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Nabriva Shares Tumble After FDA Issues CRL For Antibiotic Candidate

Nabriva Shares Tumble After FDA Issues CRL For Antibiotic Candidate

Nabriva Therapeutics PLC – ADR (NASDAQ: NBRV), which gained about 8 percent over the previous two sessions in anticipation of a binary event, is giving up those gains and much more after the event materialized as a negative for the company. 

What Happened

Microcap biotech Nabriva announced Tuesday after the close that it received a complete response letter for its New Drug Application for Contepo injection, chemically fosfomycin, for treating complicated urinary tract infections, or cUTIs, including acute pyelonephritis.

Contepo, according to the company, is a novel, potentially first-in-class antibiotic in the U.S. to be administered intravenously with a broad spectrum of gram-negative and gram-positive activity, including activity against most contemporary multi-drug resistant strains such as ESBL-producing Enterobacteriaceae.

Nabriva said the letter pertains to issues related to facility inspections and manufacturing deficiencies at one of its contract manufacturers. The FDA did not request any new clinical data or raise any safety concerns, the company said.

Why It's Important

Nabriva also pointed that an estimated 40 percent of cUTIs are likely to be caused by multi-drug resistant bacteria and limited treatment options are available for these patients in the U.S.

What's Next

Nabriva said it will seek a Type A meeting with the FDA to discuss the findings.

Type A meetings are those which are immediately necessary for restarting a stalled clinical program, and are intended to resolve disputes and discuss clinical holds, special protocols and more. 

"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," Nabriva CEO Ted Schroeder said in a statement. 

Nabriva shares were plunging 16.22 percent to $2.50 at the time of publication Wednesday. 

Related Links:

The Daily Biotech Pulse: Nabriva Stumbles At FDA Hurdle, Gilead CFO To Retire, Eisai Ends Collaboration With Purdue

Attention Biotech Investors: Mark Your Calendar For These May PDUFA Dates


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