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Biotech Calendar: Key Dates for September

BOSTON (TheStreet) -- A calendar of important, potentially stock-moving biotech events for September:

Sept. 7
Hospira (HSP) investor/analyst meeting.

Sept. 7-8
Baird 2011 Healthcare Conference

Sept. 8
FDA advisory panel meeting to review Johnson & Johnson's (JNJ) Xarelto for the prevention of strokes and blood clots in patients with atrial fibrillation.

Sept. 9
FDA advisory panel meeting to review the benefits and risks of long-term use of bisphosphonates to treat osteoporosis in light of safety concerns related to jawbone death and unusual thigh-bone fractures. Drugs to be examined include Merck's (MRK) Fosamax, Novartis' (NVS) Reclast, Warner Chilcott's (WCRX) Actonel and Roche's (RHHBY) Boniva.

Sept. 11-13
Rodman & Renshaw Global Investment Conference

Sept. 12
Delcath Systems (DCTH) presenting data from phase II study in neuroendocrine tumors at the Cardiovascular and Interventional Radiology Society of Europe meeting.

Sept. 14
FDA advisory panel to discuss development and possible clinical trial design of products for the treatment of patients with non-metastatic castration resistant prostate cancer (CRPC) who have a rising serum level of prostate-specific antigen (PSA) despite being on androgen deprivation therapy (ADT). There are no drugs currently approved for this indication and no specific drugs will be presented or discussed. The FDA's experts will consider possible trial designs and suitable clinical endpoints to establish efficacy that would support approval of a drug for the treatment of non-metastatic CRPC after PSA progression on ADT.

Companies with possible interest in this segment of prostate cancer therapy include Dendreon (DNDN), Exelixis (EXEL), Medivation (MDVN) and Johnson & Johnson.

Sept. 17-20
51st Interscience Conference on Antimicrobial Agents and Chemotherapy (ICAAC). Presentations include Dynavax's (DVAX) Heplisav phase III results in hepatitis B prevention on Sept. 18 and updated phase I data on Sangamo BioSciences' (SGMO) experimental HIV drug SB-728.

Sept. 18-21
Heart Failure Society of America Annual Scientific Meeting. Presentations include data from a phase II "catheter" study of Aastrom Biosciences' (ASTM) Ixmyelocel-T in patients with dilated cardiomyopathy.

Sept. 19-21
UBS Global Healthcare Conference

Sept. 23-27
European Society for Medical Oncology (ESMO) Multidisciplinary Cancer Congress

Sept. 25-27
American Neurological Association Annual Meeting

Sept. 27-28
JMP Securities Healthcare Conference

Biotech events expected before the end of September:
Chelsea Therapeutics (CHTP): Complete FDA approval filing for Northera as treatment for neurogenic orthostatic hypotension.
Amarin (AMRN): Complete FDA approval filing for AMR101 for treatment of patients with high triglyceride levels.
Celsion (CLSN): Interim analysis of phase III study of Thermodox in primary liver cancer.
Exelixis (EXEL): Top-line results of phase III study of cabozantinib in medullary thyroid cancer.
Vertex Pharmaceuticals (VRTX): Top-line results of phase II study of VX-509 in rheumatoid arthritis.
Gilead Sciences (GILD): Top-line results from phase III "103" study of experimental Quad HIV pill versus Reyataz and Truvada.

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