BRIEF-Acelrx Receives Ide Approval For Niyad And Advances To A Single Registration Study

Reuters
2023/10/03

Oct 3 (Reuters) - AcelRx Pharmaceuticals Inc :

* ACELRX RECEIVES IDE APPROVAL FOR NIYAD AND ADVANCES TO A SINGLE REGISTRATION STUDY

* ACELRX PHARMACEUTICALS - INVESTIGATIONAL DEVICE EXEMPTION APPROVAL BY FDA ALLOWS ACELRX TO BEGIN PIVOTAL STUDY OF NIYAD

* ACELRX PHARMACEUTICALS - SINGLE REGISTRATION STUDY WITH PRE-AGREED UPON ENDPOINTS PLANNED TO INITIATE IN Q4 2023 WITH TOPLINE DATA EXPECTED MID-2024

* ACELRX PHARMACEUTICALS INC - CLINICAL SITE READINESS IS CURRENTLY UNDERWAY

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