New 483 Observations Unlikely to Impact Much Awaited Revance's Daxi Approval, Says This Analyst

Revance Therapeutics Inc RVNC delivered a solid Q2 of RHA filler sales of $25.5 million, up 22%Q/Q and 50%Y/Y.
OPUL/HintMD revenues reached $1.2 million (+43%Q/Q).
Needham says that the main focus of the 2Q22 earnings update centered on news of three new Form 483 observations following the mid-July FDA pre-approval inspection of RVNC's DaxibotulinumtoxinA for glabellar lines manufacturing facility.
The analyst says that none of the new issues are related to the five 483 observations that led to the Daxi CRL and have since been resolved.
According to Needham analyst, these new 483 issues are primarily administrative and significantly more minor.
This development may cause some investor jitters.
Needham notes that Form 483 observations are part of the regular FDA inspection process and typically remain undisclosed.
Needham expects PDUFA for FDA approval to remain at September 8 and thus maintains a Buy rating and $25 price target.
With the current cash, cash equivalents, and short-term investments of $233.8 million, the company's management projects are funded into 2024.
Price Action: RVNC shares closed 23.50% higher at $21.57 on the last check Wednesday.

Earnings Calendar