Bragar Eagel & Squire, P.C., 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 behalf of those who purchased or otherwise acquired Orphazyme publicly traded securities between September 29, 2020 and June 18, 2021, inclusive (the “Class Period”). Investors have until September 7, 2021 to apply to the Court to be appointed as lead plaintiff in the lawsuit.

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On March 29, 2021, Orphazyme issued a press release “announc[ing] its phase 2/3 trial evaluating arimoclomol for the treatment of [IBM] … did not meet its primary and secondary endpoints. On this news Orphazyme’s American depositary share (“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 issued a press release “announc[ing] topline data from pivotal trial of arimoclomol in [ALS.]” The press release disclosed that the Company’s “pivotal trial…did not meet its primary and secondary endpoints to show benefit in people living with ALS.” On 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 receipt of a Complete Response Letter (“CRL”) from the FDA following the agency’s review of the NDA for arimoclomol for the treatment of NPC. The press release disclosed that the FDA had rejected the arimoclomol NDA for NPC.

On 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 September 3, 2020 registration statement (the “Registration Statement”) and throughout the Class Period, defendants made materially false and misleading statements regarding the Company’s business, operations, and compliance policies. Specifically, the Registration Statement and defendants made false and/or misleading statements and/or failed to disclose that: (i) arimoclomol was not as effective in treating Inclusion Body Myositis (“IBM”) as defendants had represented; (ii) arimoclomol was not as effective in treating Amyotrophic Lateral Sclerosis (“ALS”) as defendants had represented; (iii) the arimoclomol new drug application (“NDA”) for Niemann-Pick disease type C (“NPC”) was incomplete and/or required additional evidence to support the benefit-risk assessment of that NDA; (iv) as a result of (iii), the FDA was unlikely to approve the arimoclomol NDA for NPC in its present form; (v) the Company’s overall business prospects, as well as arimoclomol’s commercial prospects, were significantly overstated; and (vi) as a result, the Registration Statement and defendants’ public statements throughout the Class Period were materially false and/or misleading and failed to state information required to be stated therein.

If you purchased or otherwise acquired Orphazyme shares and suffered a loss, are a long-term stockholder, have information, would like to learn more about these claims, or have any questions concerning this announcement or your rights or interests with respect to these matters, please contact Brandon Walker, Melissa Fortunato, or Marion Passmore by email at investigations@bespc.com, telephone at (212) 355-4648, or by filling out this contact form. There is no cost or obligation to you.

About Bragar Eagel & Squire, P.C.:

Bragar Eagel & Squire, P.C. is a nationally recognized law firm with offices in New York, California, and South Carolina. The firm represents individual and institutional investors in commercial, securities, derivative, and other complex litigation in state and federal courts across the country. For more information about the firm, please visit www.bespc.com. Attorney advertising. Prior results do not guarantee similar outcomes.

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