FDA Accepts United Therapeutics' NDA Filing for Ralinepag in PAH
UTHR's ralinepag NDA receives FDA acceptance, with a 2027 decision ahead as positive phase III data support its PAH potential.
UTHR's ralinepag NDA receives FDA acceptance, with a 2027 decision ahead as positive phase III data support its PAH potential.
Three revenue streams continue to feed modest growth for MannKind. Two new FDA approvals show promise of turbocharging product growth in two of MNKD's established products. MNKD's existing liquidity should be adequate to fund its operations and launches for ~2.3 years.
MannKind Corporation (MNKD) Q2 2026 Earnings Call Transcript
MannKind NASDAQ: MNKD reported second-quarter revenue of $109.4 million, up 43% from the prior-year period, as growth in its commercial products and collaboration revenue helped offset increased spending tied to product launches and development programs.
The headline numbers for MannKind (MNKD) give insight into how the company performed in the quarter ended June 2026, but it may be worthwhile to compare some of its key metrics to Wall Street estimates and the year-ago actuals.
MannKind (MNKD) came out with a quarterly loss of $0.06 per share versus the Zacks Consensus Estimate of a loss of $0.02. This compares to break-even earnings per share a year ago.
Achieved three major catalysts to drive future growth: Launched the pediatric indication of Afrezza ® following FDA approval FUROSCIX ReadyFlow™ autoinjector approved for treatment of edema in HF and CKD Positive nintedanib DPI Phase 1b data in IPF patients validates continued Phase 2 advancement Encouraging early momentum in Afrezza pediatric launch 1 in 3 of the top 100 pediatric insulin writers have prescribed Q2 2026 total revenues of $109.4M, +43% vs. Q2 2025 Conference call and webcast today at 4:30 p.m.
MannKind Corporation (MNKD) Discusses Phase 1b Results and Clinical Progress of Nintedanib DPI for IPF Transcript
MannKind NASDAQ: MNKD reported Phase 1b results for its inhaled nintedanib dry-powder inhalation, or DPI, candidate in patients with idiopathic pulmonary fibrosis, or IPF, saying the seven-day study met its objective of demonstrating short-term safety and tolerability.
We also report on an experimental diagnostic approach that can detect tuberculosis exposure and infection at an earlier stage than current methods.
MNKD Reports Positive Phase 1b INFLO-1 Results, Demonstrating Safety & Tolerability of Nintedanib DPI and Clinical Validation of Its DPI Technology in IPF
DANBURY, Conn. and WESTLAKE VILLAGE, Calif., July 28, 2026 (GLOBE NEWSWIRE) -- MannKind Corporation (Nasdaq: MNKD), today announced that the Company will report second quarter 2026 financial results after market close on Wednesday, August 5, 2026.
MannKind Corporation (NASDAQ: MNKD - Get Free Report)'s stock price gapped up prior to trading on Friday. The stock had previously closed at $3.89, but opened at $4.06. MannKind shares last traded at $3.9950, with a volume of 1,925,140 shares traded. Key Stories Impacting MannKind Here are the key news stories impacting MannKind this week:
Mannkind Corporation (NASDAQ:MNKD) shares are trading higher as the company recently announced the U.S. Food and Drug Administration's (FDA) approval of Furoscix ReadyFlow, an at-home treatment option for adults with heart failure or chronic kidney disease.
MannKind Corporation (MNKD) Discusses FDA Approval of Furoscix ReadyFlow for IV-Equivalent Diuretic Therapy in Fluid Overload Transcript
MannKind NASDAQ: MNKD said the U.S. Food and Drug Administration approved Furoscix ReadyFlow, an auto-injector designed to deliver an 80-milligram dose of subcutaneous furosemide in five to 10 seconds for the management of fluid overload.
DANBURY, Conn. and WESTLAKE VILLAGE, Calif.
MannKind announces FDA approval of Furoscix ReadyFlow™, the first & only autoinjector delivering IV-equivalent diuretic therapy for the treatment of edema
This MannKind insider filing details the disposition of 46,795 shares. The transaction reduced the insider's direct equity holdings by 9%.
The transactions involved 76,880 shares with a total value of about $313,000, based on a weighted average execution price of $4.07 per share. The disposition represented 9% of direct common stock holdings, which included shares delivered upon the recent vesting of performance-based awards.