Shares of Cempra Inc. (NASDAQ: CEMP) were halved on Thursday after the company received a Complete Response Letter (CRL) from the U.S. Food and Drug Administration (FDA). The CRL was relating to the company’s New Drug Applications (NDAs) for oral and intravenous solithromycin for the treatment of community-acquired bacterial pneumonia (CABP) in adults.

For some background, CRLs state that the FDA cannot approve the NDAs in their present form and more data and research may be required before they may be approved. However in this CRL, the FDA did not request any further information on solithromycin efficacy for CABP.

In fact, the FDA determined the risk of hepatotoxicity had not been adequately characterized because the sample size was too small to assess the nature and frequency of serious hepatic adverse effects.

To address this deficiency, the FDA is recommending a comparative study to evaluate the safety of solithromycin in patients with CABP. Specifically, the CRL recommends that Cempra consider a study of approximately 9,000 patients exposed to solithromycin to enable exclusion of serious drug induced liver injury (DILI) events.

Cempra plans to request a meeting with the FDA as soon as possible to discuss the issues identified in the CRL, including the design of the recommended clinical safety study.

David Zaccardelli, Pharm.D., acting CEO of Cempra, commented:

As the rates of antibiotic resistance continue to rise, there is an unmet medical need for new antibiotics to treat patients with CABP and Cempra is committed to working with the FDA to achieve the approval of solithromycin as quickly as possible.

Zaccardelli added:

With more than $225 million of cash on hand, patent protection for solithromycin through 2032 and a pipeline that includes fusidic acid and other potential programs for solithromycin, including an ophthalmic formulation, we have flexibility to determine the best course forward for solithromycin and Cempra.

Shares of Cempra were last seen down about 57% at $2.60 on Thursday, with a consensus analyst price target of $13.77 and a 52-week trading range of $2.55 to $32.00.

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