Business briefs, Dec. 25

Dec. 24, 2013 @ 04:42 PM

RTP pharma company plans to go public

DURHAM – NephroGenex, a Research Triangle Park-based pharmaceutical company that’s working to develop kidney disease treatments, is looking to go public to raise money for clinical trials for a drug candidate designed to slow a degenerative kidney disease that’s caused by diabetes.

According to a registration statement filed with the U.S. Securities and Exchange Commission, the company expects to use the money raised from the stock sale to pay for anticipated Phase 3 clinical trials for its main product candidate, Pyridorin, for the treatment of diabetic kidney disease in patients with type 2 diabetes, as well as for further development of an intravenous formulation of the candidate and for other business.

The company licensed patents for the candidate from BioStratum Inc. in May 2006, and acquired them through a financing completed in May of 2007. The president and co-founder of NephroGenex, J. Wesley Fox, also was the co-founder and chief scientific officer of BioStratum.

To date, the company does not have any revenue from product sales, and has no products approved. It said the U.S. Food and Drug Administration has agreed to the design of its Phase 3 trials under a “special protocol assessment,” but also said it will require substantial additional funding beyond the offering to complete development and commercialization of its main candidate.

The company expects the initial offering price of its stock to be $12-$14 a share.

BioCryst files for drug approval

DURHAM – BioCryst Pharmaceuticals has filed for approval for peramivir, an intravenuous flu treatment candidate.

Last year, the company suspended enrollment in a clinical trial for the candidate after an independent analysis of testing the drug in patients in the hospital with serious flu found the drug was "trending toward futility."

The company got a stop-work order for peramivir from the U.S. Department of Health and Human Services except for certain activities.

But in April of this year, BioCryst Pharmaceuticals says it has received a letter from the U.S. Food and Drug Administration outlining a way it could file for regulatory approval of its antiviral drug candidate.