Kadmon Holdings, Inc. (KDMN - Free Report) has completed enrollment in the KD025-213 study of its advanced product candidate, KD025, for the treatment of chronic graft-versus-host disease (cGVHD), a complication arising from allogenic hematopoietic stem cell transplantation.
KD025 is an oral, small-molecule inhibitor of Rho-associated coiledcoil kinase 2 (ROCK2). KD025-213 is an open-label registration study of the candidate in adults and adolescents with cGVHD, who have received at least two prior lines of systemic therapy.
In the study, patients were randomized to receive KD025 200 mg QD or 200 mg BID, enrolling 63 patients per arm. The primary endpoint is the Overall Response Rate (ORR), defined as the percentage of patients achieving a complete or partial response at any time point during the study. The company expects to release outcomes from a planned interim analysis of the study before the end of the year. Data from this analysis are expected to support a pre-new drug application (NDA) meeting with the FDA regarding KD025 in cGVHD.
Share price of the company has rallied 21.6% year to date against the industry’s decline of 1.7%.
Notably,the FDA has granted Breakthrough Therapy designation to KD025 for the treatment of cGVHD following at least two prior systemic therapies. The FDA has also granted Orphan Drug designation to the candidate for the treatment of cGVHD.
Kadmon is also conducting a phase II proof-of-concept study of KD025 for the treatment of idiopathic pulmonary fibrosis (IPF). Initial findings from this study demonstrated clinical benefit and tolerability of KD025 in IPF. The company expects data from this study to support the ongoing development of its novel ROCK inhibitors for the treatment of fibrotic diseases, including IPF.
Zacks Rank & Other Stocks to Consider
Kadmon currently carries a Zacks Rank #2 (Buy).
Some other top-ranked stocks are Acorda Therapeutics Inc. (ACOR - Free Report) , Celldex Therapeutics, Inc. (CLDX - Free Report) and Eton Pharmaceuticals, Inc. (ETON - Free Report) . While Acorda and Celldex sport a Zacks Rank #1 (Strong Buy), Eton carries a Zacks Rank #2. You can see the complete list of today’s Zacks #1 Rank stocks here.
Acorda’s loss per share estimates have narrowed from $3.59 to $2.74 for 2019 in the past 60 days. The company delivered a positive earnings surprise in the trailing four quarters, the average being 69.68%.
Celldex’s loss per share estimates have narrowed from $4.80 to $3.98 for 2019 and from $3.69 to $3.37 for 2020 in the past 60 days. The company delivered a positive earnings surprise in the trailing four quarters, the average being 24.15%.
Eton Pharmaceuticals’ loss per share estimates have narrowed from $1.41 to $1.04 for 2019 and from $1.03 to 50 cents for 2020 in the past 60 days.
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