Viking Therapeutics Inc (NASDAQ: VKTX) shares are rising Thursday after the biotech company announced plans to advance its experimental weight loss drug to late-stage trials.
What Happened: After the market close on Wednesday, Viking Therapeutics reported financial results for the second quarter that included an update on VK2735, the lead candidate of the company's unique series of novel dual agonists of the glucagon-like peptide 1 (GLP-1) and glucose-dependent insulinotropic polypeptide (GIP) receptors for the potential treatment of obesity.
Viking said earlier this year that it expected to start another mid-stage trial for VK2735, but announced late Wednesday that it would move the weekly injection into a Phase 3 trial. Viking shares popped on the news, while shares of Eli Lilly And Co (NYSE: LLY) and Novo Nordisk A/S (NYSE: NVO) fell. Viking is one of several companies racing to capture market share in the GLP-1 market, currently being led by Lilly and Novo Nordisk.
Viking said it received feedback from the U.S. Food and Drug Administration (FDA) based on a Type C meeting packet it submitted to the agency earlier this year. After reviewing the feedback, the company decided to advance VK2735 into late-stage trials for obesity.
"The Phase 2 VENTURE study of VK2735 in obesity demonstrated up to an approximately 15% reduction in body weight from baseline following 13 weeks of dosing, as well as promising safety and tolerability. Following receipt of written feedback from an FDA Type C meeting, we are advancing this compound into Phase 3 development," said Brian Lian, CEO of Viking Therapeutics.
Viking expects to schedule an end-of-Phase 2 meeting with the FDA later this year. The company noted that details on the Phase 3 trial design and timing will be disclosed following the end-of-Phase 2 meeting.
On the conference call late Wednesday, Lian said the company plans to test VK2735 as a monthly injection in future studies. The company also said the oral tablet version of VK2735 demonstrated encouraging signs in early trials, with up to 5.3% weight loss after 28 days. Viking expects to initiate a Phase 2 trial for the oral program later this year.
Viking reported an earnings loss of 20 cents per share for the second quarter, beating analyst estimates for a loss of 27 cents per share. Analysts at HC Wainwright reiterated Buy on Thursday with a price target of $90, while Raymond James maintained a Strong Buy and lifted its target to $118.
VKTX Price Action: Viking Therapeutics shares were up 30% at $65.68 at the time of publication, according to Benzinga Pro.