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Jun 30, 2023
AcelRx Q2 2023 Earnings Report
Reported second quarter 2023 financial results and provided a corporate update.
Key Takeaways
AcelRx reported its second quarter 2023 financial results, highlighting a focus on their late-stage product portfolio following the divestment of DSUVIA. They await the FDA's response to their Emergency Use Authorization (EUA) request for Niyad and are set to begin a registrational study in Q4 2023. The company closed a capital raise in July, gaining access to up to $26.3 million.
Closed a capital raise in July, providing access to up to $26.3 million in capital.
AcelRx awaits response to Emergency Use Authorization (EUA) of Niyad™ submitted to the FDA in April.
Registrational study for Niyad is set to initiate in Q4 2023.
Senior debt with Oxford was fully repaid in Q2 2023.
Forward Guidance
AcelRx is on track to begin its registrational study for Niyad later this year with an expected data readout mid-2024. They expect continued support from the FDA for their planned PMA submission in the second half of 2024. A potential earlier milestone for Niyad is the receipt of an Emergency Use Authorization, which was submitted to the FDA in April.
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