Valeant Pharmaceuticals Intl Inc (NYSE:VRX) stock took a hit on Monday after the U.S. Food and Drug Administration (FDA) rejected its psoriasis treatment.
The Valeant Pharmaceuticals Intl Inc treatment that was rejected by the FDA is DUOBRII. This is a lotion made by the company’s Ortho Dermatologics division to treat plaque psoriasis. The Complete Response Letter (CRL) from the FDA rejects VRX’s New Drug Application for the treatment.
Here’s what Joseph Papa, Chairman and CEO of Valeant Pharmaceuticals Intl Inc, has to say about the rejection.
“The CRL did not specify any deficiencies related to the clinical efficacy or safety of DUOBRII and no issues with CMC processes. The CRL only noted questions regarding pharmacokinetic data. We are working to resolve this matter expeditiously and have already requested a meeting with the FDA. We hope to bring forward this important new treatment option for those who suffer from plaque psoriasis as quickly as possible.”
Despite the rejection from the FDA for DUOBRII, some still see hope for the stock. This includes Mizuho analyst Irina Rivkind Koffler. She reiterated a “Buy” rating and price target of $27 for VRX stock today. The analysts also says that the setback won’t harm the company’s long-term earnings if it can quickly address the FDA’s concerns about the new drug, reports Smarter Analyst.
VRX stock was down 7% as of noon Monday, but the stock is still up 22% year-to-date.
As of this writing, William White did not hold a position in any of the aforementioned securities.