Benzinga | Aug 10, 2021 02:42PM EDT

Orphazyme To Cut Two-Third Workforce Under Restructuring; Reaffirms FY21 Outlook



* Orphazyme A/S (NASDAQ:ORPH) plans an approximate two-thirds reduction in its global workforce due to a restructuring, aiming to advance its corporate strategy and the development of arimoclomol for Niemann-Pick disease type C (NPC).

* The company further said it remains committed to pursuing regulatory approval in Europe and assessing a path forward for arimoclomol in the U.S. after being hit by a Complete Response Letter from the FDA last week.

* NPC is a rare, genetic, progressively debilitating, and often fatal neurovisceral disease.

* Regarding its trading, Orphazyme said its financial outlook remains unchanged for 2021.

* With the planned restructuring and resulting cost savings, the company intends to free resources.

* Concurrently, the company announced 24-month interim results of an open-label extension trial for arimoclomol in NPC.

* The data were shared at the Parseghian Scientific Conference for Niemann-Pick disease type C Research.

* A slowing of progression from baseline was observed through 36 months in participants who received arimoclomol from the start of the double-blind phase (mean change, 3.5 points).

* The effect was consistent across pre-specified subgroups, including those treated with miglustat among participants more than four years of age.

* Also, slowing of progression through 24 months was observed in those participants who initiated arimoclomol treatment upon entering the open-label period (mean change, 0.9 points).

* Price Action: ORPH shares are down 1.78% at $7.71 during the premarket session on the last check Monday.