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Daily Dose Newsletter

Thursday
Apr192012

Cytokinetics ($CYTK) announces CK-2017357 receives fast track designation from the FDA for the potential treatment of amyotrophic lateral sclerosis 

Cytokinetics (NASDAQ: CYTK) announced that CK-2017357, its fast skeletal muscle troponin activator, has received Fast Track designation from the FDA for the potential treatment of amyotrophic lateral sclerosis (ALS), also commonly known as Lou Gehrig's Disease.

  • Cytokinetics anticipates that results from two recently completed Phase II clinical trials, designed to assess the safety and tolerability of CK-2017357 in patients with ALS, will be presented at the American Academy of Neurology 64th Annual Meeting in New Orleans, LA on April 25, 2012.
  • Cytokinetics has met with the FDA's Division of Neurology Products and with the European Medicines Agency to discuss its progress in the development of CK-2017357 as a potential treatment for patients with ALS and the company's plans for its further development, including potential registration strategies.
  • Cytokinetics is assessing options that may enable the initiation of a registration program for CK-2017357.
  • Cytokinetics anticipates having additional interactions with U.S. and European regulatory authorities during 2012 to discuss the development of CK-2017357 as a potential treatment for patients with ALS, including potential registration strategies.

Daily Dose Conclusion: New treatments for ALS and competition could pressure cell therapy company Neuralstem (CUR).

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