REVANCE THERAPEUTICS, INC. (NASDAQ:RVNC) Files An 8-K Regulation FD Disclosure
ITEM7.01
| REGULATION FD DISCLOSURE |
As reported under Item 8.01 of this current report on Form
8-K, Revance
Therapeutics, Inc. (the Company) issued a press release on May18,
2017 announcing results from all three cohorts in its Phase 2
open-label, dose-escalating clinical study to evaluate the safety
and preliminary efficacy of its investigational drug product
candidate, DaxibotulinumtoxinA for Injection (RT002) for the
treatment of cervical dystonia, a muscle movement disorder.
During a conference call and webcast scheduled to be held at 4:30
PM Eastern Time on May18, 2017, Company management will discuss
the results from the study. The slide presentation for the
conference call and webcast is furnished as Exhibit 99.1 hereto
and is incorporated by reference herein. A copy of the press
release is furnished as Exhibit 99.2 hereto and is incorporated
by reference herein.
The furnishing of
the attached presentation is not an admission as to the
materiality of any information therein. The information contained
in the slides is summary information that is intended to be
considered in the context of more complete information included
in the Companys filings with the Securities and Exchange
Commission (the SEC) and other public announcements that the
Company has made, including the press release furnished as
Exhibit 99.2 hereto, and may make from time to time by press
release or otherwise.
The information in
this Item 7.01 of this current report on Form 8-K and Exhibits
99.1 and 99.2 attached hereto shall not be deemed filed for
purposes of Section18 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.
| ITEM8.01 | OTHER EVENTS |
On May18, 2017,
the Company announced results from all three cohorts in its Phase
2 open-label, dose-escalating clinical study to evaluate the
safety and preliminary efficacy of RT002 injectable for the
treatment of cervical dystonia. The topline 24-week results are
as follows:
|
Duration: The median duration of effect was at least 24 weeks for each of the three dose cohorts studied. Duration of effect was defined as the number of weeks from treatment until the return of signs and symptoms that warrant retreatment, based on subjects reaching their target Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) score. |
|
Efficacy: The trials 4-week primary efficacy measurement was the improvement in signs and symptoms of cervical dystonia as determined by reduction of the TWSTRS-Total score from baseline. At Week 4, RT002 injectable showed a clinically significant mean reduction of 38% from baseline across all three cohorts. This reduction continued to increase to 50% at Week 6 for all subjects, was 42% at Week 12 and was maintained at or above 30% through Week 24. On the key secondary endpoint, percentage of responders showing improvement on Clinician Global Impression of Change (CGIC), 97% of all subjects experienced an improvement in cervical dystonia symptoms at Week 4. |
|
Safety: In all three cohorts, RT002 injectable appeared to be generally safe and well-tolerated through Week 24. 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 in severity, with one case of neck pain reported as severe. The most common adverse events were dysphagia, or difficulty in swallowing (14%), of which all cases were mild in severity, injection site redness (8%), injection site bruising (5%), injection site pain (5%), muscle tightness (5%) and muscle weakness (5%). |
| ITEM9.01 | FINANCIAL STATEMENTS AND EXHIBITS |
| (d)Exhibits |
|
Number |
Description |
|
| 99.1 | Company slide presentation dated May18, 2017. | |
| 99.2 | Press Release dated May18, 2017. |
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. REVANCE THERAPEUTICS, INC. (NASDAQ:RVNC) Recent Trading Information
REVANCE THERAPEUTICS, INC. (NASDAQ:RVNC) closed its last trading session up +0.25 at 19.35 with 158,390 shares trading hands.