Robbins Geller Rudman & Dowd LLP announces that purchasers of Orphazyme A/S (NASDAQ: ORPH) American Depositary Shares (“ADSs”) pursuant and/or traceable to the offering documents issued in connection with Orphazyme’s initial public offering conducted on or about September 29, 2020 (the “IPO”); and/or (ii) Orphazyme securities between September 29, 2020 and June 18, 2021, both dates inclusive (the “Class Period”) have until September 7, 2021 to seek appointment as lead plaintiff in the Orphazyme class action lawsuit. The Orphazyme class action lawsuit charges Orphazyme and other defendants with violations of the Securities Act of 1933 and/or Securities Exchange Act of 1934. The Orphazyme class action lawsuit was commenced on July 9, 2021 in the Northern District of Illinois and is captioned Busic v. Orphazyme A/S, No. 21-cv-03640.

If you suffered substantial losses and wish to serve as lead plaintiff of the Orphazyme class action lawsuit, please provide your information by clicking here. You can also contact attorney J.C. Sanchez of Robbins Geller by calling 800/449-4900 or via e-mail at jsanchez@rgrdlaw.com. Lead plaintiff motions for the Orphazyme class action lawsuit must be filed with the court no later than September 7, 2021.

CASE ALLEGATIONS: The Orphazyme class action lawsuit alleges that the IPO’s offering documents were negligently prepared and, as a result, contained untrue statements of material fact or omitted to state other facts necessary to make the statements made not misleading. In addition, the Orphazyme class action lawsuit alleges that defendants made false and misleading statements and failed to disclose that: (i) arimoclomol was not as effective in treating Inclusion Body Myositis (“IBM”) as Orphazyme had represented; (ii) arimoclomol was not as effective in treating Amyotrophic Lateral Sclerosis (“ALS”) as Orphazyme had represented; (iii) the arimoclomol new drug application (“NDA”) for Niemann-Pick disease type C (“NPC”) was incomplete and/or required additional evidence and data to support the benefit-risk assessment of that NDA; (iv) as a result, the U.S. Food and Drug Administration (“FDA”) was unlikely to approve the arimoclomol NDA for NPC in its present form; (v) Orphazyme’s overall business prospects, as well as arimoclomol’s commercial prospects, were significantly overstated; and (vi) consequently, the offering documents and defendants’ public statements throughout the Class Period were materially false and/or misleading and failed to state information required to be stated therein.

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 ADS price fell nearly 29%. Then, 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 Orphazyme’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 nearly 33%.

Thereafter, 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. Orphazyme disclosed that the FDA had rejected the arimoclomol NDA for NPC “based on needing additional qualitative and quantitative evidence to further substantiate the validity and interpretation” of certain data and “that additional data are needed to bolster confirmatory evidence beyond the single phase 2/3 clinical trial to support the benefit-risk assessment of the NDA.” On this news, Orphazyme’s ADS price fell more than 49%.

Finally, on June 21, 2021, Seeking Alpha reported that “Orphazyme [was] cut to sell at Guggenheim after [Orphazyme’s] regulatory snub” by the FDA, stating, among other things, that “[w]ith a $1.00 price target for the stock indicating a downside of ~86.4%, Guggenheim notes that there is ‘little optionality left in the stock,’ and adds ‘it might make sense to wind down the company.’” On this news, Orphazyme’s ADS price fell an additional 11%, further damaging investors.

THE LEAD PLAINTIFF PROCESS: The Private Securities Litigation Reform Act of 1995 permits any investor who purchased Orphazyme ADSs pursuant and/or traceable to the offering documents issued in connection with Orphazyme’s IPO and/or Orphazyme securities during the Class Period to seek appointment as lead plaintiff in the Orphazyme class action lawsuit. A lead plaintiff is generally the movant with the greatest financial interest in the relief sought by the putative class who is also typical and adequate of the putative class. A lead plaintiff acts on behalf of all other class members in directing the Orphazyme class action lawsuit. The lead plaintiff can select a law firm of its choice to litigate the Orphazyme class action lawsuit. An investor’s ability to share in any potential future recovery of the Orphazyme action lawsuit is not dependent upon serving as lead plaintiff.

ABOUT ROBBINS GELLER RUDMAN & DOWD LLP: With 200 lawyers in 9 offices nationwide, Robbins Geller Rudman & Dowd LLP is the largest U.S. law firm representing investors in securities class actions. Robbins Geller attorneys have obtained many of the largest shareholder recoveries in history, including the largest securities class action recovery ever – $7.2 billion – in In re Enron Corp. Sec. Litig. The 2020 ISS Securities Class Action Services Top 50 Report ranked Robbins Geller first for recovering $1.6 billion for investors last year, more than double the amount recovered by any other securities plaintiffs’ firm. Please visit https://www.rgrdlaw.com/firm.html for more information.

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