Shares of clinical-stage drug firm Cempra Inc. (NASDAQ:CEMP) nosedived during Thursday session, following the U.S. Food and Drug Administration reported that it cannot accept a pneumonia drug without further safety data and enhancements at a manufacturing plant.
Shares of the N.C.–based Chapel Hill, firm declined 57% to $2.65, enhancing year-to-date declines to 91.5%. The stock is now moving toward its minimum level since the firm went public in February 2012 at $6 per share. The company held 13.3 million shares of trading volume which was more than five times the normal average. Cempra (CEMP) reported that the FDA had moved it a supposed finalized response letter regarding its new drug applications (NDAs) for solithromycin, a cure for community-possessed bacterial pneumonia. The letter indicates that the FDA cannot accept the NDAs in their present form and that the firm must give further safety data and end unspecified problems with its manufacturing plant.
Founded on their assessment of the NDAs, the CRL reported that the FDA determined the risk of hepatotoxicity had not been sufficiently characterized, the firm reported in a statement.
The FDA stated that the size of the safety database — 920 patients — is not sufficient to assess antagonistic impacts and is suggesting a research of almost 9,000 patients. That would give the firm the capability to omit stern drug-induced liver injury events at a rate of almost 1:3,000 with a 95% probability. The firm reported that it would look for a meeting with the FDA immediately to talk about the concerns raised in the letter but moved to comfort investors that it has satisfactory finances to stay in business.