Trading FDA, Clinical Trial Binary Events: $ASTM $CAPS $FRX $MRK

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

1.) Aastrom Biosciences (NASDAQ:ASTM) ($1.43, $40 million market cap)

Autologous (patient-derived) vascular repair cells (VRCs) are being evaluated in an ongoing Phase 2b clinical trial for the treatment of critical limb ischemia (CLI). ASTM announced treatment of the final patient in this study in March 2010 and expects to report six-month data on all patients during 4Q10 and plans to pursue the CLI indication in a late-stage Phase 3 program through the FDA Special Protocol Assessment (SPA) process.

2.) Capstone Therapeutics (NASDAQ:CAPS) ($0.70, $28.5 million market cap)

AZX100 (a novel, synthetic 24-amino acid peptide) – Phase 2a Clinical Trial

Being evaluated to inhibit scarring during the wound healing process and with certain disease states, expects to report data 1Q11 for keloid scar revision and dermal scarring following shoulder surgery, independent review 7/6/10 recommended continuation of trial following interim subset analysis.

3.) Nycomed (private), Merck (NYSE:MRK) ($34.53, $107.7 billion market cap), Forest Labs (NYSE:FRX) ($27.49, $8.3 billion market cap)

DAXAS (roflumilast) (a once-daily oral treatment) (PDE4 Enzyme Inhibitor)

Nycomed has partnered DAXAS with Merck (MRK) in Canada and select EU countries while the drug is partnered with Forest Labs in the US. Announced marketing approval for DAXAS in Europe on 7/6/10 for the maintenance treatment of severe chronic obstructive pulmonary disease (COPD) associated with chronic bronchitis in adults.

In May 2010, Nycomed/FRX CRL received a Complete Response Letter (CRL) from the FDA for DAXAS, which is seeking approval as a treatment to reduce COPD exacerbations associated with chronic bronchitis in patients at risk for exacerbations, no new studies required, expected response to FDA during 3Q10.

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