On September 4, 2020, Orphazyme filed a registration statement on Form F-1 with the SEC in connection with the IPO, which, after several amendments, was declared effective by the SEC on September 28, 2020 (the “Registration Statement”). On September 29, 2020, pursuant to the Registration Statement, Orphazyme’s ADSs began trading on the Nasdaq Global Select Market (“NASDAQ”) under the ticker symbol “ORPH.” That same day, Orphazyme filed a prospectus on Form 424B4 with the SEC in connection with the IPO, which incorporated and formed part of the Registration Statement (collectively, the “Offering Documents”).
The Complaint alleges that the 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 and were not prepared in accordance with the rules and regulations governing their preparation. Additionally, the Complaint alleges that, throughout the Class Period, Defendants made materially false and misleading statements regarding the Company's business, operations, and compliance policies. Specifically, the Complaint alleges the Offering Documents and Defendants made false and/or misleading statements and/or failed to disclose that: (i) arimoclomol was not as effective in treating IBM as Defendants had represented; (ii) arimoclomol was not as effective in treating ALS as Defendants had represented; (iii) the arimoclomol NDA for NPC was incomplete and/or required additional evidence and data 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 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.