Why Avadel Pharmaceuticals Shares Are Trading Higher Premarket Today - Avadel Pharmaceuticals (NASDAQ:AVDL)

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.

Market News and Data brought to you by Benzinga APIs

-

-

-

-

-

-

-

-

-

-

-

-

-

-

Avadel Cuts Workforce, Optimizes Cost Structure To Support This