The US Food and Drug Administration (FDA) has issued a complete response letter (CRL) to US biopharma Trevena (Nasdaq: TRVN) in relation to the opioid painkiller, oliceridine.
Trevena, which closed 32% down on Friday and was a further 12% lower after an hour’s trading on Monday, was told in the letter that more data was needed for the FDA to consider approving the New Drug Application (NDA).
The company’s chief executive, Carrie Bourdow, said: “While we are disappointed with FDA’s decision, we continue to believe in the strength of the data and the ultimate approvability of oliceridine.
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