) -- A calendar of important, potentially stock-moving biotech events for September:
Baird 2011 Healthcare Conference
FDA advisory panel meeting to review
Johnson & Johnson's
Xarelto for the prevention of strokes and blood clots in patients with atrial fibrillation.
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
Rodman & Renshaw Global Investment Conference
presenting data from phase II study in neuroendocrine tumors at the Cardiovascular and Interventional Radiology Society of Europe meeting.
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
and Johnson & Johnson.
51st Interscience Conference on Antimicrobial Agents and Chemotherapy (ICAAC). Presentations include
Heplisav phase III results in hepatitis B prevention on Sept. 18 and updated phase I data on
experimental HIV drug SB-728.
Heart Failure Society of America Annual Scientific Meeting. Presentations include data from a phase II "catheter" study of
Ixmyelocel-T in patients with dilated cardiomyopathy.
UBS Global Healthcare Conference
European Society for Medical Oncology (ESMO) Multidisciplinary Cancer Congress
American Neurological Association Annual Meeting
JMP Securities Healthcare Conference
Biotech events expected before the end of September:
: Complete FDA approval filing for Northera as treatment for neurogenic orthostatic hypotension.
: Complete FDA approval filing for AMR101 for treatment of patients with high triglyceride levels.
: Interim analysis of phase III study of Thermodox in primary liver cancer.
: Top-line results of phase III study of cabozantinib in medullary thyroid cancer.
: Top-line results of phase II study of VX-509 in rheumatoid arthritis.
: Top-line results from phase III "103" study of experimental Quad HIV pill versus Reyataz and Truvada.
research, company announcements,
--Written by Adam Feuerstein in Boston
>To contact the writer of this article, click here:
>To follow the writer on Twitter, go to
>To submit a news tip, send an email to:
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;
to send him an email.