The U.S. Food and Drug Administration (FDA) has said that it will not meet the Prescription Drug User Fee Act (PDUFA) action dates for biopharmaceutical firm AbbVie’s (ABBV) supplemental New Drug Applications (sNDAs) for Rinvoq (upadacitinib) for treating adults with active ankylosing spondylitis and active psoriatic arthritis, according to a report published by StreetInsider.com.
The FDA said it was reviewing the post-marketing ORAL Surveillance trial of Pfizer’s (PFE) tofacitinib in patients suffering from rheumatoid arthritis. (See AbbVie stock chart on TipRanks)
The company said the FDA did not take any formal action on the sNDAs for Rinvoq in ankylosing spondylitis and psoriatic arthritis. AbbVie specializes in gastroenterology, women’s health, virology, eye care, neuroscience, oncology, and immunology treatments.
The MD, Vice-Chairman, and President of AbbVie, Michael Severino, said, “We remain committed to working with the FDA to bring Rinvoq to patients living with psoriatic arthritis, ankylosing spondylitis and other immune-mediated diseases.”
Piper Sandler analyst Christopher Raymond recently maintained a Buy rating on the stock with a price target of $124 (9.75% upside potential).
In a research note to investors, Raymond said the FDA’s reason for not meeting the PDUFA target dates makes Rinvoq’s label expansion uncertain. It also casts doubt on whether AbbVie will be able to achieve its revenue guidance of $8 billion for 2025.
Overall, the stock has a Strong Buy consensus rating based on 10 Buys and 2 Holds. The average AbbVie price target of $122.82 implies 8.7% upside potential from current levels. The company’s shares have gained 17.2% over the past year.
According to TipRanks’ Smart Score rating system, AbbVie scores a “Perfect 10”. This suggests that the stock is likely to outperform market averages.
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