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) (Zerenex) on Sept. 5, Orexigen Therapeutics ( OREX) (Contrave) on Sept. 11, AstraZeneca ( AZN) and Nektar Therapeutics ( NKTR) (Movantik) on Sept. 16, Alimera Sciences ( ALIM) (Iluvien) on Sept. 26 and Salix Pharmaceuticals ( SLXP) (Relistor) on Sept. 29.
Amarin ( AMRN) is expected to hear from the FDA about the Vascepa Anchor SPA appeal in September.
NPS Pharmaceuticals ( NPSP) brings the hypoparathryoidism drug Natpara in front of an FDA advisory panel on Sept. 12.
Medicare officials are expected to propose a reimbursement price for Exact Sciences' ( EXAS) Cologuard colon cancer screening test.
The FDA has until October to render an approval decision on Gilead Sciences' ( GILD) single-pill combination therapy for hepatitis C and Merck's ( MRK) 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) (Firdapse phase III)
Alcobra ( ADHD) (MG01CI phase III)
Discovery Labs ( DSCO) (AeroSurf phase II)
Sunesis Pharma ( SNSS) (Qinprezo phase III)
Tetraphase Pharma ( TTPH) (eravacycline phase III)
Xoma ( XOMA) (gevokizumab phase III)
Lipocine ( LPCN) (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)