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Viking Therapeutics Advances Weight Loss and Metabolic Disease Programs

• Viking Therapeutics is progressing VK2735, a dual GLP-1/GIP agonist, into Phase 3 trials for obesity, with an end-of-Phase 2 meeting with the FDA expected by year-end. • Oral formulation of VK2735 demonstrated encouraging Phase 1 results, with Phase 2 trials anticipated to begin in the final quarter of the year, offering a potentially more appealing treatment option. • VK2809, targeting non-alcoholic steatohepatitis (NASH), met primary and secondary endpoints in a Phase 2b trial, showcasing Viking's broader focus on metabolic disorders. • Analysts are optimistic about Viking's potential, with JPMorgan initiating coverage with an "Overweight" rating and anticipating positive data from oral VK2735 at Obesity Week.

Viking Therapeutics (VKTX) is making significant strides in its clinical programs targeting obesity and metabolic disorders, positioning itself as a potential key player in these high-growth markets. The company's lead candidate, VK2735, a dual GLP-1/GIP receptor agonist, is advancing towards Phase 3 clinical trials for injectable formulation, with Phase 2 trials for its oral formulation slated to begin later this year.

VK2735: A Potential Game-Changer in Obesity Treatment

VK2735 has demonstrated promising results in clinical trials. The Phase 2 VENTURE study of the injectable form showed patients experienced up to a 15% reduction in body weight over 13 weeks. Furthermore, Phase 1 trial results for the oral tablet formulation of VK2735 indicated an average weight loss of 5.3% over 28 days, with a favorable safety profile. These results suggest VK2735 could be a strong competitor in the obesity market, potentially capturing a significant share as demand for effective weight loss treatments continues to surge.
Following discussions with the FDA, Viking Therapeutics plans to proceed directly to Phase 3 trials for VK2735, skipping the Phase 2b trial. An end-of-Phase 2 meeting with the FDA is anticipated by the end of the year to finalize trial details. This decision reflects the confidence in the drug's potential and could expedite its path to market.

Expanding Beyond Obesity: VK2809 for NASH

Viking Therapeutics is also developing VK2809 for the treatment of non-alcoholic steatohepatitis (NASH), now referred to as metabolic dysfunction-associated steatohepatitis (MASH), a liver disease characterized by excessive fat accumulation, inflammation, and fibrosis. In a Phase 2b trial, VK2809 met both its primary and secondary endpoints, demonstrating its potential to resolve MASH without worsening fibrosis in up to 75% of patients after 52 weeks, compared to 29% in the placebo group.

Analyst Optimism and Market Potential

Analysts are increasingly positive about Viking Therapeutics' prospects. JPMorgan recently initiated coverage with an "Overweight" rating on VKTX stock, anticipating positive data from the oral formulation of VK2735 at the upcoming Obesity Week in San Antonio in early November. Analyst Hardik Parikh estimates that Viking could capture approximately 10% of the oral obesity drug market, setting a price target of $80 for the shares. The consensus among Wall Street analysts is a "Strong Buy" rating for the stock, with an average price target of $110.82, representing a substantial upside potential.

Financial Position and Future Outlook

Viking Therapeutics maintains a strong financial position, with $942 million in cash, cash equivalents, and short-term investments as of Q2 2024. This robust financial foundation supports the company's ongoing clinical trials and research and development efforts. As Viking advances its pipeline and approaches key milestones, it is well-positioned to capitalize on the growing markets for obesity and metabolic disease treatments.
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[1]
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[2]
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[3]
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[4]
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[5]
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[6]
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[7]
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[8]
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[9]
Snag This Biotech Stock Before November, Here's Why - The Globe and Mail
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