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MannKind (MNKD) FDA Events

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FDA Events for MannKind (MNKD)

This section highlights FDA-related milestones and regulatory updates for drugs developed by MannKind (MNKD). Over the past two years, MannKind has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as Afrezza, Clofazimine, and MNKD-101. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.

MannKind's Drugs in FDA Review

Afrezza (Technosphere Insulin or TI) - FDA Regulatory Timeline and Events

Afrezza (Technosphere Insulin or TI) is a drug developed by MannKind for the following indication: Type 2 (T2D) diabetes. This drug is under review by the U.S. Food and Drug Administration (FDA). Below is a timeline of key regulatory milestones for this therapy.

Clofazimine inhalation suspension (MNKD 101) - FDA Regulatory Timeline and Events

Clofazimine inhalation suspension (MNKD 101) is a drug developed by MannKind for the following indication: Nontuberculous mycobacterial (NTM) lung disease. This drug is under review by the U.S. Food and Drug Administration (FDA). Below is a timeline of key regulatory milestones for this therapy.

MNKD-101 - FDA Regulatory Timeline and Events

MNKD-101 is a drug developed by MannKind for the following indication: For Nontuberculous Mycobacterial Lung Disease. This drug is under review by the U.S. Food and Drug Administration (FDA). Below is a timeline of key regulatory milestones for this therapy.

MannKind FDA Events - Frequently Asked Questions

However, the company does has had drugs under review or in active clinical development.

In the past two years, MannKind (MNKD) has reported FDA regulatory activity for the following drugs: Afrezza (Technosphere Insulin or TI), Clofazimine inhalation suspension (MNKD 101) and MNKD-101.

The most recent FDA-related event for MannKind occurred on June 9, 2025, involving Afrezza (Technosphere Insulin or TI). The update was categorized as "Provided Update," with the company reporting: "MannKind Corporation announced that it will showcase inhaled insulin at the American Diabetes Association's (ADA) 85th Scientific Sessions from June 20-23 in Chicago."

Current therapies from MannKind in review with the FDA target conditions such as:

  • Type 2 (T2D) diabetes - Afrezza (Technosphere Insulin or TI)
  • Nontuberculous mycobacterial (NTM) lung disease - Clofazimine inhalation suspension (MNKD 101)
  • For Nontuberculous Mycobacterial Lung Disease - MNKD-101

More FDA Event Resources from MarketBeat

  • NDA: New Drug Application
  • ANDA: Abbreviated New Drug Application
  • sNDA: Supplemental New Drug Application
  • BLA: Biologics License Application
  • sBLA: Supplemental Biologics License Application
  • FDA Approved: Approved by the FDA
  • EMA: European Medicines Agency
  • CE Mark: European Union Certification
  • NMPA: China National Medical Products Administration
  • MHLW: Japanese Ministry of Health
  • FDA Meeting: Consultation with FDA
  • Pre-IND: Pre-Investigational New Drug Meeting
  • Breakthrough Therapy: Special FDA designation for promising therapies
  • Fast Track: Accelerated FDA approval pathway
  • Orphan Drug: Designation for rare disease treatments
  • RPD: Rare Pediatric Disease Designation
  • RMAT: Regenerative Medicine Advanced Therapy
  • DSMB Review: Data Safety Monitoring Board Review
  • IDMC Review: Independent Data Monitoring Committee
  • MAA: MHRA Marketing Authorization Application
  • RTF: Refusal to File (Rejected Application)
  • 510(k): FDA Clearance for Medical Devices
  • Rolling Submission: Staggered regulatory review process

This page (NASDAQ:MNKD) was last updated on 7/9/2025 by MarketBeat.com Staff
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