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BioCentury
ARTICLE | Product Development

Aug. 9 Quick Takes: BioNTech earnings drive shares to another all-time high

Plus NDA ‘deficiencies’ sink Axsome shares, Hutchmed-Epizyme, Polivy and more

August 10, 2021 1:27 AM UTC

Shares of BioNTech SE (NASDAQ:BNTX) continued their run Monday, touching a record high of $459.88 before settling to a 15% gain at $447.23, after the company’s 2Q21 earnings report exceeded expectations. BioNTech reported EPS of €2.79 on revenues of €5.3 billion, easily surpassing analysts’ consensus estimates of €1.75 on revenues of €3.3 billion; the biotech anticipates €15.9 billion in full-year sales of its COVID-19 vaccine. BioNTech has doubled in value since mid-July; its shares are up 455% from their close at $80.55 on Dec. 31, 2020.

In its 2Q21 earnings report, Axsome Therapeutics Inc. (NASDAQ:AXSM) said FDA has “identified deficiencies that preclude labeling discussions” during its review of AXS-05, its dextromethorphan-bupropion combination under the agency’s review to treat major depressive disorder. Its PDUFA date is Aug. 22. Axsome shed $23.79 (47%) to $27.37 on the news. The biotech also said AXS-05 met the primary endpoint in a Phase II trial for treatment-resistant depression...

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