NASHVILLE - Revance Therapeutics, Inc. (NASDAQ:RVNC) announced the assignment of a permanent J-code for DAXXIFY by the U.S. Centers for Medicare & Medicaid Services (CMS), facilitating reimbursement for the cervical dystonia treatment in adults. The J-code, J0589, is expected to streamline provider reimbursement and enhance patient access.
Concurrent with the J-code assignment, the company reported the publication of the ASPEN-1 Pivotal Phase 3 study results in Neurology®, the journal of the American Academy of Neurology. The study, which played a pivotal role in the FDA's approval of DAXXIFY in August 2023, confirmed the treatment's safety, efficacy, and notably long duration of effect.
The Phase 3 clinical trial included 301 participants, with outcomes showing significant improvement in cervical dystonia symptoms and a median duration of effect surpassing 20 weeks for both tested doses. The study also highlighted a favorable safety profile, with low incidences of dysphagia and muscle weakness.
Mark J. Foley, CEO of Revance, expressed optimism about DAXXIFY's market potential, citing over 100 million commercial lives already secured with top payers. The company is preparing for the therapeutic launch of DAXXIFY, anticipated in mid-2024. Foley also noted the positive real-world feedback from the PrevU program physicians and patients, reinforcing the product's clinical profile.
Dr. Atul Patel, involved in the ASPEN program and the PrevU program, echoed Foley's sentiments, emphasizing the real-world clinical results align with the ASPEN-1 study findings. The long-lasting effects of DAXXIFY could significantly advance cervical dystonia treatment, which has not seen such development in decades.
The U.S. therapeutic neuromodulator market for DAXXIFY is estimated at $2.7 billion, with cervical dystonia representing over $350 million of this market.
This news is based on a press release statement.
InvestingPro Insights
As Revance Therapeutics (NASDAQ:RVNC) gears up for the mid-2024 therapeutic launch of DAXXIFY, recent market data from InvestingPro provides a financial context for investors following the company's progress. The assignment of a permanent J-code by CMS for DAXXIFY is a pivotal step for Revance, and it's important for stakeholders to be aware of the company's financial health and stock performance.
InvestingPro Data shows a significant revenue growth for Revance, with a 97.21% increase over the last twelve months as of Q3 2023, signaling a strong market response to its products. Despite this, the company's operating income margin during the same period was -114.06%, reflecting substantial investment in its growth and development stages. The stock price has been volatile, currently trading near its 52-week low, which could represent a potential entry point for investors who believe in the long-term prospects of the company's cervical dystonia treatment.
Two InvestingPro Tips indicate that Revance is quickly burning through cash and analysts do not anticipate the company will be profitable this year, which are crucial considerations for investors. However, the company's liquid assets exceed short-term obligations, suggesting a degree of financial resilience in the near term. For those looking to delve deeper into Revance's financials and stock performance, InvestingPro offers additional insights. There are over 10 more InvestingPro Tips available for RVNC, accessible with a subscription that is currently on a special New Year sale, offering up to 50% off.
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