Orphazyme A/S (NASDAQ: ORPH) shares skyrocketed over 300% in the regular session on Thursday.
What Happened: Shares of the Denmark-based biopharmaceutical firm touched an intraday high of $77.77, running up 1,387%.
There was no announcement made by the company on Thursday that could explain the volatility in shares which halted trading 20 times until the afternoon.
On Thursday, volumes touched 7.56 million shares whereas the average volume is 61,335.
Orphazyme shares ended Thursday’s regular session 302.4% higher at $21 and fell 9.29% in the after-hours trading to $19.05.
Why It Matters: On Monday, Orphazyme said its application for arimoclomol, which will be branded as MIPLYFFA for Niemann-Pick disease type C, is under priority review with the U.S. Food and Drug Administration — with the expected Prescription Drug User Fee Act action date of June 17.
On the same day, Orphazyme had announced that ORARIALS-01 pivotal trial of arimoclomol in amyotrophic lateral sclerosis (ALS) did not meet both primary and secondary endpoints.
In March, arimoclomol failed to meet primary and secondary endpoints in Phase 2 and 3 trials in inclusion body myositis patients.
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