BioNTech, Pfizer expect clinical 'answer' on coronavirus vaccine in late October

BioNTech BNTX, +2.15% and Pfizer Inc. PFE, -1.18%, which are developing a COVID-19 vaccine candidate, said in a news release on Wednesday that they plan to pursue regulatory review for BNT162b2 in October, depending on the success of the vaccine in late-stage clinical trials. However, the companies did not say what countries they plan to seek review in. In premarket trading on Wednesday, BioNTech's stock is up 6.9%, while shares of Pfizer gained 1.3%. "When the [Phase 3] study reads out will depend on multiple variables but right now, our model, our best case, predicts that we will have an answer by the end of October," Pfizer CEO Albert Bourla said Tuesday on the Today show, later noting that he means a clinical answer, not a regulatory one. Shares of both companies rallied in premarket trading on Wednesday, in part due to the news that AstraZeneca's AZN, +2.10% AZN, -0.57% coronavirus vaccine trial had been halted over safety concerns, which was confirmed by a company spokesperson. The companies also announced findings from the preclinical study of BNT162b2, which were published as a preprint, showing that when the vaccine was tested in macaques it prevented infection with the virus. So far this year, shares of BioNTech have gained 76.6%, Pfizer's stock is down 8.3%, and the S&P 500 SPX, -2.77% is up 3.3%.

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