Featured Company News - Kadmon Holdings' KD025 Receives Orphan Drug Designation for the Treatment of cGVHD by FDA
LONDON, UK / ACCESSWIRE / October 10, 2017 / Pro-Trader Daily looks at the latest corporate events and news making the headlines for Kadmon Holdings, Inc. (NYSE: KDMN) ("Kadmon"), following which we have published a free report that can be viewed by signing up at http://protraderdaily.com/optin/?symbol=KDMN. The Company announced on October 06, 2017, that its Rho-associated coiled-coil kinase (ROCK) inhibitor, KD025, has received orphan drug designation from the US Food and Drug Administration (FDA) for the treatment of chronic graft-versus-host disease (cGVHD), a serious complication following allogeneic bone marrow or stem cell transplantation. For immediate access to our complimentary reports, including today's coverage, register for free now at:
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KD025's Phase-2 Clinical Trial
KD025 is being studied in an ongoing Phase-2 clinical trial in adults with steroid-dependent or steroid-refractory cGVHD and active disease. As a part of the study, 48 patients were enrolled and divided into three cohorts at different dose levels. The preliminary analysis suggests that the lowest-dose cohort demonstrated clinically meaningful responses. There were no serious adverse events related to the drug.
Kadmon to Present the Additional Data from the Study in the Year End
Harlan W. Waksal, M.D., President and Chief Executive Officer at Kadmon, mentioned that cGVHD is a debilitating condition with few available therapies, and many patients lack treatment options. He stated that the Company is pleased with the continued progress of KD025 in the ongoing clinical trial, and additional data from the study is anticipated to be presented towards the end of 2017.
FDA Granted Orphan Drug Designation to Kadmon's Tesevatinib for the Treatment of EGFR-Mutated Non-Small Cell Lung Cancer
News release reported that on August 7, 2017, FDA also granted orphan drug designation to tesevatinib, Kadmon's oral tyrosine kinase inhibitor, for the treatment of non-small cell lung cancer (NSCLC) with epithelial growth factor receptor (EGFR)-activating mutations.
About KD025
KD035 is an orally available, proprietary anti-angiogeneic antibody targeting VEGFR2, which inhibits the formation of new blood vessels, blocking blood supply to tumors. KDO35 is the most advanced candidate of Kadmon's monoclonal antibody platform.
About Chronic Graft-Versus-Host Disease (cGVHD)
Chronic GVHD usually begins later after transplant and lasts longer than acute GVHD. Patients with Chronic GVHD may present with a wide variety of symptoms. Skin rash and/or mouth sores are among the most common initial signs of the disease. Prednisone or other similar anti-inflammatory or immunosuppressive medications are used for its treatment.
Oral Drug Designation by FDA
The Orphan designation is a special status granted to a drug or biological product by FDA to treat a rare disease or condition upon request of a sponsor and to promote the development of promising products for rare conditions affecting fewer than 200,000 US patients annually. Orphan designation qualifies the sponsor of the drug for various development incentives, including tax credits for qualified clinical testing.
About Kadmon Holdings, Inc.
Founded in 2009, Kadmon Holdings, Inc. is a fully integrated biopharmaceutical company engaged in the discovery, development, and commercialization of small molecules and biologics to address disease areas of significant unmet medical need. The Company develops product candidates within autoimmune and fibrotic diseases, oncology and genetic diseases. Kadmon is headquartered in New York City, New York.
Last Close Stock Review
On Monday, October 09, 2017, the stock closed the trading session at $3.70, sliding 1.86% from its previous closing price of $3.77. A total volume of 495.26 thousand shares have exchanged hands, which was higher than the 3-month average volume of 437.90 thousand shares. Kadmon's stock price soared 30.28% in the last one month, 9.47% in the past three months, and 22.52% in the previous six months. The stock currently has a market cap of $177.64 million.
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