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Jason Butler, PhD, Analyst for San Francisco based JMP Securities, is “remaining positive on CaPre potential (Acasti) following Vascepa (Amarin) label expansion disappointment.”
JMP sees many positives for Acasti Pharma and this is the basis for it maintaining its $7 price target and Market Outperform Rating. This comes on the heels of the FDA Advisory Committee voting 9-2 against expanding the label of Amarin’s fish oil-based omega-3 product, Vascepa, to the broader indication of mixed dyslipidemia in combination with a statin.
The panel concluded that results from the ongoing REDUCE-IT trial for Vascepa should demonstrate beneficial cardiovascular outcomes in order to support label expansion. For more information on yesterday’s Amarin FDA Advisory vote, please click here....
Mr. Butler acknowledged, “While this is a negative for the omega-3 space generally, we remain positive on the potential for CaPre, the krill-based omega-3 drug candidate being developed by Neptune’s subsidiary Acasti, for several reasons:
- The regulatory pathway in patients with very high levels of triglycerides (≥500 mg/dL) is well established and does not require CV (Cardiovascular) outcomes data;
- We continue to believe that CaPre has the potential to be the best-in-class omega-3 product due to key differentiating attributes of the krill source, and;
- Should the best-in-class potential hold true, positive results for the Vascepa REDUCE-IT trial could result in broader use of CaPre (including off-label use in patients with triglycerides 200-500 mg/dL).”
To view the full JMP report, please click here....