Acorda Therapeutics, Inc. products

GGF2 is a member of the neuregulin growth factor family, and has been shown to promote recovery after neurological injury, as well as to enhance heart function in animal models of heart failure. GGF2 showed positive effects on cardiac function in the two Phase 1 clinical studies conducted to date. The Phase 1b trial assessed three doses of cimaglermin alfa in people with heart failure, but discontinued enrollment and then received an FDA clinical hold based on the occurrence of a case of markedly elevated bilirubin and liver enzymes. The FDA clinical hold was lifted in April 2017 after Acorda presented additional data on this effect, but the Company has not restarted any clinical studies. Acorda is currently deferring further investment in this program, and is considering next steps, which could include potential partnering or out-licensing.