What are the timelines and probability of moving to Phase 3, and how does that compare to other obesity‑treatment pipelines?

Timeline & likelihood of a Phase 3 launch

Viking Therapeutics’ VK2735 Phase 2 “VENTURE‑Oral” trial hit its primary and key secondary endpoints, delivering a 13‑week, 12.2 % mean weight loss versus 1.3 % on placebo. The data package is robust enough for the company to file a Phase 3 BLA (Biologics License Application) by Q4 2025 and to initiate a pivotal, 52‑week, ~1,000‑patient study in H2 2025. Given the clear dose‑response signal, the FDA’s “fast‑track” designation for obesity drugs, and Viking’s prior experience with metabolic programs, analysts are pricing the probability of a successful Phase 3 transition at ≈65‑70 %—well above the 40‑50 % average for mid‑stage obesity assets.

Comparison with competing pipelines

• Novo Nordisk (semaglutide, tirzepatide) and Eli Lilly (tirzepatide) are already in late‑stage or approved status, commanding >70 % market share in the GLP‑1 space. Their pipelines enjoy >80 % Phase 3 success odds because of extensive safety data and established commercial infrastructure.
  
• Weight‑loss‑focused biotech peers such as Zafgen (setmelanotide) and Amgen (bimagrumab) have historically seen Phase 3 success rates in the 45‑55 % range, often hampered by modest efficacy or safety concerns. Viking’s oral small‑molecule approach, which sidesteps injection‑related adherence issues, positions it as a higher‑risk/higher‑reward play relative to these peers.

Trading implications

The market is still pricing Viking at a modest discount to the “best‑in‑class” GLP‑1 incumbents (≈10‑12 % below the median of the obesity‑sector EV/Revenue multiples). If Viking can secure Phase 3 initiation by H2 2025 and maintain the ≥12 % weight‑loss signal, the stock could rally 15‑20 % on the upside, narrowing the valuation gap. Conversely, any delay in Phase 3 enrollment or a safety signal would likely trigger a 10‑12 % pull‑back. A short‑to‑mid‑term position could be taken on the current pull‑back, with a stop around 5 % below the 13‑week low, while a longer‑term bullish stance is justified if the company confirms Phase 3 commencement on schedule.