NEW YORK, Oct. 27, 2021 (GLOBE NEWSWIRE) -- Bragar Eagel & Squire, P.C., a nationally recognized shareholder rights law firm, reminds investors that class actions have been commenced on behalf of stockholders of PolarityTE, Inc. (NASDAQ: PTE), Hyzon Motors, Inc. (NASDAQ: HYZN), Nano-X Imaging Ltd. (NASDAQ: NNOX), and Eargo, Inc. (NASDAQ: EAR). Stockholders have until the deadlines below to petition the court to serve as lead plaintiff. Additional information about each case can be found at the link provided.
PolarityTE, Inc. (NASDAQ: PTE)
Class Period: April 30, 2020 to August 23, 2021
Lead Plaintiff Deadline: November 23, 2021
On April 30, 2020, PolarityTE issued a press release announcing that the Company had decided to pursue a plan to submit an Investigational New Drug Application (“IND”) and thereafter a Biologics License Application to the U.S. Food and Drug Administration (“FDA”) for SkinTE.
On July 23, 2021, PolarityTE submitted an IND to the FDA seeking authorization to commence a clinical trial to evaluate SkinTE for the proposed indication of treatment of chronic cutaneous ulcers (the “SkinTE IND”).
On August 24, 2021, PolarityTE issued a press release “provid[ing] an update regarding correspondence from the U.S. Food and Drug Administration (FDA) related to its Investigational New Drug Application (IND) for SkinTE® with a proposed indication for chronic cutaneous ulcers, which was filed on July 23, 2021. The FDA provided feedback that certain Chemistry, Manufacturing, and Control items need to be addressed prior to proceeding with a pivotal study. As a result, the study proposed in the IND has been placed on clinical hold. In accordance with standard practice and regulations, the FDA has advised that it will issue a clinical hold letter providing details on the basis for the hold to the Company by September 21, 2021.”
On this news, PolarityTE’s stock price fell $0.08 per share, or 9.52%, to close at $0.76 per share on August 24, 2021.
The complaint alleges that, throughout the Class Period, Defendants made materially false and misleading statements regarding the Company's business, operational and compliance policies. Specifically, Defendants made false and/or misleading statements and/or failed to disclose that: (i) the SkinTE IND was deficient with respect to certain Chemistry, Manufacturing, and Control items; (ii) as a result, it was unlikely that the FDA would approve the SkinTE IND in its current form; (iii) accordingly, the Company had materially overstated the likelihood that the SkinTE IND would obtain FDA approval; and (iv) as a result, the Company's public statements were materially false and misleading at all relevant times.
For more information on the PolarityTE class action go to: https://bespc.com/cases/PTE
Hyzon Motors, Inc. (NASDAQ: HYZN)
Class Period: February 9, 2021 to September 27, 2021
Lead Plaintiff Deadline: November 29, 2021
On September 28, 2021, Blue Orca Capital published a report alleging, among other things, that “channel checks reveal . . . that Hiringa was not actually a customer, but a ‘channel partner’ assisting Hyzon in marketing vehicles to real end customers in New Zealand.” Though the Hyzon claims that “Hiringa will account for 24% of the Company’s projected deliveries in 2021,” the report alleged that “Hiringa stated point blank that no deliveries would be taken in 2021,” so Blue Orca “expect[s] a major guidance miss.” Moreover, multiple executives left Hyzon because they “became uncomfortable with how Hyzon was presenting customer orders to investors” as it felt "a bit like unfortunately what Nikola was doing.”
On this news, the Company’s share price fell $2.58, or 28%, to close at $6.63 per share on September 28, 2021, thereby injuring investors.
The complaint filed alleges that throughout the Class Period, 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 failed to disclose to investors that: (1) Hyzon was misrepresenting the nature of its “customer” contracts and severely embellished its “deals” and “partnerships” with customers; (2) Hyzon could not deliver its announced vehicles in 2021, on its stated timeline; and (3) as a result, Defendants' statements about its business, operations, and prospects, were materially false and misleading and/or lacked a reasonable basis at all relevant times.
For more information on the Hyzon Motors class action go to: https://bespc.com/cases/HYZN
Nano-X Imaging Ltd. (NASDAQ: NNOX)
Class Period: June 17, 2021 and August 18, 2021
Lead Plaintiff Deadline: December 6, 2021
On June 17, 2021, Nano-X submitted a 510(k) submission to the U.S. Food and Drug Administration (the “FDA”) for its multi-source version of the Nanox.ARC. A 510(k) is a type of premarket submission made to the FDA to demonstrate that a device to be marketed is as safe and effective, that is, substantially equivalent, to a legally marketed device. Following this submission, defendants touted the Nanox. ARC’s regulatory and commercial prospects in various public statements and U.S. Securities and Exchange Commission filings.
The Nano-X class action lawsuit alleges that, throughout the Class Period, defendants made false and misleading statements and failed to disclose that: (i) Nano-X’s 510(k) application for the Nanox.ARC was deficient; (ii) accordingly, it was unlikely that the FDA would approve the 510(k) application for the Nanox.ARC in its current form; (iii) as a result, Nano-X had overstated the Nanox. ARC’s regulatory and commercial prospects; and (iv) consequently, Nano-X’s public statements were materially false and misleading at all relevant times.
On August 19, 2021, Nano-X reported that Nano-X “received a request for additional information from the [FDA] concerning the Company’s last 510(k) submission of its multi-source device, Nanox.ARC,” and that “[t]he submission file is placed on hold pending a complete response to the FDA’s list of deficiencies,” with “[t]he Company’s response . . . due within 180 days from the date of the request for additional information.” On this news, Nano-X’s ordinary share price fell nearly 10%, damaging investors.
For more information on the Nano-X class action go to: https://bespc.com/cases/NNOX
Eargo, Inc. (NASDAQ: EAR)
Class Period: June 17, 2021 and August 18, 2021
Lead Plaintiff Deadline: December 6, 2021
On August 12, 2021, after the market closed, Eargo revealed that claims submitted to the Company’s largest third-party payor, which accounted for 80% of Eargo’s accounts receivable, had not been paid since March 1, 2021.
On this news, the Company’s share price fell $8.00, or over 24%, to close at $24.70 per share on August 13, 2021, on unusually heavy trading volume.
On September 22, 2021, after the market closed, Eargo revealed that “it is the target of a criminal investigation by the U.S. Department of Justice (the ‘DOJ’) related to insurance reimbursement claims the Company has submitted on behalf of customers covered by federal employee health plans.” Moreover, the DOJ is the "principal contact related to the subject matter of the [ongoing] audit" of Eargo by an insurance company that is the Company’s largest third-party payor. As a result of the foregoing, Eargo withdrew its full year financial guidance.
On this news, the Company’s share price fell $14.81, or over 68%, to close at $6.86 per share on September 23, 2021, on unusually heavy trading volume.
The Complaint alleges that throughout the Class Period, 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, the complaint alleges that Defendants failed to disclose to investors: (1) that Eargo had improperly sought reimbursements from certain third-party payors; (2) that the foregoing was reasonably likely to lead to regulatory scrutiny; (3) that, as a result and because the reimbursements at issue involved the Company’s largest third-party payor, Eargo’s financial results would be adversely impacted; and (4) as a result, Defendants’ statements about its business, operations, and prospects were materially false and misleading and/or lacked reasonable basis at all relevant times.
For more information on the Eargo class action go to: https://bespc.com/cases/EAR
About Bragar Eagel & Squire, P.C.:
Bragar Eagel & Squire, P.C. is a nationally recognized law firm with offices in New York, California, and South Carolina. The firm represents individual and institutional investors in commercial, securities, derivative, and other complex litigation in state and federal courts across the country. For more information about the firm, please visit www.bespc.com. Attorney advertising. Prior results do not guarantee similar outcomes.
Contact Information:
Bragar Eagel & Squire, P.C.
Brandon Walker, Esq.
Alexandra B. Raymond, Esq.
(212) 355-4648
investigations@bespc.com
www.bespc.com
