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AbbVie, Inc. ($ABBV) said on Thursday that the FDA has approved Vyalev, the first and only 24-hour subcutaneous infusion of levodopa-based therapy for adults with advanced Parkinson’s disease experiencing motor fluctuations.
The approval was based on a Phase 3 study showing that Vyalev helped reduce motor issues in patients. It increased the time when patients had better control over their movements without troublesome side effects and decreased the time when they had poor movement control, compared to the standard oral treatment.
A 52-week open-label study also supported Vyalev’s long-term safety and efficacy. Most adverse reactions were mild or moderate in severity.
AbbVie expects Medicare coverage for Vyalev by the second half of 2025.
Despite the FDA approval, AbbVie’s stock dipped slightly on Thursday, with retail sentiment on Stocktwits remaining within the ‘neutral’ zone.
AbbVie is leaning on newer treatments to offset the revenue loss from Humira, a blockbuster autoimmune drug, which faces biosimilar competition after losing patent protection.
Its other autoimmune treatments, Skyrizi and Rinvoq, have generated billions, while recent acquisitions in oncology and neuroscience are expected to drive future growth, according to Bloomberg.
Bernstein initiated coverage of AbbVie on Thursday with a ‘Market Perform’ rating and a $203 price target. Analyst Courtney Breen noted that while the biopharma sector looks promising, investment outcomes will depend on specific company opportunities, as competition and regulatory pressures increase.
BMO Capital raised its price target on AbbVie to $220 from $214, citing strong growth from Skyrizi and Rinvoq, which have outperformed consensus expectations.
So far in 2024, AbbVie’s stock has gained 23%, keeping pace with the S&P 500 and Nasdaq.
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