FDA declines to issue EUA for AcelRx's Niyad; company will pursue PMA by 2024

TALPHERA, INC.

FDA notified AcelRx on Sept 22, 2023 it declined EUA for Niyad (nafamostat) in CRRT due to prioritization of other requests.
FDA encouraged continued clinical development of Niyad device.
AcelRx plans to initiate registrational study later in 2023 and submit PMA to FDA in 2024.
EUA was sought for use as regional anticoagulant in CRRT patients who cannot tolerate heparin.

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