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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 [...]

Thoughts on the Price Surge of Cytokinetics (CYTK, $8.75)

Cytokinetics has been on a tear this year. Is started the year at $6.72 and closed yesterday (January 10) at $9.58, this is a 43% increase in just over a week. So what is going on? I checked in with management and they could point to no recent announcement or event that would cause such [...]

If You’re Going to San Francisco

This has always been one of my favorite songs and I love the lyrics. If you’re going to San Francisco Be sure to wear some flowers in your hair If you’re going to San Francisco You’re gonna meet some gentle people there For those who come to San Francisco Summertime will be a love-in there [...]

Cytokinetics: 2014 Will Bring Critical Data Readouts on Tirasemtiv and Omecamtiv Mecarbil (CYTK, $6.03)

Key Takeaways From 3Q, 2013 Conference Call The BENEFIT-ALS trial of tirasemtiv has nearly completed enrollment and Cytokinetics (CYTK) believes that topline data will be reported as early as the American Academy of Neurology (AAN) Meeting in Philadelphia in April 2014. The most likely path forward in the event that the data is positive is [...]