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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