San Diego, CA -- (SBWIRE) -- 07/28/2021 -- An investor, who purchased NASDAQ: ORPH shares, filed a lawsuit against Orphazyme A/S in the U.S. over alleged violations of Federal Securities Laws in connection with the Company's initial public offering conducted on or about September 29, 2020 (the "IPO" or "Offering") and between September 29, 2020 and June 18, 2021.

Investors who purchased shares of Orphazyme A/S (NASDAQ: ORPH) have certain options and for certain investors are short and strict deadlines running. Deadline: September 7, 2021. NASDAQ: ORPH investors should contact the Shareholders Foundation at mail@shareholdersfoundation.com or call +1(858) 779 - 1554.

Denmakr based Orphazyme A/S, a biopharmaceutical company, develops therapies for the treatment of neurodegenerative orphan diseases. Its leading drug candidate is arimoclomol, which is in clinical development for four orphan diseases, including Niemann-Pick disease type C ("NPC"), Amyotrophic Lateral Sclerosis ("ALS"), and Inclusion Body Myositis ("IBM").

In September 2020, Orphazyme A/S completed its initial public offering ("IPO"), selling approximately 4 million American Depositary Shares ("ADSs" or "shares") 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, Orphazyme A/S 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 May 7, 2021, Orphazyme A/S disclosed "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 June 18, 2021, Orphazyme A/S 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 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" "it might make sense to wind down the company."

Shares of Orphazyme A/S (NASDAQ: ORPH) from $14.78 per share on March 24, 2021, to as low as $5.84 per share on June 22, 2021.

The plaintiff alleges on behalf of purchasers of Orphazyme A/S (NASDAQ: ORPH) common shares, that the defendants violated Federal Securities Laws. More specifically, the plaintiff claims 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, the Offering Documents and Defendants made false and/or misleading statements and/or failed to disclose that arimoclomol was not as effective in treating IBM as Defendants had represented, that arimoclomol was not as effective in treating ALS as Defendants had represented, that the arimoclomol NDA for NPC was incomplete and/or required additional evidence and data to support the benefit-risk assessment of that NDA, that as a result of , that the FDA was unlikely to approve the arimoclomol NDA for NPC in its present form, that the Company's overall business prospects, as well as arimoclomol's commercial prospects, were significantly overstated, and that as a result, the Offering Documents and Defendants' public statements between September 29, 2020 and June 18, 2021 were materially false and/or misleading and failed to state information required to be stated therein.

Those who purchased shares of Orphazyme A/S (NASDAQ: ORPH) have certain options and should contact the Shareholders Foundation.

Contact:
Shareholders Foundation, Inc.
Michael Daniels
3111 Camino Del Rio North - Suite 423
92108 San Diego
Phone: +1-(858)-779-1554
Fax: +1-(858)-605-5739
mail@shareholdersfoundation.com

About Shareholders Foundation, Inc.
The Shareholders Foundation, Inc. is a professional portfolio monitoring and settlement claim filing service, , which does research related to shareholder issues and informs investors of securities class actions, settlements, judgments, and other legal related news to the stock/financial market. Shareholders Foundation, Inc. is in contact with a large number of shareholders and offers help, support, and assistance for every shareholder. The Shareholders Foundation, Inc. is not a law firm. Referenced cases, investigation, and/or settlements are not filed/reached and/or related to Shareholders Foundation. The information is provided as a public service. It is not intended as legal advice and should not be relied upon.