Glancy Prongay & Murray LLP ("GPM"), a leading national shareholder rights law firm, today announced that it has commenced an investigation on behalf of Orphazyme A/S ("Orphazyme" or the "Company") (ORPH) - Get ORPH Report investors concerning the Company's possible violations of the federal securities laws.
If you suffered a loss on your Orphazyme investments or would like to inquire about potentially pursuing claims to recover your loss under the federal securities laws, you can submit your contact information at https://www.glancylaw.com/cases/orphazyme-a-s/. You can also contact Charles H. Linehan, of GPM at 310-201-9150, Toll-Free at 888-773-9224, or via email at email@example.com to learn more about your rights.
Orphazyme is a biopharmaceutical company that 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 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, 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 Compnay 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" "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.
Whistleblower Notice: Persons with non-public information regarding Orphazyme should consider their options to aid the investigation or take advantage of the SEC Whistleblower Program. Under the program, whistleblowers who provide original information may receive rewards totaling up to 30 percent of any successful recovery made by the SEC. For more information, call Charles H. Linehan at 310-201-9150 or 888-773-9224 or email firstname.lastname@example.org.
Glancy Prongay & Murray LLP is a premier law firm representing investors and consumers in securities litigation and other complex class action litigation. ISS Securities Class Action Services has consistently ranked GPM in its annual SCAS Top 50 Report. In 2018, GPM was ranked a top five law firm in number of securities class action settlements, and a top six law firm for total dollar size of settlements. With four offices across the country, GPM's nearly 40 attorneys have won groundbreaking rulings and recovered billions of dollars for investors and consumers in securities, antitrust, consumer, and employment class actions. GPM's lawyers have handled cases covering a wide spectrum of corporate misconduct including cases involving financial restatements, internal control weaknesses, earnings management, fraudulent earnings guidance and forward looking statements, auditor misconduct, insider trading, violations of FDA regulations, actions resulting in FDA and DOJ investigations, and many other forms of corporate misconduct. GPM's attorneys have worked on securities cases relating to nearly all industries and sectors in the financial markets, including, energy, consumer discretionary, consumer staples, real estate and REITs, financial, insurance, information technology, health care, biotech, cryptocurrency, medical devices, and many more. GPM's past successes have been widely covered by leading news and industry publications such as The Wall Street Journal, The Financial Times, Bloomberg Businessweek, Reuters, the Associated Press, Barron's, Investor's Business Daily, Forbes, and Money.
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