Valeant Pharmaceuticals International Inc.'s stock fell after its plaque psoriasis therapy Duobrii was not approved by the U.S. Food and Drug Administration.
The company's stock was down 12.36% to $23.54 as of 3:59 p.m. ET on June 18.
Valeant's unit Ortho Dermatologics said the U.S. regulator's complete response letter for Duobrii did not specify any deficiencies related to the clinical efficacy or safety of the lotion being sought as a treatment for the skin disease.
The company said the letter only noted questions about data relating to the drug's absorption in the body. Valeant's CEO Joseph Papa said the company is working to resolve the matter quickly and has requested a meeting with the FDA.
Valeant submitted an application in November 2017 to seek approval for the drug from the U.S. regulator.