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CANF

Can-Fite BioPharma

$2.13

-0.01 (-0.47%)

06:33
10/15/19
10/15
06:33
10/15/19
06:33

Can-Fite BioPharma completes enrollment in Phase II NASH study of Namodenoson

Can-Fite BioPharma announced it has completed patient enrollment in its Phase II study of Namodenoson in the treatment of NAFLD/NASH. The multicenter, randomized, double-blinded, placebo-controlled, dose-finding efficacy and safety study has enrolled 60 patients with NAFLD (non-alcoholic fatty liver disease) with or without NASH (non-alcoholic steatohepatitis). Patients who suffer from NAFLD/NASH with evidence of active inflammation are treated twice daily with 12.5 mg or 25 mg of oral Namodenoson, or placebo for 12 weeks. The primary endpoint of the Phase II study is the anti-inflammatory effect of the drug, as determined by mean percent change from baseline in ALT blood levels and safety. Secondary endpoints include percentage change from baseline of liver fat, as measured by MRI-PDFF. Topline results are expected in Q1 of 2020. Namodenoson has been out-licensed for the indication of NASH in South Korea and China. There is currently no U.S. FDA approved drug for the treatment of NASH, which is an addressable pharmaceutical market estimated to reach $35B-$40B by 2025.

CANF Can-Fite BioPharma
$2.13

-0.01 (-0.47%)

10/31/18
HCWC
10/31/18
NO CHANGE
HCWC
Buy
H.C. Wainwright 'cautiously optimistic' about Can-Fite after trial results delay
After Can-Fite BioPharma announced earlier today that top line efficacy results are now expected during the first quarter of 2019 in its Phase 2 clinical trial of drug candidate Namodenoson for the treatment of advanced hepatocellular carcinoma due to patient survival, H.C. Wainwright analyst Jason Kolbert said he is "cautiously optimistic" given that he finds it surprising that the trial has gone on this long. His understanding is that a six week or bigger difference between the active and control arms is considered clinically meaningful in this indication, adding that if the data is strong enough the trial is could be used as a registrational study given the unmet medical need. He keeps a Buy rating on Can-Fite shares, which were down 5% in morning trading.
03/27/19
HCWC
03/27/19
NO CHANGE
Target $3
HCWC
Buy
Can-Fite selloff yesterday on trial miss unwarranted, says H.C. Wainwright
H.C. Wainwright analyst Vernon Bernardino recommends Can-Fite BioPharma shares, especially on weakness, based on expectations for positive catalysts with piclidenoson in 2019. The company yesterday announced that its Phase 2 study with namodenoson in hepatocellular carcinoma did not achieve its primary endpoint of overall survival. The analyst, however, did not have this indication in his model and thinks the stock pullback yesterday is unwarranted. He recommends Can-Fite shares based on the potential for second half of 2019 data readouts from Phase 3 studies with its lead candidate piclidenoson in rheumatoid arthritis and psoriasis to be positive. Bernardino reiterates a Buy rating on Can-Fite BioPharma with a $3 price target. The stock closed yesterday down 28%, or 36c, to 93c.

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BBIO

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