Kadmon Holdings, Inc.
Lead Plaintiff Deadline: 06/01/2021
SUMMARY OF CASE:
A securities class action has been filed against Kadmon Holdings, Inc. (KDMN) 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 through March 10, 2021. This case has been filed in the USDC – E.D.N.Y.
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; (m) 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, “kin a notice received from the FDA on March 9, 2021, the Company was informed that the [PDUFAJ goal date for its Priority Review of belumosudil has been extended to August 30, 2021.” Kadmon advised investors that “Whe 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 “Whe 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.