NEW YORK, April 06, 2022 (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 Fennec Pharmaceuticals, Inc. ( FENC), Astra Space, Inc. ( ASTR), Acutus Medical, Inc. ( AFIB), and Pulse Biosciences, Inc. ( PLSE). 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.
Fennec Pharmaceuticals, Inc. ( FENC)
Class Period: May 28, 2021 – November 26, 2021
Lead Plaintiff Deadline: April 11, 2022
According to the complaint, Fennec completed its submission of a New Drug Application (“NDA”) with the U.S. Food and Drug Administration (“FDA”) for PEDMARK for the prevention of ototoxicity induced by cisplatin chemotherapy in patients 1 month to <18 years of age with localized, non-metastatic, solid tumors, in February 2020. In August 2020, Fennec announced it had received a Complete Response Letter (“CRL”) from the FDA for the NDA because of deficiencies identified at the manufacturing facility of the Company's drug product manufacturer. Fennec resubmitted the NDA in May 2021.
On November 29, 2021, Fennec announced “that it expects to receive a [CRL] after the PDUFA [Prescription Drug User Fee Act] target action date of November 27, 2021 from the [FDA] regarding its [Resubmitted Pedmark NDA].” Deficiencies at the manufacturing facility of Fennec’s drug product manufacturer had again been identified, and “[o]nce the official CRL is received, the Company plans to request a Type A meeting to discuss the deficiencies and steps required for the resubmission of the NDA for PEDMARK™.”
On this news, Fennec’s share price fell over 50%, to close at $4.78 per share on November 29, 2021.
For more information on the Fennec class action go to: https://bespc.com/cases/FENC
Astra Space, Inc. ( ASTR)
Class Period: February 2, 2021 – December 29, 2021
Lead Plaintiff Deadline: April 11, 2022
On December 29, 2021, Kerrisdale Capital published a report stating that Astra’s claim of being able to launch its rockets “anywhere in the world” was “simply not true.” The report alleged that in the US, Astra could only launch from an FAA-licensed commercial spaceport approved for vertical launch, and that only five such sites exist in the country. Furthermore, the report pointed out that Astra had managed just a single successful orbital test flight, despite the Company’s forecast calling for 165 launches by 2024 and 300 launches by 2025.
On this news, Astra’s stock fell $1.10, or 14%, to close at $6.61 per share on December 29, 2021, thereby injuring investors.
The complaint alleges that, throughout the Class Period, Defendants made materially false and misleading statements and/or failed to disclose that: (1) Astra cannot launch “anywhere”; (2) Astra significantly overstated its addressable market; (3) Astra overstated the effectiveness of its designs and reliability; (4) Astra significantly overstated its plans for diversification and its broadband constellation plan; and (5) as a result, defendants’ public statements were materially false and/or misleading at all relevant times.
For more information on the Astra class action go to: https://bespc.com/cases/ASTR
Acutus Medical, Inc. ( AFIB)
Class Period: May 13, 2021 – November 11, 2021
Lead Plaintiff Deadline: April 18, 2022
The complaint alleges that, throughout the Class Period, Defendants made materially false and misleading statements and/or failed to disclose that: (1) their ability to grow and scale Acutus’ business; (2) Acutus’ strategy regarding AcQMap system placements; and (3) the ability of Acutus to improve commercial execution in the United States, including through the expansion and training of sales staff to “ensure” adequate customer account support, which defendants claimed would be a major growth driver. Specifically, Defendants made materially false and misleading statements and failed to disclose that: (a) a material percentage of the AcQMap systems under evaluation had been randomly installed at sites with little, if any, consideration given to whether the healthcare providers at the selected locations were likely to adopt, or desire, Acutus Medical's products; (b) a material percentage of the AcQMap systems under evaluation had been installed in locations where Acutus Medical did not possess the infrastructure necessary to appropriately educate, train, and support medical service providers on the system's operations; (c) as a result, defendants were in the process of designing a strategic plan to terminate and relocate approximately 20% of then-existing AcQMap systems evaluation arrangements; (d) the Company’s management discussion and analysis was materially false and misleading and failed to disclose that the termination and relocation of approximately 20% of existing AcQMap systems evaluation arrangements was reasonably likely to have a material adverse effect on Acutus Medical's 2021 financial results; and (e) Acutus Medical’s risk factor discussions were materially false and misleading and made reference to potential risks without disclosing that such risks were then-existing or adequately describing the specific nature of the risks then facing the Company.
For more information on the Acutus class action go to: https://bespc.com/cases/AFIB
Pulse Biosciences, Inc. ( PLSE)
Class Period: January 12, 2021 – February 7, 2022
Lead Plaintiff Deadline: April 18, 2022
In October 2020, Pulse initiated its investigational device exemption (“IDE”) study to evaluate the treatment of sebaceous hyperplasia lesions using the CellFX System.
On February 8, 2022, before the market opened, Pulse announced that the U.S. Food and Drug Administration (“FDA”) concluded there was insufficient clinical evidence to support the Company’s 510(k) submission to expand the label for the CellFX System to treat sebaceous hyperplasia. Among other things, the FDA found “that the Company had not met the primary endpoints of the sebaceous hyperplasia FDA-approved IDE study.”
On this news, the Company’s share price fell $3.74, or over 34%, to close at $7.12 per share on February 8, 2022, 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 IDE study evaluating the use of the CellFX System to treat sebaceous hyperplasia lesions failed to meet its primary endpoints; (2) that, as a result, there was a substantial risk that the FDA would reject Pulse’s 510(k) submission seeking to expand the label for the CellFX System to treat sebaceous hyperplasia lesions; and (3) 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 Pulse class action go to: https://bespc.com/cases/PLSE
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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.
Contact Information:
Bragar Eagel & Squire, P.C.
Brandon Walker, Esq.
Alexandra B. Raymond, Esq.
(212) 355-4648
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www.bespc.com
