Benzinga | Jun 11, 2021 06:39AM EDT

Orphazyme Announced Earlier it is Not Aware of Any Material Change in Its Clinical Development Programs, Financial Condition or Results of Operations That Would Explain Recent Price Volatility, Trading Volume

Orphazyme A/S (NASDAQ:ORPH), a late-stage biopharmaceutical company pioneering the heat shock protein response for the treatment of rare diseases, today announced that American Depositary Shares (ADSs) representing its ordinary shares on Nasdaq US have since June 10, 2021 experienced extreme volatility in price and trading volume. The company is not aware of any material change in its clinical development programs, financial condition or results of operations that would explain such price volatility or trading volume that has occurred since June 10, 2021. Investors who purchase the company's ADS or shares may lose a significant portion of their investments if the price of such securities subsequently declines.

Orphazyme's applications for arimoclomol (to be branded MIPLYFFATM)1 for Niemann-Pick disease type C (NPC) are under priority review with the U.S. Food and Drug Administration, with an expected PDUFA action date of June 17 2021, as well as with the European Medicines Agency, with an opinion from the Committee for Medicinal Products for Human Use (CHMP) expected later this year.