Orphazyme (NASDAQ: ORPH) Stock trades at $7.38 during intraday trade on June 30, 2021. It is now declined by 15.07%.
Orphazyme stock lost 14.84% in the past five days. Investors can enter this stock at current levels for a target of $8.
The stock gained 24.6% on the closing hours of June 23, 2021, because Goldman Sachs increased its stake in the company to 5.58% on Friday (June 16, 2021). However, Goldman Sachs lowered its position to less than 5% on June 19, 2021.
Orphazyme fails to receive FDA approval for its arimoclomol
The US FDA disapproved Orphazyme’s arimoclomol to cure NPC (Niemann-Pick Disease Type C), a rare disease. It is a setback for Orphazyme. As a result, Orphazyme stock plunged in the last week.
Orphazyme forecasts to get approval for its arimoclomol in Europe in 2022. It is also seeking paths to get experimental drug designation from the US FDA.
The company plans staff reduction to achieve cost savings and focus on developing arimoclomol to cure NPC.
As part of the restructuring, the company plans to slash two-thirds of its workforce worldwide. The company will focus on receiving regulatory approvals in Europe for its innovative formulation.
Orphazyme received A CRL (Complete Response Letter) from the US FDA on June 17, 2021, and staging plans to push forward with its arimoclomol.
Christophe Bourdon, CEO of Orphazyme, said the company has to say goodbye to its most valued and talented colleagues as part of the restructuring process. However, it enables the company to achieve significant cost savings to advance its developmental efforts. He expressed gratitude to each of them for their strong commitment to Orphazyme.
Christophe restructuring is essential to support and protect its approval processes in the EU and establish a path in the US to move forward with its innovative formulation.
Anders Hedegaard, Martijn Kleijwegt, and Rémi Droller will relinquish their director positions on June 30, 2021.