NEW YORK, April 3, 2021 / PRNewswire / –Pomerantz LLP announces that a class action lawsuit has been filed against Kadmon Holdings, Inc. (“Kadmon” or the “Company”) (NASDAQ: KDMN) and certain of its officers. The class action, filed in United States District Court of the East District new York, and listed under 21-cv-01797, is in the name of a class consisting of all persons and entities other than the Defendants who have purchased or otherwise acquired Kadmon securities between October 1, 2020 and March 10, 2021, both dates inclusive (the “Recourse Period”), seeking to recover damages caused by defendants’ breaches of federal securities laws and to bring remedies under Sections 10 (b) and 20 (a ) of the Securities Exchange Act of 1934 (the “Exchange Act”) and rules 10b-5 promulgated hereunder, against the Company and certain of its senior 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 the principal 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 protected] or 888.476.6529 (or 888.4-POMLAW), toll free, Ext. 7980. Those inquiring by e-mail are encouraged to provide their mailing address, telephone number and the number of shares purchased.
Kadmon is a biopharmaceutical company that discovers, develops and markets small molecules and biologics primarily for the treatment of inflammatory and fibrotic diseases. The Company’s main product candidates include, among others, belumosudil (KD025), an orally administered selective inhibitor of rho-associated coiled coil kinase 2 (“ROCK2”), which is in Phase II clinical development. for the treatment of chronic transplant. disease versus host (“cGVHD”).
Sure September 30, 2020, post-marketing, Kadmon announced the submission of a New Drug Application (“NDA”) for belumosudil for the treatment of cGVHD (the “Belumosudil NDA”) to the Food and Drug Administration (“ FDA ”) from the United States.
Then on November 30, 2020, Kadmon announced the FDA acceptance of 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 period of the action, the defendants made materially false and misleading representations regarding the activities, operations and compliance policies of the company. Specifically, the defendants made false and / or misleading statements and / or failed to disclose that: (i) 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 FDA information request significantly modified the NDA’s submission; (iii) therefore, Belumosudil NDA’s initial bid did not have the level of support that the Company had led investors to believe; (iv) as a result, the FDA was likely to extend the target action date of PDUFA to review Belumosudil NDA; and (v) therefore, the Company’s public statements were materially false and misleading at all material times.
Sure March 10, 2021, Kadmon issued a press release “announcement[ing] that the [FDA] extended the review period “for Belumosudil NDA and that”[i]n notice received from the FDA on March 9, 2021, the company has been informed that the [PDUFA] the deadline for its priority review of belumosudil has been extended to August 30, 2021. “Kadmon informed investors that”[t]The FDA has extended the PDUFA date to allow time to consider additional information submitted by Kadmon in response to a recent FDA request for information, “and that”[t]The 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 date of the PDUFA by three months. “
At this news, the Kadmon share price fell 0.52 USD 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, Angels, and Paris is recognized as one of the leading companies in the areas of corporate, securities and antitrust litigation. Founded by the late Abraham L. Pomerantz, known as the dean of the class action bar, Pomerantz was a pioneer in the field of class actions in securities. Today, more than 80 years later, Pomerantz continues the tradition it established, fighting for the rights of victims of securities fraud, breach of fiduciary duty and professional misconduct. The firm has recovered numerous indemnities of several million dollars on behalf of the members of the group. See www.pomerantzlaw.com
Robert S. Willoughby
888-476-6529 ext. 7980
SOURCE Pomerantz LLP
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