Cempra Inc (NASDAQ:CEMP) announced that the majority of the U.S. Food and Drug Administration (FDA) Antimicrobial Drugs Advisory Committee (AMDAC) voted (7-6) that efficacy results of Cempra’s solithromycin outweigh the risks for the treatment of community-acquired bacterial pneumonia (CABP).
Members of AMDAC voted unanimously (13-0) that there was substantial evidence of the efficacy of solithromycin for CABP. The committee also voted (12-1) that the risk of hepatotoxicity with solithromycin had not been adequately characterized and discussed a variety of potential approaches to further characterize the existing liver safety information on solithromycin.
“We appreciate the meaningful discussion from today’s panel. Their supportive view and thoughtful comments on approaches to ensuring appropriate use are consistent with Cempra’s commitment to make solithromycin available to the right patients for a five to seven day course of an oral and/or IV macrolide as monotherapy for CABP,” said Prabhavathi Fernandes Ph.D., president and chief executive officer of Cempra.
“Antibiotic resistance is reaching alarming rates across the globe. In the U.S. alone, pneumonia is the leading cause of death due to infectious disease and rates of pneumococcal resistance to current macrolides for the treatment of CABP can exceed 50 percenti. We believe solithromycin has the potential to offer patients and physicians an important new treatment option and we look forward to continuing to work with the FDA as it completes its review,” Fernandes added.
The target date for the FDA to take action under the Prescription Drug User Fee Act (PDUFA) is December 27 and 28, 2016 for the oral and IV filings, respectively.
The FDA is not bound by the Advisory Committee’s guidance, but takes its advice into consideration when reviewing investigational medicines. If approved, solithromycin would be the first new macrolide antibiotic with an oral and IV formulation in over 20 years. (Original Source)
Shares of Cempra are currently trading at $8.31, up $0.76 or 10%. CEMP has a 1-year high of $34.24 and a 1-year low of $7.05. The stock’s 50-day moving average is $23.51 and its 200-day moving average is $19.97.
On the ratings front, Cempra has been the subject of a number of recent research reports. In a report issued on November 3, J.P. Morgan analyst Jessica Fye downgraded CEMP to Hold, with a price target of $6.00, which implies a downside of 21% from current levels. Separately, on November 2, Cowen’s Ritu Baral maintained a Buy rating on the stock and has a price target of $31.
According to TipRanks.com, which ranks over 7,500 financial analysts and bloggers to gauge the performance of their past recommendations, Jessica Fye and Ritu Baral have a yearly average loss of 25.3% and 1.3% respectively. Fye has a success rate of 26% and is ranked #3937 out of 4167 analysts, while Baral has a success rate of 32% and is ranked #3340.
Cempra, Inc. engages as a clinical-stage pharmaceutical company, which focuses on the development of antibacterials to meet critical medical needs. Its antibiotic candidates includs Solithromycin and Taksta.