Cytokinetics (CYTK) BENEFIT-ALS Update 'Encouraging'; Roth Maintains 'Buy' Rating

Roth Capital affirms its Buy rating and $13 target price on Cytokinetics, Inc. (Nasdaq: CYTK) following an update to BENEFIT-ALS.

Analyst Josepn Pantginis said, We believe that these updated outcome measurements following tirasemtiv discontinuation at the end of the study are encouraging as they suggest that tirasemtiv can not only affect skeletal muscle troponin rapidly but also have an enduring effect on the respiratory muscles. We believe the positive enduring effect of tirasemtiv on SVC should inform the future steps that CYTK will take regarding the clinical development of tirasemtiv. Recall that while the primary endpoint was not met, it was the first time that benefits in respiratory (statistically significant) and muscle function in an ALS study was shown. Analyses on the data are continuing and pending FDA input, a new study would pay special attention to the tolerability issues seen in the study and could include more gradual dose titrations and longer leadin periods. KOLs believe that respiratory function could certainly represent a primary endpoint in the study. We now look forward to further analyses of the study and upcoming meetings with the FDA to decide potential next steps for the drug. For CK-2127107, the current Phase I is continuing and additional Phase II readiness studies will initiate in 2014. Amgen (AMGN-NC) is moving omecamtiv mecarbil forward with the ongoing COSMIC-HF study, which is enrolling well (complete enrollment by year end 2014) and a projected top-line data readout timeline could be announced at the next quarterly call.

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Cytokinetics closed at $4.99 yesterday.

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