- Avadel Pharmaceuticals plc AVDL announced its steps to explore every available pathway to accelerate the FDA approval of its lead drug candidate, FT218, before June 2023.
- Avadel has received and agreed upon what is expected to be a final label and is completing the last edits of the Risk Evaluation and Mitigation Strategy (REMS) with the FDA and expects to receive tentative approval of FT218.
- Related: What Does HC Wainwright Have To Say On Avadel's Narcolepsy Candidate's Potential Approval?
- The company is optimizing the cost structure to reduce quarterly cash operating expenses to $12.0 - $14.0 million.
- A restructuring charge of between $3.0 - $4.0 million, comprised primarily of severance-related costs associated with a nearly 50% reduction in the workforce, is expected to be recorded in Q2.
- Avadel expects to report over $100.0 million of cash, cash equivalents, and marketable securities as of June 30, 2022.
- Avadel estimates the current twice-nightly U.S. narcolepsy oxybate market is estimated at $1.8 billion, comprised of approximately 16,000 patients.
- The company estimates that 10,000 – 15,000 patients have discontinued their twice-nightly oxybate use in the last three years.
- It believes that each year approximately 3,000 patients initiate oxybate treatment and expects this to grow by 25-50% with the introduction of FT218. Based on the estimated patient population, the potential market opportunity could be more than $3.0 billion annually.
- Price Action: AVDL shares traded 15.30% higher at $2.70 during the premarket session on the last check Wednesday.
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