SAN DIEGO–()–Robbins Geller Rudman & Dowd LLP announces that a class action lawsuit has been filed in the Eastern District of New York on behalf of purchasers of Kadmon Holdings, Inc. (NASDAQ:KDMN) securities between October 1, 2020 and March 10, 2021, inclusive (the “Class Period”). The case is captioned Tadros v. Kadmon Holdings, Inc., No. 21-cv-01797. The Kadmon Holdings class action lawsuit charges Kadmon Holdings and certain of its executives with violations of the Securities Exchange Act of 1934.

The Private Securities Litigation Reform Act of 1995 permits any investor who purchased Kadmon Holdings securities during the Class Period to seek appointment as lead plaintiff in the Kadmon Holdings class action lawsuit. A lead plaintiff is generally the movant with the greatest financial interest in the relief sought by the putative class who is also typical and adequate of the putative class. A lead plaintiff acts on behalf of all other class members in directing the Kadmon Holdings class action lawsuit. The lead plaintiff can select a law firm of its choice to litigate the Kadmon Holdings class action lawsuit. An investor’s ability to share in any potential future recovery of the Kadmon Holdings class action lawsuit is not dependent upon serving as lead plaintiff. If you wish to serve as lead plaintiff of the Kadmon Holdings class action lawsuit or have questions concerning your rights regarding the Kadmon Holdings class action lawsuit, please provide your information here or contact counsel, Michael Albert of Robbins Geller, at 800/449-4900 or 619/231-1058 or via e-mail at malbert@rgrdlaw.com. Lead plaintiff motions for the Kadmon Holdings class action lawsuit must be filed with the court no later than June 2, 2021.

Kadmon is a biopharmaceutical company that discovers, develops, and commercializes small molecules and biologics primarily for the treatment of inflammatory and fibrotic diseases. Kadmon’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, 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”). 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 Kadmon Holdings class action lawsuit alleges that, throughout the Class Period, 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 Kadmon submitted in support of the Belumosudil NDA in response to an information request from the FDA materially altered the NDA submission; (iii) accordingly, the initial Belumosudil NDA submission lacked the degree of support that Kadmon 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, Kadmon’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, “[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 more than 10%, damaging investors.

Robbins Geller Rudman & Dowd LLP is one of the world’s leading law firms representing investors in securities class action litigation. With 200 lawyers in 9 offices, Robbins Geller has obtained many of the largest securities class action recoveries in history. For eight consecutive years, ISS Securities Class Action Services has ranked the Firm in its annual SCAS Top 50 Report as one of the top law firms in the world in both amount recovered for shareholders and total number of class action settlements. Robbins Geller attorneys have helped shape the securities laws and have recovered tens of billions of dollars on behalf of aggrieved victims. Beyond securing financial recoveries for defrauded investors, Robbins Geller also specializes in implementing corporate governance reforms, helping to improve the financial markets for investors worldwide. Robbins Geller attorneys are consistently recognized by courts, professional organizations, and the media as leading lawyers in the industry. Please visit http://www.rgrdlaw.com for more information.

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