On Tuesday, Viking Therapeutics, Inc. VKTX highlighted the final results from its VOYAGE Phase 2b trial of VK2809 in patients with biopsy-confirmed non-alcoholic steatohepatitis (NASH, also referred to as metabolic dysfunction-associated steatohepatitis, MASH) at the American Association for the Study of Liver Disease.Reduction in Liver Fat Content at 52 Weeks: Patients receiving VK2809 demonstrated statistically significant reductions in liver fat at Week 12, the primary endpoint.Patients receiving VK2809 ...

Oral Late Breaker Presentation Summarizes Positive Results Including Successful Achievement of Study's Primary and Secondary EndpointsData Support VK2809's Best-in-Class Profile Highlighted by Robust Liver Fat Reductions, Histologic Results Demonstrating NASH/MASH Resolution and Fibrosis Improvement, and Promising Tolerability and SafetySAN DIEGO, Nov. 19, 2024 /PRNewswire/ -- Viking Therapeutics, Inc. ("Viking") (NASDAQ: VKTX), a clinical-stage biopharmaceutical company focused on the development of novel ...

Core Viewpoint - Viking Therapeutics is positioned as an exciting biotech company with significant potential for growth, primarily driven by its clinical-stage candidate for weight loss, VK2735, which could lead to substantial share price increases in the coming years [1][2]. Group 1: Major Catalysts - Viking Therapeutics has at least two major catalysts on the horizon, primarily related to clinical trial data readouts that could impact the company's profitability outlook [3]. - The clinical trials for VK2735, aimed at treating obesity, include an injectable formulation expected to enter phase 3 trials in late 2024 or early 2025, and a pill formulation set to begin phase 2 trials in Q4 2023, with potential weight loss of up to 8.2% within 28 days [4][5]. - Interim data updates for both formulations are anticipated in 2025, which could result in a total of four catalysts if preliminary data is released [5]. Group 2: Financial Position - Viking Therapeutics has a strong financial position, with $930 million in cash, equivalents, and short-term investments as of Q3, and operating expenses totaling $100.8 million for 2023, providing ample resources for upcoming clinical trials and manufacturing preparations [7][8]. - The company has less than $1 million in noncurrent liabilities, allowing for significant borrowing capacity if needed, and the current inflated share price would minimize the impact of issuing new equity for capital [9][10]. Group 3: Additional Pipeline Programs - In addition to its obesity treatments, Viking Therapeutics is developing therapies for metabolic dysfunction-associated steatohepatitis (MASH) and X-linked adrenoleukodystrophy (X-ALD), with the former recently completing phase 2b trials and data expected to be reported on November 19 [11][13]. - The X-ALD program is in earlier stages, having just finished phase 1b trials, with management evaluating safety data to determine the next steps [12].

Equity markets have performed well in 2024, but their showing pales next to that of Viking Therapeutics (VKTX -7.45%), a mid-cap biotech that rose in prominence this year. The drugmaker's shares are up by nearly 200% since January.However, while many investors are excited about Viking's prospects, others worry they have already missed the boat. How much upside does a clinical-stage biotech with a market cap of $6.3 billion have? Is it too late to invest in Viking Therapeutics, or do the company's shares rem ...

Mergers and acquisitions could make a comeback with Trump headed back to Washington.The 2024 presidential election and President-elect Donald Trump is headed back to Washington. The Republican party also won control of the Senate and the House of Representatives.If Trump's previous tenure in the Oval Office is an indicator for what can be expected, there's a good chance for a less stringent regulatory environment.One of my big predictions under a Trump presidency is that mergers and acquisitions (M&A) will ...

Viking Therapeutics just revealed a new plan that could make waves in the weight loss industry.So far this year, Eli Lilly (LLY 0.54%) has been on an absolute tear and is swiftly becoming the world's most prolific pharmaceutical operation in my eyes. In addition to the unprecedented growth of its diabetes and obesity care treatments, Lilly has also secured some major wins from the Food and Drug Administration (FDA), including approval for both its Alzheimer's disease candidate and eczema drug.While it looks ...

Core Insights - Viking Therapeutics, Inc. announced that results from its Phase 2b clinical trial of VK2809 will be presented at the 75th Liver Meeting® 2024, focusing on nonalcoholic steatohepatitis (NASH) [1][2] Company Overview - Viking Therapeutics is a clinical-stage biopharmaceutical company dedicated to developing novel therapies for metabolic and endocrine disorders, with three compounds currently in clinical trials [4] - The company leverages its expertise in metabolism to create innovative therapeutics aimed at improving patient outcomes [4] VK2809 Details - VK2809 is an orally available, selective thyroid hormone receptor beta agonist with a focus on liver tissue, showing potential in treating lipid disorders [3] - The Phase 2b VOYAGE study of VK2809 successfully met both primary and secondary endpoints in patients with biopsy-confirmed NASH and fibrosis [3] - In a Phase 2a study, VK2809 demonstrated significant reductions in LDL-C and liver fat content compared to placebo in patients with non-alcoholic fatty liver disease (NAFLD) [4] Upcoming Presentation - The oral presentation titled "Results from the 52-Week Phase 2b VOYAGE Trial of VK2809 in Patients with Biopsy-Confirmed NonAlcoholic Steatohepatitis and Fibrosis" will be delivered by Dr. Rohit Loomba on November 19, 2024, at the San Diego Convention Center [2]

Viking stock has slipped more than 20% from its peak.Viking Therapeutics (VKTX -0.54%) soared to center stage earlier this year as a potentially promising player in one of today's highest-growth healthcare markets: weight loss drugs. The biotech company presented solid data for a candidate that could eventually rival blockbuster weight loss drugs from big pharma companies Eli Lilly and Novo Nordisk. And in just one trading session, the shares skyrocketed, rising more than 100%.Since then, Viking has reitera ...

Core Viewpoint - Viking Therapeutics is positioned for success with multiple compelling reasons to invest in its stock, particularly as it approaches revenue generation and has a strong pipeline of clinical programs [1]. Group 1: Revenue Generation - Viking is on track to generate revenue for the first time, with its lead candidate VK2735 expected to enter phase 3 clinical trials in early 2025 after discussions with the FDA [2][3]. - In a 13-week trial, VK2735 demonstrated an average weight loss of 13.1% on a placebo-adjusted basis, with mild side effects, indicating its potential effectiveness compared to competitors [4][5]. Group 2: New Clinical Programs - The company plans to file for early-stage clinical trials in 2025 for a new weight loss therapy that targets amylin and calcitonin receptors, which are not currently represented in its pipeline [6]. - This new program could lead to rapid weight loss and improved maintenance of weight, positioning Viking competitively against other companies like AstraZeneca and Novo Nordisk [7][8]. Group 3: Financial Flexibility - Viking has over $930 million in cash and equivalents, with trailing-12-month R&D expenditures of $91 million, indicating strong financial health and minimal risk of share dilution [9][10]. - The absence of long-term debt and the ability to borrow at reasonable rates if needed further enhance its financial flexibility [11]. Group 4: Collaboration Opportunities - Viking has the potential to form collaboration agreements and partnerships, particularly for VK2735, as other biopharma companies may seek to participate in its success [12][13]. - Currently, Viking does not require additional resources from collaborators, but future partnerships could expedite market entry and enhance its commercialization strategy [14].

Core Viewpoint - Viking Therapeutics is positioned for significant growth with its lead candidate VK2735 in the anti-obesity market, supported by promising clinical data and strong financials [2][5][10]. Company Overview - Viking Therapeutics has not yet received approval for any drugs but is developing VK2735, which aims to compete with established players like Eli Lilly and Novo Nordisk in the weight loss drug market [4][5]. - The company presented new data at the Obesity Week 2024 conference, reinforcing the investment thesis for VK2735, indicating potential for substantial market share if approved [5][7]. Clinical Development - VK2735 is being tested in two formulations: a weekly injection and a daily pill, with the pill expected to enter phase 2 trials by the end of the year and the injection moving to phase 3 soon [6]. - In trials, participants using the highest dose of the VK2735 pill lost an average of 6.8% of body mass compared to 1.4% for the placebo group, with weight maintenance observed for at least a month post-treatment [7][8]. Competitive Advantage - VK2735 may offer a long-term weight maintenance solution, a capability currently lacking in major competitors, which could lead to sustained revenue from patients [8][9]. - The company has a strong financial position with $930 million in cash and no long-term debt, allowing it to fund ongoing clinical trials and additional R&D programs [10][11]. Financial Stability - Viking's operating expenses were only $134 million over the trailing 12 months, indicating ample resources to support its clinical programs without the risk of dilution from new stock offerings [10][12]. - The financial health of the company suggests it can withstand setbacks in clinical trials without significant impact [12].