Nabriva Therapeutics PLC (NASDAQ: NBRV) shares dropped sharply on Wednesday after the firm received a Complete Response Letter (CRL) from the U.S. Food and Drug Administration (FDA) for the New Drug Application (NDA) seeking marketing approval of Contepo (fosfomycin).
Note that Contepo is used for the treatment of complicated urinary tract infections, including acute pyelonephritis.
The CRL requests that Nabriva address issues related to facility inspections and manufacturing deficiencies at one of Nabriva’s contract manufacturers prior to the FDA approving the NDA.
Going forward, Nabriva plans to request a “Type A” meeting to discuss the FDA’s findings. The FDA did not request any new clinical data and did not raise any concerns with regard to the safety of Contepo.
Ted Schroeder, CEO of Nabriva, commented:
We will be working with the FDA in the coming weeks to gain a full understanding of the FDA’s comments, with the goal of bringing this important treatment to patients as quickly as possible.
Excluding Wednesday’s move, Nabriva had outperformed the broad markets, with its stock up about 105% year to date. In the past 52 weeks, the stock was actually down about 38.5%.
Shares of Nabriva were last seen down about 19% at $2.42 on Wednesday, in a 52-week range of $1.12 to $6.05. The consensus price target is $9.50.