NEW YORK, April 12, 2021 (GLOBE NEWSWIRE) -- Lowey Dannenberg P.C., a preeminent law firm in obtaining redress for consumers and investors, is investigating claims of violations of federal securities laws on behalf of investors of Kadmon Holdings, Inc. ("Kadmon" or the "Company") (NASDAQ: KDMN). If you are a shareholder of Kadmon with more than $300,000 in losses, you should contact the Firm.
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.
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 $0.52 per share, or 10.57%, to close at $4.40 per share on March 11, 2021.
If you are a shareholder of Kadmon who purchased Kadmon securities between October 1, 2020 and March 10, 2021, inclusive, you have until June 2, 2021 to ask the Court to appoint you as Lead Plaintiff for the class. To participate, learn more, or discuss the issues surrounding the investigation, please contact our attorneys at (914) 733-7256 or via email at investigations@lowey.com .
Whistleblowers: Persons with non-public information regarding Kadmon should consider their options to help in the investigation or take advantage of the SEC Whistleblower program. Under the new program, whistleblowers who provide original information may receive rewards totaling up to 30 percent of any successful recovery made by the SEC.
About Lowey Dannenberg
Lowey Dannenberg is a national firm representing institutional and individual investors, who suffered financial losses resulting from corporate fraud and malfeasance in violation of federal securities and antitrust laws. The firm has significant experience in prosecuting multi-million-dollar lawsuits and has previously recovered billions of dollars on behalf of investors.
Contact
Lowey Dannenberg P.C.
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White Plains, NY 10601
Tel: (914) 733-7256
Email: investigations@lowey.com
