MannKind Announces U.S. FDA Accepts for Review its Supplemental Biologics License Application (sBLA) for Inhaled Insulin (Afrezza) in Children and Adolescents Aged 4-17 Years Living with D...
MannKind Corporation (MNKD)
Last mannkind corporation earnings: 2/25 08:00 am
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Source: GlobeNewswire
If approved, it would be the first needle-free insulin option for pediatric patients in 100+ years of insulin therapysBLA submission based on data from the Phase 3 INHALE-1 study PDUFA target action date of May 29, 2026 WESTLAKE VILLAGE, Calif. and DANBURY, Conn., Oct. 13, 2025 (GLOBE NEWSWIRE) -- MannKind Corporation (Nasdaq: MNKD) today announced that the U.S. Food and Drug Administration (FDA) has accepted the supplemental biologics license application (sBLA) seeking approval for Afrezza (insulin human) Inhalation Powder in children and adolescents living with type 1 or type 2 diabetes. The application has been assigned a Prescription Drug User Fee Act (PDUFA) target action date of May 29, 2026. “Today’s milestone brings us one step closer to offering young children and teenagers living with diabetes a potential alternative therapy to multiple daily injections or an insulin pump system,” said Dr. Kevin Kaiserman, M.D., Senior Vice President, Therapeutic Area Head, Endocrine
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News
- Reassessing MannKind (MNKD) Valuation After Recent Share Price Reset [Yahoo! Finance]Yahoo! Finance
- MannKind Announces U.S. FDA Accepts for Review its Supplemental New Drug Application (sNDA) of FUROSCIX ReadyFlow™ Autoinjector for the Treatment of Edema in Adults with Chronic Heart Failure or Chronic Kidney DiseaseGlobeNewswire
- MannKind (NASDAQ:MNKD) was given a new $9.00 price target on by analysts at Truist Financial Corporation.MarketBeat
- MannKind (NASDAQ:MNKD) is now covered by analysts at Truist Financial Corporation. They set a "buy" rating on the stock.MarketBeat
- MannKind (NASDAQ:MNKD) is now covered by analysts at Leerink Partners. They set an "outperform" rating and a $7.00 price target on the stock.MarketBeat
MNKD
Earnings
- 11/5/25 - Beat
MNKD
Sec Filings
- 12/4/25 - Form 4
- 12/4/25 - Form 4
- 12/2/25 - Form 144
- MNKD's page on the SEC website