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Tanvex's US Unit Receives FDA Nod for TX05 Cancer Drug Biosimilar; Shares Drop 10%

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Tanvex Biopharma's (TPE:6541) US unit received a Complete Response Letter (CRL) from the US Food and Drug Administration for the biologics license application of TX05, a biosimilar to Herceptin used to treat breast and gastric cancers.

Shares slumped about 10% in Thursday's late afternoon trade.

The FDA's comments relate to issues at a third-party downstream manufacturing facility, while no concerns were raised regarding the drug substance produced by Tanvex, the pharmaceutical company said.

Tanvex is working with the contract manufacturer to address the issues and expects to resubmit the application by the end of July, it said.

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