secwatch.observer — SEC 8-K summary
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Issuer:     TALPHERA, INC. (TLPH)
CIK:        0001427925
Form:       8-K
Filed at:   2024-01-09T23:59:59+00:00
Accession:  0001437749-24-000938
Event type: other_material
Sentiment:  neutral
Materiality: 0.50
Item codes: 5.03, 7.01, 9.01
LLM model:  deepseek-v4-flash:cloud@v2

AcelRx rebrands to Talphera; ticker changes to TLPH Jan 10; Niyad PMA submission H2 2024
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- Name changed from AcelRx Pharmaceuticals to Talphera, Inc.; new symbol TLPH effective Jan 10.
- Rebranding reflects broader focus on medically supervised settings; lead candidate Niyad for dialysis circuit.
- Niyad's registrational NEPHRO study to begin shortly; first patient expected Q1 2024.
- PMA submission for Niyad targeted for H2 2024; product has FDA Breakthrough Designation.

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1427925/000143774924000938/0001437749-24-000938-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1427925/000143774924000938/acrx20240108_8k.htm
  HTML page:      https://secwatch.observer/filing/0001437749-24-000938

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