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Nabriva, Heron Bleed On FDA Rejection

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Nabriva Therapeutics plc (NBRV) plunged more than 27% and Heron Therapeutics Inc. (HRTX) slipped 18% on Wednesday as both the companies were declined FDA approval for their respective investigational drugs.


Nabriva's drug which has failed to get the FDA's stamp of approval is Contepo, an investigational antibiotic, for the treatment of complicated urinary tract infections (cUTIs), including acute pyelonephritis.

In its Complete Response Letter, the FDA has requested Nabriva to address issues related to facility inspections and manufacturing deficiencies at one of its contract manufacturers before Contepo could be approved. However, the regulatory agency has not sought additional data or raised any concerns with regard to the safety of Contepo

What next?

Nabriva plans to request a "Type A" meeting to discuss the FDA's findings related to Contepo.

The Company has another regulatory event coming its way in August. The FDA is expected to announce its decision on the New Drug Applications for both intravenous and oral formulations of Lefamulin for the treatment of community-acquired bacterial pneumonia (CABP) on August 19, 2019.

NBRV closed Wednesday's trading at $2.17, down 27.42%.


Heron's drug candidate which failed to get the FDA nod is HTX-011, proposed for the management of postoperative pain.

The Complete Response Letter issued to Heron has sought additional Chemistry Manufacturing and Controls (CMC), and non-clinical information related to HTX-011 before it could be approved. The regulatory agency has not raised any clinical safety or efficacy issues, or has requested additional clinical studies or data analyses.

What next?

The Company plans to request a meeting with the FDA to obtain its agreement on its approach to resolve the issues outlined in the Complete Response Letter and resubmit the NDA as soon as possible.

The news of FDA refusing to approve Heron's post-surgery pain drug boosted the share price of its rival Pacira Pharmaceuticals, Inc. (PCRX), which gained over 16% to $46.25. Pacira's post-surgery pain drug Exparel has been marketed in the U.S. since 2012.

HRTX closed Wednesday's trading at $17.75, down 18.13%.

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