secwatch.observer — SEC 8-K summary
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Issuer:     TALPHERA, INC. (TLPH)
CIK:        0001427925
Form:       8-K
Filed at:   2023-09-22T23:59:59+00:00
Accession:  0001437749-23-026612
Event type: regulatory
Sentiment:  negative
Materiality: 0.65
Item codes: 8.01, 9.01
LLM model:  deepseek-v4-flash:cloud@v2

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

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1427925/000143774923026612/0001437749-23-026612-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1427925/000143774923026612/acrx20230922_8k.htm
  HTML page:      https://secwatch.observer/filing/0001437749-23-026612

License: Source filings: public domain (SEC EDGAR). Summaries (headline + bullets): CC-BY-4.0; attribute https://secwatch.observer