Mannkind Stock Price, News & Analysis

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.

MannKind (Nasdaq: MNKD) completed its acquisition of scPharmaceuticals on October 7, 2025, creating a cardiometabolic-focused commercial platform. The deal consideration was $5.35 per share in cash plus one non-tradable contingent value right (CVR) for up to $1.00, for total consideration of up to $6.35 per share. MannKind cited an annualized revenue run rate of over $370 million based on Q2 2025 results, driven by Afrezza, FUROSCIX, V-Go and Tyvaso DPI–related revenues. The FUROSCIX ReadyFlow autoinjector supplemental NDA was filed in Q3 2025. Following a merger under Delaware law, scPharmaceuticals became a wholly owned subsidiary and its Nasdaq symbol SCPH ceased trading.

MannKind Corporation (Nasdaq: MNKD), a developer of inhaled therapeutic products for endocrine and orphan lung diseases, has appointed Dr. Ajay Ahuja as Executive Vice President and Chief Medical Officer, effective September 29, 2025.

Dr. Ahuja brings over 20 years of biopharmaceutical leadership experience, most recently serving as Development and Launch Leader at Kardigan Bio. His extensive background includes senior roles at Idorsia Pharmaceuticals, Allergan, Takeda, Pfizer, and Novartis. Dr. Ahuja holds an MD from Washington University and an MBA from Harvard Business School, and practiced medicine at Boston Children's Hospital for over a decade.

MannKind Corporation (Nasdaq: MNKD), a developer of inhaled therapeutic products for endocrine and orphan lung diseases, has announced its participation in four upcoming investor conferences in September 2025.

CEO Michael Castagna and CFO Chris Prentiss will present at the Wells Fargo Health Care Conference (Sept. 3), Cantor Global Healthcare Conference (Sept. 4), H.C. Wainwright Global Investment Conference (Sept. 9), and Morgan Stanley Global Healthcare Conference (Sept. 9). Live webcasts will be available on MannKind's investor relations website, with recordings accessible for 90 days post-event.

MannKind Corporation (NASDAQ: MNKD) has expanded its collaboration with United Therapeutics (NASDAQ: UTHR) to develop a second dry powder inhalation therapy. This follows their successful partnership that resulted in Tyvaso DPI, the first FDA-approved dry powder inhalation treatment for pulmonary hypertension.

Under the expanded agreement, MannKind will utilize its Technosphere® platform to formulate a new investigational molecule, while United Therapeutics will handle preclinical and clinical development. The deal includes an upfront payment of $5 million to MannKind, potential development milestones up to $35 million, and 10% royalties on net sales of any resulting product.