On February 11, Orphazyme A/S (ORPH) provided updates regarding its NDA resubmission for arimoclomol for Niemann-Pick Disease Type-C NPC). Consequently, the stock surged in the premarket on Friday.
In the previous trading session, the stock suffered a loss of 1.45% at its closing price of $2.04. Following the announcement, the stock was trading at $2.31 per share in the premarket, at the last check. Hence, the stock had increased by 13.24% in the premarket, at the time of writing on Friday.
The biopharmaceutical company, Orphazyme A/S has a market capitalization of $71.43 million. Currently, its 34.95 million outstanding shares stand at a year-to-date loss of 15.35%. ORPH stock had lost a value of 83.48% in the past year.
ORPH’s NDA Resubmission Updates
Previously, the company had submitted an NDA application for its investigational product candidate, arimoclomol for NPC. In response to the submission, FDA sent a Complete Response Letter to the company.
In October 2021, the company had a Type A meeting with the Food and Drug Administration. In line with the recommendations during the meeting, ORPH plans to request a Type C Meeting. The purpose of the meeting is the discussion of the additional data along with certain items of the previous Complete Response Letter. Presently, the request for the Type C Meeting is expected in the second quarter of 2022. Therefore, based on the discussions and outcomes of the meeting ORPH hopes to resubmit the NDA during the second half of 2022.
Recent Presentations
On February 07, the company announced its participation in the 18th Annual WORLDSymposiumTM Scientific Meeting. The meeting was set to take place from February 07 to February 11, 2022. Marc Patterson, M.D. and Nikolaj Petersen, Ph.D. presented new non-clinical data on arimiclomol during the event.
ORPH’s Executive Management Changes
On January 31, the company announced certain changes to its executive management. The company’s CEO Christophe Bourdon will be resigning from ORPH. Mr. Bourdon will take on the role of Pharma A/S’s chief executive officer following his resignation.
Furthermore, the company’s chief financial officer, Anders Vadsholt will be taking on the role of the new CEO, effective April 1, 2022.
Conclusion
In conclusion, investors seem happy with the company’s developments in the NDA resubmission timeline and updates. The good news resulted in the stock rising in the premarket. Even though the small volume in the before-hours session calls for higher volatility in the session, the stock so far seems to be on the right path.
