Trading FDA, Clinical Trial Binary Events: $VRTX $INHX $ELN $TTHI

Below are some Regulatory Catalyst Index updates for companies with recent FDA and clinical trial related news…

Vertex Pharma (NASDAQ:VRTX) reported Phase 3 ILLUMINATE study results for telaprevir (VX-950 or TVR) that included SVR / viral cure rates of 92% (24-week treatment) and 88% (48-week treatment) for patients with hepatitis C virus (HCV) infection. VRTX announced that the safety / tolerability profile in this study was consistent with the previously reported pivotal Phase 3 ADVANCE and REALIZE studies to support a planned New Drug Application (NDA) filing during 4Q10.

After the market close yesterday, Transition Therapeutics (NASDAQ:TTHI) reported along with partner Elan (NYSE:ELN) that a placebo-controlled, 18-month Phase 2 study of ELND005 (AZD-103) (scyllo-inositol) in 351 mild to moderate Alzheimer’s disease patients  failed to meet co-primary end-points. However, based on bio-marker and clinical data, both companies plan to advance into Phase 3 development after finalizing the study protocol following regulatory input from FDA.

Anika Therapeutics (NASDAQ:ANIK) reported that additional info (statistical analyses) was requested by the FDA with an expected submission by next month to support the Pre-Market Approval (PMA) submission, which is seeking marketing clearance for MONOVISC in the treatment of knee osteoarthritis.  

Inhibitex (NASDAQ:INHX) expects to complete an ongoing Phase I double-blind, placebo-controlled, single ascending dose study of INX-189 (hepatitis C virus or HCV nucleotide polymerase inhibitor) in health volunteers during 3Q10 with plans to advance the compound into a Phase 1b multi-ascending dose study in patients with chronic HCV infection.

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