NEW YORK, Aug. 21, 2023 (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 ImmunityBio, Inc. (NASDAQ: IBRX), BioXcel Therapeutics, Inc. (NASDAQ: BTAI), and Seagate Technology Holdings Plc (NASDAQ: STX). 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.
ImmunityBio, Inc. (NASDAQ: IBRX)
Class Period: May 23, 2022 – May 10, 2023
Lead Plaintiff Deadline: August 29, 2023
ImmunityBio is a clinical-stage biotechnology company that engages in developing therapies and vaccines that complement, harness, and amplify the immune system to defeat cancers and infectious diseases in the U.S. and Europe. The Company offers immunotherapy and cell therapy platforms, including, inter alia, antibody cytokine fusion protein N-803, commercially referred to as “Anktiva”. The Company uses third-party contract manufacturing organizations (“CMOs”) to produce certain of its product candidates, including Anktiva.
In May 2022, ImmunityBio submitted a Biologics License Application (“BLA”) for Anktiva to the U.S. Food and Drug Administration (“FDA”). Following submission of its application, ImmunityBio consistently assured investors that “[w]e have established Good Manufacturing Practice (GMP) manufacturing capacity at scale with cutting-edge cell manufacturing expertise and ready-to-scale facilities[.]”
On May 11, 2023, during pre-market hours, ImmunityBio announced that the FDA had rejected the BLA for Anktiva in its present form, citing “deficiencies relat[ing] to the FDA’s pre-license inspection of the Company’s third-party contract manufacturing organizations.”
On this news, ImmunityBio’s stock price fell $3.43 per share, or 55.14%, to close at $2.79 per share on May 11, 2023.
The complaint alleges that throughout the Class Period, Defendants made materially false and misleading statements regarding the Company’s business, operations, and prospects. Specifically, Defendants made false and/or misleading statements and/or failed to disclose that: (i) ImmunityBio conducted insufficient due diligence to discover, or else did discover and ignored, GMP deficiencies at its third-party CMOs for Anktiva; (ii) one or more of the Company’s third-party CMOs for Anktiva did in fact suffer from GMP deficiencies; (iii) the foregoing deficiencies was likely to cause the FDA to reject the Anktiva BLA in its present form; (iv) accordingly, the Company overstated the regulatory approval prospects for the Anktiva BLA; and (v) as a result, the Company’s public statements were materially false and misleading at all relevant times.
For more information on the ImmunityBio class action go to: https://bespc.com/cases/IBRX
BioXcel Therapeutics, Inc. (NASDAQ: BTAI)
Class Period: December 15, 2021 – June 28, 2023
Lead Plaintiff Deadline: September 5, 2023
On December 15, 2021, the Company announced that it had initiated a program to evaluate BXCL501 for the treatment of acute agitation associated with Alzheimer’s disease. The Company announced that the program consisted of two randomized, double-blind, placebo-controlled studies: TRANQUILITY II and TRANQUILITY III. The studies were purportedly designed to evaluate the safety and efficacy of BXCL501 in adults 65 years and older across the range of illness including mild, moderate, and severe dementia in assisted living or residential facilities and nursing homes.
However, on June 29, 2023, before the market opened, BioXcel disclosed that its principal investigator for the Phase 3 TRANQUILITY II clinical trial had failed to “adhere to the informed consent form approved by the Institutional Review Board” for some subjects and failed to maintain adequate case histories for certain patients whose records were reviewed by the Food and Drug Administration (“FDA”). The Company further disclosed that the same principal investigator “may have fabricated” email correspondence purporting to demonstrate that the investigator timely submitted to the Company’s pharmacovigilance safety vendor a report of a serious adverse event (“SAE”) and purporting to show that the vendor had confirmed receipt. BioXcel further disclosed that the fabricated email correspondence was provided to the FDA during an on-site inspection in December 2022. The Company further disclosed that it was in the process of conducting an investigation into protocol adherence and data integrity at the principal investigator’s trial site and was in the process of retaining an independent third party to audit the data collected at the site. The Company also disclosed that the foregoing “may impact the timing of the Company’s development plans for, and prospects for regulatory approval of, BXCL501 for the acute treatment of agitation associated with dementia in patients with probable Alzheimer’s disease.”
On this news, BioXcel’s stock price fell $11.28 per share, or 63.8%, to close at $6.39 per share on June 29, 2023, 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 the Company lacked adequate internal controls over protocol adherence and data integrity; (2) that, as a result, the Company’s principal investigator failed to adhere to the informed consent form approved by the Institutional Review Board; (3) that the Company’s principal investigator failed to maintain adequate case histories for certain patients whose records were reviewed by the FDA; (4) that the Company’s principal investigator fabricated email correspondence with a pharmacovigilance safety vendor that was then provided to the FDA; (5) that the foregoing would negatively impact the Company’s ability to obtain regulatory approval of BXCL501 for the treatment of agitation associated with dementia in patients with probable Alzheimer’s disease; and (6) 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.
For more information on the BioXcel class action go to: https://bespc.com/cases/BTAI
Seagate Technology Holdings Plc (NASDAQ: STX)
Class Period: September 15, 2020 – October 25, 2022
Lead Plaintiff Deadline: September 8, 2023
Seagate is a leading global supplier of data storage products, including hard disk drives (“HDDs”). By the start of the Class Period, Huawei Technologies Co. Ltd. (“Huawei”), a Chinese multinational technology, had emerged as a significant global purchaser of data storage products, including HDDs, produced by Seagate and other U.S.-based suppliers.
On May 16, 2019, Huawei and certain of its non-U.S. affiliates were added to the U.S. Department of Commerce Bureau of Industry and Security’s (“BIS”) Export Administration Regulations (“EAR”) Entity List (“Entity List”). The EAR Entity List is a list of names of certain foreign persons and entities that are subject to specific license requirements for the export, re-export, and/or transfer (in-country) of specified items. The Entity List designation was based on a determination made by multiple U.S. government agencies “that there is reasonable cause to believe that Huawei has been involved in activities contrary to the national security or foreign policy interests of the United States.”
Then, on August 17, 2020, the BIS imposed export controls over certain foreign-produced items “to better address the continuing threat to U.S. national security and U.S. foreign policy interests posed by Huawei and its non-U.S. affiliates.”
On October 26, 2022, Seagate disclosed that it received a Proposed Charging Letter from the BIS alleging that Seagate violated the EAR by providing Seagate HDDs to “a customer and its affiliates listed on the BIS Entity List between August 2020 and September 2021.”
On this news, the price of Seagate common stock fell nearly 8%, damaging investors. Over the following three trading days, Seagate’s stock price continued to drift lower, falling an additional nearly 7%.
As the Seagate class action lawsuit alleges, defendants throughout the Class Period made false and/or misleading statements and/or failed to disclose: (i) the nature and magnitude of Seagate’s HDD sales to Huawei, including that Seagate experienced a significant acceleration in sales to Huawei immediately after the BIS rules went into effect and Seagate’s competitors stopped selling to Huawei; and (ii) that the underlying details of Seagate’s HDD manufacturing process, including the use of covered U.S. software and technology in “essential ‘production’” processes, rendered its sales to Huawei in violation of the BIS export rules As a result, Seagate was in blatant violation of the BIS export rules which resulted in an ongoing investigation by the U.S. Department of Commerce and exposed Seagate to hundreds of millions of dollars in fines and penalties.
For more information on the Seagate class action go to: https://bespc.com/cases/STX
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.