'Wild' Week Will Be Followed by a 'Crazy' Week for Amarin (AMRN)
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Price: $0.86 -2.27%
Rating Summary:
6 Buy, 12 Hold, 2 Sell
Rating Trend:
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Today's Overall Ratings:
Up: 11 | Down: 12 | New: 13
Rating Summary:
6 Buy, 12 Hold, 2 Sell
Rating Trend:
Up
Today's Overall Ratings:
Up: 11 | Down: 12 | New: 13
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It's been somewhat of a wild week for Amarin Corporation plc (NASDAQ: AMRN) as investors await the all-important July 26 PDUFA date with the FDA for AMR101. Yesterday, the company posted data on a website which showed AMR101, marketed under VASCEPA, was approved. The company later said the data was outdated and was inadvertently published through the draft website. But analysts said the inadvertent site may give investors insight into the potential label.
"Mock-up prescribing information (PI) for AMR101 (now potentially named Vascepa) was briefly available and may give some insight into the final label," said MKM Partners' Jon LeCroy. "Amarin stated that the information is outdated, and we do not think the information implies that an FDA approval is guaranteed. That said, we continue to expect an FDA approval on or before the July 26 PDUFA date."
LeCroy said there are a few significant differences exist between Lovaza and mock-Vascepa PIs - "The Vascepa PI discusses triglycerides, apolipoprotein B (apoB) and lipids in general, whereas the Lovaza PI primarily discusses triglycerides. The mock-up Vascepa PI does not contain liver, LDL-C or fish allergy warnings that are listed for Lovaza. Vascepa is listed as Pregnancy category B (more benign), whereas the Lovaza is Category C. The Vascepa mock-PI contains the ANCHOR data, which, if included in the final label, could help Amarin market the product to primary care physicians. The Vascepa mock-PI also contains language related to diabetics, whereas the Lovaza PI does not. Finally, Vascepa contains only EPA, while Lovaza contains a combination of ethyl esters. In our view, if the FDA reasons that Lovaza's contents are a mixture that cannot be exactly defined, it could support Amarin's argument that AMR101 deserves NCE status."
The next catalysts for AMRN, according to LeCroy are: an official allowance of the '889 patent (could happen in the next few weeks), the July 26 PDUFA date with the FDA for AMR101, and the NCE status update by the FDA, possibly by August 17.
The firm maintained a Buy rating and $21.50 price target on the stock.
For an analyst ratings summary and ratings history on Amarin Corporation click here. For more ratings news on Amarin Corporation click here.
Shares of Amarin Corporation are down 2.7 percent.
"Mock-up prescribing information (PI) for AMR101 (now potentially named Vascepa) was briefly available and may give some insight into the final label," said MKM Partners' Jon LeCroy. "Amarin stated that the information is outdated, and we do not think the information implies that an FDA approval is guaranteed. That said, we continue to expect an FDA approval on or before the July 26 PDUFA date."
LeCroy said there are a few significant differences exist between Lovaza and mock-Vascepa PIs - "The Vascepa PI discusses triglycerides, apolipoprotein B (apoB) and lipids in general, whereas the Lovaza PI primarily discusses triglycerides. The mock-up Vascepa PI does not contain liver, LDL-C or fish allergy warnings that are listed for Lovaza. Vascepa is listed as Pregnancy category B (more benign), whereas the Lovaza is Category C. The Vascepa mock-PI contains the ANCHOR data, which, if included in the final label, could help Amarin market the product to primary care physicians. The Vascepa mock-PI also contains language related to diabetics, whereas the Lovaza PI does not. Finally, Vascepa contains only EPA, while Lovaza contains a combination of ethyl esters. In our view, if the FDA reasons that Lovaza's contents are a mixture that cannot be exactly defined, it could support Amarin's argument that AMR101 deserves NCE status."
The next catalysts for AMRN, according to LeCroy are: an official allowance of the '889 patent (could happen in the next few weeks), the July 26 PDUFA date with the FDA for AMR101, and the NCE status update by the FDA, possibly by August 17.
The firm maintained a Buy rating and $21.50 price target on the stock.
For an analyst ratings summary and ratings history on Amarin Corporation click here. For more ratings news on Amarin Corporation click here.
Shares of Amarin Corporation are down 2.7 percent.
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