Shares of BioNTech (BNTX 1.31%) had jumped 11.8% higher at 11:42 a.m. EDT on Wednesday. The gain came after The New York Times reported that the U.S. Food and Drug Administration will likely approve the Pfizer-BioNTech COVID-19 vaccine by early September.
The potential for full FDA approval of its COVID-19 vaccine is certainly good news for BioNTech. However, it probably doesn't justify the biotech stock adding more than $10 billion to its market cap today.
For one thing, the timing of the potential FDA decision isn't surprising at all. STAT News reported last week that the agency was under pressure to make a quick approval.
Also, full FDA approval isn't likely to affect BioNTech's sales. The U.S. government has already purchased more than enough COVID-19 vaccine doses for near-term needs.
BioNTech could have another positive catalyst sooner than the FDA approval decision that's anticipated by early next month. The German drugmaker is scheduled to provide its second-quarter update on Aug. 9.