Cempra’s Shares Fall 60+ Percent After FDA Raises Concerns About Drug

11/2/16

Shares ofCempra Inc., a clinical-stage pharmaceutical company focused on developing antibiotics, fell more than 60 percent Wednesday after the Food and Drug Administration found issues with its pneumonia drug.

The stock closed Wednesday at $7.30, down $11.35, or 60.9 percent. This comes just a week after shares fell 21 percent to $18.50 after the company announced its third-quarter earnings on Oct. 27.

Chapel Hill-based Cempra, founded in 2006, currently has no drugs on the market.

The company has asked the FDA to approve its drug solithromycin to treat a common form of pneumonia that causes more than 1 million infections and roughly 7,000 U.S. deaths per year, according to Cempra.

The drug-maker’s pipeline is heavily-leveraged on solithromycin, and the issues the FDA identified with the drug imply a nine-month launch delay at least, according toJanney Montgomery Scott analyst Debjit Chattopadhyay, who holds a “neutral” rating on the company.

A neutral rating means he believes the company is fairly valued and will perform in line with comparable companies within its sector.

The FDA posted its review of the drug online Wednesday, noting elevated liver enzymes in patients, a major risk with virtually all new prescription drugs that can lead to more serious damage because drugs are principally metabolized by the liver.

The review notes that Cempra’s drug is similar to Ketek, another antibiotic that was linked to cases of severe liver damage and deaths in 2007.

Cempra’s study of roughly 900 patients was not large enough to predict the risk to a larger population.

An FDA advisory committee will meet on Friday, Nov. 4, tovote on whether to recommend approval for the drug; a positive recommendation typically leads to FDA approval.

In March, Cempra received $25 million in continuing funding from the government’s Biomedical Advanced Research and Development Authority to study its drug in pediatric patients.

North Carolina Business News Wire reported on Nov. 1 that Cempra received a $10 million payment from its Japanese business partner that owns exclusive rights to develop and sell the bacterial pneumonia-fighting drug in Japan, the world’s second-largest antibiotic market.

Cempra’s partner, Toyama Chemical Co., is a subsidiary of FujiFilm Holdings Corp.

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