Cempra (CEMP) Stock Soars on Solithromycin Results

Shares of Cempra Inc. (CEMP) were trading up +6.60 or +28.83 percent to $29.49 per share in Monday's premarket. The company announced on January 4th that its lead product, solithromycin, had positive results in clinical trials. Cempra stock closed at $22.89 per share, down -0.62 or -2.64 percent in Friday's regular trading session.

Chapel Hill, North Carolina based Cempra Inc., was founded in 2006 and was formerly known as Cempra Holdings Inc. The company is a clinical and development stage pharmaceutical company specializing in antibacterial and antibiotic drugs for the treatment of infectious diseases such as skin structure and respiratory tract infections.
The company's two principal candidates, which are currently both in clinical trials are solithromycin (CEM-101) and TAKSTA (CEM-102, sodium fusidate), both targeting antimicrobial resistance.

An oral version of solithromycin capsules (Solitaire-Oral) showed positive results in a global Phase 3 clinical trial for the treatment of CAPB or community acquired bacterial pneumonia. CAPB is the leading cause of death caused by an infection, with approximately five to ten million cases reported annually in the United States. The infection typically manifests as a cough with fever and shortness of breath.

Cempra revealed data that showed solithromycin as effective as moxifloxacin, an antibiotic produced by German pharmaceutical company, Bayer AG and met the study's goal of a clinical response 72 hours after dosing. Solithromycin actually outperformed moxifloxacin by a slight margin, according to Cempra.

Prabhavathi Fernandes, Ph.D., President and Chief Executive Officer of Cempra Inc. stated in the company's press release, "I congratulate Dr. David Oldach, senior vice president of Clinical Research, his clinical group and the entire Cempra team for running this landmark oral study which has produced these positive efficacy results for the Solitaire-Oral clinical trial, the first of our two pivotal Phase 3 studies for solithromycin".

He continued saying, "The management of CABP remains a challenge for healthcare providers and I believe solithromycin has the potential to be a rational option for the treatment of this life threatening illness. Our Phase 3 Solitaire intravenous study continues to enroll patients as planned."

Solithromycin also proved to be extremely safe compared to previous generation macrolide antibiotics. Other treatments had toxicity issues such as Sanofi's (SNY) telthromycin, which was shown to have liver toxicity and Pfizer Inc.'s (PFE) azithromycin that has been found to be a heart risk. Solithromycin showed a low degree of gastrointestinal toxicity in clinical trials.

Anti microbial drugs and treatments for superbugs attracted considerable investor interest after Merck & Co. announced its takeover of Cubist Pharmaceuticals Inc. (CBST) on December 8th for $9.5 billion. In addition to the oral capsules in Phase 3 trials, Cempra is also developing an intravenous version of solithromycin for treating CAPB.

Cempra stock will open higher than its previous 52- week high this morning and considerably higher than where the stock was trading just one year ago, when the stock was under $7 per share. As more pharmaceutical companies invest in the new generation antibiotics, Cempra could be a candidate for an acquisition by a larger firm.

Other News About Cempra
Stifel Reiterates Raises PT On Cempra On Good Risk/Reward Profile
Stifel Nicolaus raises its price target on Cempra to $33 per share.
Cempra to Receive BARDA Funding for 1b and Start-Up of Phase 2/3 Solithromycin Pediatric Studies
Company to develop first pediatric antibiotic in three decades.

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Published on Jan 5, 2015
By Jay Hawk
Jay Hawk
Jay Hawk enjoyed a 12-year professional financial markets career incorporating extensive first hand futures and options experience obtained by trading in the stock, commodity and forex markets on U.S. exchanges. Since retiring as a full-time financial market professional, he has been actively trading stock, commodities, forex and options for his own account and managing funds for others, as well as writing financial market commentary and educational articles.

Copyrighted 2016. Content published with author's permission.

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