Nabriva Shares Volatile As Biopharma Updates FDA Filing Timeline

Shares of the thinly-traded, micro-cap biotech Nabriva Therapeutics PLC – ADR NBRV were  seeing some volatility Friday following an announcement concerning the timeline for its regulatory filing for Contepo.

Resubmission Planned For Q4

Following the receipt of the final minutes of a Type A meeting Nabriva had with the FDA, the company said it expects to resubmit the NDA for injectable Contepo — which is being evaluated for complicated urinary tract infections, including acute pyelonephritis — early in the fourth quarter of 2019.

Nabriva's original NDA was accepted by the FDA for priority review Jan. 4, with a PDUFA action date of June 30.

The FDA, however, handed down a complete response letter to the NDA April 30, urging the company to address issues related to facility inspections and deficiencies at one of the company's manufacturers.

The FDA did not request any new clinical data or raise any safety concerns at that time.

On June 19, the company placed a request for a Type A meeting and briefing document to the FDA to discuss the CRL.

Nabriva and the FDA had a Type A meeting in July, the company said in its second-quarter report. Aug. 8. 

Working On FDA's Guidance

Nabriva said Friday that it is collaborating with its contract manufacturers to address the issues raised in the CRL based on the feedback from the FDA at the Type A meeting and the meeting minutes.

The FDA meeting minutes said the resubmission will be designated as "Class 2," which suggests the resubmitted application will be reviewed within six months of receipt. 

"We look forward to the opportunity to bring this important treatment to patients as quickly as possible and providing clinicians an urgently needed early and appropriate therapeutic option to manage patients at risk of resistant infections with limited available treatment options for cUTIs," CEO Ted Schroeder said in a statement. 

Nabriva shares were trading higher by 2.55% at $2.21 at the time of publication Friday. 

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