Viking Therapeutics: Investor Focus Shifts to Phase 3 Obesity Program

This week, Viking Therapeutics’ management is engaging directly with institutional investors at two separate events in Miami. The central topic will be the company’s pivotal Phase 3 program, VANQUISH, for its drug candidate VK2735. However, following recently lowered earnings estimates and ongoing discussions about the tolerability of an oral tablet formulation, the market is scrutinizing the durability of the clinical benefit and the associated cost structure.

A Dual-Pronged Investor Outreach

The company has scheduled a fireside chat at the Leerink Partners Global Healthcare Conference tomorrow (10:40–11:10 AM ET). Additionally, it will conduct one-on-one meetings at the Jefferies “Biotech on the Beach” gathering, taking place over the next two days. Viking plans to post a recording of the Leerink discussion on its investor relations website afterward.

This timing is strategic. The near-term trajectory of the stock is largely tied to developments and data from the VANQUISH trials. Concurrently, analysts have revised their earnings-per-share estimates downward, anticipating a significant year-over-year decline in upcoming results. This has brought heightened attention to the company’s losses, cash burn rate, and potential future dilution pressure.

The Oral Tablet: Efficacy Meets Tolerability Questions

The profile of the oral VK2735 tablet is more nuanced. In a 13-week analysis, participants receiving a once-daily dose achieved statistically significant weight reductions of up to 12.2% from baseline. The placebo-adjusted difference reached up to 10.9%. Reductions progressed across all dose levels without showing a plateau by week 13.

However, the discontinuation rate caused investor concern. While 18% of placebo participants ended treatment early, the figure was 28% for the VK2735 group. This effect was dose-dependent, ranging from 20% at the two lowest doses to 38% at the highest dose, with nausea being the primary driver. Upon the data’s release, the stock reportedly fell as much as 37% intraday.

Regarding safety, 98% of treatment-emergent adverse events deemed drug-related were classified as mild or moderate; for gastrointestinal events, that proportion was 99%. Some market observers have noted that a registration-enabling study could potentially employ lower maintenance doses and that tolerability might improve with a four-week titration schedule instead of two weeks.

In competitive cross-trial comparisons, while VK2735 met its primary endpoint, the magnitude of weight loss trailed behind Novo Nordisk’s Rybelsus and Eli Lilly’s orforglipron. One analyst firm pointed out that the highest doses in Viking’s 13-week study were “clearly” above Lilly’s candidate but emphasized that such comparisons require caution due to differing trial designs. Following an End-of-Phase 2 meeting with the FDA, Viking aims to initiate a Phase 3 trial for the oral formulation in the third quarter.

Should investors sell immediately? Or is it worth buying Viking Therapeutics?

The VANQUISH Program as the Core Catalyst

The VANQUISH program consists of two Phase 3 studies evaluating a subcutaneous (injected) form of VK2735 for obesity. The company states that VANQUISH-1 is already fully enrolled ahead of schedule, with VANQUISH-2 nearing full recruitment.

VANQUISH-1 is a randomized, double-blind, placebo-controlled multicenter trial. It is assessing the efficacy and safety of a once-weekly injection over 78 weeks. The study enrolled approximately 4,650 adults with obesity or overweight plus at least one weight-related comorbidity.

A separate maintenance dose study is also underway. After week 19, participants transition to various regimens, including weekly, bi-weekly, and monthly subcutaneous administrations, as well as daily or weekly oral dosing or placebo. This study aims to evaluate safety, tolerability, and pharmacokinetics across the different schedules, with exploratory tracking of weight change through week 31.

Supporting data comes from a publication in Obesity on Phase 2 results (VENTURE) for the weekly injection. Over 13 weeks, mean weight reductions of up to 14.7% from baseline were reported, with no clear plateau observed. Most side effects were rated as mild or moderate.

Corporate Updates and Forward Milestones

Recent corporate updates include a liquidity position of $706 million, the enrollment of over 4,500 participants in VANQUISH-1, and data from the fully recruited maintenance dose study expected in the third quarter. Furthermore, the company announced plans to submit an Investigational New Drug (IND) application for a dual amylin/calcitonin receptor agonist in the first quarter. In parallel, Viking secured a multi-year manufacturing agreement with CordenPharma for large-scale production of VK2735.

Consequently, the critical near-term catalysts are clear: further progress and data readouts from the VANQUISH trials, and the detailed design of the planned Phase 3 study for the oral tablet, which Viking intends to start in the coming quarter.