Welcome to our dedicated page for Mannkind news (Ticker: MNKD), a resource for investors and traders seeking the latest updates and insights on Mannkind stock.
MannKind Corporation reports developments across its biopharmaceutical business in cardiometabolic and orphan lung diseases. Company updates center on commercial products such as Afrezza, an inhaled insulin for diabetes, and Furoscix, a furosemide injection for fluid overload in heart failure and chronic kidney disease, as well as financial results, product demand, launch infrastructure and capital-structure actions.
MannKind news also covers dry powder inhalation programs and drug-device combinations, including work using its Technosphere platform. Recurring topics include Afrezza clinical and real-world data, Furoscix device and regulatory updates, Nintedanib DPI for idiopathic pulmonary fibrosis, ralinepag DPI collaboration activity with United Therapeutics, and other pipeline decisions affecting inhaled therapies.
MannKind (NASDAQ: MNKD) announced first patient enrollment in INHALE-1ST, a single-arm U.S. study evaluating initiation of Afrezza inhaled insulin with once-daily basal insulin in youth aged 10 to <18 years newly diagnosed with type 1 diabetes.
About 100 patients across ~10 sites will be followed 13 weeks (plus optional extension to 26 weeks); primary endpoint is ≥70% time-in-range (70–180 mg/dL) by CGM. An Afrezza pediatric sBLA is under FDA review with a PDUFA date of May 29, 2026.
MannKind (Nasdaq: MNKD) announced that the U.S. Food and Drug Administration approved an update to the Afrezza prescribing information on January 26, 2026 to provide starting mealtime dose guidance when switching adult patients from subcutaneous mealtime insulin (multiple daily injections or insulin pump boluses) to inhaled Afrezza.
The label revision includes a conversion table mapping current injected mealtime doses to recommended Afrezza starting doses (e.g., up to 3 units → 4 units; 4–5 → 8 units; 6–7 → 12 units; 8+ → 16 units). The change was supported by modeling and in vivo data from the Dose Optimization study and the INHALE-3 trial showing improved postprandial glucose outcomes with the approved conversion doses.
MannKind (Nasdaq: MNKD) provided business updates and outlined 2026 growth drivers including commercial momentum, recent acquisition activity, and clinical progress.
Key points: a record fourth quarter with net revenue >$100 million, acquisition of scPharmaceuticals, multiple FDA review acceptances with PDUFA dates (Afrezza label update Jan 23, 2026; Afrezza pediatric sBLA May 29, 2026; FUROSCIX ReadyFlow sNDA July 26, 2026), first patient enrolled in INFLO-1 (nintedanib DPI) in Dec 2025, and ongoing collaborations with United Therapeutics including a planned Tyvaso DPI bridging study.
MannKind (Nasdaq: MNKD) announced FDA approval of FUROSCIX On-body Infusor for pediatric patients weighing 43 kg or more and reported issuance of five U.S. patents for the FUROSCIX ReadyFlow Autoinjector, extending IP protection potentially through 2040. The ReadyFlow autoinjector is under FDA review with a PDUFA target action date of July 26, 2026 and, if approved, would deliver an IV-equivalent subcutaneous furosemide dose (80 mg/mL) in under 10 seconds. The pediatric sNDA fulfillment completes post-marketing Pediatric Research Equity Act requirements for FUROSCIX, which previously had adult approvals for CHF (2022) and CKD (2025).
MannKind (Nasdaq: MNKD) announced the U.S. FDA has accepted its supplemental NDA for FUROSCIX ReadyFlow Autoinjector (SCP-111) to treat edema in adults with chronic heart failure or chronic kidney disease.
The sNDA carries a PDUFA target action date of July 26, 2026. If approved, ReadyFlow would deliver a subcutaneous furosemide dose in under 10 seconds, compared with the on-body infusor's five-hour administration, potentially enabling at-home treatment and reduced hospital use.
The sNDA references an open-label crossover study in 21 healthy volunteers showing bioavailability of 107.3% (90% CI: 103.9–110.8) and similar urine output and electrolyte excretion versus IV furosemide, with tolerable injection-site pain.
MannKind (Nasdaq: MNKD) announced that CEO Michael Castagna and CFO Chris Prentiss will present updates at the Jefferies London Healthcare Conference on Wednesday, November 19, 2025 at 6:30 AM ET / 11:30 AM GMT. A live audio webcast will be available on the company's investor site and recorded versions will be accessible on the same site for approximately 90 days after the conference.
Investors can access the live and recorded sessions via the company’s events and presentations page at the investor relations website.
MannKind (Nasdaq: MNKD) announced discontinuation of the Phase 3 ICoN-1 trial of MNKD-101, a nebulized clofazimine inhalation suspension, after a futility determination.
An interim analysis of sputum culture conversion in the first 46 participants showed no conversions, and an ad hoc meeting on Nov 8, 2025 led the independent DSMB to agree to stop the trial for futility; the DSMB reported no safety concerns.
The outcome does not affect development of MNKD-102, a dry powder inhalation (DPI) clofazimine formulation progressing toward Phase 1 development. MannKind will host a conference call today at 9:00 AM EST with a webcast and a replay available for ~90 days.
MannKind (Nasdaq: MNKD), together with Alfred E. Mann Charities and The Diabetes Link, launched the Centennial Al Mann Scholarship on Nov 6, 2025 to mark Alfred E. Mann’s 100th birthday.
The program will distribute $100,000 to at least 10 students living with diabetes pursuing 2- or 4-year life sciences degrees, with awards up to $10,000 per student paid in annual installments of $2,500 over two to four years. The first awards target the 2026 academic year and the application window opens in early 2026; details and an early interest form will be available at thediabeteslink.org.
MannKind (NASDAQ: MNKD) reported Q3 2025 revenue $82.1M (+17% YoY) and YTD revenue $237.0M (+14% YoY). The company completed the acquisition of scPharmaceuticals on October 7, 2025 to accelerate FUROSCIX revenue growth and used ~$133.2M cash plus a $250M delayed-draw term loan in October to fund the transaction.
Pipeline and regulatory milestones include FDA acceptance of the Afrezza pediatric sBLA with a PDUFA date of May 29, 2026, submission of a FUROSCIX ReadyFlow Autoinjector sNDA, MNKD-101 Phase 3 enrollment ahead of schedule, and initiation of an IPF Phase 2 trial (MNKD-201).
MannKind (Nasdaq: MNKD) will release its third quarter 2025 financial results before the market opens on November 5, 2025. The company will host a webcast at 9:00 a.m. Eastern Time the same day to discuss results and provide a business update.
Investors can access the live webcast and a replay via the company’s investor website at https://investors.mannkindcorp.com/events-and-presentations; the replay will be available within 24 hours and remain accessible for approximately 90 days.