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 Intercept Pharmaceuticals, Inc., Neovasc, Inc., Interface, Inc., and Biogen, Inc.. 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.
Intercept Pharmaceuticals, Inc.
Class Period: September 28, 2019 to October 7, 2020
Lead Plaintiff Deadline: January 4, 2021
Intercept’s lead product candidate is Ocaliva (obeticholic acid (“OCA”)), a farnesoid X receptor agonist used for the treatment of primary biliary cholangitis (“PBC”), a rare and chronic liver disease, in combination with ursodeoxycholic acid in adults. The Company is also developing OCA for various other indications, including nonalcoholic steatohepatitis (“NASH”).
On May 22, 2020, Intercept reported that the FDA “has notified Intercept that its tentatively scheduled June 9, 2020 advisory committee meeting (AdCom) relating to the company’s [NDA] for [OCA] for the treatment of liver fibrosis due to [NASH] has been postponed” to “accommodate the review of additional data requested by the FDA that the company intends to submit within the next week.”
On this news, Intercept’s stock price fell $11.18 per share, or 12.19%, to close at $80.51 per share on May 22, 2020.
On June 29, 2020, Intercept issued a press release announcing that the FDA had issued a Complete Response Letter (“CRL”) rejecting the Company’s NDA for Ocaliva for the treatment of liver fibrosis due to NASH.
On this news, Intercept’s stock price fell $30.79 per share, or 39.73%, to close at $46.70 per share on June 29, 2020.
Then, on October 8, 2020, news outlets reported that Intercept was “facing an investigation from the [FDA] over the potential risk of liver injury in patients taking Ocaliva, [Intercept’s] treatment for primary biliary cholangitis, a rare, chronic liver disease.”
On this news, Intercept’s stock price fell $3.30 per share, or 8.05%, to close at $37.69 per share on October 8, 2020.
The complaint, filed on November 5, 2020, 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) Defendants downplayed the true scope and severity of safety concerns associated with Ocaliva’s use in treating PBC; (ii) the foregoing increased the likelihood of an FDA investigation into Ocaliva’s development, thereby jeopardizing Ocaliva’s continued marketability and the sustainability of its sales; (iii) any purported benefits associated with OCA’s efficacy in treating NASH were outweighed by the risks of its use; (iv) as a result, the FDA was unlikely to approve the Company’s NDA for OCA in treating patients with liver fibrosis due to NASH; and (v) as a result of all the foregoing, the Company’s public statements were materially false and misleading at all relevant times.
Class Period: November 1, 2019 to October 27, 2020
Lead Plaintiff Deadline: January 4, 2021
Neovasc is a specialty medical device company that develops, manufactures and markets products for cardiovascular diseases, including the Tiara technology and the Reducer. The Company’s Reducer is a medical device that treats refractory angina by altering blood flow in the heart’s circulatory system.
On October 28, 2020, before the market opened, the Company announced that an FDA advisory panel voted overwhelmingly against the safety and effectiveness of the Reducer. The panel noted concerns with the Company’s clinical data, including “that the lack of blinding assessment made the primary endpoint difficult to interpret.” As a result, the panel reached a consensus “that additional premarket randomized clinical data was necessary.”
On this news, the Company’s share price fell $0.77, or 42%, to close at $1.06 per share on October 28, 2020.
The complaint, filed on November 5, 2020, 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: (1) that the results of COSIRA, Neovasc’s clinical study for the Reducer, contained imbalances in missing information present in the control group versus the treatment group, including significant missing information for secondary endpoints but none for the primary endpoint; (2) that the imbalance in missing information indicated that control subjects were aware of their treatment assignment (not blinded) and less inclined to participate in additional data collection; (3) that blinding is critical when studying a placebo-responsive condition such as angina; (4) that the lack of blinding assessment made the primary endpoint difficult to interpret; (5) that, as a result of the foregoing, the FDA was reasonably likely to require additional premarket clinical data; (6) that, as a result, the Company’s PMA for Reducer was unlikely to be approved without additional clinical data; and (7) that, as a result of the foregoing, defendants’ positive statements about the Company’s business, operations, and prospects were materially misleading and/or lacked a reasonable basis.
Class Period: March 2, 2018 to September 28, 2020
Lead Plaintiff Deadline: January 11, 2021
On April 24, 2019, Defendants filed a current report on Form 8-K with the SEC, disclosing, inter alia, that Interface “received a letter in November 2017 from the [SEC] requesting that the Company voluntarily provide information and documents in connection with an investigation into the Company’s historical quarterly [EPS] calculations and rounding practices during the period 2014-2017”; that “[t]he Company subsequently received subpoenas from the SEC in February 2018, July 2018 and April 2019 requesting additional documents and information”; and that “[i]n the fourth quarter of 2018, the Company conducted at the SEC’s request an internal investigation into these and other related issues for seven quarters in 2015, 2016 and 2017.”
On this news, Interface’s stock price fell $1.43 per share, or 8.37%, to close at $15.66 per share on April 25, 2019.
Then, on September 28, 2020, the SEC announced the conclusion of its investigation into Interface’s historical quarterly EPS calculations and rounding practices. Interface agreed to pay a $5 million fine to resolve the matter and was ordered to cease and desist from violating the federal securities laws. In the SEC’s enforcement order issued that same day, the SEC also disclosed how, inter alia, “Interface employees caused Interface to produce documents in response to Commission investigative requests that were suggestive of contemporaneous support for journal entries that, in truth, did not exist at the time the entries were recorded,” and had modified certain documents after the SEC’s investigation began.
On this news, Interface’s stock price fell $0.20 per share, or 3.13%, over the following two trading sessions to close at $6.18 per share on September 29, 2020.
The complaint, filed on November 12, 2020, 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) Interface had inadequate disclosure controls and procedures and internal control over financial reporting; (ii) consequently, Interface, inter alia, reported artificially inflated income and earnings per share (“EPS”) in 2015 and 2016; (iii) Interface and certain of its employees were under investigation by the Securities and Exchange Commission (“SEC”) with respect to the foregoing issues since at least as early as November 2017, had impeded the SEC’s investigation, and downplayed the true scope of the Company’s wrongdoing and liability with respect to the SEC investigation; and (iv) as a result, the Company’s public statements were materially false and misleading at all relevant times.
Class Period: October 22, 2019 to November 6, 2020
Lead Plaintiff Deadline: January 12, 2021
On November 6, 2020, Reuters published an article entitled “FDA advisory panel convenes to discuss whether Biogen Alzheimer’s drug should be approved” which stated that “Biogen shares were halted ahead of the advisory panel meeting.” Later on November 6, 2020, Reuters published an article entitled “U.S. FDA panel votes cannot ignore unsuccessful trial data on Biogen Alzheimer’s drug.”
On this news, Biogen’s stock price fell $92.64 per share, or 28%, to close at $236.26 per share on November 9, 2020, the next trading day.
The complaint, filed on November 13, 2020, alleges that throughout the Class Period defendants made false and/or misleading statements and/or failed to disclose that: (1) the larger dataset did not provide necessary data regarding aducanumab’s effectiveness; (2) the EMERGE study did not and would not provide necessary data regarding aducanumab’s effectiveness; (3) the PRIME study did not and would not provide necessary data regarding aducanumab’s effectiveness; (4) the data provided by the Company to the FDA’s Peripheral and Central Nervous System Drugs Advisory Committee did not support finding efficacy of aducanumab; and (5) 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. When the true details entered the market, the lawsuit claims that investors suffered damages.
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Bragar Eagel & Squire, P.C.
Brandon Walker, Esq.
Melissa Fortunato, Esq.
Marion Passmore, Esq.