LOS ANGELES--(BUSINESS WIRE)--The Law Offices of Frank R. Cruz announces that a class action lawsuit has been filed on behalf of persons and entities that purchased or otherwise acquired Orphazyme A/S (“Orphazyme” or the “Company”) (NASDAQ: ORPH) (a) American Depositary Shares (“ADSs” or “shares”) pursuant and/or traceable to the registration statement and prospectus (collectively, the “Registration Statement”) issued in connection with the Company’s September 2020 initial public offering (“IPO” or the “Offering”); and/or (b) securities between September 29, 2020 and June 18, 2021, inclusive (the “Class Period”). Orphazyme investors have until September 7, 2021 to file a lead plaintiff motion.
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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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If you purchased Orphazyme ADSs pursuant and/or traceable to the IPO and/or securities during the Class Period, you may move the Court no later than September 7, 2021 to ask the Court to appoint you as lead plaintiff. To be a member of the Class you need not take any action at this time; you may retain counsel of your choice or take no action and remain an absent member of the Class. If you purchased Orphazyme ADSs pursuant and/or traceable to the IPO and/or securities, have information or 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 Frank R. Cruz, of The Law Offices of Frank R. Cruz, 1999 Avenue of the Stars, Suite 1100, Los Angeles, California 90067 at 310-914-5007, by email to email@example.com, or visit our website at www.frankcruzlaw.com. If you inquire by email please include your mailing address, telephone number, and number of shares purchased.
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