Viking Therapeutics Advances Oral Obesity Drug Toward Final Clinical Trials

Viking Therapeutics has received regulatory clearance to proceed with Phase 3 development for its oral obesity treatment, VK2735, with plans to initiate the late-stage study this year. The biopharmaceutical company's shares saw significant after-hours gains following the announcement, which stems from feedback received during an End-of-Phase 2 meeting with the U.S. Food and Drug Administration (FDA) held in December.

The company concluded 2025 with a robust financial position, reporting $706 million in cash, cash equivalents, and short-term investments. This capital is expected to fund operations through key upcoming milestones. Notably, Viking also announced its intention to file an Investigational New Drug (IND) application for a novel amylin agonist within the current quarter.

Financially, increased investment in its clinical programs was evident in its yearly results. For the full year 2025, Viking reported a net loss of $358.5 million, compared to a loss of $110.0 million in 2024. Research and development expenses rose to $345.0 million from $101.6 million the prior year. In the fourth quarter alone, the net loss widened to $157.7 million (or $1.38 per share), up from $35.4 million (or $0.32 per share) in the same period of 2024.

The market responded positively to the pipeline updates. According to Reuters, the stock climbed approximately 8.9% in after-hours trading to $31.10. Additional pre-market data from RTTNews indicated gains of more than 10%. Investors are now looking ahead to two major catalysts scheduled for the third quarter of 2026: the planned initiation of the Phase 3 trial for the oral tablet and the release of data from a maintenance dosing study.

Dual-Formulation Strategy and Phase 3 Timeline

A central component of Viking's strategy is the concurrent development of both an oral and an injectable formulation containing the same active drug molecule. Management highlights that this approach could potentially reduce the risk of unexpected side effects compared to switching between therapies based on different active substances.

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

The Phase 3 program for the oral tablet formulation of VK2735 is slated to begin in Q3 2026. This timeline was established following constructive discussions with the FDA.

Progress Across the Clinical Portfolio

VANQUISH Phase 3 Program (Injectable VK2735):
* VANQUISH-1: This trial, focusing on adults with obesity, has already completed patient enrollment.
* VANQUISH-2: Targeting individuals with both obesity and type 2 diabetes, this study is nearly fully enrolled. Viking anticipates finalizing recruitment in the first quarter of 2026.

The company attributes the rapid enrollment pace across these studies to strong interest from clinical trial sites, healthcare providers, and potential patients.

Maintenance Dosing Study:
A separate Phase 1 trial investigating various long-term maintenance dosing regimens has also completed enrollment. The study includes approximately 180 adults with obesity and is evaluating several administration schedules, including monthly subcutaneous injections as well as daily and weekly oral doses. Results from this study are expected in Q3 2026.