Pfizer, Inc. [NYSE: PFE] and BioNTech SE [NASDAQ: BNTX] has got a ‘Fast Track’ designation from US Food and Drug Administration (FDA) for their two COVID-19 vaccine candidate, the companies announced today. Both companies continuously striving to develop a coronavirus vaccine.
The BNT162b1 and BNT162b2 are two highly developed vaccine candidates in the BNT162 program that are currently being tested in Phase 1/2 clinical studies in the United States and Germany. The ‘Fast Track’ designation was granted to the companies based on the preliminary data from phase 1/2 data.
The fast-track label allows for a more fast development process between companies and regulatory agencies and enables drug manufacturers to gain faster approval with the rolling review process of the data presented.
Pfizer and BioNTech disclosed the data of Phase 1/2 study for the product candidate BNT162b1 on July 1, 2020. The chief medical officer at BioNTech Özlem Türeci said that the company is looking forward to work with the FDA and its partner Pfizer for the development of the coronavirus vaccine.
After receiving ‘Fast Track’ label the shares of Pfizer and BioNTech both jumped and closed green. Pfizer shares soared 3.49% during the trading of Monday. PFE has a day low and high range of $34.53-$35.05, respectively. This company had a trading volume of roughly 8.12 million as compared to the average volume of 27.89 million.
In the past 52-weeks of trading, this company has fluctuated from a low of $27.88 and a high of 43.56. Its return on assets, investment, and equity is $9.60%, 14.70%, and 25.00%, respectively.
On the other hand, BioNTech SE shares climbed 10.33% at $77.63 during the trading of Monday. This company has a total market capitalization of 15.00 billion. It has moved up 519.80% from its 52-weeks low and moved down -26.07% from 52-weeks high.
BNTX has a gross margin of 88.30% and returns on investment (ROI) is -31.40%. Meanwhile, if we look at its liquidity, BNTX showed the current ratio of 3.70 and the quick ratio is also the same.