Biotech Values

[DewDiligence]

RVNC will start two phase-3 trials of RT002 in glabellar lines during 2016:

http://investors.revance.com/releasedetail.cfm?ReleaseID=979658

Revance Therapeutics, Inc…today announced the completion of its Type B / pre-IND / pre-Phase 3 meeting with the U.S. Food and Drug Administration (FDA) regarding DaxibotulinumtoxinA for Injection (RT002) for the treatment of glabellar (frown) lines. Based upon the discussion with the FDA and the minutes received following the meeting, Revance is moving forward with an Investigational New Drug (IND) submission for the Phase 3 clinical program for RT002 in glabellar lines and other supportive studies required for Biologics License Application (BLA) filing. Revance expects to initiate its Phase 3 clinical trials in the second half of 2016.

The company's Phase 3 program will include two placebo-controlled pivotal studies conducted at multiple sites in the US and Canada.

The primary endpoint of these studies will be a composite of the proportion of subjects who achieve a score of 0 or 1 (none or mild) and a two-point improvement from baseline in glabellar line severity on investigator assessment (IGS-FWS) and patient assessment (PFWS) scales, at maximum contraction (frown), at Week 4. [Emphasis added.]

Duration of the reduction of severity of the glabellar lines will be assessed as a secondary endpoint in the Phase 3 pivotal studies. In addition, the Phase 3 program will include a long-term, open-label safety study. Revance plans to announce additional details on the study designs when the company begins dosing patients.

All of the above—including the open-label safety study—is consistent with prior expectations.