Mannkind Stock Price, News & Analysis

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.

MannKind Corporation (Nasdaq: MNKD) announced its participation in the Lytham Partners Fall 2021 Investor Conference on October 5, 2021, at 11:45 am ET. CEO Michael Castagna, PharmD, will represent the company during the event. Interested parties can access a live webcast of the presentation through the Company’s website. MannKind focuses on developing inhaled therapeutic products, including Afrezza®, the only inhaled ultra rapid-acting insulin available in the U.S. The webcast replay will be available for 14 days post-event.

MannKind Corporation (Nasdaq: MNKD) announced its participation in two upcoming conferences, featuring CEO Michael Castagna, PharmD as a presenter. The events include the Oppenheimer Fall Healthcare Life Sciences & MedTech Summit on September 22, 2021, and the 2021 Cantor Global Virtual Healthcare Conference on September 27, 2021. Interested individuals can access live webcasts and replays on the company’s website for 14 days post-event. MannKind is known for developing inhaled therapeutic products, including Afrezza, an FDA-approved inhaled insulin available in the U.S. and Brazil.

MannKind Corporation (Nasdaq: MNKD) announced that CEO Michael Castagna, PharmD, will participate in a Fireside Chat at the H.C. Wainwright 23rd Annual Global Investment Conference, available on demand from September 13, 2021. Interested parties can access the webcast through the Company’s Events & Presentations section on their website, where a replay will be available for 14 days. MannKind focuses on developing inhaled therapeutic products for endocrine and orphan lung diseases, including Afrezza®, the only inhaled ultra rapid-acting mealtime insulin in the U.S.

United Therapeutics Corporation (Nasdaq: UTHR) showcased the BREEZE study results for Tyvaso DPI™ at the European Respiratory Society Congress 2021. This next-generation inhalation solution for pulmonary arterial hypertension (PAH) demonstrated significant safety and tolerability, with 96% completion rate in a three-week trial. Key findings included an 11.5-meter increase in six-minute walk distance and enhanced patient satisfaction with the device. The FDA is expected to review Tyvaso DPI's NDA in October 2021, which could enhance therapeutic accessibility for PAH patients.

MannKind Corporation (MNKD) reported Q2 2021 revenues of $23.3 million, a 54% increase year-over-year, driven by Afrezza net revenue of $10.0 million. The company reported a net loss of $35.5 million, or $0.14 per share, compared to a net loss of $10.3 million in Q2 2020. Gross profit from Afrezza surged 68% to $5.6 million, enhancing gross margin to 56% (or 76% on a non-GAAP basis). Cash equivalents amounted to $201.4 million as of June 30, 2021, bolstered by $230 million in convertible notes issued earlier this year.

NRx Pharmaceuticals has partnered with MannKind Corporation to develop a dry powder formulation of ZYESAMI™ (aviptadil) for respiratory conditions. Utilizing MannKind's Technosphere® platform, the collaboration aims to create an inhalable delivery system that enhances patient convenience. ZYESAMI™ has shown promising results in clinical trials for COVID-19 patients. NRx has received Fast Track Designation from the FDA and is conducting phase 3 trials for both intravenous and inhaled formulations, funded by the NIH and BARDA.