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Sep 30, 2023
AcelRx Q3 2023 Earnings Report
AcelRx reported Q3 2023 financial results and provided a corporate update, highlighting Niyad™ IDE approval and plans for a registrational study.
Key Takeaways
AcelRx announced Niyad™ IDE approval by the FDA and plans to start its Niyad registrational study this quarter, with topline data expected mid-2024. The company reported cash and investments of $13.4 million as of September 30, 2023 and revenues of $0.1 million for the third quarter.
Niyad™ Investigational Device Exemption (IDE) approval by the FDA was achieved in the third quarter.
The company plans to begin its Niyad registrational study this quarter, with topline data expected mid-2024.
Cash and investments were $13.4 million as of September 30, 2023.
A financing closed in July led by new healthcare investors providing up to $26.3 million, of which $10 million was made immediately available.
Forward Guidance
AcelRx plans to begin its Niyad registrational study this quarter with topline data expected mid-2024 and submission of an application for Premarket Approval, or PMA, planned in the second half of next year.
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