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Investigations  /  04.06.2021

Investigation of Kadmon Holdings, Inc.

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Kadmon Holdings, Inc. (KDMN) Misled Investors Regarding its New Drug Submission for its Lead Drug Candidate 

On September 30, 2020, Kadmon announced the submission of a New Drug Application (“NDA”) for belumosudil for the treatment of cGVHD with the U.S. Drug and Food Administration (“FDA”).  On November 30, 2020, Kadmon announced the FDA’s acceptance of the NDA and that the FDA had assigned the NDA a Prescription Drug User Fee Act [PDUFA] target date of May 30, 2021.  Throughout the class period, Kadmon touted the drug’s trial milestones and efficacy.  However, the Company failed to disclose that the NDA was incomplete and/or deficient when submitted and the additional data submitted in support of the NDA materially altered the initial submission, and therefore, the PDUFA target date.

On March 10, 2021, Kadmon announced that the FDA “has extended the review period” for the 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 stock continues to decline.

If you purchased shares of Kadmon Holdings, Inc. (KDMN) between October 1, 2020 and March 10, 2021, you have until June 2, 2021, to ask the court to appoint you lead plaintiff for the class.

All representation is on a contingency fee basis.  Shareholders pay no fees or expenses.

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