Baupost Group, the hedge fund headed by Seth Klarman, acquired 9,151,600 shares or a 10.7% stake in Keryx Pharmaceuticals (NASDAQ:KERX), based on its latest 13D filing with the Securities and Exchange Commission (SEC).
Keryx Pharmaceuticals (NASDAQ:KERX) is based in New York, and is focused on acquisition, development and commercialization of pharmaceutical products. The company was established in 1998.
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New drug application
Keryx Pharmaceuticals (NASDAQ:KERX) completed a US-based Phase 3 clinical trial of KRX-0502, an investigational, ferric citrate, oral compound that binds to phosphate. It is intended to treat hyperphosphatemia (elevated phosphate levels) in patients with chronic kidney disease (CKD) on dialysis.
The Food and Drug Administration (FDA) assigned June 7, 2014 as the Prescription Drug User Fee Act (PDUFA) goal date for Keryx Pharmaceuticals (NASDAQ:KERX) after the company submitted its new drug application (NDA). According to the company, it will soon submit its marketing authorization application (MAA) with the European Medicines Agency (EMA). Both NDA and MAA are applications for marketing approval.
According to Keryx Pharmaceuticals (NASDAQ:KERX), KRX-0502 is also being tested for the treatment of iron deficiency anemia and elevated phosphorous in stage 5 to 5 non-dialysis-dependent chronic kidney disease (NPD-CKD).
First quarter financial results
Keryx Pharmaceuticals (NASDAQ:KERX) reported a net loss of $13.5 million or a $0.15 loss per share. During the same period a year ago, its net losses were or $0.03 per share. The biopharmaceutical company obtained $10 million license revenue for a milestone payment for Zerenex from its Japanese partner, Japan Tobacco Inc. and Torii Pharmaceutical (JT/Torii) in January 2014.
“Over the past few months we have made significant strides in expanding our leadership team and building our commercial organization to support the launch of Zerenex, pending potential approval,” said Ron Bentsur, CEO of Keryx Pharmaceuticals (NASDAQ:KERX).
“This work, along with the progress made on regulatory filings and clinical development, bring us closer to potentially providing Zerenex to patients in the U.S. and Europe,” added Bentsur.
The biopharmaceutical company ended the quarter with $155.1 million of cash, cash equivalents, short-term investments and interest receivable. Keryx Pharmaceuticals (NASDAQ:KERX) has no debt.
Meanwhile, Baupost Group also disclosed that it owns 3,283,235 shares or an 11% stake in ChipMOS Technologies (Bermuda) Ltd (NASDAQ: IMOS) as of April 30, 2014.