Cempra, Inc. announced that the European Medicines Agency (EMA) has validated its marketing authorization application (MAA) for the oral capsule and intravenous (IV) formulations of pipeline candidate solithromycin, for the treatment of community-acquired bacterial pneumonia (CABP).
CABP is commonly known as community-acquired pneumonia (CAP) in the EU. As per the information provided by the company, upon approval, solithromycin would be the first new oral and IV antibiotic available in the EU in more than 15 years. According to the European Respiratory Society (ERS), more than 3,000,000 cases of CAP are diagnosed annually, resulting in approximately 1,000,000 hospitalizations.
Since the EMA has validated the application, the submission is deemed to be complete and the formal review process will start shortly. The EMA’s Committee for Medicinal Products for Human Use (CHMP) will start the assessment of solithromycin under a centralized review procedure followed by the European Commission.
A potential approval and successful commercialization will significantly boost Cempra’s growth prospects as the company does not have any approved product in its portfolio yet. It is developing solithromycin in oral capsules, IV and suspension formulations. Solithera (solithromycin) is one of the two lead product candidates at Cempra.
The company also has a new drug application for solithromycin for the treatment of CABP under review in the U.S. Meanwhile, the company is evaluating solithromycin is in a phase III study for the treatment of uncomplicated urogenital urethritis caused by Neisseria gonorrhoeae or chlamydia.
We note that Allergan’s Teflaro is also approved for the treatment of CABP.
Another candidate in Cempra’s pipeline is Taksta, which is being evaluated in a phase III study for the treatment of patients with acute bacterial skin and skin structure infections.
Cempra currently carries a Zacks Rank #3 (Hold). A couple of better-ranked stocks in the health care sector include Pacira Pharmaceuticals, Inc. (PCRX - Free Report) and Corcept Therapeutics Inc. (CORT - Free Report) . Both the stocks sport a Zacks Rank #1 (Strong Buy).
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It’s a little-known chemical company that’s up 65% over last year, yet still dirt cheap. With unrelenting demand, soaring 2022 earnings estimates, and $1.5 billion for repurchasing shares, retail investors could jump in at any time.
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Cempra, Inc. announced that the European Medicines Agency (EMA) has validated its marketing authorization application (MAA) for the oral capsule and intravenous (IV) formulations of pipeline candidate solithromycin, for the treatment of community-acquired bacterial pneumonia (CABP).
CABP is commonly known as community-acquired pneumonia (CAP) in the EU. As per the information provided by the company, upon approval, solithromycin would be the first new oral and IV antibiotic available in the EU in more than 15 years. According to the European Respiratory Society (ERS), more than 3,000,000 cases of CAP are diagnosed annually, resulting in approximately 1,000,000 hospitalizations.
Since the EMA has validated the application, the submission is deemed to be complete and the formal review process will start shortly. The EMA’s Committee for Medicinal Products for Human Use (CHMP) will start the assessment of solithromycin under a centralized review procedure followed by the European Commission.
A potential approval and successful commercialization will significantly boost Cempra’s growth prospects as the company does not have any approved product in its portfolio yet. It is developing solithromycin in oral capsules, IV and suspension formulations. Solithera (solithromycin) is one of the two lead product candidates at Cempra.
The company also has a new drug application for solithromycin for the treatment of CABP under review in the U.S. Meanwhile, the company is evaluating solithromycin is in a phase III study for the treatment of uncomplicated urogenital urethritis caused by Neisseria gonorrhoeae or chlamydia.
We note that Allergan’s Teflaro is also approved for the treatment of CABP.
Another candidate in Cempra’s pipeline is Taksta, which is being evaluated in a phase III study for the treatment of patients with acute bacterial skin and skin structure infections.
Cempra currently carries a Zacks Rank #3 (Hold). A couple of better-ranked stocks in the health care sector include Pacira Pharmaceuticals, Inc. (PCRX - Free Report) and Corcept Therapeutics Inc. (CORT - Free Report) . Both the stocks sport a Zacks Rank #1 (Strong Buy).
Want the latest recommendations from Zacks Investment Research? Today, you can download 7 Best Stocks for the Next 30 Days. Click to get this free report >>
Zacks Names "Single Best Pick to Double"
From thousands of stocks, 5 Zacks experts each have chosen their favorite to skyrocket +100% or more in months to come. From those 5, Director of Research Sheraz Mian hand-picks one to have the most explosive upside of all.
It’s a little-known chemical company that’s up 65% over last year, yet still dirt cheap. With unrelenting demand, soaring 2022 earnings estimates, and $1.5 billion for repurchasing shares, retail investors could jump in at any time.
This company could rival or surpass other recent Zacks’ Stocks Set to Double like Boston Beer Company which shot up +143.0% in little more than 9 months and NVIDIA which boomed +175.9% in one year.
Free: See Our Top Stock and 4 Runners Up >>
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