- The stock price of Orphazyme (NASDAQ: ORPH) increased by over 1,386% during intraday trading. This is why it happened.
The stock price of Orphazyme (NASDAQ: ORPH) increased by over 1,386% during intraday trading. Orphazyme’s partner CytRx (OTCMKTS:CYTR) also saw a stock price increase of about 135% during intraday trading.
Investors are rallying around a rumored decision from the FDA involving Arimoclomol. Arimoclomol is an investigational drug candidate that amplifies the production of heat shock proteins (HSPs). HSPs are able to rescue defective misfolded proteins, clear protein aggregates, and improve the function of lysosomes.
Arimoclomol — which is administered orally — has been studied in 10 phase 1, four phase 2 and three pivotal phase 2/3 trials and it is in clinical development for NPC and Gaucher disease. And Arimoclomol has received orphan drug designation (ODD) for NPC in the US and EU.
Plus Arimoclomol has received fast-track designation (FTD) from the U.S. Food and Drug Administration (FDA) for NPC. Arimoclomol has also received breakthrough therapy designation (BTD) and rare-pediatric disease designation (RPDD) from the FDA for NPC. However, it has not been approved by the FDA.
It is now under the FDA priority review with a PDUFA action date of June 17, according to Seeking Alpha. Arimoclomol is CytRx’s drug candidate and it was sold to Orphazyme in exchange for royalties and milestone payments.
As part of the agreement, CytRx is entitled to receive $100 million in potential milestone payments and future single-digit royalties paid on the sales of arimoclomol.
Disclaimer: This content is intended for informational purposes. Before making any investment, you should do your own analysis.