Below are some Regulatory Catalyst Index updates for FDA and clinical trial related news from today...

1.) Northwest Biotherapeutics (OTCBB:NWBO) ($0.64, $41 million market cap)

On 7/7/10, NWBO.OB announced additional funding of $2.65M was raised during 2Q10 as part of ongoing debt restructuring and fund-raising activities to support resuming enrollment in Phase 2 brain cancer (GBM) study (expected to occur later this summer) for the Company's DCVax Personalized Therapeutic Cancer Vaccine.

2.) Nile Therapeutics (NASDAQ:NLTX) ($0.32, $11 million market cap)

On 7/7/10, NLTX announced that it completed dosing of the last patient in ongoing acute, de-compensated heart failure Phase 2a study of CD-NP (a natriuretic peptide, intravenous or IV formulation) in 77 patients with mild to moderate kidney insufficiency). The Company expects to report the final results from this study during 4Q10.

3.) Neoprobe (OTCBB:NEOP) ($1.80, $148 million market cap)

Neoprobe is developing LYMPHOSEEK for the detection of lymph nodes in breast cancer and melanoma to predict possible spread (metastasis) of the disease, has completed pre-NDA meetings and expects to begin NDA filing in summer (3Q10 estimate), initial Phase 3 results expected during 1Q11 (not required for NDA filing)

4.) XenoPort (NASDAQ:XNPT) ($6.43, $196 million market cap) GlaxoSmithKline (NYSE:GSK) ($33.94, $88 billion market cap)

Shares of XNPT are losing over 27% on heavy volume during early morning trading following news that a Phase 2b study of HORIZANT (gabapentin enacarbil) (GSK1838262) Extended-Release Tablets failed to reach its primary endpoint in a study for the prevention of migraine headaches.

Along with partner GSK, a Complete Response Letter (CRL) was received from the FDA on 2/17/10 for a New Drug Application (NDA) seeking approval for the treatment of restless legs syndrome. The FDA cited safety concerns such as pancreatic cancer in rats from this gabapentin (Neurontin) pro-drug, and a response is expected to occur by year-end to supply additional pre-clinical data with no requirement for further clinical testing in the CRL.

Next week, an FDA Advisory Panel meeting is scheduled for July 13-14 to review cardiovascular safety data at a joint public meeting (Endocrine / Metabolic Drugs and Drug Safety / Risk Management) to provide an updated assessment of risk / benefit profile of AVANDIA (rosiglitazone), which is currently marketed for the treatment of type 2 diabetes but has recently come under fire due to concerns over cardiovascular events in patients taking the drug.

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