NEW YORK, June 23, 2021 (GLOBE NEWSWIRE) – Bragar Eagel & Squire, PC, a nationally recognized law firm, reminds investors that class actions have been filed on behalf of shareholders of ChemoCentryx, Inc. (NASDAQ: CCXI), AcelRx Pharmaceuticals, Inc. (NASDAQ: ACRX), Ocugen, Inc. (NASDAQ: OCGN) and Tarena International, Inc. (NASDAQ: TEDU). Shareholders have until the deadlines below to request the court to act as principal plaintiff. Additional information on each case can be found at the link provided.
ChemoCentryx, Inc. (NASDAQ: CCXI)
Class period: November 26, 2019 to May 6, 2021
Lead Applicant Deadline: July 6, 2021
After market closure on November 25, 2019, ChemoCentryx issued a press release announcing: âPositive first-line data from the pivotal phase III ADVOCATE trial demonstrating superiority of Avacopan over standard of care in vasculitis associated with ANCA â. Throughout the class-action period, defendants have praised the results of the phase III ADVOCATE trial, as well as the safety profile of avacopan for the treatment of ANCA-associated vasculitis (âAVAâ). ).
However, the truth was revealed on May 3, 2021 when the United States Food and Drug Administration (âFDAâ) released a ChemoCentryx New Drug Application (âNDAâ) Backgrounder No. 214487 for avacopan. In this backgrounder, the FDA wrote that â[c]The complexities of the study design, as detailed in the backgrounder, raise questions about the interpretability of the data to define a clinically significant benefit of avacopan and its role in the management of AAV. The briefing paper continued that â[a]Although the primary efficacy comparisons were statistically significant, the review team identified several areas of concern, which raises uncertainties about the interpretability of these data and the clinical significance of these results. The FDA has also raised serious safety concerns with avacopan for the treatment of vasculitis associated with ANCA.
As a result of this news, ChemoCentryx’s common stock price fell more than 45% in one day, from its closing price of $ 48.82 per share on May 3, 2021 to a closing price of 26, $ 63 per share on May 4, 2021.
The complaint alleges that throughout the period of the action, the defendants made false representations and / or failed to disclose to investors that: (1) the design of the Phase III ADVOCATE study had interpretive issues trial data to define a clinically significant benefit of avacopan and its role in the management of vasculitis associated with ANCA; (2) data from the phase III ADVOCATE trial raised serious concerns about the safety of avacopan; (3) these issues were of significant concern regarding the viability of ChemoCentryx NDA for avacopan for the treatment of vasculitis associated with ANCA; and (4) because of the foregoing, the defendants’ public statements were materially false and misleading at all material times.
For more information on the ChemoCentryx class action lawsuit, visit: https://bespc.com/cases/CCXI
AcelRx Pharmaceuticals, Inc. (NASDAQ: ACRX)
Class period: March 17, 2020 to February 12, 2021
Principal applicant deadline: August 9, 2021
AcelRx is a specialty pharmaceutical company focused on the development and commercialization of therapies for the treatment of acute pain. The Company’s lead product candidate is DSUVIA, a 30 mcg sufentanil sublingual tablet for the treatment of moderate to severe acute pain.
On November 2, 2018, AcelRx announced that the United States Food and Drug Administration (âFDAâ) had approved DSUVIA for the management of acute pain in adults severe enough to require an opioid pain reliever in health facilities certified under. medical supervision, such as hospitals. , surgical centers and emergency services.
On February 16, 2021, AcelRx disclosed that on February 11, 2021, the Company received a warning letter from the FDA regarding promotional claims for DSUVIA. Specifically, after “reviewing an ‘SDS banner ad’ (banner) (PM-US-DSV-0018) and a tabletop display (PM-US-DSV-0049) (display)”, the FDA concluded that “[t]Promotional communications, banner and display, make false or misleading statements and statements about the risks and effectiveness of DSUVIA â, andâ[t]hus. . . fake Dsuvia brand within the meaning of the Federal Food, Drug and Cosmetic Law (FD&C Law) and makes its distribution illegal. The warning letter “asks[ed] that AcelRx cease any violation of FD&C law âandâ submit a written response to the[e] letter within 15 days of receipt. “
On this news, the AcelRx share price fell $ 0.21 per share, or 8.37%, to close at $ 2.30 per share on February 16, 2021.
The complaint alleges that, throughout the Class Period, the Defendants made materially false and misleading representations regarding the Company’s business, operations and compliance policies. Specifically, the defendants made false and / or misleading statements and / or failed to disclose that: (i) AcelRx had deficient disclosure controls and procedures with respect to its marketing of DSUVIA; (ii) as a result, AcelRx had made false or misleading statements and representations about the risks and effectiveness of DSUVIA in certain advertisements and displays; (iii) the foregoing conduct has subjected the Company to increased regulatory oversight and enforcement; and (iv) accordingly, the Company’s public statements were materially false and misleading at all material times.
For more information on the AcelRx class action lawsuit, visit: https://bespc.com/cases/ACRX
Ocugen, Inc. (NASDAQ: OCGN)
Class period: February 2, 2021 to June 10, 2021
Principal applicant deadline: August 17, 2021
On May 26, 2021, Ocugen announced that it plans to submit an Emergency Use Authorization (âEUAâ) application to the FDA for COVAXIN, a COVID-19 vaccine, in June 2021. June 10, 2021 , Ocugen announced that it “will no longer apply for an Emergency Use Authorization (EUA) for COVAXIN”, choosing instead to “continue with the submission of a Biologics License Application (BLA) for its vaccine candidate. COVID-19, COVAXIN â. Ocugen CEO said, “Although we were close to finalizing our EUA request, we have received a recommendation from the FDA to pursue a BLA path,” and that “this will extend our timelines.” .
Ocugen shares fell more than 24% in intraday trading on the same day, based on the news.
On June 10, 2021, the company said it would no longer seek an EUA for Covaxin and instead aim to seek full approval for the shooting in the United States.
On this news, the stock price fell and closed on June 11, 2021 at $ 6.69 per share, down 25.17% from the June 10, 2021 closing price of $ 9.31. per share.
The Ocugen The class action alleges that, throughout the Class Period, the Defendants made false and misleading statements and failed to disclose that: (i) the information Ocugen submitted to the United States Food and Drug Administration- United States (âFDAâ) were insufficient to justify an EUA; (ii) Ocugen would not file an EUA with the FDA; and (iii) as a result, Ocugen’s financial statements, as well as the statements of the defendants regarding Ocugen’s business, operations and prospects were false and misleading and / or lacked reasonable basis.
For more information on the Ocugen class action lawsuit, visit: https://bespc.com/cases/OCGN
Tarena International, Inc. (NASDAQ: TEDU)
Class period: August 16, 2016 to November 1, 2019
Lead Applicant Deadline: August 23, 2021
On April 30, 2019, the Company filed with the SEC Form NT 20-F Notification of Inability to Timely File Form 20-F for the fiscal year ended December 31, 2018. The company stated that the delay in filing Form 20-F was due, in part, to “the independent audit committee of the registrant’s board of directors [. . .] conduct a review of certain issues identified during the audit of the registrant’s financial statements for the fiscal year ended December 31, 2018, including issues related to the registrant’s revenue recognition.
On this news, the price of Tarena ADS fell 1% to close at $ 5.02 per ADS on May 1, 2019, to the detriment of investors.
Then, on November 1, 2019, Tarena announced the results of her independent investigation. Tarena revealed issues regarding inaccuracies in income and expenditure, conflicts of interest and related party transactions, and interference with external audit processes, which meant that the financial statements from 2014 to 2018 could not be relied on and had to be restated.
On this news, the price of Tarena ADSs fell 9% to open on November 4, 2019, the next trading day, to $ 0.76, further hurting investors.
It is alleged in this complaint that Tarena throughout the Class Action Period made misleading and / or false statements and / or failed to disclose that: (1) certain employees interfered with the external audits of the financial statements of Tarena during certain periods; (2) Tarena suffered from inaccuracies in expenses and income; (3) Tarena has engaged in business transactions with organizations owned, vested in or controlled by Tarena employees or members of their families, in some cases not properly disclosed by Tarena; (4) Tarena’s 2014 financial statements at the end of the Class Period were not accurate, due to the foregoing; and (5) Tarena’s statements regarding its business, operations and prospects were materially misleading and false and / or lacked reasonable basis at all material times. The lawsuit claims investors suffered damage when the real details entered the market.
For more information on the Tarena class action lawsuit, please visit: https://bespc.com/cases/TEDU
About Bragar Eagel & Squire, PC:
Bragar Eagel & Squire, PC is a nationally recognized law firm with offices in New York City, California and South Carolina. The firm represents individual and institutional investors in commercial, securities, derivatives and other complex litigation in state and federal courts across the country. For more information about the company, please visit www.bespc.com. Lawyer advertising. Past results do not guarantee similar results.
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Brandon Walker, Esq.
Melissa Fortunato, Esq.
Marion Passmore, Esq.