Expert Financial Analysis and Reporting

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 […]

Overview on Clinical Status of Tirasemtiv I believe that Cytokinetics (CYTK) will decide to move tirasemtiv into phase 3 registration trials and that this decision will likely be announced later this year or early next. After listening to the conference call on April 30 that discussed the disappointing results in BENEFIT-ALS, it was my feeling […]

Overview Cytokinetics held a conference call on the results of the BENEFIT-ALS trial on the morning of April 30. The Company announced on April 25, that the trial had failed to meet its primary endpoint of change in ALSFRS-r and that results on secondary endpoints were mixed. Based on this, investors concluded that tirasemtiv was […]

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 […]

This Has Been a Tough Correction The recent sharp market correction and rotation out of growth stocks like biotechnology and technology has had a major impact on the small biotechnology names that I specialize in. The correction has been stomach churning for me even though I have been through this many times before. I am […]

Phase 2b Data on Tirasemtiv will be Presented on April 29th Cytokinetics has an extremely important binary event upcoming as the data on the phase 2b trial of tirasemtiv in ALS will be presented at the American Academy of Neurology meeting in Philadelphia on Tuesday April 29th at 4:15 PM. The data comes from a […]

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 (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 […]

Purpose of This Report The biggest clinical trial event in all of biotechnology for 2014 could be the reporting of phase 2b results from the BENEFIT-ALS trial of tirasemtiv in ALS. This in-depth report analyzes earlier phase 1 and 2 results for tirasemtiv and how they might be predictive of a positive outcome in BENEFIT-ALS. […]

Back From BIO CEO Conference I have returned from spending two days at the BIO CEO conference at the Waldorf Astoria in New York City. Through attending presentations or one on one meetings,  I heard presentations from Advanced Cell Technology ACTC), Advaxis (ADXS), Agenus (AGEN), Alexion (ALXN) , Alkermes (ALKM), Aradigm (ARDM), Athersys (ATHX), Celator […]