April 02, 2021- An investor in shares of Kadmon Holdings Inc (NYSE: KDMN) filed a lawsuit in the U.S. District Court for the Eastern District of New York over alleged violations of Federal Securities Laws by Kadmon Holdings Inc in connection with certain allegedly false and misleading statements made between October 1, 2020 and March 10, 2021.
New York based Kadmon Holdings Inc is an integrated biopharmaceutical company engaged in the discovery, development and commercialization of small molecules and biologics to address disease areas of various unmet medical needs. Kadmon Holdings Inc’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 Holdings Inc 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 Holdings Inc 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.
On March 10, 2021, Kadmon Holdings Inc 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."
Shares of Kadmon Holdings Inc (NYSE: KDMN) declined to as low as $3.51 per share on March 30, 20201.
According to the complaint the plaintiff alleges on behalf of purchasers of Kadmon Holdings Inc (NYSE: KDMN) common shares between October 1, 2020 and March 10, 2021, that the defendants violated Federal Securities Laws. More specifically, the plaintiff claims that between October 1, 2020 and March 10, 2021, the Defendants made false and/or misleading statements and/or failed to disclose that the Belumosudil NDA was incomplete and/or deficient, that 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, that accordingly, the initial Belumosudil NDA submission lacked the degree of support that the Company had led investors to believe, that accordingly, the FDA was likely to extend the PDUFA target action date to review the Belumosudil NDA, and that as a result, the Company's public statements were materially false and misleading at all relevant times.