NEW YORK--(BUSINESS WIRE)--Bragar Eagel & Squire, P.C., a nationally recognized shareholder rights law firm, announces that a class action lawsuit has been filed in the United States District Court for the Eastern District of New York on behalf of investors that purchased Kadmon Holdings, Inc. (NASDAQ: KDMN) securities between October 1, 2020 and March 10, 2021, inclusive (the “Class Period”). Investors have until June 2, 2021 to apply to the Court to be appointed as lead plaintiff in the lawsuit.
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Kadmon is a biopharmaceutical company that discovers, develops, and commercializes small molecules and biologics primarily for the treatment of inflammatory and fibrotic diseases. The Company’s lead product candidates include, among others, belumosudil (KD025), an orally administered selective inhibitor of the rho-associated coiled-coil kinase 2 (“ROCK2”), which is in Phase II clinical development for the treatment of chronic graft-versus host disease (“cGVHD”).
On September 30, 2020, post-market, Kadmon announced the submission of a New Drug Application (“NDA”) for belumosudil for the treatment of cGVHD (the “Belumosudil NDA”) with the U.S. Food and Drug Administration (“FDA”).
On March 10, 2021, Kadmon issued a press release “announc[ing] that the [FDA] has extended the review period” for the Belumosudil NDA and that, “[i]n a notice received from the FDA on March 9, 2021, the Company was informed that the [PDUFA] goal date for its Priority Review of belumosudil has been extended to August 30, 2021.” Kadmon advised investors that “[t]he FDA extended the PDUFA date to allow time to review additional information submitted by Kadmon in response to a recent FDA information request,” and that “[t]he submission of the additional information has been determined by the FDA to constitute a major amendment to the NDA, resulting in an extension of the PDUFA date by three months.”
On this news, Kadmon’s stock price fell $0.52 per share, or 10.57%, to close at $4.40 per share on March 11, 2021.
The complaint, filed on April 2, 2021, 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) the Belumosudil NDA was incomplete and/or deficient; (ii) the additional new data that the Company submitted in support of the Belumosudil NDA in response to an information request from the FDA materially altered the NDA submission; (iii) accordingly, the initial Belumosudil NDA submission lacked the degree of support that the Company had led investors to believe; (iv) accordingly, the FDA was likely to extend the PDUFA target action date to review the Belumosudil NDA; and (v) as a result, the Company’s public statements were materially false and misleading at all relevant times.
If you purchased Kadmon securities during the Class Period and suffered a loss, are a long term stockholder, have information, would like to learn more about these claims, or have any questions concerning this announcement or your rights or interests with respect to these matters, please contact Brandon Walker, Melissa Fortunato, or Marion Passmore by email at firstname.lastname@example.org, telephone at (212) 355-4648, or by filling out this contact form. There is no cost or obligation to you.
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