JanOne Inc. (JAN) stock prices were up by 7.54% as of the market closing on September 28th, 2021. This brought the price per share up to USD$7.42 at the end of the trading day. Subsequent premarket fluctuations have seen the stock fall by 5.26%, bringing it down to USD$7.03.
JAN Stock’s Revised Strategy
September 28th, 2021 saw JAN stock announce the revision of its development strategy for its lead drug candidate, JAN101. This development comes in light of the company’s recent communications with the United States Food and Drug Administration. Previous data for the treatment of Peripheral Artery Disease (PAD)’s Phase 1 and Phase 2a studies were highly promising. They showed improved vascular function and a reduction in pain, which was integrated into Phase 2b protocols and primary and secondary endpoints.
Collaborating with FDA
The company is working closely FDA in response to its pre-Phase 2 submission. The early interactions between the two parties is hoped to facilitate efficient and effective application of directives in the trial. This could serve to potentially reduce the number of review cycles between trial phases in the drug development process. JAN stock is now allocating resources towards incorporating the FDA’s recommendations and comments into its Phase 2b protocol and supporting documents.
PAD is a chronic disorder that reduces blood flow to the extremities, resulting in severe pain, restricted mobility, and, in some cases, death. The disease affects more than 8.5 million people in the United States, incurring an annual cost of care of more than USD$10 billion every year. 25% of patients being treated for pain related to PAD are at risk of being prescribed opioid prescriptions. The treatment of PAD at the source eliminates the risk of having to resort to a dangerous and highly addictive opioid treatment to relieve pain.
JAN Stock JAN101 Treatment
JAN101 is a twice daily, orally dosed slow-release formulation of the therapeutic compound sodium nitrite, which has been approved by the FDA. Results from Phase 2a clinical trials of JAN101 serve to support the use of sodium nitrite for the treatment and prevention of PAD. Patients’ significant reduction in pain from PAD was an unexpected outcome of the company’s earlier studies. This led JAN stock to develop clinical protocols for PAD and PAD associated pain for Phase 2b trials.
Future Outlook for JAN Stock
The company reported a promising quarter, consolidated by the strength of its clinical development of JAN101. JAN stock is keen to push for the accelerated development and commercialization of its flagship treatment. Current and potential investors are hopeful that management will be able to leverage the resources at their disposal. This is hoped to facilitate significant and sustained increases in shareholder value.