Company Update (NASDAQ:CEMP): FDA Grants Qualified Infectious Disease Product Designation to Cempra Inc’s Taksta(TM)

Cempra Inc (NASDAQ:CEMP), a clinical-stage pharmaceutical company focused on developing antibiotics to meet critical medical needs in the treatment of bacterial infectious diseases, today announced that the U.S. Food and Drug Administration (FDA) has granted a qualified infectious disease product (QIDP) designation to Cempra’s investigational antibiotic product candidate, Taksta™ (CEM-102, sodium fusidate, the sodium salt of fusidic acid). The designation is for Taksta oral tablets for the indication of acute bacterial skin and skin structure infections (ABSSSI).

“Taksta is Cempra’s second antibiotic product candidate to obtain QIDP status, which should enable us to expedite its development and bring this promising drug to the patients who need it the most,” said Prabhavathi Fernandes, Ph.D., president and chief executive officer of Cempra. “Previously our lead product, solithromycin, received QIDP status and together we view these designations as further validation of Cempra’s progress in achieving its goal of becoming a leader in the global anti-infective market.”

The QIDP designation was created by the Generating Antibiotic Incentives Now (GAIN) Act of 2012. It provides certain incentives for the development of new anti-infectives, including eligibility for priority review, the FDA’s Fast Track program, and a five-year extension of exclusivity under the Hatch-Waxman Act. The FDA has previously granted QIDP designation to Cempra’s lead product development candidate solithromycin IV and capsules for the treatment of community acquired bacterial pneumonia (CABP) and solithromycin capsules for the treatment of gonorrhea. (Original Source)

Shares of Cempra closed yesterday at $37.49. CEMP has a 1-year high of $46.99 and a 1-year low of $9.61. The stock’s 50-day moving average is $36.79 and its 200-day moving average is $36.37.

On the ratings front, Cempra has been the subject of a number of recent research reports. In a report issued on September 9, Roth Capital analyst Debjit Chattopadhyay reiterated a Buy rating on CEMP, with a price target of $56, which represents a potential upside of 49.4% from where the stock is currently trading. Separately, on July 30, Needham’s Alan Carr reiterated a Buy rating on the stock and has a price target of $48.

According to, which ranks over 7,500 financial analysts and bloggers to gauge the performance of their past recommendations, Debjit Chattopadhyay and Alan Carr have a total average return of 30.7% and 35.9% respectively. Chattopadhyay has a success rate of 69.6% and is ranked #8 out of 3771 analysts, while Carr has a success rate of 70.7% and is ranked #4.

Cempra Inc is a clinical-stage pharmaceutical company. It develops antibiotics for acute care & community settings to meet critical medical needs in treatment of bacterial infectious diseases, respiratory tract & chronic staphylococcal infections.

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