Amarin (AMRN): FDA acceptance (or rejection) of the Vascepa supplemental New Drug Application (sNDA) covering the larger "ANCHOR" trial population covering patients with mixed dyslipidemia in late April or early May. Acceptance is widely expected so this is an important (negative) catalyst for Amarin if FDA chooses to reject the sNDA or require pre-approval cardiovascular outcomes data. Amarin will also announce first quarter financial results (including the first reporting of Vascepa sales) in May.
Raptor Pharmaceuticals (RPTP): FDA approval decision for Procysbi in cystinosis on April 30.
Sangamo Biosciences (SGMO): Interim results from phase II studies of SB-728 in HIV will be presented at the American Society of Gene and Cell Therapy annual meeting, May 15-19.
Vertex Pharmaceuticals (VRTX): Data from the phase II study of next-generation cystic fibrosis "corrector" VX-661 in combination with Kalydeco.NewLink Genetics (NLNK): Interim analysis of "IMPRESS" phase III trial of algenpantucel-L in resected pancreatic cancer. AstraZeneca (AZN) and Rigel (RIGL): Top-line results from phase III studies of fostamatinib in rheumatoid arthritis. Depomed (DEPO): FDA approval decision for Sefelsa in menopause on May 31. An FDA advisory panel in March voted against the drug's approval. Biogen Idec (BIIB): The commercial launch of the multiple sclerosis pill Tecfidera. Sucampo Pharmaceuticals (SCMP): FDA approval decision date for Amitiza in opioid-induced constipation on April 26. Dendreon (DNDN): European approval decision on Provenge possible before end of the second quarter. Valeant Pharmaceuticals (VRX): FDA approval decision for efinaconazole to treat toenail fungus infection on May 24. GlaxoSmithKline (GSK): FDA approval decision for dabrafenib and trametinib in melanoma on June 3. Aegerion Pharmaceuticals (AEGR): Potential European approval decision for Juxtapid in the second quarter. Cancer drug stocks: Research abstracts for the American Society of Clinical Oncology (ASCO) annual meeting will be released on May 16, ahead of the actual meeting taking place May 31 through June 4. Relevant "ASCO" stocks include Ariad Pharmaceuticals (ARIA), Clovis Oncology (CLVS), Bristol-Myers Squibb (BMY), Pharmacyclics (PCYC), Spectrum Pharmaceuticals (SPPI), Amgen (AMGN), Infinity Pharmaceuticals (INFI), Curis (CRIS) and Synta Pharmaceuticals (SNTA). -- Reported by Adam Feuerstein in Boston. Follow @AdamFeuerstein
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