14.01.2016 03:41:28
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ESPR To Provide Clear Details, FPRX' FPA008 Is An Orphan Drug, GTXI On Watch
(RTTNews) - Esperion Therapeutics Inc. (ESPR) has initiated a global phase III long-term safety and tolerability study of Bempedoic acid (ETC-1002) in patients with hyperlipidemia whose LDL-C is not adequately controlled with low- and moderate-dose statins.
The full development strategy of the phase III trial, dubbed CLEAR, as well as the design of the planned cardiovascular outcomes trial is expected to be provided in the second quarter of 2016.
The top-line results from the CLEAR study are expected to be released in the fourth quarter of 2017.
ESPR closed Wednesday's trading at $14.11, down 14.38%.
Five Prime Therapeutics Inc.'s (FPRX) drug candidate FPA008 has been granted orphan drug designation by the FDA for the treatment of Pigmented Villonodular Synovitis.
Pigmented villonodular synovitis is a locally aggressive tumor of the synovium - the thin layer of tissue that lines the joints and tendons.
FPA008 is under phase I testing for Pigmented Villonodular Synovitis.
FPRX closed Wednesday's trading at $33.36, down 6.66%.
GTx Inc. (GTXI) has initiated a phase II clinical trial of its investigational drug Enobosarm to treat postmenopausal women with stress urinary incontinence.
The trial is designed to enroll up to 35 patients, and topline results are expected this year.
Enobosarm is also being tested in a phase II trial in women with androgen receptor positive (AR+), triple negative breast cancer, as well as in a phase II trial in women with estrogen receptor positive (ER+), AR+ breast cancer.
GTXI closed Wednesday's trading at $0.50, down 7.41%.
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