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News Breaks
June 26, 2014
07:22 EDTEGLT, CORT, EBS, RPTP, OVAS, DRTXJanney Capital to hold a conference
2nd Annual Healthcare 1x1 Corporate Access Day to be held in Boston on June 26.
News For RPTP;CORT;DRTX;EBS;EGLT;OVAS From The Last 14 Days
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January 29, 2015
16:15 EDTCORTCorcept says dose-finding portion of Phase 1/2 trial of Korlym combo completed
Corcept has completed the dose-finding portion of its Phase 1/2 trial of Korlym in combination with eribulin for the treatment of glucocorticoid receptor-positive TNBC. Recruitment of 20 patients to participate in the trial's efficacy phase is underway. These patients will receive 300 mg of Korlym daily, with eribulin at a dose of 1.1 mg/m2 administered intravenously. Results are expected in 2015. Although the dose-finding phase of the study was designed to assess only safety and tolerability, some preliminary efficacy data are available. Of the six patients in that phase who received the selected dose, three have TNBC. The only patient known to have GR-positive TNBC exhibited a partial response, defined as a 30 percent or greater reduction in tumor size, and has been on therapy for nine cycles. In contrast, the only patient known to have GR-negative TNBC suffered progression of disease. The third patient with TNBC began treatment recently. Her GR status and response to therapy is not yet known.
16:14 EDTCORTCorcept Therapeutics sees FY15 revenue $47M-$53M, consensus $49.54M
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16:13 EDTCORTCorcept Therapeutics reports Q4 revenue $9.0M, consensus $8.93M
The company's estimated cash and cash equivalents were $24.2M at year-end.
January 26, 2015
07:52 EDTEGLTEgalet price target raised to $18 from $12 at Canaccord
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January 22, 2015
08:09 EDTEGLTEgalet reports HAL study of Egalet-001 met primary endpoint
Egalet announced positive results from a Category 3 human abuse liability, or HAL, study of Egalet-001, an abuse-deterrent, extended-release, oral morphine formulation in late-stage clinical development for the management of pain severe enough to require daily, around-the-clock opioid treatment and for which alternative treatments are inadequate. The clinical HAL study demonstrated that in nondependent, recreational opioid users, the abuse potential of manipulated Egalet-001 taken orally was significantly lower than that for manipulated MS Contin. This Category 3 abuse-deterrent HAL study was conducted in accordance with the FDA draft guidance on Abuse-Deterrent Opioids: Evaluation and Labeling. It was a single-center, randomized, double-blind, double-dummy, four-way crossover study which assessed the abuse potential of Egalet-001 versus MS Contin in 38 nondependent, recreational opioid users when taken orally. The primary objective was to compare the relative abuse potential of intact and manipulated formulations of Egalet-001 versus manipulated MS Contin. Since Egalet-001 is extremely hard and difficult to chew, the manipulation of the product involved a series of maneuvers using different household tools to try and reduce the particle size to maximally defeat the tablet. This procedure was based on the outcome of the first phase, physical tampering, of the Category 1 abuse-deterrent studies for Egalet-001. In addition to this Category 3 HAL study, Egalet presented positive results from Category 1 studies for Egalet-001 last year at PainWeek and will share the results from additional abuse-deterrent studies later this year.

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