REVANCE THERAPEUTICS, INC. (NASDAQ:RVNC) Files An 8-K Regulation FD Disclosure
ITEM 7.01
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REGULATION FD DISCLOSURE
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Revance Therapeutics, Inc. (the Company) issued a press release
on June 5, 2017, announcing additional clinical results from its
Phase 2 open-label, dose-escalating clinical study of
DaxibotulinumtoxinA Injectable (RT002 injectable) to treat
moderate-to-severe isolated cervical dystonia, a movement
disorder of the neck, in adults. A copy of the press release is
furnished as Exhibit 99.1 hereto and is incorporated by reference
herein.
8-K and Exhibit 99.1 attached hereto shall not be deemed filed
for purposes of Section 18 of the Securities Act of 1934, as
amended (the Exchange Act), or otherwise subject to the
liabilities of that Section, or incorporated by reference in any
filing under the Securities Act of 1933, as amended, or the
Exchange Act, except as shall be expressly set forth by specific
reference in any such filing.
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ITEM 8.01
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OTHER EVENTS
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results from its Phase 2 open-label, dose-escalating clinical
study of RT002 injectable to treat moderate-to-severe isolated
cervical dystonia in adults. The key results are as follows:
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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 trials 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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About REVANCE THERAPEUTICS, INC. (NASDAQ:RVNC)
Revance Therapeutics, Inc. is a biotechnology company. The Company is focused on the development, manufacturing and commercialization of botulinum toxin products for multiple aesthetic and therapeutic indications. Its TransMTS technology enables delivery of botulinum toxin type A through investigational drug product candidates, including DaxibotulinumtoxinA Topical Gel (RT001), or RT001 topical, and DaxibotulinumtoxinA for Injection (RT002), or RT002 injectable. Its botulinum toxin-peptide complex has over two components that contribute to the performance of RT001 and RT002. Its TransMTS peptide provides the delivery across the skin and restricts the toxin molecule to the target site. Then, the botulinum toxin type A provides the mechanism of pharmacologic action and is responsible for the drug effects demonstrated in its clinical trials. Its TransMTS peptide technology serves various purposes depending on whether it is used in a topical formulation or in an injectable formulation.