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

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.

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