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CBAY

CymaBay

$5.65

-0.15 (-2.59%)

07:37
07/17/17
07/17
07:37
07/17/17
07:37

CymaBay announces 'positive' results from seladelpar Phase 2 study

CymaBay announced positive interim results from its ongoing low-dose Phase 2 study of seladelpar in patients with primary biliary cholangitis, or PBC, a life-threatening and life-limiting chronic cholestatic liver disease. In the first part of the study, patients at high risk of disease progression, with an inadequate response to ursodeoxycholic acid, or UDCA, as characterized by a persistent elevation in alkaline phosphatase, or AP, or who were intolerant to UDCA, received either 5 mg or 10 mg of seladelpar once-daily. A planned interim analysis of the first 24 patients enrolled in these two dose groups demonstrated after 12 weeks of treatment a significant AP reduction from baseline of 39% and 45% for the 5 mg and 10 mg groups, respectively. On seladelpar, 45% of patients in the 5 mg and 82% of patients in the 10 mg dose groups had AP values less than 1.67 times the upper limit of normal, or ULN. AP is an established surrogate marker of disease progression in PBC, and reaching a level of less than 1.67 x ULN is a key component in the composite endpoint used for regulatory approval. Alongside substantial reductions in AP, patients in both dose groups experienced decreases in other liver markers of cholestasis including gamma glutamyl transferase and total bilirubin. Seladelpar also improved metabolic and inflammatory markers with patients experiencing decreases in low-density lipoprotein-C and high sensitivity C-reactive protein. There were no serious adverse events and no safety transaminase signal was observed at either dose. Instead, mean transaminase levels decreased over the course of treatment, further supporting seladelpar's anti-inflammatory activity. Consistent with prior studies, there was no signal for drug-induced pruritus. After sharing preliminary results from the study, the FDA has agreed to allow continuation of seladelpar treatment beyond six months for the 5 mg and 10 mg doses.

CBAY CymaBay
$5.65

-0.15 (-2.59%)

06/22/17
OPCO
06/22/17
INITIATION
Target $8
OPCO
Outperform
CymaBay initiated with an Outperform at Oppenheimer
Oppenheimer analyst Jay Olson started CymaBay with an Outperform rating and $8 price target.
03/24/17
ROTH
03/24/17
NO CHANGE
Target $6
ROTH
Buy
CymaBay recent pull back represents 'attractive entry point,' says Roth Capital
Roth Capital analyst Sa'ar Yaniv notes that CymaBay expects that data from two arms of the ongoing, second Phase 2 study of seladelpar in primary biliary cholangitis will be released in Q3, and data from the third arm will be available by YE17. The analyst believes that shares continue to trade up in front of the data, and with recent pull back, the current price represents an "attractive entry point." He reiterates a Buy rating and $6 price target on the shares.
01/30/17
HCWC
01/30/17
UPGRADE
Target $6
HCWC
Buy
CymaBay upgraded to Buy from Neutral at H.C. Wainwright
H.C. Wainwright analyst Ed Arce upgraded CymaBay to Buy citing the potential for up to $200M of milestone payments from Kowa, the company's new U.S. partner for arhalofenate, and a more positive view of the potential of MBX-8025 to treat Primary Biliary Cirrhosis. The analyst raised his price target for the shares to $6 from $2.50.
11/16/16
PIPR
11/16/16
NO CHANGE
Target $5
PIPR
Overweight
CymaBay price target raised to $5 from $4 at Piper Jaffray
Piper Jaffray analyst Edward Tenthoff raised his price target for CymaBay Therapeutics to $5 after the company gave two oral presentations on MBX-8025. In the Phase II study, both 50mg and 200mg MBX-8025 significantly reduced Alkaline Phosphatase, but three patients had dose-dependent transaminase elevations, Tenthoff tells investors in a research note. To analyst sees increased value for MBX-8025 and reiterates an Overweight rating on CymaBay.

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