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Vivus up 15% premarket on positive data for PAH candidate VI-0106

Jul. 10, 2018 8:42 AM ETVIVUS, Inc. (VVUS) StockBy: Douglas W. House, SA News Editor
  • Nano cap Vivus (NASDAQ:VVUS) is up 15% premarket on increased volume on the heels of its announcement of positive data from a Phase 1 clinical trial evaluating VI-0106 in healthy volunteers.
  • The company says the results show that once-daily dosing may facilitate of the low tacrolimus concentrations needed for the treatment of pulmonary arterial hypertension (PAH) with minimal monitoring of drug levels.
  • Per the ongoing COMPERA registry study, the five-year survival rate for high-risk PAH patients is 22.8%. Also, data from three class 3/4 patients treated with VI-0106 under compassionate use status showed dramatically reduced hospitalization rates and improvements in functional class.
  • VI-0106 is a soft capsule formulation of tacrolimus (topical formulation is used to treat atopic dermatitis) being developed to treat PAH. The company plans to request Fast Track and Breakthrough Therapy designations in the U.S. for the indication in conjunction with its planned 505(b)(2) marketing application which allows the inclusion of data generated by others.

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