Vericel Receives FDA Fast Track Designation for Ixmyelocel-T, an Investigational Product for the Treatment of Patients with Advanced Heart Failure Due to Ischemic Dilated Cardiomyopathy
Vericel Corporation (VCEL)
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Source: GlobeNewswire
CAMBRIDGE, Mass., Feb. 21, 2017 (GLOBE NEWSWIRE) -- Vericel Corporation (NASDAQ:VCEL), a leading developer of autologous expanded cell therapies for the treatment of patients with serious diseases and conditions, today announced that the U.S. Food and Drug Administration (FDA) has designated the investigation of ixmyelocel-T for reduction in the risk of death and cardiovascular hospitalization in patients with chronic advanced heart failure due to ischemic dilated cardiomyopathy as a Fast Track Development Program. “Receiving Fast Track designation highlights both the unmet medical need for improved therapies to treat advanced heart failure due to dilated cardiomyopathy and the significance of the results from the ixmyelocel-T Phase 2b ixCELL-DCM clinical study” said Nick Colangelo, president and CEO of Vericel. "We believe that achieving important regulatory milestones such as Fast Track designation enhances the value of ixmyelocel-T and our efforts to partner the further developm
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Earnings
- 2/29/24 - Beat
VCEL
Sec Filings
- 5/1/24 - Form 4
- 4/19/24 - Form 4
- 4/18/24 - Form 144
- VCEL's page on the SEC website