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KDMN

Kadmon

$2.06

-0.235 (-10.24%)

08:07
10/25/18
10/25
08:07
10/25/18
08:07

Kadmon initiates Phase 2 KD025 trial in cGVHD

Kadmon Holdings announced that the first patient has been dosed in a pivotal clinical trial of KD025 in chronic graft-versus-host disease. The study will evaluate the efficacy and safety of KD025, Kadmon's ROCK2 inhibitor, in adults with cGVHD who have received at least two prior lines of systemic therapy. The trial is designed to support a filing for U.S. regulatory approval of KD025. ROCKstar is a Phase 2 open-label trial in which patients will be randomized to receive KD025 200 mg QD or KD025 200 mg BID, enrolling 63 patients per arm. Either KD025 dose may be considered by the U.S. Food and Drug Administration for the registrational dose. The primary endpoint is the Overall Response Rate (ORR), defined as the percentage of patients who meet the 2014 National Institutes of Health Consensus Conference overall response criteria of complete or partial response. The ROCKstar study protocol is based on FDA guidance received in a Type C meeting and was designed in consultation with leading cGVHD experts.

KDMN Kadmon
$2.06

-0.235 (-10.24%)

12/21/17
JEFF
12/21/17
NO CHANGE
Target $9
JEFF
Buy
Kadmon Q1 data could bring 'significant' upside, says Jefferies
Jefferies analyst Biren Amin believes Kadmon's Phase II data for KD025 in chronic graft-versus-host disease, expected in Q1 of 2018, represent "significant" upside with little downside risk. KD025 has shown "encouraging activity" in a difficult to treat population, Amin tells investors in a research note. He assumes U.S. market entry of KD025 for treatment of chronic graft-versus-host disease in 2020 and estimates U.S. peak sales of 333.1M. The analyst has a Buy rating on Kadmon shares with a $9 price target.
02/13/18
JEFF
02/13/18
NO CHANGE
Target $16
JEFF
Buy
Kadmon price target raised to $16 from $9 at Jefferies
Jefferies analyst Biren Amin raised his price target for Kadmon Holdings to $16 after the company announced positive data on its Phase II trial of KD025 in idiopathic pulmonary fibrosis. The absolute improvement of 127 mL between arms surpasses the bar of 45-85 mL seen with existing therapies and the shares should react positively, Amin tells investors in a research note. He keeps a Buy rating on Kadmon shares.
02/13/18
PIPR
02/13/18
NO CHANGE
Target $9
PIPR
Overweight
Kadmon price target raised to $9 after data on KD025 at Piper Jaffray
Piper Jaffray analyst Edward Tenthoff noted that Kadmon announced "positive" topline Phase 2 data on KD025 in 29 evaluable idiopathic pulmonary fibrosis, or IPF, patients. Upon adding value for KD025 in IPF, the analyst increased his price target on Kadmon shares to $9 from $7 and reiterated his Overweight rating on the stock.
10/17/18
WBBS
10/17/18
UPGRADE
WBBS
Hold
Kadmon upgraded to Hold from Sell at WBB Securities

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