- Viking Therapeutics Inc (NASDAQ: VKTX) stock price fell more than 14% in intraday trading today. That’s why it happened.
The stock price of Viking Therapeutics Inc (NASDAQ: VKTX) – a clinical-stage biopharmaceutical company focused on developing new therapies for metabolic and endocrine disorders – fell more than 14% in intraday trading today. today. Investors react negatively to Viking Therapeutics announcing that its Phase 1b clinical trial of VK0214 in patients with X-linked adrenoleukodystrophy (X-ALD) has been placed on clinical hold by the US Food and Drug Administration (FDA) United States.
The FDA had requested an additional preclinical study before continuing the phase 1b study of VK0214 in X-ALD. And the request is not due to the results of studies in progress or already completed. The company expects to provide the information to the FDA in the second quarter.
The company was recently informed that the FDA considers the ongoing trial to be a phase 2 trial rather than a phase 1b trial. And as a phase 2 trial, a rodent genotoxicity study is required before proceeding. The company planned to conduct this study before phase 2 and will now accelerate its execution. As a short-term delay is expected, the company does not expect the long-term development schedule of VK0214 to be significantly impacted.
VK0214 is a novel, orally available, small molecule TRβ agonist that has received orphan drug designation from the FDA for the treatment of X-ALD. And results from a successful phase 1 single ascending dose (SAD) and multiple ascending dose (MAD) study in healthy subjects showed that VK0214 demonstrated encouraging safety and tolerability, as well as predictable pharmacokinetics. . Additionally, subjects who received VK0214 experienced reductions in low-density lipoprotein cholesterol (LDL-C), triglycerides, and apolipoprotein B after 14 days of treatment.
“We look forward to providing the FDA with the requested information in a timely manner. The current application follows industry guidelines for Phase 2 studies and is not based on data from previously submitted or ongoing studies. We are confident in the overall safety and potential efficacy profile of VK0214 and plan to submit a response with the goal of resuming the assay in the study later this year.
— Brian Lian, Ph.D., Managing Director of Viking Therapeutics
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