Pomerantz Law Firm Reminds Shareholders with Losses on their Investment in Orphazyme A/S of Class Action Lawsuit and Upcoming Deadline – ORPH

NEW YORK, Aug 13, 2021 (GLOBE NEWSWIRE) – Pomerantz LLP announces that a class action lawsuit has been filed against Orphazyme A / S (“Orphazyme” or the “Company”) (NASDAQ: ORPH) and some of its officers and directors . The class action lawsuit, filed in the United States District Court for the Northern District of Illinois, Eastern Division, filed under 21-cv-03640, is on behalf of a class action lawsuit consisting of all natural and legal persons other than the defendants who purchased or otherwise acquired: (a) Orphazyme American Depositary Shares (“ADSs”) pursuant to and / or traceable to the offering documents (defined below) in connection with the Company’s initial public offering on or about September 29, 2020 (the “IPO” or “Offer”); and / or (b) Orphazyme Securities between September 29, 2020 and June 18, 2021, both days inclusive (the “Class Period”). Plaintiff is pursuing claims against defendants under the Securities Act of 1933 (the “Securities Act”) and the Securities Exchange Act of 1934 (the “Exchange Act”).

If you are a shareholder who has purchased or otherwise acquired (a) Orphazyme ADSs pursuant to the offering documents issued in connection with the IPO and / or (b) Orphazyme Securities during the Class Action Period, you will have by 7th 2021, to ask the court to appoint you as the lead plaintiff for the class action. A copy of the complaint is available at www.pomerantzlaw.com. To discuss this promotion, contact Robert S. Willoughby at newaction@pomlaw.com or 888.476.6529 (or 888.4-POMLAW) toll free ext. 7980. Inquiries by email are encouraged to include their postal address, telephone number, and the number of shares purchased.

[Click here for information about joining the class action]

Orphazyme is a biopharmaceutical company developing therapies to treat neurodegenerative rare diseases. The company conducts its US businesses through its wholly owned subsidiary Orphazyme US, Inc., which is focused on reviewing US regulation and preparing for the company’s first potential US launch, including legal, commercial, financial , Advocacy, regulatory and medical affairs functions.

The story goes on

Orphazyme’s lead drug candidate is arimoclomol, which is in clinical development for four rare diseases including Niemann-Pick Type C Disease (“NPC”), Amyotrophic Lateral Sclerosis (“ALS”) and Inclusion Body Myositis (“IBM”) . In August 2017, Orphazyme initiated a multicenter, randomized, 1: 1, double-blind, placebo-controlled phase 2/3 clinical trial to evaluate the efficacy and safety of 400 mg arimoclomol citrate three times daily in patients with IBM; In August 2018, Orphazyme started a randomized, double-blind, placebo-controlled, 2: 1 clinical phase 3 study to evaluate the efficacy and safety of 400 mg arimoclomol citrate three times daily in patients with ALS; and in September 2020, the US Food and Drug Administration (“FDA”) approved Orphazyme’s new drug application (“NDA”) for arimoclomol for NPC.

On September 4, 2020, Orphazyme filed a public offering following several changes by the SEC on September 28, 2020 (the “Registration Statement”).

On September 29, 2020, Orphazyme’s ADS began trading on the Nasdaq Global Select Market under the ticker symbol “ORPH” as per the declaration of registration. On the same day, Orphazyme filed a prospectus with the SEC on Form 424B4 in connection with the IPO, which included and formed a part of the registration statement (collectively, the “Offering Documents”).

According to the offering documents, Orphazyme went public and issued 3,966,146 of its common shares to the US public in the form of 3,966,146 ADSs at the offering price of $ 11.00 per ADS, while offering 3,650,000 of its common shares in Europe as part of an offer Private placement to qualified investors for total proceeds of approximately $ 77,913,174 to the Company, before expenses and after applicable subscription fees.

The complaint alleges that the offer documents were created negligently and, as a result, contained false information about material facts or other facts that were necessary in order not to make the statements made misleading, omitted and not in accordance with the rules and regulations for their creation were created. In addition, the complaint alleges that throughout the class action period, defendants made essentially false and misleading statements about the company’s business, operational and compliance policies. In particular, the Offer Documents and Defendants made false and / or misleading statements and / or did not disclose that: (i) Arimoclomol was not as effective in treating IBM as Defendants had stated; (ii) arimoclomol was not as effective in treating ALS as defendants had shown; (iii) the arimoclomol NDA for NPC was incomplete and / or required additional evidence and data to support the benefit-risk assessment of this NDA; (iv) as a result of (iii) it was unlikely that the FDA would approve the arimoclomol NDA for NPC in its current form; (v) the general business prospects of the company as well as the business prospects of Arimoclomol have been significantly overstated; and (vi) as a result, Defendants’ offer documents and public statements during the Class Action Period were materially inaccurate and / or misleading and did not contain any information required to be disclosed therein.

On March 29, 2021, Orphazyme published an “announce” press release[ing] its phase 2/3 trial evaluating arimoclomol for the treatment of [IBM] . . . did not meet its primary and secondary endpoints. “

As a result of this news, Orphazyme’s ADS price fell $ 3.59 per ADS, or 28.97%, to close at $ 8.80 per ADS on March 29, 2021.

On May 7, 2021, Orphazyme published a press release “announce”[ing] Top-line data from the pivotal study with arimoclomol in [ALS.]”The press release announced that the” crucial study of the company. . . did not meet its primary and secondary endpoints to show benefit for people with ALS. “

Following this news, Orphazyme’s ADS price fell $ 2.81 per ADS, or 32.83%, to close at $ 5.75 per ADS on May 7, 2021.

Then, on June 18, 2021, Orphazyme issued a press release announcing the receipt of a full response letter from the FDA following the agency’s review of the NDA for arimoclomol for the treatment of NPC. The press release announced that the FDA had rejected the arimoclomol-NDA for NPC “due to the need for additional qualitative and quantitative evidence to further substantiate the validity and interpretation of certain data” and “that additional data is required to be confirmatory Evidence to Support Beyond Single Phase 2/3 clinical trial in support of NDA benefit-risk assessment. “

Following this news, Orphazyme’s ADS price fell $ 7.23 per ADS, or 49.66%, to close at $ 7.33 per ADS on June 18, 2021.

Finally, on June 21, 2021, investor resource website Seeking Alpha reported that “Orphazyme” [was] cut in order to then sell in Guggenheim [the Company’s] regulatory snub “by the FDA, which states, among other things, that”[w]heed a target price of $ 1.00 on the stock, indicating a downtrend of ~ 86.4%, Guggenheim notes that the stock is ‘little optional’ and adds, ‘it might make sense to run the company down.’ “

Following this news, Orphazyme’s ADS price fell $ 0.81 per ADS, or 11.05%, to close at $ 6.52 per ADS on June 21, 2021.

At the time the lawsuit was filed, Orphazyme ADS continued to trade below the offering price of $ 11.00 per ADS, causing harm to investors.

Pomerantz Firm, with offices in New York, Chicago, Los Angeles and Paris, is one of the leading law firms in corporate, securities and antitrust litigation. Founded by the late Abraham L. Pomerantz, known as the dean of class actions, the Pomerantz law firm pioneered the field of securities class actions. Today, more than 80 years later, the law firm Pomerantz continues the tradition he founded and fights for the rights of victims of securities fraud, breaches of duty of loyalty and corporate misconduct. The company has collected numerous millions of dollars in damages on behalf of class members. See www.pomerantzlaw.com

CONTACT:
Robert S. Willoughby
Pomerantz LLP
rswilloughby@pomlaw.com
888-476-6529 ext. 7980