Plus Therapeutics Inc [NASDAQ: PSTV] has been trading in a bullish channel for months now. Yesterday, the stock gained some more upside momentum and closed the day with gains of 24%. Yesterday’s rally followed the company’s announcement that it had got fast track designation from the U.S FDA for its new Glioblastoma treatment.
With the fast track designation, the company will now have access to a number of benefits. For starters, it will be in a position to hold more regular meetings with the FDA on issues touching on its drug development process.
The company will also have regular communication from the FDA on many issues including the design of its upcoming clinical trials and the biomarkers that it will use in its process. On top of that, the company will be eligible for accelerated review and approval whenever it meets the laid down criteria.
Most importantly, the company will be in a position to submit sections of its new drug application whenever they are completed rather than waiting for the entire application to be reviewed by the FDA. This puts the company in an advantageous position in its quest to develop and sell its new treatment for Glioblastoma.
Commenting on the fast track designation, the company CEO, Dr, Marc Hedrick stated that the award of a fast track designation was a validation of the company’s treatment’s potential for people suffering from recurring cases of glioblastoma, and do not have any viable treatment options at the moment. He added that now that the company had received the fast track designation, it planned on moving the trial to cohort, a major step toward making the new therapy a reality.
From an investor perspective, the FDA fast track designation means that the company is close to unlocking a new revenue stream. This would have the effect of driving up the company’s value and the stock price. For this reason, buyers are likely to keep bidding up this stock in the near-term.
The stock is also likely to be the uplifted by the increased optimism in the market. Stocks are on the rise on hopes of a potential COVID-19 vaccine in the near-term. In this environment, any stock that has good fundamentals stands to gain at a higher rate than the rest of the market.
About Plus Therapeutics Inc
Plus Therapeutics Inc is a pharmaceutical company that develops treatments for cancer and other ailments. It is based in Austin, Texas.
