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Cytokinetics: Takeaways from January 5, 2014 Conference Call (CYTK, Buy, $7.82)

Cytokinetics held a conference call on January 5th in which they added some detail on the collaboration with Astellas on CK-107 for the first indication of spinal muscular atrophy. I discussed this collaboration in a note on December 24, 2014 and you may want to read that note for more background. The Company provided some additional [...]

Cytokinetics: With the Stock Up 63% in the Last Seven Trading Days, What Do We Do Now? (CYTK, $8.01, Buy)

The strength followed the announcement of a new collaboration agreement with Astellas on CYTK’s unique skeletal muscle activators program This added an important third product to CYTK’s portfolio of products in advanced human trials We may hear on a scheduled January 5 conference call if there is a path forward for a phase 3 trial [...]

Cytokinetics (CYTK, Buy $5.52) New Collaboration with Astellas on CK-2127107 Greatly Improves Investment Outlook

This deal adds a third leg to the development pipeline at Cytokinetics along with omecamtiv for congestive heart failure and tirasemtiv for ALS. My Buy recommendation has been based on the possibility that tirasemtiv will begin a phase 3 in ALS in 2015. Investors had written this product off after a phase 2b disappointment. This [...]

Cytokinetics: An Update on Tirasemtiv and Omecamtiv Mecarbil (CYTK, Buy, $3.67)

Investment Thinking Cytokinetics could announce the decision on whether it will advance tirasemtiv into a pivotal phase 3 trial by the end of 2014. In my opinion, management will only make this decision if the FDA agrees under a Special Protocol Assessment that a new primary endpoint of slow vital capacity, SVC, can be used. [...]

Cytokinetics Is Planning for a Phase 3 Trial in 2015 for Tirasemtiv in ALS (CYTK, $3.26, Buy)

Cytokinetics (CYTK) has announced   that it is planning a phase 3 trial for tirasemtiv using sustained vital capacity-SVC- as a primary endpoint. The new trial could begin in 2015, but the gating factor almost certainly will be whether the FDA agrees to a Special Protocol Assessment- SPA- in which the agency agrees that SVC [...]

Cytokinetics: More Thoughts on the Potential for a Phase 3 Trial of Tirasemtiv in ALS (CYTK, Buy, $4.20)

Investment Thesis In listening carefully to Cytokinetics’ (CYTK) comments over the last three months, I am convinced that the Company will consult with the FDA and EMEA about the design of a new phase 3 trial of tirasemtiv in ALS. They will ask for approval to use the respiratory measure of sustained vital capacity (SVC) [...]

Cytokinetics: Tirasemtiv May Still Be Successfully Developed in ALS (CYTK, Buy, $4.77)

I think that there is a strong possibility that Cytokinetics (to the surprise of Wall Street) could announce sometime in coming months that it will undertake a phase 3 registrational trial for tirasemtiv in ALS. After tirasemtiv failed to reach the primary endpoint of ALSFRS-r in the phase 2 BENEFIT-ALS trial, the stock crashed and [...]

Cytokinetics Announces that Tirasemtiv Phase 2b Trial in ALS Failed (CYTK, Buy, $5.01)

Cytokinetics announced that tirasemtiv failed to reach the primary endpoint in the phase 2b BENEFIT-ALS trial in ALS. The mean change from baseline in the ALS Functional Rating Scale in its revised form (ALSFRS-R) for tirasemtiv was -2.98 as compared to -2.40 in the placebo group indicating no difference from placebo. The Company said that there [...]

SmithOnStocks Mailbox February 25, 2014

I have found that there are some very smart people out there who have interesting questions and perspectives concerning my articles. I periodically share with subscribers questions asked of me and my response. Also, some subscribers have a different perspective or additional insights beyond mine that I find informative. Sharing this information is the purpose [...]

Cytokinetics: Institutional Investors Give BENEFIT-ALS Potential Results a Vote of Confidence (CYTK, $9.06)

Cytokinetics (CYTK) announced that it has completed an equity offering in which it issued 4.375 million shares at a price of $8.00 that brought in gross proceeds of $35 million and estimated net proceeds of $33 million after underwriting discounts. Underwriters have 30 days to exercise a Green Shoe that would result in an issuance [...]