Orphazyme AS said that American depositary shares representing its ordinary shares on Nasdaq have experienced extreme volatility in price and trading volume since Thursday.
The biopharmaceutical company said it isn’t 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.
The stock is down 57% to $9.08 in premarket trading, after closing Thursday’s session up 300%. Premarket volume was 909,000 shares at 6:30 a.m. ET, while the stock has a 65-average volume of 183,000 shares.
Orphazyme said investors who purchase the company’s ADSs or shares may lose a significant portion of their investments if the price of such securities subsequently declines.
Orphazyme’s applications for arimoclomol for Niemann-Pick disease Type C are under priority review with the U.S. Food and Drug Administration, with an expected Prescription Drug User Fee Act action date of June 17, as well as with the European Medicines Agency, with an opinion from the Committee for Medicinal Products for Human Use expected later this year.