On Friday, Shares of Cempra, Inc. (NASDAQ:CEMP), declined -27.97% to $19.29.
Cempra, declared positive topline results from a global, pivotal Phase 3 clinical trial of intravenous (IV) to oral solithromycin (Solitaire-IV) in the treatment of patients with community-attained bacterial pneumonia (CABP).
In the intent-to-treat population (ITT, all randomized patients), solithromycin met the FDA primary objective of statistical non-inferiority (NI, 10% non-inferiority margin) contrast to moxifloxacin at the early clinical response (ECR, 72 [-12/+36] hours after initiation of therapy). The point estimates for the primary endpoint of early clinical response were 79.3% for solithromycin and 79.7% for moxifloxacin. The 95% confidence interval for the treatment difference had lower and upper bounds of -6.1% and 5.2%, respectively.
Solithromycin also met the co-primary objective of statistical NI contrast to moxifloxacin at the ECR in the microbiological ITT (mITT) population (those patients with an etiologic diagnosis of the cause of CABP) from the pooled data from both Phase 3 studies. The point estimates were 77.2% for solithromycin and 78.9% for moxifloxacin with lower and upper bounds of the 95% confidence interval for the treatment difference of -7.4% and 4.2%.
Solithromycin also met the secondary endpoint of NI contrast to moxifloxacin in the mITT population at the ECR time point from Solitaire-IV alone. The point estimates for this endpoint were 80.3% for solithromycin and 79.1% for moxifloxacin with lower and upper bounds of the 95% confidence interval for the treatment difference of -8.1% and 10.6%.
Cempra, Inc., a clinical-stage pharmaceutical company, focuses on developing antibiotics to meet medical needs in the treatment of bacterial infectious diseases in North America. Its lead product candidates comprise solithromycin (CEM-101), which is in Phase III clinical trials for the treatment of community attained bacterial pneumonia, in addition to for uncomplicated bacterial urethritis; and Taksta (CEM-102), an antibiotic that has accomplished Phase II clinical trials for refractory bone and joint infections.
On other hand, Shares of Pfizer Inc. (NYSE:PFE), gained 0.97% to $34.41.
Pfizer, recently closed at market price of $34.41 with a 1 year price target of $39.33. The company has a market cap of $212.22B. The forward P/E ratio is 14.65. Its 52-week range is $27.60 - $36.46. 19,202,040 shares were exchanged as compared to its average daily volume of 26,252,100 shares.
Pfizer, declared it has received a Complete Response Letter from the U.S. Food and Drug Administration (FDA) for its supplemental New Drug Application (sNDA) for XELJANZ® (tofacitinib citrate) for the treatment of adult patients with moderate to severe chronic plaque psoriasis. The Agency offered recommendations specific to the moderate to severe chronic plaque psoriasis sNDA. Pfizer will work with the Agency to determine an appropriate path forward to address their comments, counting providing additional safety analyses of XELJANZ for the projected indication.
“Pfizer remains committed to XELJANZ based on the strength of the clinical data for the treatment of psoriasis,” said Kenneth Verburg, PhD, senior vice president and head of global medicines development, Global Innovative Pharma Business. “It is our aim to work closely with the FDA to understand and address their comments about our filing for the use of XELJANZ in patients with chronic plaque psoriasis.”
Psoriasis affects 7.4 million people in the United States. The most common form is plaque psoriasis, which affects about 80 percent of people who have the condition. Of those, as many as 20 percent have moderate to severe chronic plaque psoriasis.
Pfizer Inc., a biopharmaceutical company, discovers, develops, manufactures, and sells healthcare products worldwide. The company operates through Global Innovative Pharmaceutical (GIP); Global Vaccines, Oncology and Consumer Healthcare (VOC); and Global Established Pharmaceutical (GEP) segments.