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CBAY

CymaBay

$4.95

0.46 (10.25%)

08:30
11/04/19
11/04
08:30
11/04/19
08:30

CymaBay reaches target enrollment in ENHANCE global Phase 3 study

CymaBay Therapeutics announced achievement of the targeted 240 patient enrollment goal for ENHANCE, a global Phase 3 study evaluating seladelpar for patients with Primary Biliary Cholangitis. CymaBay is on track to complete full enrollment by the end of November. With more than 240 patients enrolled, ENHANCE is CymaBay's lead regulatory registration study evaluating the safety and efficacy of its investigational drug, seladelpar, for patients already diagnosed with PBC who have been using ursodeoxycholic acid, but have not achieved the recommended treatment goal or cannot tolerate UDCA. ENHANCE is a 52-week, placebo-controlled, randomized study conducted in over 20 countries.

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CBAY CymaBay
$4.95

0.46 (10.25%)

06/24/19
STFL
06/24/19
INITIATION
STFL
Buy
CymaBay initiated with a Buy at Stifel
Stifel analyst Derek Archila initiated CymaBay with a Buy rating and $14 price target, saying he believes the company's seladelpar "will ultimately prove efficacious in its Phase 2b NASH study." He added that he sees the recent pullback as a significant buying opportunity.
08/08/19
OPCO
08/08/19
NO CHANGE
Target $150
OPCO
Outperform
Intercept price target lowered to $150 from $160 at Oppenheimer
Oppenheimer analyst Jay Olson lowered his price target for Intercept (ICPT) to $150 from $160, while reiterating an Outperform rating on the shares following quarterly results. The analyst recognizes the PBC business faces challenges including the potential for price erosion assuming OCA becomes available for NASH at a higher dose and lower price and multiple competitive entries including CymaBay's (CBAY) seladelpar, which is also being studied for NASH. Olson also believes recent competitor studies in NASH increase the scarcity value of Intercept's registrational asset, and thinks MRI-PDFF results for seladelpar have no impact on Intercept's plans to study a combination of OCA plus bezafibrate in NASH. Additionally, he considers the Q3 regulatory submission for OCA in NASH as a positive catalyst if granted a priority review.
09/18/19
CANT
09/18/19
NO CHANGE
Target $20
CANT
Overweight
CymaBay CMO change about getting liver expertise, says Cantor Fitzgerald
After speaking to management, Cantor Fitzgerald analyst Eliana Merle thinks CymaBay Therapeutics' decision to replace its chief medical officer is driven by the goal to deepen its regulatory and liver expertise ahead of potential filing and launch in primary biliary cholangitis. The analyst notes that CymaBay remains blinded to the ongoing nonalcoholic steatohepatitis study, with 52-week histology data coming in early 2020. She sees a "highly favorable" risk/reward into the NASH updates and keeps an Overweight rating on CymaBay shares with a $20 price target.
10/01/19
HCWC
10/01/19
NO CHANGE
Target $72
HCWC
Buy
Genfit selloff brings 'compelling' entry point, says H.C. Wainwright
H.C. Wainwright analyst Ed Arce sees a "compelling" entry point for Genfit (GNFT) with the shares down 34% since June 10. An "uninformed and unfair derivative response" to the failure of CymaBay's (CBAY) seladelpar to reduce steatosis in nonalcoholic steatohepatitis patients by week 12 has drove the weakness in Genfit shares, Arce tells investors in a research note. He points out that while seladelpar is a highly selective PPAR delta agonist, Genfit's elafibranor is a dual agonist of PPAR alpha and PPAR delta. As such, there are clear mechanistic differences between the two PPAR-targeted compounds, says the analyst. He affirms a Buy rating on Genfit with a $72 price target.

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