(Reuters) -Danish pharmaceutical company Orphazyme has failed to win support from the U.S. Food and Drug Administration (FDA) for its arimoclomol drug, a treatment designed for the Niemann-Pick disease type C genetic disorder, the company said on Friday.
Following the FDA’s review, Orphazyme predicted its revenue for the year will be lower than previously expected and the operating loss significantly wider, forcing the company to cut costs.
Orphazyme said the FDA in a letter had said additional qualitative and quantitative evidence was needed for the drug’s effectiveness.
Orphazyme, which is dually listed in Copenhagen and New York, now expects an operating loss of 670 million crowns to 700 million crowns ($107 million-$112 million) in 2021, against a previous forecast for a loss of 100 million-150 million crowns.
“As representative for Orphazyme’s shareholders and as a shareholder myself, I am extremely disappointed,” deputy board chairman Bo Jesper Hansen said in a statement.
The drugmaker will continue to seek approval for the treatment in Europe, it said.
The company’s share price has risen threefold this month, earnings a reputation as a “meme stock” during frenzied trading as many smaller investors positioned themselves for the outcome of the FDA’s decision.
($1 = 6.2456 Danish crowns)
(Reporting by Boleslaw Lasocki in Gdansk and Terje Solsvik in Oslo, Editing by Sherry Jacob-Phillips and Jason Neely)
