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PureTech’s Vedanta Biosciences receives US FDA fast track designation

ALN

PureTech Health PLC on Tuesday said its founded entity, Vedanta Biosciences, has been granted fast track designation from the US Food & Drug Administration for its bacterial consortium candidate, VE303, for the prevention of recurrent Clostridioides difficile infection.

Fast Track designation is a process designed to facilitate the development and expedite the review of drugs that treat serious conditions and fill an unmet medical need.

Clostridium difficile is a type of bacteria that can cause diarrhoea.

‘The FDA’s decision to grant fast track designation to VE303 underscores the continuing need for medical innovation for this condition. Over 150,000 people experience recurrent CDI annually in the U.S. alone, and this requires scalable, effective treatment solutions,’ said Jeffrey Silber, chief medical officer at Vedanta Biosciences.

PureTech/is a clinical-stage biotherapeutics company. Shares in the firm were down 0.8% at 219.20 pence on Tuesday morning in London.

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