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CYTK

Cytokinetics

$6.83

-0.19 (-2.71%)

07:43
01/22/19
01/22
07:43
01/22/19
07:43

Cytokinetics announces FDA feedback for potential reldesemtiv program

Cytokinetics announced that it has received feedback from the FDA that the six minute walk test, or 6MWT, is an acceptable primary efficacy endpoint for a potential registration program for reldesemtiv in patients with spinal muscular atroph, or SMA, who have maintained ambulatory function. The FDA also recommended adding a global function scale as a secondary endpoint, such as the Hammersmith Functional Motor Scale, or HFMSE. In collaboration with Astellas, Cytokinetics is developing reldesemtiv as a potential treatment for people with SMA and certain other debilitating diseases and conditions associated with skeletal muscle weakness and/or fatigue. The companies are discussing potential next steps regarding the ongoing development program for reldesemtiv in this patient population. Results from a Phase 2 clinical study of reldesemtiv in patients with SMA showed a statistically significant exposure-response relationship in changes from baseline in six minute walk distance, or 6MWD, a sub-maximal exercise test of aerobic capacity and endurance. The study also showed statistically significant increases for maximal expiratory pressure, or MEP, a measure of strength of respiratory muscles. Other assessments, including the HFMSE, did not demonstrate differences between reldesemtiv versus placebo. Adverse events in the Phase 2 study in patients with SMA were similar between treatment groups receiving reldesemtiv and placebo. Cytokinetics is preparing to conduct an additional Phase 1 study of reldesemtiv in healthy volunteers designed to assess whether higher doses than were evaluated in the Phase 2 study of patients with SMA may result in higher plasma concentrations. This study is expected to begin in Q1.

CYTK Cytokinetics
$6.83

-0.19 (-2.71%)

10/05/18
HCWC
10/05/18
NO CHANGE
Target $21
HCWC
Buy
Cytokinetics price target lowered to $21 from $24 at H.C. Wainwright
H.C. Wainwright analyst Joseph Pantginis lowered his price target on Cytokinetics shares to $21 from $24 after partner Astellas reported that both primary and secondary endpoints were not met in a trial of reldesemtiv in COPD patients and another trial testing reldesemtiv in elderly frailty was discontinued. However, omecamtiv drives the "lion's share" of his valuation of Cytokinetics shares, said Pantginis. The analyst, who noted that the omecamtiv mecarbil pivotal programs are progressing as planned, keeps a Buy rating on the stock.
10/05/18
PIPR
10/05/18
NO CHANGE
Target $13
PIPR
Overweight
Piper focus for Cytokinetics remains ALS, SMA after reldesemtiv fails in COPD
After Cytokinetics and partner Astellas announced that reldesemtiv failed in a Phase 2 study in COPD and Phase 1b in frailty, Piper Jaffray analyst Edward Tenthoff noted that he had not valued reldesemtiv in either of these indications. The analyst, who said he remains focused on the indications of Spinal Muscular Atrophy and Amyotrophic Lateral Sclerosis, keeps an Overweight rating and $13 price target on Cytokinetics shares.
10/05/18
MSCO
10/05/18
NO CHANGE
Target $10
MSCO
Equal Weight
Cytokinetics' reldesemtiv Phase 2 miss not a surprise, says Morgan Stanley
After Cytokinetics and partner Astellas announced that their Phase 2 study of reldesemtiv in COPD did not meet the primary endpoint and did not demonstrate a significant difference in any secondary endpoints, Morgan Stanley analyst Jeffrey Hung said he was not surprised by the "disappointing" results since Cytokinetics management has been suggesting for at least a month that the results from both COPD and frailty would be used to guide development of another compound rather than reldesemtiv. The upcoming R&D Day will focus on the cardiac muscle franchise, added Hung, who keeps an Equal Weight rating and $10 price target on Cytokinetics shares.
09/21/18
CANT
09/21/18
INITIATION
Target $14
CANT
Overweight
Cytokinetics initiated with an Overweight at Cantor Fitzgerald
Cantor Fitzgerald analyst Charles Duncan last night initiated coverage of Cytokinetics with an Overweight rating and $14 price target. The analyst, who started coverage on seven Neuro-Innovator and Platform-Enabled Therapeutic companies, believes that "biotech has entered a golden age of innovation and productivity across many therapeutic areas."

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