Polarityte Inc. (PTE) stock prices were down by 13.99% shortly after market trading commenced on August 23rd 2021. This brought the price per share down to USD$0.72 early on in the trading day.
PTE Stock’s IND Application
August 24th, 2021 saw the company provide an update about the status of its IND Application to the U.S FDA for SkinTE. The treatment developed by PTE stock has a proposed indication for chronic cutaneous ulcers and was filed on July 23rd 2021. As per the FDA’s feedback, the company needs to address certain Chemistry, Manufacturing, and Control (CMC) items before proceeding with a pivotal study.
SkinTE Study Placed on Clinical Hold
As a result of the FDA’s feedback, the study proposed in the IND has been placed on a clinical hold. As per standard practice and regulations, the Food and Drug Administration has advised that it will issue a clinical hold letter to the company by September 21st 2021, wherein it will provide details on the basis for the hold. PTE stock recently announced the potential for a wide range of outcomes with respect to its SkinTE IND submission.
PTE Stock’s Response
PTE stock is already composing a strategy to address the issues identified by the FDA. As per the FDA’s feedback, the company is confident that the changes made to its proposed clinical trial protocol will resolve any issues. The Wagner Grade 2 diabetic foot ulcers trial will be modified so as to enable the pivotal study to begin enrolling.
PTE Stock’s Press Release
July 26th 2021 saw the company’s press release regarding its IND submission. In the release, PTE stock cited CMC issues as being fairly common in companies seeking to transition their products from 261 HCT/Ps to 351 HCT/Ps. The company is taking active measures to address the CMC issues identified by the FDA, with the team planning to respond to the FDA’s feedback as quickly as possible. The company is confident in address the significant unmet medical need in patients with chronic cutaneous ulcers. This results in a substantial economic burden.
Future Outlook for PTE Stock
The company reported a promising quarter despite the lack of approval from the FDA for SkinTE. PTE stock is keen to leverage the resources at its disposal to meet FDA requirements for its IND application. Investors are hopeful that the commercialization of SkinTE will lead to consistent gains in shareholder value over the long term.
