The law firm of Kirby McInerney LLP announces that a class action lawsuit has been filed in the U.S. District Court for the Northern District of Illinois on behalf of those who acquired Orphazyme A/S (“Orphazyme” or the “Company”) (NASDAQ: ORPH) ADS pursuant and/or traceable to the registration statement dated September 3, 2020 (the “Registration Statement”) from September 26, 2020 through 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.
The lawsuit alleges that in the Company’s Registration Statement and throughout the Class 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 Period were materially false and / or misleading and did not contain any required information.
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. On this news, Orphazyme’s American Depositary Share (“ADS”) declined by $3.59 per ADS, or approximately 28.97%, from $12.39 per ADS 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. ” On this news, Orphazyme’s ADS price declined by $2.81 per ADS, or approximately 32.83%, from $8.56 per ADS 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. On this news, Orphazyme’s ADS price declined by $7.23 per ADS, or approximately 49.66%, from $14.56 per ADS to close at $ 7.33 per ADS on June 18, 2021.
If you purchased or otherwise acquired Orphazyme ADS, have information, or would like to learn more about these claims, please contact Thomas W. Elrod of Kirby McInerney LLP at 212-371-6600, by email at email@example.com, or by filling out this contact form, to discuss your rights or interests with respect to these matters without any cost to you.