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 Fast Track designation for solithromycin intravenous (IV) and capsules for the treatment of community acquired bacterial pneumonia (CABP). Solithromycin is currently in Phase 3 development for the treatment of CABP and submission of a New Drug Application (NDA) is planned for 2016. Additional clinical studies with solithromycin include a Phase 3 trial in uncomplicated gonorrhea that is expected to complete patient enrollment by the end of 2015, a Phase 2 trial in chronic obstructive pulmonary disease (COPD), a Phase 2 trial in nonalcoholic steatohepatitis (NASH), and a Phase 1b trial in pediatric patients.
“We are pleased that the FDA has granted Fast Track status for solithromycin IV and capsules in the treatment of CABP,” said Prabhavathi Fernandes, Ph.D., president and chief executive officer of Cempra. “We look forward to working with the FDA to streamline the development and review of this promising drug and we currently remain on track to release top line data from our Phase 3 solithromycin IV clinical study conducted in patients withCABP by the end of this year.”
The FDA’s Fast Track program was designed to facilitate the development and expedite the review of new drugs that are intended to treat serious or life-threatening conditions and that demonstrate the potential to address unmet medical needs. Drugs with the Fast Track designation ordinarily qualify for priority review, thereby expediting the FDA review process. Additionally, companies that receive Fast Track designation are allowed to submit completed sections of their NDA on a rolling basis.
The FDA has previously designated solithromycin IV and capsules for the treatment of CABP and solithromycin capsules for the treatment of gonorrhea as a Qualified Infectious Disease Product (QIDP). The QIDP designation will make solithromycin eligible to benefit from certain incentives as provided under the Generating Antibiotic Incentives Now (GAIN) program. These incentives include FDA priority review, eligibility for fast-track status and, if ultimately approved by the FDA, solithromycin would be eligible for an additional five-year extension of Hatch-Waxman new chemical entity exclusivity. (Original Source)
Shares of Cempra closed yesterday at $36.78. CEMP has a 1-year high of $46.99 and a 1-year low of $9.20. The stock’s 50-day moving average is $39.73 and its 200-day moving average is $35.52.
On the ratings front, Cempra has been the subject of a number of recent research reports. In a report issued on July 30, Needham analyst Alan Carr reiterated a Buy rating on CEMP, with a price target of $48, which implies an upside of 30.5% from current levels. Separately, on July 27, Roth Capital’s Debjit Chattopadhyay maintained a Buy rating on the stock and has a price target of $56.
According to TipRanks.com, which ranks over 7,500 financial analysts and bloggers to gauge the performance of their past recommendations, Alan Carr and Debjit Chattopadhyay have a total average return of 36.3% and 26.6% respectively. Carr has a success rate of 72.0% and is ranked #4 out of 3740 analysts, while Chattopadhyay has a success rate of 61.0% and is ranked #23.
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.