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BioNTech, COVID-19 and FDA

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The Pharma Letter · 1d
Pfizer and BioNTech win FDA approval for XFG-adapted COVID vaccine
US pharma major Pfizer and German biotech firm BioNTech have secured US Food and Drug Administration (FDA) clearance for the 2026-2027 formula of their COVID-19 vaccine Comirnaty (COVID-19 vaccine, mRNA),

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 · 2d
Pfizer and BioNTech Receive U.S. FDA Approval for XFG-adapted COVID-19 Vaccine
 · 2d · on MSN
FDA approves latest version of Pfizer's COVID-19 mRNA vaccine
 · 1d
The FDA just approved this year’s Covid vaccines - here’s what you need to know about the shots
The U.S. Food and Drug Administration has approved updated Covid vaccines as cases of coronavirus continue to surge this month across the nation.

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 · 1d
FDA approves updated COVID vaccines for certain groups
 · 1d
FDA Approves New COVID Vaccines, but There’s a Catch for Millions of Americans
1d

BioNTech Tumbles 8% as Colorectal Cancer Vaccine Trial Fails, Moderna Drops 6%, Pfizer Holds Flat

A single trial readout is reshuffling the mRNA vaccine trade this morning. BioNTech SE (NASDAQ:BNTX) stock is down 8% to $102.38 after the company terminated its Phase 2 colorectal cancer vaccine trial for futility,
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1d

BioNTech halts mid-stage trial of personalized mRNA vaccine in colorectal cancer

Shares of Germany-based BioNTech were down as much as 8% Friday after announcing a Phase 2 trial of autogene cevumeran would be discontinued for futility. The news follows Merck and Moderna’s Phase 3 win last week for their cancer vaccine plus Keytruda in melanoma.
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12m

BioNTech's Colorectal Cancer Trial Halt Raises Hard Questions About Its mRNA Monotherapy Bet

Shares in the Mainz-based biotech tumbled 7.7 percent on Friday to EUR 88.30, extending the weekly decline to 12 percent. The stock now sits 17 percent below its 52-week high of EUR 105.80 reached in January, though it remains roughly 29 percent above the March trough of EUR 68.35.
2d

The Bull Case For Pfizer (PFE) Could Change Following New COVID And Lyme Vaccine Milestones - Learn Why

In August 2026, Pfizer and BioNTech received U.S. FDA approval for their updated COMIRNATY COVID-19 vaccine targeting the XFG variant for high-risk individuals, while Pfizer and Valneva’s Lyme disease vaccine candidate PF-07307405 had its Marketing Authorization Application validated by the European Medicines Agency based on Phase 3 trial data.
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