Pomerantz LLP announces that a class action lawsuit has been filed against Kadmon Holdings, Inc. and certain of its officers. The class action, filed in the United States District Court for the Eastern District of New York, and docketed under 21-cv-01797, is on behalf of a class consisting of all persons and entities other than Defendants that purchased or otherwise acquired Kadmon securities between October 1, 2020 and March 10, 2021, both dates inclusive (the “Class Period”), seeking to recover damages caused by Defendants’ violations of the federal securities laws and to pursue remedies under Sections 10(b) and 20(a) of the Securities Exchange Act of 1934 (the “Exchange Act”) and Rule 10b-5 promulgated thereunder, against the Company and certain of its top officials.
If you are a shareholder who purchased Kadmon securities during the Class Period, you have until June 2, 2021 to ask the Court to appoint you as Lead Plaintiff for the class. A copy of the Complaint can be obtained at www.pomerantzlaw.com. To discuss this action, contact Robert S. Willoughby at email@example.com or 888.476.6529 (or 888.4-POMLAW), toll-free, Ext. 7980. Those who inquire by e-mail are encouraged to include their mailing address, telephone number, and the number of shares purchased.
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”).
Then, on November 30, 2020, Kadmon announced the FDA’s acceptance of the Belumosudil NDA, and that the FDA had assigned the NDA a Prescription Drug User Fee Act (“PDUFA”) target action date of May 30, 2021.
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) 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.
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 Pomerantz Firm, with offices in New York, Chicago, Los Angeles, and Paris is acknowledged as one of the premier firms in the areas of corporate, securities, and antitrust class litigation. Founded by the late Abraham L. Pomerantz, known as the dean of the class action bar, the Pomerantz Firm pioneered the field of securities class actions. Today, more than 80 years later, the Pomerantz Firm continues in the tradition he established, fighting for the rights of the victims of securities fraud, breaches of fiduciary duty, and corporate misconduct. The Firm has recovered numerous multimillion-dollar damages awards on behalf of class members. See www.pomerantzlaw.com
Robert S. Willoughby
888-476-6529 ext. 7980