ORPHAZYME ALERT: Bragar Eagel & Squire, P.C. Announces that a Class Action Lawsuit Has Been Filed Against Orphazyme A/S and Encourages Investors to Contact the Firm

By On Jul 13, 2021

NEW YORK–(BUSINESS WIRE) – Bragar Eagel & Squire, PC, a nationally recognized shareholder rights law firm, announces that a class action lawsuit has been filed against Orphazyme A / S (NASDAQ: ORPH) in the United States District Court for the Northern District of Illinois on their behalf who purchased or otherwise acquired publicly traded securities of Orphazyme between September 29, 2020 and June 18, 2021 inclusive (the “Class Period”). Investors have until September 7, 2021 to apply to the court for appointment as the lead plaintiff in the proceedings.

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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. Following the news, Orphazyme’s American Depositary Share (“ADS”) 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 revealed that the company’s” pivotal study … failed to meet its primary and secondary endpoints to show any benefit to 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 (“CRL”) 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.

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.

The complaint alleges that in the company’s registration statement dated September 3, 2020 (the “Registration Statement”) and throughout the class action period, the defendants made materially false and misleading information about the company’s business, operational and compliance policies to have. In particular, the Registration Statement and Defendants made false and / or misleading statements and / or did not disclose that: (i) arimoclomol was not as effective as Defendants had shown in the treatment of inclusion body myositis (“IBM”); (ii) Arimoclomol was not as effective in treating Amyotrophic Lateral Sclerosis (“ALS”) as Defendants claimed; (iii) the Arimoclomol New Medicinal Product (“NDA”) application for Niemann-Pick Disease Type C (“NPC”) was incomplete and / or required additional evidence 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 Company’s general business prospects and Arimoclomol’s business prospects have been significantly overstated; and (vi) as a result, Defendants’ registration and public statements during the class action period were materially false and / or misleading and did not contain any required information.

If you have bought or otherwise acquired Orphazyme stock and have suffered a loss, are a long-term shareholder, have information, want to learn more about these claims, or have questions about this release or your rights or interests in relation to these matters, please contact Brandon Walker, Melissa Fortunato or Marion Passmore by email at [email protected], by phone at (212) 355-4648, or by completing this contact form. There are no costs or obligations for you.

About Bragar Eagle & Squire, PC:

Bragar Eagel & Squire, PC is a nationally recognized law firm with offices in New York, California and South Carolina. The firm represents private and institutional investors in commercial, securities, derivatives and other complex litigation in state and federal courts across the country. More information about the company can be found at www.bespc.com. Lawyer advertising. Previous results do not guarantee similar results.