Amarin (AMRN) Recovers as NCE Delay Seen as Immaterial and Maybe Positive
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Shares of Amarin Corporation plc (Nasdaq: AMRN) fell as much as 9 percent early Friday after disclosing a delay in receiving NCE status from the FDA for Vascepa. However, after an initial knee-jerk lower shares have been creeping higher as the news is not a death knell and was expected by some.
While investors know now that regulatory exclusivity status of Vascepa will not be included in the FDA July Orange Book Supplement, the two sides are still talking and this could be a good thing. According to some, the ongoing dialogue is a good sign for NCE approval.
In fact, just a few weeks ago analysts at Jefferies predicted such a delay and said it would be immaterial.
"Ultimately, we see a potential minor delay of 1-2 months as having no material impact on our valuation thesis, which is largely driven by current patent protection well into the 2020s with upside from 2030 patents," analyst Thomas Wei said on August 9.
Others took it a step further, saying that the delay was an outright "positive" as it will give the FDA time to fully address the uniqueness of Vascepa.
Shares of AMRN are down 1.6 percent to $12.01, but again are well off the lows.
While investors know now that regulatory exclusivity status of Vascepa will not be included in the FDA July Orange Book Supplement, the two sides are still talking and this could be a good thing. According to some, the ongoing dialogue is a good sign for NCE approval.
In fact, just a few weeks ago analysts at Jefferies predicted such a delay and said it would be immaterial.
"Ultimately, we see a potential minor delay of 1-2 months as having no material impact on our valuation thesis, which is largely driven by current patent protection well into the 2020s with upside from 2030 patents," analyst Thomas Wei said on August 9.
Others took it a step further, saying that the delay was an outright "positive" as it will give the FDA time to fully address the uniqueness of Vascepa.
Shares of AMRN are down 1.6 percent to $12.01, but again are well off the lows.
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