Viking Therapeutics has initiated its Phase 3 VANQUISH clinical program for VK2735, a GLP-1/GIP dual agonist targeting obesity. The program comprises two studies: one involving adults with obesity and another including obese or overweight adults with type 2 diabetes. Enrollment for the Phase 2 VENTURE-Oral dosing trial has been completed, with topline results expected in the second half of 2025, potentially as early as the third quarter. Viking is also progressing with an amylin agonist program, planning an Investigational New Drug (IND) application by the fourth quarter of 2025. The company reported a strong cash position of $808 million at the end of the second quarter of 2025. Management highlighted the potential advantages of VK2735, including a weekly subcutaneous dosing regimen expected to start in late third quarter 2025, which may improve patient adherence and reduce manufacturing costs. Analysts and investors have noted the drug's competitive profile, with some suggesting VK2735 could become the second GLP-1/GIP dual agonist to market, potentially offering better efficacy and safety than existing treatments such as tirzepatide. Viking's upcoming Phase 2 oral data readout is highly anticipated, with expectations for significant weight loss results and a favorable safety profile. The company also plans to explore transitioning from weekly subcutaneous dosing to daily or weekly oral maintenance regimens. Viking Therapeutics released its second quarter 2025 financial results along with these corporate updates. Separately, Celcuity announced clinically meaningful improvements in progression-free survival in the PIK3CA wild-type cohort of its Phase 3 VIKTORIA-1 trial and expects to submit a New Drug Application (NDA) for Gedatolisib in the fourth quarter of 2025, with topline data for the mutation cohort expected by year-end 2025.
$CELC Celcuity report statistically significant results from Phase 3 VIKTORIA-1 trial
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$CELC expects to submit a NDA for Gedatolisib in Q4. Topline data for the VIKTORIA-1 PIK3CA mutation cohort is expected by EOY'25.