NEW YORK, June 23, 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 ChemoCentryx, Inc. (NASDAQ: CCXI), AcelRx Pharmaceuticals, Inc. (NASDAQ: ACRX), Ocugen, Inc. (NASDAQ: OCGN), and Tarena International, Inc. (NASDAQ: TEDU). 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.
ChemoCentryx, Inc. (NASDAQ: CCXI)
Class Period: November 26, 2019 to May 6, 2021
Lead Plaintiff Deadline: July 6, 2021
After the market closed on November 25, 2019, ChemoCentryx issued a press release announcing, “Positive Topline Data from Pivotal Phase III ADVOCATE Trial Demonstrating Avacopan’s Superiority Over Standard of Care in ANCA-Associated Vasculitis.” Throughout the Class Period, the defendants lauded the results of the ADVOCATE Phase III trial, as well as the safety profile of avacopan for the treatment of ANCA-associated vasculitis (“AAV”).
However, the truth was revealed on May 3, 2021 when, the United States Food and Drug Administration (“FDA”) published a Briefing Document concerning ChemoCentryx’s New Drug Application (“NDA”) #214487 for avacopan. In this Briefing Document, the FDA wrote that “[c]omplexities of the study design, as detailed in the briefing document, raise questions about the interpretability of the data to define a clinically meaningful benefit of avacopan and its role in the management of AAV.” The Briefing Document continued that “[a]lthough primary efficacy comparisons were statistically significant, the review team has identified several areas of concern, raising uncertainties about the interpretability of these data and the clinical meaningfulness of these results.” The FDA also raised serious safety concerns with avacopan for the treatment of ANCA-associated vasculitis.
Following this news, the price of ChemoCentryx’s common stock fell over 45% in one day, down from its May 3, 2021 closing price of $48.82 per share to a May 4, 2021 close of $26.63 per share.
The complaint alleges that throughout the Class Period, the defendants misrepresented and/or failed to disclose to investors that: (1) the study design of the Phase III ADVOCATE trial presented issues about the interpretability of the trial data to define a clinically meaningful benefit of avacopan and its role in the management of ANCA-associated vasculitis; (2) the data from the Phase III ADVOCATE trial raised serious safety concerns for avacopan; (3) these issues presented a substantial concern regarding the viability of ChemoCentryx’s NDA for avacopan for the treatment of ANCA-associated vasculitis; and (4) as a result of the foregoing, the defendants’ public statements were materially false and misleading at all relevant times.
For more information on the ChemoCentryx class action go to: https://bespc.com/cases/CCXI
AcelRx Pharmaceuticals, Inc. (NASDAQ: ACRX)
Class Period: March 17, 2020 to February 12, 2021
Lead Plaintiff Deadline: August 9, 2021
AcelRx is a specialty pharmaceutical company that focuses 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 U.S. Food and Drug Administration (“FDA”) had approved DSUVIA for the management of acute pain in adults that is severe enough to require an opioid analgesic in certified medically supervised healthcare settings, such as hospitals, surgical centers, and emergency departments.
On February 16, 2021, AcelRx disclosed that, on February 11, 2021, the Company received a warning letter from the FDA concerning promotional claims for DSUVIA. Specifically, having “reviewed an ‘SDS Banner Ad’ (banner) (PM-US-DSV-0018) and a tabletop display (PM-US-DSV-0049) (display),” the FDA concluded that "[t]he promotional communications, the banner and display, make false or misleading claims and representations about the risks and efficacy of DSUVIA,” and “[t]hus . . . misbrand Dsuvia within the meaning of the Federal Food, Drug and Cosmetic Act (FD&C Act) and make its distribution violative.” The warning letter “request[ed] that AcelRx cease any violations of the FD&C Act” and "submit a written response to th[e] letter within 15 days from the date of receipt."
On this news, AcelRx’s stock 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, defendants made materially false and misleading statements regarding the Company's business, operations, and compliance policies. Specifically, 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 been making false or misleading claims and representations about the risks and efficacy of DSUVIA in certain advertisements and displays; (iii) the foregoing conduct subjected the Company to increased regulatory scrutiny and enforcement; and (iv) as a result, the Company's public statements were materially false and misleading at all relevant times.
For more information on the AcelRx class action go to: https://bespc.com/cases/ACRX
Ocugen, Inc. (NASDAQ: OCGN)
Class Period: February 2, 2021 to June 10, 2021
Lead Plaintiff Deadline: August 17, 2021
On May 26, 2021, Ocugen announced that it planned to submit to the FDA an Emergency Use Authorization (“EUA”) application for COVAXIN, a COVID-19 vaccine, in June 2021. On June 10, 2021, Ocugen announced that it “will no longer pursue an Emergency Use Authorization (EUA) for COVAXIN,” instead choosing to “pursue submission of a biologics license application (BLA) for its COVID-19 vaccine candidate, COVAXIN.” Ocugen’s Chairman and CEO stated, “Although we were close to finalizing our EUA application for submission, we received a recommendation from the FDA to pursue a BLA path,” and that “this will extend our timelines.”
Shares of Ocugen fell by more than 24% in intraday trading on the same day, based on this news.
On June 10, 2021, the Company said it would no longer pursue a EUA for Covaxin and would instead aim to file for a full U.S. approval of the shot.
On this news, the stock price plummeted and closed on June 11, 2021 at $6.69 per share, representing a 25.17% drop from the June 10, 2021 closing price of $9.31 per share.
The Ocugen class action lawsuit alleges that, throughout the Class Period, defendants made false and misleading statements and failed to disclose that: (i) the information that Ocugen submitted to the U.S. Food and Drug Administration (“FDA”) was insufficient to support an EUA; (ii) Ocugen would not file an EUA with the FDA; and (iii) as a result, Ocugen’s financial statements, as well as defendants’ statements about Ocugen’s business, operations, and prospects were false and misleading and/or lacked a reasonable basis.
For more information on the Ocugen class action go to: https://bespc.com/cases/OCGN
Tarena International, Inc. (NASDAQ: TEDU)
Class Period: August 16, 2016 to November 1, 2019
Lead Plaintiff Deadline: August 23, 2021
On April 30, 2019, the Company filed a Form NT 20-F Notification of inability to timely file a Form 20-F for the fiscal year ended December 31, 2018 with the SEC. The Company stated the delay in filing the Form 20-F was due, in part, to, “the independent audit committee of the registrant’s board of directors [. . .] conducting a review of certain issues identified during the course of the audit of the registrant’s financial statements for the year ended December 31, 2018, including issues related to the registrant's revenue recognition.”
On this news, the price of Tarena ADSs fell 1% to close at $5.02 per ADS on May 1, 2019, damaging investors.
Then on November 1, 2019, Tarena announced the results of its independent investigation. Tarena revealed issues surrounding revenue and expense inaccuracies, conflicts of interest and related party transactions, and interference with the external audit processes which meant that financial statements from 2014 through 2018 could not be relied upon and would have to be restated.
On this news, the price of Tarena ADSs dropped 9% to open on November 4, 2019, the next trading day, at $0.76, further damaging investors.
It is alleged in this complaint, Tarena throughout the Class Period made misleading and/or false statements and/or failed to disclose that: (1) certain employees had interfered with external audits of Tarena’s financial statements for certain periods; (2) Tarena suffered from expense and revenue inaccuracies; (3) Tarena engaged in business transactions with organizations that were owned, invested in or controlled by employees of Tarena or their family members, in some instances were not properly disclosed by Tarena; (4) Tarena’s financial statements from 2014 through the end of Class Period were not accurate, as a result of the foregoing; and (5) Tarena’s statements about its business, operations, and prospects, were materially misleading and false and/or lacked a reasonable basis at all relevant times, as a result. The lawsuit claims that investors suffered damages when the true details entered the market.
For more information on the Tarena class action go to: https://bespc.com/cases/TEDU
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.