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KDMN

Kadmon

$2.89

0.195 (7.25%)

09:23
10/17/18
10/17
09:23
10/17/18
09:23

Kadmon announces FDA breakthrough therapy designation granted to KD025

Kadmon announced that the FDA has granted breakthrough therapy designation to KD025, the company's ROCK2 inhibitor, for the treatment of patients with chronic graft-versus-host disease, or cGVHD, after failure of two or more lines of systemic therapy. Kadmon is currently enrolling patients in a pivotal Phase 2 clinical trial of KD025 in patients with cGVHD. The designation of KD025 in cGVHD is supported by data from an ongoing Phase 2 clinical trial. In the study, KD025 was well tolerated and demonstrated clinical activity in approximately two-thirds of patients across Cohort 1 and Cohort 2. Preliminary results from the trial were previously presented at the 23rd Congress of the European Hematology Association, or EHA in June and at the Blood and Marrow Transplantation, or BMT meetings. Enrollment is ongoing in KD025-213, the pivotal Phase 2 clinical trial of KD025 in adults with cGVHD who have received at least two prior lines of systemic therapy. KD025-213 is an open-label trial in which patients are randomized to receive either KD025 200 mg QD or 200 mg BID, enrolling 63 patients per arm. Either KD025 dose may be considered by the FDA for the registrational dose.

KDMN Kadmon
$2.89

0.195 (7.25%)

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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