BOSTON (TheStreet) -- If you're like me, a dad with school-age kids, September is a real page turner in the calendar. Everyone gets a fresh start on January 1, but Labor Day serves the same purpose. The lazy days of summer are over, school is back in session and it's time to get back to real work.
The biotech sector hews close to an academic calendar and September marks the start of the busy, event-filled push into the end of the year. Here's a list of noteworthy and stock-moving September events:
The FDA has a full menu of approval decisions to make next month, including Keryx Pharmaceuticals (KERX) - Get Report (Zerenex) on Sept. 5, Orexigen Therapeutics (OREX) (Contrave) on Sept. 11, AstraZeneca (AZN) - Get Report and Nektar Therapeutics (NKTR) - Get Report (Movantik) on Sept. 16, Alimera Sciences (ALIM) - Get Report (Iluvien) on Sept. 26 and Salix Pharmaceuticals (SLXP) (Relistor) on Sept. 29.
NPS Pharmaceuticals (NPSP) brings the hypoparathryoidism drug Natpara in front of an FDA advisory panel on Sept. 12.
The FDA has until October to render an approval decision on Gilead Sciences' (GILD) - Get Report single-pill combination therapy for hepatitis C and Merck's (MRK) - Get Report anti PD-1 cancer immunotherapy pembrolizumab, but do not be surprised at all if approvals are announced early.
A list of significant clinical trials with data announcements that could come in September:
Catalyst Pharmaceuticals (CPRX) - Get Report (Firdapse phase III)
Alcobra (ADHD) (MG01CI phase III)
Discovery Labs (DSCO) (AeroSurf phase II)
Sunesis Pharma (SNSS) - Get Report (Qinprezo phase III)
Tetraphase Pharma (TTPH) - Get Report (eravacycline phase III)
Xoma (XOMA) - Get Report (gevokizumab phase III)
Lipocine (LPCN) - Get Report (oral testosterone phase III)
ECTRIMS (multiple sclerosis) Sept. 10-14
EASD (diabetes0 Sept. 15-19
ESMO (oncology) Sept. 26-30
Healthcare investor conferences:
Baird (Sept. 3-4)
Citi (Sept. 3-4)
Rodman & Renshaw (Sept. 9-10)
Morgan Stanley (Sept. 8-10)
BioCentury (Sept. 26)
Adam Feuerstein writes regularly for TheStreet. In keeping with company editorial policy, he doesn't own or short individual stocks, although he owns stock in TheStreet. He also doesn't invest in hedge funds or other private investment partnerships. Feuerstein appreciates your feedback;
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