---
schema_version: "secwatch.filing_event.v1"
accession: "0001564590-22-001402"
form_type: "8-K"
ticker: "MNKD"
cik: "0000899460"
company_name: "MANNKIND CORP"
filed_at: "2022-01-18T23:59:59+00:00"
generated_at: "2026-06-27T17:48:50.981341+00:00"
event_type: "regulatory"
sentiment: "positive"
materiality_score: 0.6
calibrated_materiality_score: 0.6
confidence: "high"
source: SEC EDGAR
---

# MannKind partner UT's Tyvaso DPI NDA accepted for FDA Class 1 review; goal Feb 2022

## Summary
- FDA accepted United Therapeutics' resubmitted NDA for Tyvaso DPI as a Class 1 response.
- User fee goal date set for February 2022.
- UT previously received a Complete Response Letter in October 2021 for the NDA.

## SEC filing metadata
- accession: 0001564590-22-001402
- form_type: 8-K
- ticker: MNKD
- cik: 0000899460
- company_name: MANNKIND CORP
- filed_at: 2022-01-18T23:59:59+00:00
- event_type: regulatory
- sentiment: positive
- materiality_score: 0.6
- calibrated_materiality_score: 0.6
- confidence: high
- sec_items: 8.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/899460/000156459022001402/0001564590-22-001402-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/899460/000156459022001402/mnkd-8k_20220118.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001564590-22-001402
- JSON: https://secwatch.observer/filing/0001564590-22-001402.json
- Plain text: https://secwatch.observer/filing/0001564590-22-001402.txt

This AI-assisted summary is a reading aid. Review the linked SEC EDGAR filing before relying on any specific claim.