Risk Factors Update Summary
- FDA accepted sNDA for HETLIOZ in insomnia, with a target action date of March 4, 2024.
- Positive results from Phase III study announced in May 2023 for tradipitant in motion sickness.
- FDA accepted sNDA for Fanapt in bipolar I disorder, with a target action date of April 2, 2024.
- FDA accepted NDA for tradipitant in gastroparesis with PDUFA target action date of September 18, 2024.
- FDA accepted NDA for tradipitant in gastroparesis, with a target action date of September 18, 2024. If approved, it will be the first novel drug for gastroparesis in over 40 years.
- FDA accepted sNDA for HETLIOZ® in insomnia with PDUFA target action date of March 4, 2024.
- Number of full-time employees decreased from 290 in 2022 to 203 in 2023.
- Net sales for HETLIOZ decreased from $159 million in 2022 to $100 million in 2023.
- Net sales for Fanapt decreased from $94 million in 2022 to $90 million in 2023.
- Number of major customers decreased from five in 2022 to three in 2023, representing 87% of total revenues.
Full Text Changes in Most Recent 10-K
Intended use: review the highlighted statements. These are additions to the risk factors disclosure in the most recent 10-K filing compared to the previous 10-K filing. Deleted and moved text is less important and is shown for context.
To view the full company filings, click on the following link to be taken to the SEC EDGAR database landing page for the company: https://www.sec.gov/edgar/browse/?CIK=1347178&owner=exclude
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