-=Revance Therapeutics' (RVNC) : FDA rejects frown lines treatment

 

The Food and Drug Administration rejected Revance Therapeutics' (RVNC) frown lines treatment, causing RVNC stock to crash to an 18-month low on Monday.

In its letter, the FDA cited manufacturing deficiencies. Those issues were highlighted in a form made public last week. During its inspection, the FDA identified five different deficiencies related to cell bank quality testing methods, discrepancies with the proposed commercial manufacturing processes and quality control procedures, Needham analyst Serge Belanger said in a note.

Now, Revance says it will seek a meeting with the FDA to address those problems. At the minimum, Belanger expects a six- to 12-month delay for the drug called DaxibotulinumtoxinA. That assumes the deficiencies are minor and Revance can address them quickly.