Roth Keeps Concert Pharma (CNCE) at 'Buy'; AVP-923 Phase 2 Data is Encouraging (AVNR)

Roth Capital maintains its Buy rating and $28 price target on Concert Pharmaceuticals (Nasdaq: CNCE) following positive Phase II results from a study of AVP-923 (licensed from CNCE) for agitation in Alzheimer's disease announced by Ananir Pharma (Nasdaq: AVNR).

Analyst Joseph Pantginis commented, We are encouraged by the Phase II data from the 220-patient study, which showed significant improvement in agitation (primary endpoint) over placebo as measured on the agitation/progression domain score of the neuropsychiatry inventory (NPI). Most secondary endpoints were also met, including NPI total score, clinical global impression of change-agitation, patient global impression of change, and measures of caregiver burden. The drug was well-tolerated, with no serious adverse events seen in the 10-week study. The most common AEs, which occurred in <10% of patients, included diarrhea, falls, and urinary tract infections. Avanir will request meetings with the FDA and EMA to discuss pivotal study designs. KOLs commented that with no currently approved treatment for Alzheimer's disease-associated agitation, treatment with '923 could lead to a significant reduction in the burden to both patients and caregivers. Further data from the study are expected to be presented at the American Neurological Association Annual Meeting on October 12-14, 2014. CNCE has a busy schedule ahead. The company expects to initiate the Phase II study of CTP-354 in spinal cord injury spasticity later this year. We look forward to top-line data from the Phase I portion of this study in October. CNCE also plans to initiate discussions with the FDA regarding a Phase III design for CTP-499, including the possibility of conducting the Phase III under a SPA. A Phase I study of CTP-730 is expected to initiate in the fall. Recall that CNCE received a $2 million milestone payment last month due to Avanir's initiation of a 10-week Phase II study of AVP-786 in MDD.

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 $10.06 yesterday.

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