San Diego, CA -- (SBWIRE) -- 04/12/2021 -- An investor, who purchased NYSE: KDMN shares, filed a lawsuit against Kadmon Holdings Inc over alleged violations of Federal Securities Laws

Investors who purchased shares of Kadmon Holdings Inc (NYSE: KDMN) have certain options and for certain investors are short and strict deadlines running. Deadline: June 2, 2021. NYSE: KDMN investors should contact the Shareholders Foundation at mail@shareholdersfoundation.com or call +1(858) 779 - 1554.

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.

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.

Those who purchased shares of Kadmon Holdings Inc (NYSE: KDMN) have certain options and should contact the Shareholders Foundation.

Contact:
Shareholders Foundation, Inc.
Michael Daniels
3111 Camino Del Rio North - Suite 423
92108 San Diego
Phone: +1-(858)-779-1554
Fax: +1-(858)-605-5739
mail@shareholdersfoundation.com

About Shareholders Foundation, Inc.
The Shareholders Foundation, Inc. is a professional portfolio monitoring and settlement claim filing service, , which does research related to shareholder issues and informs investors of securities class actions, settlements, judgments, and other legal related news to the stock/financial market. Shareholders Foundation, Inc. is in contact with a large number of shareholders and offers help, support, and assistance for every shareholder. The Shareholders Foundation, Inc. is not a law firm. Referenced cases, investigation, and/or settlements are not filed/reached and/or related to Shareholders Foundation. The information is provided as a public service. It is not intended as legal advice and should not be relied upon.