On February 23, Orphazyme A/S (ORPH) provided an update on the review of the Marketing Authorization Application (MAA) for arimoclomol in the European Union. With a tendency towards denial of the approval, the stock nosedived in the pre-market on Wednesday.
The stock remained bullish with a mild gain of 1.51% during the regular trading session on Wednesday. After fluctuating between $1.97 and $2.12, ORPH closed the regular session at $2.02. The day witnessed a below-average volume of 586.47K shares. Following the negative update, the stock plunged down by 20.79% in the pre-market. Hence, ORPH stock was trading at a value of $1.60 per share in the pre-market session on Thursday. Thus, the stock marked its new 52-week low against the previous $1.82.
The biopharmaceutical company, Orphazyme A/S has a market capitalization of $69.77 million. Its 34.95 million outstanding shares stand at a year-to-date loss of 16.18%.
ORPH’s Arimoclomol Update
Arimoclomol is the company’s investigational product candidate. Currently, it is under MAA review for Niemann-Pick disease type C (NPC) in the EU. The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) is reviewing the product. The review process is expected to convene by the end of March 2022.
On February 17, an ad-hoc expert group meeting was held regarding the review process which encouraged the company. But on February 23, CHMP notified the company of a negative trend vote after an Oral Explanation. Therefore, the trend vote indicates that CHMP would probably not approve arimoclomol.
As a result, the company is now evaluating its alternatives and options based on the recent update and its financial situation.
Recent Developments
On February 18, the company announced the issuance of new shares from February 11 to 17, 2022 under its U.S. At-the-Market Offering Program. The company has commenced the program with Cowen and Company, LLC. The company issued 360,000 ordinary shares on February 11, 2022. The new shares are expected to enter trading and official listing on Nasdaq Copenhagen by the end of this month.
ORPH’s Upcoming 2021 Earnings
The company will be posting its audited financial results for fiscal 2021 on March 15, 2022.
Recently, on January 18, the company updates its financial outlook for 2021 based on a preliminary review.
For fiscal 2021, ORPH expects net revenues between DKK 35 and 37 million, while the previous guidance was DKK 30-40 million.
Moreover, the operating loss is expected to be DKK 630-640 million against DKK 670-700 million.
