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 (Nasdaq: MNKD) generates frequent news across product, clinical, regulatory, and corporate fronts as it advances therapies for cardiometabolic and orphan lung diseases. News coverage for MNKD often centers on its commercial products Afrezza, FUROSCIX, V-Go, and Tyvaso DPI–related collaborations, as well as updates on its inhaled and subcutaneous pipeline.
Investors and healthcare observers following MNKD news can expect announcements on U.S. Food and Drug Administration (FDA) milestones, including supplemental Biologics License Applications and supplemental New Drug Applications. Recent examples include FDA acceptance for review of an sBLA for Afrezza in children and adolescents with type 1 or type 2 diabetes, and acceptance of an sNDA for the FUROSCIX ReadyFlow Autoinjector for edema in adults with chronic heart failure or chronic kidney disease.
MannKind’s news flow also covers clinical trial progress and portfolio decisions in orphan lung diseases. The company has reported on initiation of nintedanib DPI (MNKD-201) studies for idiopathic pulmonary fibrosis, as well as the discontinuation of the Phase 3 ICoN-1 trial of nebulized clofazimine (MNKD-101) for refractory nontuberculous mycobacterial lung disease following a futility analysis. Updates on pre-clinical programs such as bumetanide DPI and MNKD-102 are also featured in its communications.
Corporate and financial news items include quarterly earnings results, revenue breakdowns across royalties, collaborations, and product sales, and strategic transactions. A notable example is MannKind’s acquisition of scPharmaceuticals, which brought FUROSCIX fully into its portfolio and expanded its presence in cardiometabolic care. The company also issues releases about investor conference presentations and community initiatives, such as the Centennial Al Mann Scholarship for students living with diabetes.
This news page aggregates these developments so readers can review regulatory decisions, trial outcomes, business combinations, and financial updates related to MannKind in one place.
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.
MannKind (NASDAQ: MNKD) announced the U.S. FDA has accepted its supplemental biologics license application (sBLA) seeking approval of Afrezza inhaled insulin for children and adolescents aged 4–17 with type 1 or type 2 diabetes.
The submission is based on results from the Phase 3 INHALE-1 trial (26-week open-label, randomized) and its 26-week extension; topline results were reported in December 2024. The FDA assigned a PDUFA target action date of May 29, 2026. Full results will be presented at ISPAD in early November. Afrezza is already FDA-approved for adults (18+ since June 2014) and approved in India and Brazil.
FAQ
What is the current stock price of Mannkind (MNKD)?
What is the market cap of Mannkind (MNKD)?
