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A service for ipo industry professionals · Tuesday, May 28, 2024 · 715,146,980 Articles · 3+ Million Readers

Bragar Eagel & Squire, P.C. Reminds Investors That Class Action Lawsuits Have Been Filed Against Ventyx, Anavex, and Checkpoint and Encourages Investors to Contact the Firm

/EIN News/ -- NEW YORK, April 12, 2024 (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 Ventyx Biosciences, Inc. (NASDAQ: VTYX), Anavex Life Sciences Corp. (NASDAQ: AVXL), and Checkpoint Therapeutics, Inc. (NASDAQ: CKPT). 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.

Ventyx Biosciences, Inc. (NASDAQ: VTYX)

Class Period: pursuant and/or traceable to the Offering Documents issued in connection with the Company’s initial public offering conducted on or about October 21, 2021; and/or (b) Ventyx securities between October 21, 2021 and November 6, 2023

Lead Plaintiff Deadline: April 30, 2024

Ventyx is a clinical-stage biopharmaceutical company that develops small-molecule product candidates to address a range of inflammatory diseases. The Company's lead clinical product candidate is VTX958, a selective allosteric tyrosine kinase type 2 inhibitor for psoriasis, psoriatic arthritis, and Crohn's disease. In 2022, Ventyx initiated a Phase 2 clinical trial of VTX958 for the treatment of moderate to severe plaque psoriasis (the "Phase 2 SERENITY Trial").

On September 29, 2021, Ventyx filed a registration statement on Form S-1 with the Securities and Exchange Commission ("SEC") in connection with the IPO, which, after several amendments, was declared effective by the SEC on October 20, 2021 (the "Registration Statement").

On October 21, 2021, Ventyx filed a prospectus on Form 424B4 with the SEC in connection with the IPO, which incorporated and formed part of the Registration Statement (the "Prospectus" and, collectively with the Registration Statement, the "Offering Documents").

The complaint alleges that the Offering Documents were negligently prepared and, as a result, contained untrue statements of material fact or omitted to state other facts necessary to make the statements made not misleading and were not prepared in accordance with the rules and regulations governing their preparation. In addition, throughout the Class Period, Defendants made materially false and misleading statements regarding the Company's business, operations, and prospects. Specifically, the Offering Documents and Defendants made false and/or misleading statements and/or failed to disclose that: (i) VTX958 was less effective in treating psoriasis than Defendants had led investors to believe; (ii) as a result, VTX958's clinical and/or commercial prospects were overstated; (iii) accordingly, the Company had misrepresented its ability to develop and commercialize effective product candidates; (iv) Ventyx's post-IPO business prospects were thus inflated; and (v) as a result, the Company's public statements were materially false and misleading at all relevant times.

On November 6, 2023, during after-market hours, Ventyx issued a press release announcing results from the Phase 2 SERENITY Trial. Therein, the Company disclosed that "[a]lthough the trial achieved its primary endpoint, the magnitude of efficacy observed did not meet our internal target to support the advancement of VTX958 in plaque psoriasis." Based on these results, the Company announced that it "will terminate ongoing activities in the Phase 2 plaque psoriasis trial effective immediately" and "terminate the ongoing Phase 2 trial of VTX958 in psoriatic arthritis."

On this news, Ventyx's common stock price fell $11.36 per share, or 80.62%, to close at $2.73 per share on November 7, 2023.

Then, on November 22, 2023, Ventyx disclosed in a filing with the SEC on Form 8-K that the Company's President and Chief Medical Officer Defendant William J. Sandborn would cease to serve in those roles.

As of the time the Complaint was filed, the price of Ventyx common stock continues to trade below the $16.00 per share Offering price, damaging investors.

For more information on the Ventyx class action go to: https://bespc.com/cases/VTYX

Anavex Life Sciences Corp. (NASDAQ: AVXL)

Class Period: February 1, 2022 - January 1, 2024

Lead Plaintiff Deadline: May 13, 2024

The complaint alleges that on December 2, 2022, AVXL announced positive topline results from its Phase 2b/3 ANAVEX®2-73-AD-004 clinical trial of oral ANAVEX®2-73 (blarcamesine) for the treatment of mild cognitive impairment (MCI) due to Alzheimer’s disease (AD) and mild AD (collectively known as early AD). ANAVEX®2-73 met the primary endpoints ADAS-Cog1 and ADCS-ADL2 and key secondary endpoint CDR-SB3 with statistically significant results. An analyst questioned the Company’s claim noting “there are several key factors that point us to believe the data is provocative, but not yet compelling, given the choice of statistical analyses and other trial design/conduct ‘complexifiers’.” Additionally, a biotech journalist commented on AVXL’s findings stating “[w]hat sets Anavex apart from all the other biotechs on my radar screen is its habit of shifting the goalposts on clinical trials…Anavex announced “positive” outcomes from studies of its drug called blarcamesine — except the results were derived from efficacy endpoints that were not part of the original study designs.”

Following this news, AVXL’s stock price fell by $2.47 per share, or approximately 20% to close at $9.58.

Further on January 3, 2024, AVXL announced that results from its Phase 2/3 EXCELLENCE clinical trial for its candidate ANAVEX®2-73 in pediatric patients with Rett syndrome failed to show statistical significance towards its primary endpoints. Biotech analysts commented that “the negative study outcome was never in doubt…Anavex is a serial dissembler of clinical trial results.”

Following this news, AVXL’s stock price fell by $3.26 per share, or approximately 35%.

For more information on the Anavex class action go to: https://bespc.com/cases/AVXL

Checkpoint Therapeutics, Inc. (NASDAQ: CKPT)

Class Period: March 10, 2021 - December 15, 2023

Lead Plaintiff Deadline: June 4, 2024

Checkpoint is a clinical-stage immunotherapy and targeted oncology company that focuses on the acquisition, development, and commercialization of novel treatments for patients with solid tumor cancers in the U.S. and internationally. The Company relies on third-party contract manufacturers to, inter alia, conduct its preclinical and clinical studies and trials, as well as to complete commercial and pre-commercial manufacturing.

Checkpoint's lead antibody product candidate is cosibelimab for the treatment of selected recurrent or metastatic cancers. In January 2023, Checkpoint submitted a Biologics License Application ("BLA") to the U.S. Food and Drug Administration ("FDA") for the approval of cosibelimab as a treatment for patients with metastatic cutaneous squamous cell carcinoma ("cSCC") or locally advanced cSCC who are not candidates for curative surgery or radiation (the "cosibelimab BLA").

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) Checkpoint had overstated its oversight of, and/or its establishment of adequate manufacturing standards and controls over, its third-party contract manufacturers; (ii) accordingly, there were one or more issues with the Company's third-party contract manufacturing organization ("CMO") for cosibelimab; (iii) all the foregoing reduced the likelihood that the FDA would approve the cosibelimab BLA in its present form; (iv) as a result, the manufacturing, regulatory, and commercial prospects of cosibelimab were overstated; and (v) as a result, the Company's public statements were materially false and misleading at all relevant times.

On December 18, 2023, Checkpoint issued a press release disclosing that the FDA had not approved the cosibelimab BLA as a treatment for patients with metastatic or locally advanced cSCC who are not candidates for curative surgery or radiation. In particular, the Company announced "that the [FDA] has issued a complete response letter ('CRL') for the cosibelimab [BLA] for the treatment of patients with metastatic or locally advanced [cSCC] who are not candidates for curative surgery or radiation." The Company stated that "[t]he CRL . . . cites findings that arose during a multi-sponsor inspection of Checkpoint's third-party [CMO] as approvability issues to address in a resubmission."

On this news, Checkpoint's stock price fell $1.49 per share, or 44.88%, to close at $1.83 per share on December 18, 2023.

For more information on the Checkpoint class action go to: https://bespc.com/cases/CKPT

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.

Contact Information:

Bragar Eagel & Squire, P.C.
Brandon Walker, Esq.
Marion Passmore, Esq.
(212) 355-4648
investigations@bespc.com
www.bespc.com


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