Revance Therapeutics (NASDAQ:RVNC) – Revance Therapeutics’ DaxibotulinumtoxinA For Injection Improves Muscle Tone In Mid-Stage Upper Limb Spasticity

Revance Therapeutics (NASDAQ:RVNC) - Revance Therapeutics' DaxibotulinumtoxinA For Injection Improves Muscle Tone In Mid-Stage Upper Limb Spasticity

  • Revance Therapeutics Inc (NASDAQ: RVNC) has reported topline data from JUNIPER Phase 2 study evaluating DaxibotulinumtoxinA for Injection to treat adults with moderate to severe upper limb spasticity.
  • It is a neurological condition that affects the ability to move the arms and affects hands, fingers, wrist, forearm, elbow, and shoulder. It occurs most commonly after a stroke or brain injury.
  • All three doses (250 units, 375 units, 500 units) demonstrated numerically higher than placebo for the improvement in the muscle tone assessment score, with the 500-unit dose showing a clinically meaningful and statistically significant reduction from baseline in muscle tone versus placebo.
  • Additionally, each of the three doses demonstrated a numerical improvement compared with placebo on the patient’s illness assessment but did not reach statistical significance with the reduced enrollment.
  • In June last year, due to the ongoing COVID-19 challenges, the company curtailed enrollment at 83 subjects compared to the earlier enrollment target of 128 subjects.
  • On a key secondary endpoint, DaxibotulinumtoxinA for Injection delivered a median duration of at least 24 weeks across all three doses until the loss of improvement or a request for retreatment by the subject.
  • All three doses of DaxibotulinumtoxinA for Injection were generally safe and well-tolerated, with no increase in the incidence of adverse events observed in the higher dose treatment groups. 
  • The drug candidate showed efficacy in the Phase 2 upper facial lines study, but Phase 2 plantar fasciitis study did not meet the primary efficacy endpoint of statistically significant improvement.
  • In November last year, FDA deferred the approval of DaxibotulinumtoxinA for Injection in glabellar (frown) lines due to COVID-19 related travel restrictions impacting manufacturing site inspection.
  • Price Action: RVNC closed 3.7% lower at $26.96 on Monday.

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