12:00 AM
Jan 02, 2012
 |  BioCentury  |  Finance

Highlights of weekly biotech stock moves

Regulatory, clinical and other milestones
Regulatory milestones

Astex Pharmaceuticals Inc. (NASDAQ:ASTX) gained $0.23 (14%) to $1.89 last week after FDA's Oncologic Drugs Advisory Committee scheduled a Feb. 9 meeting to discuss an sNDA from Eisai Co. Ltd. (Tokyo:4523; Osaka:4523) for Dacogen decitabine to treat acute myelogenous leukemia (AML). The PDUFA date is March 6. Eisai markets the drug in North America to treat myelodysplastic syndromes (MDS) under a license from Astex.

Curis Inc. (NASDAQ:CRIS) was up $0.42 (10%) to $4.50 Christmas week after EMA accepted for review an MAA from partner Roche (SIX:ROG; OTCQX:RHHBY) for vismodegib to treat adults with advanced basal cell carcinoma for whom surgery is considered inappropriate. The submission triggered a $6 million milestone payment to Curis.

Gilead Sciences Inc. (NASDAQ:GILD) gained $1.64 to $40.93 last week after FDA accepted for review an NDA for a fixed-dose Quad regimen to treat HIV-1. The combination consists of elvitegravir, cobicistat and Truvada emtricitabine/tenofovir. The PDUFA date is Aug. 27. Also, Gilead was up $2.13 to $39.29 Christmas week after EMA accepted for review an MAA for the product.

Impax Laboratories Inc. (NASDAQ:IPXL) gained $1.27 to $20.22 Christmas week after submitting an NDA to FDA for IPX066 to treat idiopathic Parkinson's disease. Partner GlaxoSmithKline plc (LSE:GSK; NYSE:GSK) plans to submit an MAA to EMA this year.

ThromboGenics N.V. (Euronext:THR) gained €0.10 to €18.90 last week after submitting a BLA to FDA for ocriplasmin intravitreal injection to treat symptomatic vitreomacular adhesion.

Clinical milestones

Progenics Pharmaceuticals Inc. (NASDAQ:PGNX) gained $2.01 (31%) to $8.49 on Dec. 20 after it and Salix Pharmaceuticals Ltd. (NASDAQ:SLXP) said oral methylnaltrexone met the primary endpoint in a Phase III trial to treat opioid-induced constipation (OIC). Salix plans to submit an NDA to FDA in mid-2012 for oral methylnaltrexone to treat OIC in...

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