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Akcea to Cut Staff 10% in Wake of FDA Rejection of Rare Disease Drug

Xconomy Boston — 

Akcea Therapeutics is laying off 10 percent of its workforce, a move that follows the FDA’s rejection of the company’s rare disease drug last week.

Cambridge, MA-based Akcea (NASDAQ: AKCA) said in a regulatory filing Thursday that the board of directors approved the reorganization plan on Sept. 2. Affected employees were notified Thursday. As of February, Akcea employed 100, according to its annual report. But the company had been beefing up its staff in recent months in preparation for a commercial launch of the drug, volanesorsen (Waylivra). The FDA’s rejection last week scuttled those plans. Akcea said in the filing that most of those being laid off worked with the drug.

Akcea spun out of Carlsbad, CA-based Ionis Pharmaceuticals (NASDAQ: IONS) and went public last year, aiming to commercialize lipid disorder drugs developed with Ionis technology. Volanesorsen was developed to treat familial chylomicronemia syndrome, an ultra-rare disease that causes a painful buildup of fat in a patient’s organs. The FDA’s rejection of the drug last week was a surprise, as it followed the vote of an advisory committee in May to recommend approval, despite safety concerns. Akcea did not specify a reason for the FDA rejection, but in a prepared statement, CEO Paula Soteropoulos said the company will “work with the FDA to confirm the path forward.”

The restructuring will cost an estimated $2 million to $2.5 million, according to the regulatory filing. Here’s more on the origins of Akcea.

Photo by Flickr user walknboston under a Creative Commons license. Photo has been cropped to fit Xconomy publishing standards.