Eight Trades on FDA, Clinical Trial Binary Events

by: Mike Havrilla

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

On 7/9/10, Bristol-Myers (NYSE:BMY) announced that the FDA accepted its supplemental New Drug Application (sNDA) for a priority (six-month) review to expand the product label for SPRYCEL (dasatinib) (an oral BCR-ABL inhibitor anti-cancer agent) to include the treatment of adult patients with newly diagnosed chronic myeloid leukemia (CML) in chronic phase.

On 7/12/10, Protalix Biotherapeutics (AMEX:PLX) announced that the FDA accepted its NDA for UPLYSO (taliglucerase alfa) and issued a standard, 10-month review period for an expected final decision by the Agency in late February 2011. UPLYSO is a plant-cell expressed form of an enzyme know as gluco-cerebrosidase, seeking marketing clearance for the treatment of Gaucher's disease following the completion of a rolling NDA April 2010 under SPA.

Merck KGaA (OTCPK:MKGAY) resubmitted its NDA for cladribine (oral tablets, experimental compound for multiple sclerosis or MS) to the FDA on 6/8/10 following a refuse to file (RTF) notice on 11/30/09. A response is expected from the FDA within 60 days to formally accept the NDA and classify for a standard or priority review designation and the Company announced approval for cladribine in Russia earlier this morning.

Vivus (NASDAQ:VVUS) - At the absolute top of this week's watchlist is the FDA Advisory Panel for Qnexa. We should see the meeting notes either today or tomorrow. Check here for updates: FDA Advisory Calendar . There will be multiple day trading opportunities all week depending on the panel note, votes, and recommendations. Stay on your toes for this one.

Arena Pharma (NASDAQ:ARNA) / Orexigen Therapeutics (NASDAQ:OREX) - These companies will be watching very closely the FDA panel for VVUS. It is hard to guage how their share price will be effected by a VVUS decision. A good panel is good news for weight loss drugs, however there will be more competition on the market.

Jazz Pharma (NASDAQ:JAZZ) / MELA Sciences (NASDAQ:MELA) - I expect biotech traders to move on to the next FDA plays once they pull their money out of VVUS, so I am looking for a nice small boost is JAZZ and MELA as we are only a few weeks out from their FDA Panels.

Isotechnika Pharma [TSX:ISA.TO] - No word yet from the company Isotechnika on a CRL and the 8/3/10 FDA date seems to be still relevant. Proceed with caution though...

Disclosure: No positions