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VKTX: Is a 2029 Launch for Its Obesity Drug Within Reach?
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Key Takeaways
Viking Therapeutics sees a potential first-half 2029 launch for its lead obesity candidate, VK2735.
VANQUISH phase III studies are fully enrolled, with completion expected in 2027.
A first-half 2028 FDA filing could support a first-half 2029 decision, while delays may push launch later.
Viking Therapeutics (VKTX - Free Report) provided investors with an encouraging update during its third-quarter 2026 earnings call. During the Q&A session, CEO Brian Lian said the company was about 2.5 years away from a potential launch of its lead obesity candidate, VK2735.
Based on this timeline, Viking could bring its obesity drug to market in the first half of 2029. This would mark a milestone for the clinical-stage company as it seeks to establish a presence in the obesity space.
However, the bigger question is whether this timeline is achievable. Viking is currently advancing both the subcutaneous (SC) and oral formulations of VK2735 in separate phase III programs. The timing of study completion, top-line results, a potential regulatory filing and the subsequent FDA review will be critical in determining whether Viking can meet its commercialization target.
Where Is VKTX Currently With VK2735?
The SC version of VK2735 is currently the company's most advanced obesity candidate and is being evaluated in two phase III registration studies, VANQUISH-1 and VANQUISH-2. While VANQUISH-1 targets adults with obesity, VANQUISH-2 enrolled those with obesity and type II diabetes (T2D).
Each study compares three weekly doses (7.5 mg, 12.5 mg and 17.5 mg) of VK2735 with placebo over 78 weeks. Both studies are fully enrolled, with approximately 4,500 and 1,000 participants, respectively. Viking expects both studies to be completed in 2027.
Recently, Viking initiated SUNRISE, a phase III clinical program evaluating once-daily oral VK2735. The program comprises two studies that broadly mirror the VANQUISH studies but are smaller in scale and shorter in duration, with each evaluating treatment over 68 weeks.
Viking also intends to start extension studies for the VANQUISH studies in the first quarter of 2027 as participants complete the initial 78-week treatment period. These studies will allow participants to continue treatment for up to another 52 weeks and will evaluate additional maintenance regimens, including less-frequent dosing. Although results are expected from the extension studies in 2028, they may not necessarily be a requirement for the initial regulatory submission.
During the earnings call, management indicated that the larger extension dataset is more likely to support a supplemental filing for potential maintenance-related labeling following initial approval, although the final regulatory approach remains undecided.
When Could VKTX Seek FDA Approval
The timing of the VANQUISH top-line results will be a key factor in understanding whether Viking can achieve its potential 2029 launch target.
Although the company did not provide a definitive timeline for announcing top-line results or submitting a regulatory filing with the FDA, we expect results either toward the end of 2027 or early 2028. Assuming the pivotal studies deliver positive results, Viking could potentially prepare and submit its filings in the first half of 2028.
The FDA generally aims to review and act on standard new molecular entity applications within 10 months of the filing date, following an initial 60-day filing review period. Priority review applications have a shorter six-month review goal. Viking has not indicated that VK2735 would qualify for priority review, so a standard review timeline is a more prudent assumption.
Based on this potential timeline, a first-half 2028 filing could allow for an FDA decision in the first half of 2029, leaving room for commercialization around management's targeted timeframe. However, any delays in clinical readouts, regulatory submissions or the FDA review could push the potential launch beyond management's current target.
VKTX Builds Commercial Infrastructure Ahead of Potential Launch
Alongside clinical development, Viking is already investing in the infrastructure required to support a potential commercial launch.
During the earnings call, management highlighted that the company has established a core commercial leadership team. The team includes an experienced senior vice president of commercial, who has been involved in multiple obesity drug launches, along with leadership in market access, medical affairs and health economics and outcomes research.
VKTX has also added personnel across technical operations, chemistry, manufacturing and controls, supply chain, quality and compliance. These investments suggest that the company is preparing for the operational requirements of commercialization while its late-stage clinical programs advance.
Viking's financial position also provides resources to support these plans. It ended the third quarter of 2026 with $960 million in cash, cash equivalents and short-term investments, including approximately $550 million in net proceeds from recent financing. Management expects average quarterly cash usage of around $100 million, although spending could vary and increase as commercialization approaches.
However, higher development and commercialization expenses could affect this runway, making future cash usage and potential financing requirements important considerations for investors.
Intensifying Competition in the Obesity Space
Viking faces stiff competition from established players Eli Lilly (LLY - Free Report) and Novo Nordisk (NVO - Free Report) . Both companies are already marketing oral and injectable obesity treatments. Lilly markets the injectable Zepbound and oral Foundayo, while NVO markets injectable Wegovy and its oral Wegovy pill.
Strong sales at Lilly and continued demand for Novo Nordisk's obesity treatments underscore the scale of the commercial opportunity. Both companies are also advancing next-generation therapies, suggesting that competition in the obesity market will continue to intensify.
Lilly is developing retatrutide, an investigational triple agonist that targets the GLP-1, GIP and glucagon receptors, which has demonstrated encouraging weight loss in phase III studies. It plans to submit a regulatory filing with the FDA in the first quarter of 2027. LLY also recently reported positive results from a phase IIb study on EloraTZP, an investigational combination of eloralintide, a selective amylin receptor agonist and Zepbound. Based on these results, it plans to advance the drug to phase III development by the end of 2026.
Meanwhile, Novo Nordisk has submitted CagriSema to the FDA for weight management. The once-weekly treatment combines Wegovy with cagrilintide, a long-acting amylin receptor agonist. A final decision is expected before this year’s end.
VKTX’s Price Performance, Valuation and Estimates
Year to date, shares of Viking Therapeutics have lost nearly 24% against the industry’s 9% growth.
Image Source: Zacks Investment Research
From a valuation standpoint, VKTX is trading at a premium to the industry. Based on the price-to-book value (P/B) ratio, the company’s shares currently trade at 8.29 times trailing book value, higher than the industry’s 4.1 times.
Image Source: Zacks Investment Research
Estimates for Viking’s 2026 loss per share have improved from $4.47 to $4.46 in the past 30 days. During the same timeframe, loss estimates for 2027 have remained consistent at $4.08.
Image Source: Zacks Investment Research
Viking Therapeutics currently carries a Zacks Rank #2 (Buy).
View the Zacks #1 Rank List
Image: Bigstock
VKTX: Is a 2029 Launch for Its Obesity Drug Within Reach?
Key Takeaways
Viking Therapeutics (VKTX - Free Report) provided investors with an encouraging update during its third-quarter 2026 earnings call. During the Q&A session, CEO Brian Lian said the company was about 2.5 years away from a potential launch of its lead obesity candidate, VK2735.
Based on this timeline, Viking could bring its obesity drug to market in the first half of 2029. This would mark a milestone for the clinical-stage company as it seeks to establish a presence in the obesity space.
However, the bigger question is whether this timeline is achievable. Viking is currently advancing both the subcutaneous (SC) and oral formulations of VK2735 in separate phase III programs. The timing of study completion, top-line results, a potential regulatory filing and the subsequent FDA review will be critical in determining whether Viking can meet its commercialization target.
Where Is VKTX Currently With VK2735?
The SC version of VK2735 is currently the company's most advanced obesity candidate and is being evaluated in two phase III registration studies, VANQUISH-1 and VANQUISH-2. While VANQUISH-1 targets adults with obesity, VANQUISH-2 enrolled those with obesity and type II diabetes (T2D).
Each study compares three weekly doses (7.5 mg, 12.5 mg and 17.5 mg) of VK2735 with placebo over 78 weeks. Both studies are fully enrolled, with approximately 4,500 and 1,000 participants, respectively. Viking expects both studies to be completed in 2027.
Recently, Viking initiated SUNRISE, a phase III clinical program evaluating once-daily oral VK2735. The program comprises two studies that broadly mirror the VANQUISH studies but are smaller in scale and shorter in duration, with each evaluating treatment over 68 weeks.
Viking also intends to start extension studies for the VANQUISH studies in the first quarter of 2027 as participants complete the initial 78-week treatment period. These studies will allow participants to continue treatment for up to another 52 weeks and will evaluate additional maintenance regimens, including less-frequent dosing. Although results are expected from the extension studies in 2028, they may not necessarily be a requirement for the initial regulatory submission.
During the earnings call, management indicated that the larger extension dataset is more likely to support a supplemental filing for potential maintenance-related labeling following initial approval, although the final regulatory approach remains undecided.
When Could VKTX Seek FDA Approval
The timing of the VANQUISH top-line results will be a key factor in understanding whether Viking can achieve its potential 2029 launch target.
Although the company did not provide a definitive timeline for announcing top-line results or submitting a regulatory filing with the FDA, we expect results either toward the end of 2027 or early 2028. Assuming the pivotal studies deliver positive results, Viking could potentially prepare and submit its filings in the first half of 2028.
The FDA generally aims to review and act on standard new molecular entity applications within 10 months of the filing date, following an initial 60-day filing review period. Priority review applications have a shorter six-month review goal. Viking has not indicated that VK2735 would qualify for priority review, so a standard review timeline is a more prudent assumption.
Based on this potential timeline, a first-half 2028 filing could allow for an FDA decision in the first half of 2029, leaving room for commercialization around management's targeted timeframe. However, any delays in clinical readouts, regulatory submissions or the FDA review could push the potential launch beyond management's current target.
VKTX Builds Commercial Infrastructure Ahead of Potential Launch
Alongside clinical development, Viking is already investing in the infrastructure required to support a potential commercial launch.
During the earnings call, management highlighted that the company has established a core commercial leadership team. The team includes an experienced senior vice president of commercial, who has been involved in multiple obesity drug launches, along with leadership in market access, medical affairs and health economics and outcomes research.
VKTX has also added personnel across technical operations, chemistry, manufacturing and controls, supply chain, quality and compliance. These investments suggest that the company is preparing for the operational requirements of commercialization while its late-stage clinical programs advance.
Viking's financial position also provides resources to support these plans. It ended the third quarter of 2026 with $960 million in cash, cash equivalents and short-term investments, including approximately $550 million in net proceeds from recent financing. Management expects average quarterly cash usage of around $100 million, although spending could vary and increase as commercialization approaches.
However, higher development and commercialization expenses could affect this runway, making future cash usage and potential financing requirements important considerations for investors.
Intensifying Competition in the Obesity Space
Viking faces stiff competition from established players Eli Lilly (LLY - Free Report) and Novo Nordisk (NVO - Free Report) . Both companies are already marketing oral and injectable obesity treatments. Lilly markets the injectable Zepbound and oral Foundayo, while NVO markets injectable Wegovy and its oral Wegovy pill.
Strong sales at Lilly and continued demand for Novo Nordisk's obesity treatments underscore the scale of the commercial opportunity. Both companies are also advancing next-generation therapies, suggesting that competition in the obesity market will continue to intensify.
Lilly is developing retatrutide, an investigational triple agonist that targets the GLP-1, GIP and glucagon receptors, which has demonstrated encouraging weight loss in phase III studies. It plans to submit a regulatory filing with the FDA in the first quarter of 2027. LLY also recently reported positive results from a phase IIb study on EloraTZP, an investigational combination of eloralintide, a selective amylin receptor agonist and Zepbound. Based on these results, it plans to advance the drug to phase III development by the end of 2026.
Meanwhile, Novo Nordisk has submitted CagriSema to the FDA for weight management. The once-weekly treatment combines Wegovy with cagrilintide, a long-acting amylin receptor agonist. A final decision is expected before this year’s end.
VKTX’s Price Performance, Valuation and Estimates
Year to date, shares of Viking Therapeutics have lost nearly 24% against the industry’s 9% growth.
Image Source: Zacks Investment Research
From a valuation standpoint, VKTX is trading at a premium to the industry. Based on the price-to-book value (P/B) ratio, the company’s shares currently trade at 8.29 times trailing book value, higher than the industry’s 4.1 times.
Image Source: Zacks Investment Research
Estimates for Viking’s 2026 loss per share have improved from $4.47 to $4.46 in the past 30 days. During the same timeframe, loss estimates for 2027 have remained consistent at $4.08.
Image Source: Zacks Investment Research
Viking Therapeutics currently carries a Zacks Rank #2 (Buy).
You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.