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What Happened To Cempra's PDUFA Dates?

What Happened To Cempra's PDUFA Dates?

Cempra Inc (NASDAQ: CEMP) investors, whose shares had taken a pounding in early November, were waiting for a couple of big catalysts that could drive a rebound this week.

The FDA had set two target dates to take action on solithromycin under the PDUFA:

  • On Tuesday, it would make a decision for the oral formulation of solithromycin.
  • On Wednesday, it would rule on the intravenous administration of solithromycin.

However, December 27 passed without any announcements. December 28 did not see any news either.

Benzinga reached out to the FDA, and a spokesperson responded, "The FDA is unable to confirm or deny the existence of a new drug application due to disclosure laws."

Wednesday, Benzinga found no press releases, neither did it get a clear answer from Cempra, in spite of numerous requests for comment.

Despite the absence of news, shares of the pharmaceutical company gained 3.39 percent on Wednesday trading, remaining unchanged in after-hours.

Thursday morning, news of a "complete response letter" began circulating from Cempra regarding solithromycin. The related press release, in part, stated, "Cempra plans to request a meeting with the FDA as soon as possible to discuss the issues identified in the CRL, including the design of the recommended clinical safety study and the steps necessary to resolve the deficiencies noted at Wockhardt and Hospira. The company also plans to provide the FDA with an update on manufacturing progress at Uquifia, an alternate GMP manufacturing facility for solithromycin active pharmaceutical ingredient (API)."

Keep tuned in for further developments. Looking for live, super-fast updates on the issue? Try Benzinga Pro!

Posted-In: PDUFABiotech News Health Care FDA Movers Media General Best of Benzinga


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