Trending...
- NoviSign Sponsoring VARTECH 2025 - the B2B IT channel's #1 event - 114
- Albuquerque's Z-CoiL Footwear Brings All-American Family Business Story to Shark Tank Season Premiere
- Counseling Center of New Smyrna Beach Expands Affordable Mental Health Services for Volusia County
SAN DIEGO & LORDSTOWN, Ohio--(BUSINESS WIRE)--Shareholder rights law firm Robbins LLP announces that a purchaser of Kadmon Holdings, Inc. (NASDAQ: KDMN) filed a class action complaint against the Company and its officers and directors for alleged violations of the Securities Exchange Act of 1934 between October 1, 2020 and March 10, 2021. Kadmon is a biopharmaceutical company that develops small molecules and biologics primarily for the treatment of inflammatory and fibrotic diseases. Kadmon's lead product candidate includes belumosudil (KD025), which is in Phase II clinical development for the treatment of chronic graft-versus-host disease ("cGVHD").
If you suffered a loss due to Kadmon Holdings, Inc.'s misconduct, click here.
Kadmon Holdings, Inc. (KDMN) Misled Investors Regarding its New Drug Submission for its Lead Drug Candidate
More on Ohio Pen
According to the complaint, on September 30, 2020, Kadmon announced the submission of a New Drug Application ("NDA") for belumosudil for the treatment of cGVHD with the U.S. Drug and Food Administration ("FDA"). On November 30, 2020, Kadmon announced the FDA's acceptance of the NDA and that the FDA had assigned the NDA a Prescription Drug User Fee Act [PDUFA] target date of May 30, 2021. Throughout the class period, Kadmon touted the drug's trial milestones and efficacy. However, the Company failed to disclose that the NDA was incomplete and/or deficient when submitted and the additional data submitted in support of the NDA materially altered the initial submission, and therefore, the PDUFA target date.
On March 10, 2021, Kadmon announced that the FDA "has extended the review period" for the 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. The stock continues to decline.
More on Ohio Pen
If you purchased shares of Kadmon Holdings, Inc. (KDMN) between October 1, 2020 and March 10, 2021, you have until June 2, 2021, to ask the court to appoint you lead plaintiff for the class.
All representation is on a contingency fee basis. Shareholders pay no fees or expenses.
Contact us to learn more:
Lauren Levi
(800) 350-6003
llevi@robbinsllp.com
Shareholder Information Form
Robbins LLP is a nationally recognized leader in shareholder rights law. To be notified if a class action against Kadmon Holdings, Inc. settles or to receive free alerts about companies engaged in wrongdoing, sign up for Stock Watch today.
Attorney Advertising. Past results do not guarantee a similar outcome.
If you suffered a loss due to Kadmon Holdings, Inc.'s misconduct, click here.
Kadmon Holdings, Inc. (KDMN) Misled Investors Regarding its New Drug Submission for its Lead Drug Candidate
More on Ohio Pen
- InventHelp Inventor Develops New Jet Engine Screen (FGC-169)
- Agemin Unveils Breakthrough AI Model for Biometric Age Estimation, Setting New Standards in Online Child Safety
- Strategic Partnerships with Defiant Space Corp and Emtel Energy USA Powerfully Enhance Solar Tech Leader with NASA Agreements: Ascent Solar $ASTI
- 120% Revenue Surge with Four Straight Profitable Quarters Signal a Breakout in the Multi-Billion Dollar Homebuilding Market: Innovative Designs $IVDN
- Leading Venture Capital Firms Recognize Wzzph Exchange's Technical Architecture and Security Framework as Industry Benchmark
According to the complaint, on September 30, 2020, Kadmon announced the submission of a New Drug Application ("NDA") for belumosudil for the treatment of cGVHD with the U.S. Drug and Food Administration ("FDA"). On November 30, 2020, Kadmon announced the FDA's acceptance of the NDA and that the FDA had assigned the NDA a Prescription Drug User Fee Act [PDUFA] target date of May 30, 2021. Throughout the class period, Kadmon touted the drug's trial milestones and efficacy. However, the Company failed to disclose that the NDA was incomplete and/or deficient when submitted and the additional data submitted in support of the NDA materially altered the initial submission, and therefore, the PDUFA target date.
On March 10, 2021, Kadmon announced that the FDA "has extended the review period" for the 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. The stock continues to decline.
More on Ohio Pen
- DivX Unveils Major DivX Software Update: Seamless Video Sharing and Customizable Playback Now Available
- Nespolo Mechanical Helps New Mexico Families Save Thousands on Heating Costs This Fall
- Mamta Jha Mishra Releases New Book: "Energy Management: Mantras for Caregivers"
- Leading Digital Finance Platform YNQTL Launches Revolutionary Web3 Digital Asset Trading Platform
- IDCXS Addresses Crypto Trading Pain Points with 2 Million TPS Processing and Multi-Layer Security Architecture
If you purchased shares of Kadmon Holdings, Inc. (KDMN) between October 1, 2020 and March 10, 2021, you have until June 2, 2021, to ask the court to appoint you lead plaintiff for the class.
All representation is on a contingency fee basis. Shareholders pay no fees or expenses.
Contact us to learn more:
Lauren Levi
(800) 350-6003
llevi@robbinsllp.com
Shareholder Information Form
Robbins LLP is a nationally recognized leader in shareholder rights law. To be notified if a class action against Kadmon Holdings, Inc. settles or to receive free alerts about companies engaged in wrongdoing, sign up for Stock Watch today.
Attorney Advertising. Past results do not guarantee a similar outcome.
Filed Under: Business
0 Comments
Latest on Ohio Pen
- Meridian Bioscience Eliminates Cold Chain with the First Liquid Ambient Temperature Stable qPCR Master Mixes
- Teaming Agreement with Emtel Energy USA to Advance Thin-Film PV Energy Storage Capabilities; NASA agreements for Solar Space Tech; Ascent Solar $ASTI
- Nebuvex Acknowledges Platform "Too Secure" for Anonymous Traders; Institutional Investors Disagree
- From Tokyo to Berlin: FreeTo.Chat Unites Cultures with the World's First Confession VRX — EmojiStream™
- AZETHIO Launches Multi-Million Dollar User Protection Initiative Following Unprecedented Platform Growth
- Matecrypt Observes South American Cryptocurrency Adoption Surge Amid Economic Shifts
- Assent Uncovers Over 695 Unique PFAS Across Global Supply Chains as Regulations Increase
- Cryptocurrency Quarterly Trading Volume Surpasses $15 Trillion Record High as BrazilNex Acknowledges Industry 'Growing Pains' Amid Market Speculation
- AHRFD Initiates Legal Proceedings Against Anwalt.de for Publishing Defamatory and False Content
- New Analysis Reveals the Complex Forces Driving the 'Great Human Reshuffle'
- Elevate Unveils GroundComm X30 at 2025 International GSE Expo in Las Vegas
- NEW power supply release from Kepco Dynatronix - HSP Advanced
- St. Augustine Honors Hispanic Heritage Month
- Vesica Health Receives AUA Guideline Inclusion
- Steward's Plumbing Sponsors the 2025 Samson Challenge, Bringing Community, Fitness, and Fun Together in Albuquerque
- 10xLaw.com Extends Employment Opportunity to Kim Kardashian
- DecisionPoint Technologies Accelerates Growth with Acquisition of Acuity Technologies
- CCHR: Involuntary Commitment Is Eugenics Repackaged as "Mental Health Care"
- Abundant Frequencies Launches 24/7 Live Stream of 639Hz, 741Hz & 888Hz Healing Sounds
- Q2 2025 Industry Impact Report Underscores Semiconductor Expansion, Talent Development and Sustainability Milestones