Bragar Eagel & Squire, P.C. Reminds Investors That Class Action Lawsuits Have Been Filed Against Orphazyme, CorMedix, Koninklijke Philips, and Sesen Bio and Encourages Investors to Contact the Firm
NEW YORK, Aug. 25, 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 Orphazyme A/S (NASDAQ: ORPH), CorMedix Inc. (NASDAQ: CRMD), Koninklijke Philips N.V. (NYSE: PHG), and Sesen Bio, Inc. (NASDAQ: SESN). 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.
Orphazyme A/S (NASDAQ: ORPH)
Class Period: September 29, 2020 to June 18, 2021
Lead Plaintiff Deadline: September 7, 2021
On March 29, 2021, Orphazyme issued a press release “announc[ing] its phase 2/3 trial evaluating arimoclomol for the treatment of [IBM] … did not meet its primary and secondary endpoints. On this news Orphazyme’s American depositary share (“ADS”) price fell $3.59 per ADS, or 28.97%, to close at $8.80 per ADS on March 29, 2021.
On May 7, 2021, Orphazyme issued a press release “announc[ing] topline data from pivotal trial of arimoclomol in [ALS.]” The press release disclosed that the Company’s “pivotal trial…did not meet its primary and secondary endpoints to show benefit in people living with ALS.” On this news, Orphazyme’s ADS price fell $2.81 per ADS, or 32.83%, to close at $5.75 per ADS on May 7, 2021.
Then, on June 18, 2021, Orphazyme issued a press release announcing receipt of a Complete Response Letter (“CRL”) from the FDA following the agency’s review of the NDA for arimoclomol for the treatment of NPC. The press release disclosed that the FDA had rejected the arimoclomol NDA for NPC.
On this news, Orphazyme’s ADS price fell $7.23 per ADS, or 49.66%, to close at $7.33 per ADS on June 18, 2021.
The complaint alleges that, in the Company’s September 3, 2020 registration statement (the “Registration Statement”) and throughout the Class Period, defendants made materially false and misleading statements regarding the Company’s business, operations, and compliance policies. Specifically, the Registration Statement and defendants made false and/or misleading statements and/or failed to disclose that: (i) arimoclomol was not as effective in treating Inclusion Body Myositis (“IBM”) as defendants had represented; (ii) arimoclomol was not as effective in treating Amyotrophic Lateral Sclerosis (“ALS”) as defendants had represented; (iii) the arimoclomol new drug application (“NDA”) for Niemann-Pick disease type C (“NPC”) was incomplete and/or required additional evidence to support the benefit-risk assessment of that NDA; (iv) as a result of (iii), the FDA was unlikely to approve the arimoclomol NDA for NPC in its present form; (v) the Company’s overall business prospects, as well as arimoclomol’s commercial prospects, were significantly overstated; and (vi) as a result, the Registration Statement and defendants’ public statements throughout the Class Period were materially false and/or misleading and failed to state information required to be stated therein.
On March 1, 2021, CorMedix issued a press release “announc[ing] that the [FDA] cannot approve the [new drug application (“NDA”)] for DefenCath…in its present form.” CorMedix informed investors that the “FDA noted concerns at the third-party manufacturing facility after a review of records requested by FDA and provided by the manufacturing facility.”
On this news, CorMedix’s stock price fell $5.98 per share, or 39.87%, to close at $9.02 per share on March 1, 2021.
Then on March 13, 2021, CorMedix announced that “[b]ased on our analyses, we have concluded that additional process qualification will be needed with subsequent validation to address the deficiencies identified by FDA.”
On this news, CorMedix’s stock price fell $1.51 per share, or 19.97%, to close at $6.05 per share on May 14, 2021.
The complaint alleges that, throughout the Class Period, defendants made false and/or misleading statements and/or failed to disclose that: (i) deficiencies existed with respect to DefenCath’s manufacturing process and/or at the facility responsible for manufacturing DefenCath; (ii) in light of the foregoing deficiencies, the FDA was unlikely to approve the DefenCath NDA for catheter-related bloodstream infections (“CRBSIs”) in its present form; (iii) Defendants had downplayed the true scope of the deficiencies with DefenCath's manufacturing process and/or at the facility responsible for manufacturing DefenCath; and (iv) as a result, the Company's public statements were materially false and misleading at all relevant times.
On June 14, 2021, Philips issued a voluntary recall of certain of its Bi-Level PAP and CPAP devices, as well as mechanical ventilators, after finding that the sound abatement foam used in the devices can degrade and become toxic, potentially causing cancer.
On this news, Philips’ stock price fell $2.25 per share, or 3.98%, to close at $54.25 per share on June 14, 2021.
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) Philips had deficient product manufacturing controls or procedures; (ii) as a result, the Company’s Bi-Level PAP and CPAP devices and mechanical ventilators were manufactured using hazardous materials; (iii) accordingly, the Company’s sales revenues from the foregoing products were unsustainable; (iv) the foregoing also subjected the Company to a substantial risk of a product recall, in addition to potential legal and/or regulatory action; and (v) as a result, the Company’s public statements were materially false and misleading at all relevant times.
Class Period: December 21, 2020 to August 17, 2021
Lead Plaintiff Deadline: October 18, 2021
On December 21, 2020, the Company announced that it had submitted its Biologics License Application (“BLA”) to the U.S. Food and Drug Administration (“FDA”) for Vicineum for the treatment of BCG-unresponsive NMIBC.
On August 13, 2021, Sesen Bio announced that the FDA declined to approve its BLA for Vicineum in its current form. The FDA provided certain “recommendations specific to additional clinical/statistical data and analyses in addition to Chemistry, Manufacturing and Controls (CMC) issues pertaining to a recent pre-approval inspection and product quality.”
On this news, the Company’s share price fell $2.80, or 57%, to close at $2.11 per share on August 13, 2021, on unusually heavy trading volume.
Then, on August 16, 2021, Sesen Bio further revealed that “it appears that [the Company] will need to do a clinical trial to provide the additional efficacy and safety data necessary for the FDA to assess the benefit-risk profile, which is the basis for approval.” As a result, the Company expected that it could not resubmit its BLA until 2023.
On this news, the Company’s share price fell $0.89, or 42%, to close at $1.22 per share on August 16, 2021, on unusually heavy trading volume.
Then, on August 18, 2021, before the market opened, the health and medicine news site STAT published an article entitled “Sesen Bio trial of cancer drug marked by misconduct and worrisome side effects, documents show." Citing “hundreds of pages of internal documents” and “three people familiar with the matter,” the article detailed that the clinical trial for Vicineum was “marked by thousands of violations of study rules, damning investigator conduct, and worrying signs of toxicity the company did not publicly disclose.”
On this news, the Company’s share price fell $0.20, or 13%, to close at $1.31 per share on August 18, 2021, on unusually heavy trading volume.
The complaint filed in this class action 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 Sesen Bio’s clinical trial for Vicineum had more than 2,000 violations of trial protocol, including 215 classified as “major”; (2) that three of Sesen Bio’s clinical investigators were found guilty of "serious noncompliance,” including “back-dating data”; (3) that Sesen Bio had submitted the tainted data in connection with the BLA for Vicineum; (4) that Sesen Bio’s clinical trials showed that Vicineum leaked out into the body, leading to side effects including liver failure and liver toxicity, and increasing the risks for fatal, drug-induced liver injury; (5) that, as a result of the foregoing, the Company’s BLA for Vicineum was not likely to be approved; (6) that, as a result of the foregoing, there was a reasonable likelihood that Sesen Bio would be required to conduct additional trials to support the efficacy and safety of Vicineum; 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.
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.
