Brief: ViroGates Submits De Novo Application To U.S. FDA For suPARnostic TurbiLatex

ViroGates A/S

09/04/2026 08:04

April 9 (Reuters) -  ViroGates A/S VIROG.CO:

SAID ON WEDNESDAY SUBMITTED A DE NOVO MARKETING APPLICATION, FORMALLY REFERRED TO AS A "DE NOVO CLASSIFICATION REQUEST", TO THE U.S. FOOD AND DRUG ADMINISTRATION (FDA) FOR ITS SUPARNOSTIC TURBILATEX PRODUCT

RESTATES ITS PREVIOUSLY ANNOUNCED GUIDANCE AND EXPECTS 2026 REVENUE BETWEEN DKK 6 AND 7 MILLION AND AN EBIT OF DKK -10 TO -12 MILLION

 Source text for Workspace: nMFN1QXS5T
 Further company coverage: VIROG.CO

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