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Orphazyme A S

Company NameOrphazyme A S
Stock SymbolORPH
Class PeriodSeptember 29, 2020 to June 18, 2021
Lead Plaintiff Motion DeadlineSeptember 07, 2021

In September 2020, Orphazyme completed its IPO, selling approximately 4 million ADSs at $11.00 per share. The same month, the Company’s New Drug Application (“NDA”) for arimoclomol for NPC was accepted by the U.S. Food and Drug Administration (“FDA”).

On March 29, 2021, the Company disclosed in a press release “its phase 2/3 trial evaluating arimoclomol for the treatment of [IBM] . . . did not meet its primary and secondary endpoints.”

On this news, the Company’s ADS price fell $3.59 per ADS, or 28.97%, to close at $8.80 per ADS on March 29, 2021, thereby injuring investors.

Then, on May 7, 2021, the Company disclosed in a press release “topline data from pivotal trial of arimoclomol in [ALS],”  stating that the trial “did not meet its primary and secondary endpoints to show benefit in people living with ALS.”

On this news, the Company’s ADS price fell $2.81 per ADS, or 32.83%, to close at $5.75 per ADS on May 7, 2021, thereby injuring investors.

Then, on June 18, 2021, the Company announced it had received a Complete Response Letter (“CRL”) from the FDA. Specifically, 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, the Company’s ADS price fell $7.23 per ADS, or 49.66%, to close at $7.33 per ADS on June 18, 2021, thereby injuring investors.

Finally, on June 21, 2021, Seeking Alpha reported that “Orphazyme [was] cut to sell at Guggenheim,” which noted that there is “little optionality left in the stock” and “it might make sense to wind down the company.”

On this news, the Company’s ADS price fell $0.81 per ADS, or 11.05%, to close at $6.52 per ADS on June 21, 2021, thereby injuring investors.

The complaint filed in this class action alleges that Defendants made materially false and/or misleading statements, as well as failed to disclose material adverse facts about the Company’s business, operations, and prospects. Specifically, Defendants made false and/or misleading statements and/or failed to disclose that: (1) arimoclomol was not as effective in treating IBM as Defendants had represented; (2) arimoclomol was not as effective in treating ALS as Defendants had represented; (3) the arimoclomol NDA for NPC was incomplete and/or required additional evidence and data to support the benefit-risk assessment of that NDA; (4) as a result of the foregoing, the FDA was unlikely to approve the arimoclomol NDA for NPC in its present form; (5) the Company’s overall business prospects, as well as arimoclomol’s commercial prospects, were significantly overstated; and (6) as a result, 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.

 

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