Roth Capital Encouraged by Removal of CTP-354 Clinical Hold; Has Concert Pharma (CNCE) at 'Buy'

Roth Capital maintains Concert Pharmaceuticals (Nasdaq: CNCE) at Buy with a price target of $28 following news that the FDA has removed the partial clinical hold on its CTP-354 drug candidate for spasticity.

Analyst Joseph Pantginis commented, We are encouraged by the removal of the partial clinical hold on the study and view positively CNCE's determination to proceed onward with the ascending dose study, initiating a higher dose cohort. We look forwards to the next step in CTP-354 development with the expected Phase II study to be initiated in 2H14.

Recall also that the company’s most advanced product, CTP-499, has generated positive Phase II data in diabetic kidney disease, including data supporting the drug’s mechanism of action in reducing markers of fibrosis in the kidneys. CNCE had a successful end of Phase II meeting with the FDA and we believe the company is on the right track to proceed to the next stage. The company plans on submitting a SPA application for the Phase III study of CTP-499 and if approved, it can help speed up the approval process. We view this application as a sign of confidence of CNCE in CTP-499 and its potential benefit to diabetic kidney disease patients. We believe that the visibility garnered through this successful FDA meeting could serve as a potential trigger for partnership interest in further developing CTP-499.

For an analyst ratings summary and ratings history on Concert Pharmaceuticals click here. For more ratings news on Concert Pharmaceuticals click here.

Concert Pharmaceuticals closed at $8.29 yesterday.

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