, 2025 [7] - Viking Therapeutics shares were priced at $36.07, reflecting a 177% increase over the past year, which is in line with the S&P 500's 18% gain during the same period [7] Clinical Programs and Pipeline - Viking is advancing multiple clinical programs, including Phase 3 trials for a subcutaneous version of VK2735 and preparing an oral version for Phase 3 development [10] - The company reported encouraging early data for VK2735, which targets GLP-1 and GIP hormone pathways, showing average weight reductions of up to 14.7% in a Phase 2 study [9] - As of the end of 2025, Viking had approximately $706 million in cash, providing significant runway to advance its pipeline despite reporting a fourth-quarter net loss of $157.7 million [10] Investment Strategy - ACT Capital Management's investment in Viking Therapeutics aligns with a strategy to concentrate capital in companies developing novel therapies with potentially outsized upside [11] - The fund's top holdings include other biotech investments, indicating a focused approach on innovative healthcare solutions [7]
Viking Therapeutics Reports Fourth Quarter and Year-End 2025 Financial Results and Provides Corporate Update
Prnewswire· 2026-02-11 21:16
Core Insights - Viking Therapeutics reported strong financial results for Q4 and year-end 2025, with a cash position of $706 million and significant advancements in its obesity treatment pipeline [1][3] Financial Performance - Q4 2025 research and development expenses were $153.5 million, up from $31.0 million in Q4 2024, primarily due to increased clinical study costs [3] - General and administrative expenses decreased to $11.3 million in Q4 2025 from $15.3 million in Q4 2024 [3] - The net loss for Q4 2025 was $157.7 million, or $1.38 per share, compared to a net loss of $35.4 million, or $0.32 per share, in Q4 2024 [3] - For the full year 2025, research and development expenses totaled $345.0 million, compared to $101.6 million in 2024 [3] - The net loss for the year ended December 31, 2025, was $358.5 million, or $3.19 per share, compared to a net loss of $110.0 million, or $1.01 per share, in 2024 [3] Clinical Pipeline Updates - The Phase 3 VANQUISH trials for VK2735, a dual agonist for obesity, are ongoing, with VANQUISH-1 fully enrolled and VANQUISH-2 nearing completion [1][3] - VK2735's oral formulation is set to advance into Phase 3 trials in Q3 2026, following positive results from Phase 1 and Phase 2 studies [2][3] - A Phase 1 maintenance dosing study for VK2735 has been fully enrolled, with results expected in Q3 2026 [1][2] Upcoming Developments - The company plans to file an Investigational New Drug (IND) application for a novel amylin agonist this quarter, expanding its obesity treatment portfolio [1][3] - Viking is also developing a series of dual amylin and calcitonin receptor agonists (DACRAs) for obesity and metabolic disorders [4] Market Position and Strategy - VK2735 is positioned as a unique dual agonist with both subcutaneous and oral formulations, potentially improving treatment adherence and reducing side effects [2][3] - The company has established a comprehensive manufacturing and supply agreement for VK2735 to support its commercial activities [1][3]
Viking Therapeutics to Report Financial Results for Fourth Quarter and Year-End 2025 on February 11, 2026
Prnewswire· 2026-02-04 21:05
Core Insights - Viking Therapeutics, Inc. is set to release its financial results for Q4 and year-end 2025 on February 11, 2026, after market close [1] - A conference call will be held on the same day at 4:30 p.m. Eastern Time to discuss these results and provide corporate updates [2] Company Overview - Viking Therapeutics is a clinical-stage biopharmaceutical company focused on developing novel therapies for metabolic and endocrine disorders [3] - The company is advancing several clinical programs, including VK2735, a dual agonist for GLP-1 and GIP receptors, currently in Phase 3 trials for obesity [3] - VK2809, another key program, is an orally available small molecule for treating lipid and metabolic disorders, having met primary and secondary endpoints in a Phase 2b study for NASH [3] - The company is also developing VK0214 for X-ALD, which has shown safety and efficacy in reducing VLCFAs in a Phase 1b trial [3]
Viking Therapeutics to Report Q4 Earnings: Here's What to Know
ZACKS· 2026-01-30 14:50
Core Viewpoint - Investors are expected to focus on Viking Therapeutics' progress with VK2735, a dual agonist for obesity treatment, during the upcoming Q4 and full-year 2025 results announcement [1] Company Overview - Viking Therapeutics is developing VK2735 for obesity treatment, with no marketed drugs currently in its portfolio, leading to no expected revenues for the upcoming quarter [2] - The Zacks Consensus Estimate for Q4 earnings is a loss of 89 cents per share [2] Pipeline Development - VK2735 is being studied in multiple late-stage studies, including VANQUISH-1 and VANQUISH-2, for both oral and subcutaneous formulations [5] - The VANQUISH-1 study, completed in November 2025, evaluates VK2735 in obese adults with weight-related co-morbid conditions, while VANQUISH-2 focuses on obese or overweight adults with type II diabetes [6][7] Competitive Landscape - Eli Lilly and Novo Nordisk dominate the obesity treatment market with their GLP-1 injections, which may increase competitive pressure on Viking Therapeutics [9] - Novo Nordisk recently launched an oral version of Wegovy, and an FDA decision on Lilly's oral obesity pill is expected in the first half of 2026 [9] Financial Performance - Viking Therapeutics has a history of earnings surprises, missing estimates in the last four quarters with an average negative surprise of 21.66% [11] - The company currently has an Earnings ESP of 0.00%, indicating no expected earnings beat for the upcoming report [12][13] Future Updates - Further updates on VK2735, as well as the company's NASH and X-ALD programs, are anticipated during the upcoming earnings call [10][8]
Viking Therapeutics, Inc. (VKTX) Presents at 44th Annual J.P. Morgan Healthcare Conference Transcript
Seeking Alpha· 2026-01-13 06:35
Company Overview - Viking Therapeutics is based in San Diego and focuses on novel therapeutics for metabolic and endocrine diseases [3]. Key Programs - The company is primarily concentrating on its metabolic disease programs, particularly a peptide called VK2735, which is a dual agonist of the GLP-1 and GIP receptors, currently in a Phase III program known as the VANQUISH program [3]. - An oral formulation of VK2735 has completed a Phase II study, with data submission planned for the European Congress on Obesity in the second quarter of this year [4]. - Viking Therapeutics is also developing an amylin program, with plans to file an Investigational New Drug (IND) application later this quarter [4]. Additional Programs - The company has earlier stage programs in the thyroid receptor space, including VK2809, a thyroid receptor beta agonist for MASH, which has completed a successful study [5].
Viking Therapeutics (NasdaqCM:VKTX) FY Conference Transcript
2026-01-12 23:17
Viking Therapeutics FY Conference Summary Company Overview - **Company**: Viking Therapeutics (NasdaqCM:VKTX) - **Focus**: Development of novel therapeutics for metabolic and endocrine diseases, particularly highlighted by the peptide VK2735, a dual agonist of GLP-1 and GIP receptors [2][28] Key Points on VK2735 and Clinical Programs - **VK2735**: Currently in a Phase III program called the Vanquish program, with two trials in progress for obesity [2][3] - **Oral Formulation**: An oral version of VK2735 has completed Phase II studies, with data submission planned for the European Conference on Obesity in Q2 2026 [3][28] - **Pipeline**: Includes VK2809 (thyroid receptor beta agonist for MASH) and VK0214 (for X-linked adrenal leukodystrophy), both of which have completed early-stage studies [3][28] Clinical Trial Results - **VK2735 Phase I and II Results**: - Phase I showed a dose-dependent reduction in body weight, with up to 8.2% weight loss after 28 days [9][10] - Phase II results indicated a weight loss of up to 12% at the highest dose (120 mg) after 13 weeks, with significant results across all cohorts except the lowest dose [11][23] - Maintenance of weight loss was observed, with 6.7%-10.3% maintained three weeks after the last dose [12][18] Tolerability and Safety - **Tolerability**: VK2735 demonstrated excellent tolerability, with most adverse events being mild to moderate, primarily gastrointestinal [10][21] - **Dosing Strategy**: Future studies may adopt a slower titration approach to mitigate gastrointestinal side effects [17][18] Vanquish Trials - **Trial Design**: The Vanquish program includes two studies, one for obesity and another for obesity with type 2 diabetes, both with a one-year extension for long-term safety and efficacy [25][28] - **Enrollment Status**: Vanquish I has completed enrollment, while Vanquish II is on track to complete enrollment in Q1 2027 [29] Financials - **Cash Position**: Viking Therapeutics reported over $700 million in cash as of the end of Q3 2026, providing a strong financial foundation for ongoing and future projects [28] Future Directions - **Amylin Program**: An IND filing for an amylin program is planned for Q1 2026, with potential for combination therapies with VK2735 [3][44] - **Market Positioning**: The oral formulation of VK2735 is envisioned as a maintenance therapy following injectable treatments, aiming to provide a seamless transition for patients [38][39] Industry Context - **Regulatory Environment**: The FDA's recent developments regarding trial requirements may influence Viking's future clinical strategies, although the company plans to proceed with two Phase III trials for the oral formulation [34][35] - **Competitive Landscape**: The company acknowledges the competitive nature of the obesity treatment market, emphasizing the importance of tolerability and efficacy in their product offerings [30][31] Strategic Interest - **Industry Interest**: There is a growing interest from pharmaceutical companies in the obesity treatment space, with Viking Therapeutics positioned to capitalize on this trend as they advance their programs [47][48]
Viking Therapeutics Announces Completion of Enrollment in Maintenance Dosing Clinical Trial of VK2735 in Obesity
Prnewswire· 2026-01-08 12:00
Core Insights - Viking Therapeutics has completed patient enrollment in a Phase 1 maintenance dosing study for VK2735, a dual agonist targeting GLP-1 and GIP receptors, aimed at treating metabolic disorders like obesity [1][2]. Group 1: Study Details - The maintenance dosing study is a randomized, double-blind, placebo-controlled trial involving approximately 180 healthy adults with a BMI of 30 kg/m or higher [2]. - Participants initially receive weekly subcutaneous doses of VK2735 or placebo for 19 weeks, followed by various maintenance dosing regimens including weekly, bi-weekly, or monthly subcutaneous doses, as well as daily and weekly oral dosing options [3]. - The study aims to evaluate the safety, tolerability, and pharmacokinetic profile of VK2735, with exploratory endpoints focusing on changes in body weight from baseline and from Week 19 to Week 31 [3]. Group 2: Company Strategy and Product Differentiation - The development of effective maintenance dosing regimens is crucial for achieving long-term health benefits from weight loss, potentially differentiating VK2735 from existing obesity treatments [4]. - The same dual-acting GLP-1/GIP agonist is utilized in both subcutaneous and oral formulations, offering treatment flexibility and potentially improved adherence to therapy [4]. Group 3: Ongoing Clinical Trials - Viking is also conducting two Phase 3 studies (VANQUISH-1 and VANQUISH-2) to assess the efficacy and safety of subcutaneous VK2735 over 78 weeks, with VANQUISH-1 enrolling approximately 4,650 adults with obesity or overweight conditions, and VANQUISH-2 enrolling around 1,100 adults with type 2 diabetes [5]. - Patients in these trials are randomized into four treatment arms, receiving either VK2735 at doses of 7.5 mg, 12.5 mg, 17.5 mg, or placebo [5]. Group 4: Background on GLP-1 and GIP Agonists - GLP-1 receptor activation has been shown to decrease glucose levels, reduce appetite, lower body weight, and improve insulin sensitivity in patients with type 2 diabetes and obesity [6]. - Tirzepatide, a dual GLP-1/GIP receptor agonist, has been approved by the FDA, indicating a growing interest in this class of therapeutics [6]. Group 5: Company Overview - Viking Therapeutics is focused on developing novel therapies for metabolic and endocrine disorders, with VK2735 being a key product in their pipeline [8]. - The company is also advancing VK2809, a selective thyroid hormone receptor beta agonist, and VK0214 for rare diseases, showcasing a diverse portfolio aimed at improving patient outcomes [8].
Viking Therapeutics Announces Appointment of Neil Aubuchon as Chief Commercial Officer
Prnewswire· 2026-01-07 12:00
Core Insights - Viking Therapeutics, Inc. has appointed Neil Aubuchon as chief commercial officer, bringing over two decades of experience in the biopharmaceutical industry, particularly in global commercialization and marketing within the cardiometabolic space [1][3] Company Overview - Viking Therapeutics is a clinical-stage biopharmaceutical company focused on developing novel therapies for metabolic and endocrine disorders, leveraging expertise in metabolism to improve patients' lives [4] - The company's clinical programs include VK2735, a dual agonist for GLP-1 and GIP receptors, currently in Phase 3 trials for obesity, and VK2809, a selective thyroid hormone receptor beta agonist for lipid and metabolic disorders [4] Product Development - VK2735 is being evaluated in two Phase 3 clinical trials (VANQUISH-1 and VANQUISH-2) for obesity, with previous trials showing a favorable safety and tolerability profile [4] - VK2809 has successfully met primary and secondary endpoints in a Phase 2b study for non-alcoholic steatohepatitis (NASH) and fibrosis, demonstrating significant reductions in LDL-C and liver fat content in a Phase 2a trial for non-alcoholic fatty liver disease (NAFLD) [4] Strategic Direction - The appointment of Neil Aubuchon is seen as a strategic move to enhance Viking's commercialization capabilities for VK2735 and to engage with potential strategic partners, positioning the company for future commercial success [2][4]
Viking Therapeutics to Present at the 44th Annual J.P. Morgan Healthcare Conference
Prnewswire· 2026-01-05 21:03
Core Insights - Viking Therapeutics, Inc. is a clinical-stage biopharmaceutical company focused on developing novel therapies for metabolic and endocrine disorders [3] Group 1: Corporate Presentation - CEO Brian Lian, Ph.D., will present at the 44th Annual J.P. Morgan Healthcare Conference from January 12-15, 2026, in San Francisco, California [1][2] - The presentation is scheduled for January 12, 2026, from 2:15 to 2:55 p.m. Pacific Time, and will be available via live webcast [2] Group 2: Company Overview - Viking Therapeutics specializes in first-in-class or best-in-class therapies targeting metabolic and endocrine disorders, leveraging expertise in metabolism [3] - The company is advancing VK2735, a dual agonist for GLP-1 and GIP receptors, currently in a Phase 3 obesity program with two trials (VANQUISH-1 and VANQUISH-2) [3] - VK2809, an orally available small molecule for lipid and metabolic disorders, has shown positive results in Phase 2b studies for NASH and fibrosis, and in Phase 2a trials for NAFLD [3] - The company is also developing VK0214 for X-linked adrenoleukodystrophy (X-ALD), which has demonstrated safety and efficacy in reducing VLCFAs in a Phase 1b trial [3]