Denmark-based Orphazyme is reducing its workforce by about two-thirds following a recent U.S. regulatory finding that more data was needed before its principal drug could be approved.
Last week, Orphazyme said its application for FDA approval for arimoclomol as a treatment option for Niemann-Pick disease type C (NPC) was turned down with a complete response letter. According to the CRL, the FDA needs additional qualitative and quantitative evidence to show the drug's effectiveness. The agency has asked for additional data to strengthen evidence beyond the single-phase 2/3 clinical trial to support the benefit-risk assessment of the NDA.
Today, the drugmaker announced a restructuring intended to enable the company to advance its corporate strategy and the development of arimoclomol for NPC. As part of the restructuring, Orphazyme will significantly scale back its global organization, including teams based in the U.S. and Europe, with the purpose of reducing the number of employees to those who will support essential activities moving forward. Orphazyme employs about 200 workers, according to available data.
Orphazyme is yet to have a drug approved, but its stock made the rounds in social media earlier this month, at one point surging from $5 to $77 per share amid Reddit hype. Shares have since fallen back down to $7 after news of the FDA rejection.