CMO woes set back Nabriva bid for new antibiotic in the USA

2 May 2019

Antibiotics specialist Nabriva Therapeutics (Nasdaq: NBRV) has been hit by a Complete Response Letter (CRL) from the US regulator, sending its share price down by almost a third.

The firm applied to market Contepo (fosfomycin), as a treatment of complicated urinary tract infections such as acute pyelonephritis.

While the decision comes as a blow for the firm, the US Food and Drug Administration indicated there were no issues with safety, and no new trials are required. Rather, certain deficiencies with one of its contract manufacturers must be addressed.

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