Shares of the PolarityTE, Inc. (PTE) stock were popping high in the current market trading session today on January 18, 2022. PTE stock price saw a push of 8.07% to reach $0.77 a share at the time of this writing. The stock was gloomy in the previous trading session and went down by 1.06% at closing. Let’s deep dive to understand the current bullish momentum.
PTE stock became hot among investors after the company announced that its new drug application for the SkinTE has been approved by the U.S Food and Drug Administration. The company is evaluating SkinTE to treat patients suffering from Cutaneous ulcers. Now the company is able to initiate the first of the two expected pivotal studies which the company needs to support a biologics license application as the company seeks to pursue chronic cutaneous ulcer indication for SkinTE.
The clearance of Plaority TE’s IND is a critical milestone for the company and its entire management. The milestone has given the company great confidence in its product and now the management is looking forward to initiating the first pivotal study very soon. The company is anticipating the enrollment of up to 100 patients at up to 20 sites in the U.S for the first planned pivotal study. The company expects to begin the enrollment in the late first quarter of 2022 or early in the second quarter of 2022.
Claims against PTE stock
On December 2, 2021, the Bragar Eagel & Squire, P.C, which is the nationally recognized law firm initiated the investigations against PlaorityTE for potential claims on the behalf of long-term shareholders of the PTE stock. The investigations concerned whether the board of directors of PTE breached their fiduciary duties to the company.
The complaint had been filed on September 24, 2021, which alleged that the defendants made misleading statements related to the company’s business, operational, and compliance policies. Specifically, the complaint alleged that the defendants misguided or failed to reveal that
- SkinTE IND was not up to the mark concerning its Chemistry, Manufacturing, and Control items.
- Fewer chances of FDA approval for the SkinTE in its current form.
- The company exaggerated the likelihood of the FDA approval for its SkinTE.
- As a result, the public statements of the PTE were false or misleading at all relevant times.
The recent FDA approval for the SkinTE is indeed positive news by the company for the shareholders of the PTE stock. It also proved that the company was right at its stance of getting FDA approval for its SkinTE.