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Share Name | Share Symbol | Market | Type |
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Revance Therapeutics Inc | NASDAQ:RVNC | NASDAQ | Common Stock |
Price Change | % Change | Share Price | Bid Price | Offer Price | High Price | Low Price | Open Price | Shares Traded | Last Trade | |
---|---|---|---|---|---|---|---|---|---|---|
0.00 | 0.00% | 3.69 | 3.69 | 3.70 | 3.785 | 3.5105 | 3.63 | 909,568 | 18:21:09 |
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DELAWARE
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001-36297
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75-0551645
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(State of
incorporation)
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(Commission
File No.)
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(IRS Employer
Identification No.)
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¨
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Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
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¨
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Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
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¨
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Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
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¨
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Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))
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ITEM 7.01
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REGULATION FD DISCLOSURE
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ITEM 8.01
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OTHER EVENTS
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•
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Duration:
The study researchers analyzed efficacy results in two dose groups: Dose Group A (N=21), individuals who received 100 to 240 units of RT002 injectable, and Dose Group B (N=16), receiving 300 to 450 units. Median duration of effect, defined as the number of weeks with subjects maintaining at least 20% of the treatment benefit achieved at Week 4 (target Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) score), was greater than 24 weeks for both dose groups, consistent with duration of effect previously reported in each of the trial’s three pre-specified patient cohorts.
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TWSTRS-Total and Subscale Scores:
RT002 injectable showed a clinically significant mean reduction of the TWSTRS-Total score from baseline at Week 4 - the primary efficacy endpoint - in both Group A (37%) and Group B (39%), with the majority of this benefit maintained through Week 24. In addition, clinically meaningful reductions in TWSTRS-Severity, Disability and Pain subscales were consistent and observed at all time points through Week 24.
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Response Rates and Patient-Rated Quality of Life:
A high rate of response was observed in the study, with 94% of subjects at Week 6 experiencing a reduction of at least 20% from baseline in TWSTRS-Total Score, and 68% of subjects at week 24 observed to maintain this treatment benefit at Week 24. In addition, a mean reduction of 37% from baseline in the Cervical Dystonia Impact Profile (CDIP-58) score was observed at Week 6 for all subjects, with the majority of this clinically meaningful benefit maintained through Week 24.
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Safety:
As previously reported, RT002 injectable appeared to be generally safe and well-tolerated through Week 24 in all dose groups evaluated. There were no serious adverse events and no dose-dependent increase in adverse events. The treatment-related adverse events were generally transient and mild to moderate, with one case of neck pain reported as severe.
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ITEM 9.01
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FINANCIAL STATEMENTS AND EXHIBITS
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(d) Exhibits
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Number
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Description
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99.1
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Press Release dated June 5, 2017
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Date: June 5, 2017
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Revance Therapeutics, Inc.
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By:
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/s/ Lauren P. Silvernail
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Lauren P. Silvernail
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Chief Financial Officer and Chief Business Officer
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Number
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Description
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99.1
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Press Release dated June 5, 2017
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1 Year Revance Therapeutics Chart |
1 Month Revance Therapeutics Chart |
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