Amarin shares have already doubled in value this year, boosted by strong AMR101 clinical data and improved patent protection that should give the drug sufficient market exclusivity if approved on July 26. If AMR101 is approved, however, watch investor focus shift quickly to speculation about the sale of the company to Big Pharma. Very few Amarin shareholders will be happy if the company announces plans to launch AMR101 on its own.
Also on July 26, Horizon Pharmaceuticals (HZNP - Get Report) will also receive FDA's approval decision for a proprietary, time-release formulation of the steroid prednisone for the treatment of rheumatoid arthritis. The same drug under the brand name Lodotra is already approved in Europe.
Lastly, Onyx Pharmaceuticals (ONXX) is all but assured FDA approval of its multiple myeloma drug Kyprolis on Friday, July 27 following last month's overwhelmingly positive advisory panel vote.
Onyx share are up more than 50% since the FDA panel voted unanimously to recommend the approval of Kyprolis for patients with advanced multiple myeloma that no longer responds to current treatment.--Written by Adam Feuerstein in Boston.
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