Viking Therapeutics Shares Surge on Potential FDA Policy Shift

Shares of Viking Therapeutics experienced a significant rally on Thursday, closing with a gain of 9.4%. The catalyst was market speculation that the U.S. Food and Drug Administration (FDA) may simplify its drug approval requirements, a development that could be particularly timely for the company's lead obesity candidate, VK2735, which is currently in pivotal Phase 3 trials.

The stock climbed to approximately $38.75 intraday following reports that the regulator is considering requiring only one pivotal study for new drug approvals, instead of the standard two. Such a policy change would represent a substantial benefit for Viking's ongoing VANQUISH clinical program. Reducing the number of required trials would not only lower the immense costs of clinical development but could also significantly shorten the timeline to the potential market launch of VK2735.

Solid Financial Backing and Operational Momentum

Beyond the regulatory speculation, the company's fundamentals provide support. Viking Therapeutics reported a stronger-than-anticipated cash position, with reserves of about $715 million as of September 30. This robust balance sheet is seen as sufficient to fund its costly Phase 3 studies. The company did post a third-quarter loss of $0.81 per share, which was wider than analysts had forecast.

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

Operational progress continues to add momentum. On November 19, 2025, Viking announced the early completion of patient enrollment for its Phase 3 VANQUISH-1 trial, which now includes roughly 4,650 participants—ahead of the original schedule. Previous Phase 2 data for the injectable VK2735 demonstrated weight reductions of up to 14.7% after 13 weeks. The oral tablet version of the therapy has also shown promise in studies, achieving weight loss of up to 12.2%.

Analyst Confidence and Acquisition Speculation

Market experts remain broadly optimistic about the stock's prospects. The consensus rating, according to MarketBeat data, stands at "Moderate Buy," with the average price target above $87, implying considerable upside from current levels. In late October, Morgan Stanley reaffirmed its "Overweight" rating and raised its price target to $102. Canaccord Genuity maintains an even more bullish target of $107.

Investor attention is now turning to the first quarter of 2026. Key upcoming milestones include the planned completion of enrollment for the VANQUISH-2 study, which focuses on obesity in patients with Type 2 diabetes. Furthermore, following Pfizer's recent acquisition of Metsera, market observers continue to view Viking as a potential takeover target in the competitive weight-loss drug sector. The company's next quarterly results are scheduled for release on February 4, 2026.