Mannkind Stock Price, News & Analysis

MannKind Corporation (Nasdaq: MNKD) announced the purchase of an additional convertible note from Thirona Bio, enhancing their collaboration initiated in June 2021 focused on FBM5712, a TGF-β inhibitor for pulmonary fibrosis. MannKind is advancing its inhaled formulation, MNKD-501, into a nonclinical PD study, with results expected in Q2 2022. CEO Michael Castagna has joined Thirona's board. Positive early signals from initial studies indicate potential efficacy, which could lead to further development and commercialization rights for treating fibrotic lung diseases.

MannKind Corporation (Nasdaq: MNKD) will participate in the Lytham Partners Winter 2021 Investor Conference from December 13-16, 2021. CEO Michael Castagna will host a webcasted Fireside Chat on December 13 at 11:00 AM ET to discuss the company's vision for 2022. Additionally, Castagna and CFO Steven B. Binder will hold 1x1 virtual investor meetings. The Fireside Chat will be available on the company's website and archived for replay. MannKind focuses on inhaled therapeutic products for endocrine and orphan lung diseases, with its lead product, Afrezza, being the only inhaled ultra-rapid acting insulin available in the U.S.

MannKind Corporation (MNKD) reported a 45% increase in total revenues to $22.2 million for Q3 2021, driven by Afrezza net revenue of $9.8 million, up 34% year-over-year. Collaboration revenue also rose 54% to $12.5 million. Gross profit increased 61% to $5.9 million, leading to a gross margin improvement to 61% from 51%. Despite these gains, the net loss was $4.4 million or $0.02 per share, down from $11.3 million in the prior year. Cash equivalents stood at $181.1 million as of September 30, 2021.

MannKind Corporation (Nasdaq: MNKD) announced the completion of a sale-leaseback transaction that generated $102.25 million in non-dilutive gross proceeds on November 8, 2021. This deal involves the sale of 263,900 square feet of manufacturing space in Danbury, Conn., while MannKind retains operational control of its facilities. The company manufactures Afrezza^® (inhaled insulin) and Tyvaso DPI™ (inhaled treprostinil) at this location. MannKind also signed a 20-year lease with renewal options, allowing continued operations without the burden of ownership.

MannKind Corporation (Nasdaq: MNKD) is set to present promising findings regarding its Technosphere® Insulin (TI) at the 21^st Annual Diabetes Technology Meeting on November 11. This feasibility study highlights that a TI dose—approximately double the standard mealtime subcutaneous injection—significantly reduced postprandial glucose excursions without causing severe hypoglycemia. Specifically, the maximum mean postprandial glucose dropped from 234 to 186 mg/dL, demonstrating a 50 mg/dL improvement at 120 minutes.

MannKind Corporation (Nasdaq:MNKD) will announce its third quarter financial results on November 9, 2021, at 5:00 PM ET. CEO Michael Castagna and CFO Steven B. Binder will discuss the financial performance and corporate updates during a conference call. The call will be available for live listening on the company’s website, with a replay accessible for 14 days. MannKind specializes in developing inhaled therapeutic products, including Afrezza, the only FDA-approved inhaled ultra rapid-acting mealtime insulin in the U.S. More information can be found on their corporate site.

MannKind Corporation (Nasdaq: MNKD) announced that the FDA issued a complete response to United Therapeutics regarding the New Drug Application (NDA) for Tyvaso DPI to treat pulmonary arterial hypertension and interstitial lung disease. The rejection was due to one open inspection issue at a third-party testing center, with no deficiencies found in MannKind's Connecticut facility. MannKind continues to build pre-launch inventory and plans to support United Therapeutics in securing NDA approval in the future.

MannKind Corporation (Nasdaq: MNKD) announced the enrollment of its first pediatric patient in the INHALE-1 study, which aims to evaluate the efficacy and safety of Afrezza in children aged 4-17 with type 1 or type 2 diabetes. This multi-center, 26-week randomized trial will compare Afrezza in combination with basal insulin against multiple daily injections. The primary endpoint is the change in HbA1c levels after 26 weeks. Approximately 260 patients are expected to participate across over 30 U.S. sites, marking a significant step towards making Afrezza available for younger patients.

MannKind Corporation (Nasdaq: MNKD) announced a sale-leaseback transaction with Creative Manufacturing Properties, expected to generate $102.25 million in gross proceeds. This strategic move allows MannKind to unlock capital from its manufacturing facility, supporting growth and development initiatives.

The transaction involves a 20-year lease for a 263,900 sq. ft. manufacturing space in Danbury, where MannKind produces its FDA-approved product, Afrezza. The company plans to utilize the funds to enhance its product pipeline and expand Afrezza's commercial activities.