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MannKind Corporation (Nasdaq: MNKD) is a leading biopharmaceutical company dedicated to the discovery, development, and commercialization of innovative inhaled therapeutic products for patients with serious unmet medical needs. The company focuses on treating diseases such as diabetes, pulmonary arterial hypertension, and nontuberculous mycobacterial (NTM) lung disease.
Their flagship product, Afrezza, is an ultra-rapid-acting inhaled insulin designed to improve glycemic control in adults with diabetes. This product features a dry powder formulation of human insulin delivered via a small, portable inhaler.
MannKind's latest advancements include the initiation of a Phase 3 trial for Clofazimine Inhalation Suspension aimed at treating refractory NTM lung disease. The trial, named ICoN-1, will evaluate the efficacy and safety of the drug when added to standard therapy. This initiative is a response to the increasing global prevalence of NTM lung infections, which pose significant health risks and complications for patients.
Additionally, MannKind is progressing with a Phase 1 study of nintedanib DPI (MNKD-201) for pulmonary fibrotic diseases such as idiopathic pulmonary fibrosis (IPF). This study will assess the safety, tolerability, and pharmacokinetics of the drug in healthy volunteers.
The company's technological prowess is underlined by its proprietary Technosphere® dry-powder technology, which facilitates rapid and effective delivery of medicines to the deep lung. This technology, combined with their inhalation devices, is used to develop new treatments that can either act locally in the lungs or enter the systemic circulation, depending on the medical need.
In a strategic partnership, MannKind has in-licensed Pulmatrix's iSPERSE™ technology to enhance their formulation capabilities. This collaboration also includes exchanging MannKind's Cricket® inhaler technology to aid in the development of inhaled treatments for migraine and other neurological diseases.
Financially, MannKind continues to invest in R&D to expand its product pipeline and enhance its technological platforms. The company’s partnerships, such as the recent agreement with Pulmatrix, are also set to strengthen MannKind's market position in the biopharmaceutical landscape.
With a dedicated team and a robust pipeline, MannKind Corporation remains at the forefront of developing effective inhaled therapies, striving to improve patient outcomes and quality of life.
MannKind Corporation (Nasdaq: MNKD) will have its CEO, Michael Castagna, PharmD, participate in a Fireside Chat at the 2021 SVB Leerink Global Healthcare Conference on February 25, 2021, at 1:00 pm (ET). Interested individuals can access the webcast through the Company's website, with a replay available for 14 days post-event. MannKind is known for developing inhaled therapeutic products, including Afrezza® (insulin human) Inhalation Powder, the only FDA-approved inhaled ultra rapid-acting mealtime insulin in the U.S.
MannKind Corporation (NASDAQ:MNKD) is set to release its 2020 fourth quarter and full year financial results on February 25, 2021, at 9:00 AM ET. The call, featuring CEO Michael Castagna and CFO Steven Binder, will discuss financials and corporate updates. Investors can participate via the company's website or by telephone, with a replay available for 14 days post-call. MannKind focuses on inhaled therapeutic products, commercializing Afrezza, the only FDA-approved inhaled insulin in the U.S., which is also available in Brazil through partner Biomm SA.
MannKind Corporation (Nasdaq: MNKD) announced that its CEO, Michael Castagna, will participate in a Fireside Chat at the H.C. Wainwright Bioconnect 2021 Conference. This event will be available on demand starting January 11, 2021, at 6:00 am (ET). Interested viewers can access the webcast link from the Events & Presentations section on MannKind's website. The replay will remain accessible for 14 days post-event. MannKind specializes in inhaled therapies for endocrine and orphan lung diseases, including Afrezza, the only inhaled ultra rapid-acting mealtime insulin in the U.S.
MannKind Corporation (Nasdaq: MNKD) and Vertice Pharma announced a co-promotion agreement for Thyquidity™ (levothyroxine sodium) oral solution, aimed at treating hypothyroidism. MannKind's sales force will market Thyquidity to US healthcare providers specializing in endocrinology. Vertice will compensate MannKind with quarterly payments and royalties on sales. Michael Castagna, CEO of MannKind, emphasized the arrangement's potential to enhance customer relationships and extend market reach. Thyquidity is indicated for various forms of hypothyroidism, which affects approximately 4.6% of the US population.
MannKind Corporation (Nasdaq: MNKD) has appointed James S. Shannon, M.D., as the new Chairman of the Board effective December 9, 2020. He succeeds Kent Kresa, who remains as a Board member and Chair of the Compensation Committee. Dr. Shannon brings over 20 years of pharmaceutical leadership experience, previously serving as Chief Medical Officer at GlaxoSmithKline and leading Pharma Development at Novartis. This leadership change aims to strengthen MannKind's focus on its pipeline and innovative therapies for endocrine and orphan lung diseases.
MannKind Corporation (Nasdaq: MNKD) has acquired QrumPharma, Inc., a firm focused on inhalation therapies for severe pulmonary infections, including Nontuberculous Mycobacterial (NTM) lung disease. The acquisition includes $3.5 million in cash and 3,067,179 shares of MNKD. The lead product, QRM-003, is set to enter Phase 1 trials by late 2021 and has received FDA orphan drug and QIDP designations. This deal aims to enhance MannKind's pipeline in orphan lung disease treatments and leverage advanced inhalation technologies.
MannKind Corporation (Nasdaq: MNKD) has amended its credit agreement with MidCap Financial Trust, securing $10 million immediately and an additional $25 million contingent upon FDA approval of Treprostinil Technosphere (TreT). The interest-only period extends to September 1, 2022. Key objectives include growing Afrezza as a standard of care for mealtime insulin and advancing TreT toward NDA submission. The amendment also adjusts financial covenants linked to Afrezza's revenue and mandates TreT marketing if Tranche 3 is funded.
MannKind Corporation (NASDAQ: MNKD) announced the appointment of Sabrina Kay, Ed.D., to its Board of Directors, effective December 1, 2020. Dr. Kay will also join the Audit Committee, bringing extensive experience in marketing, finance, and executive leadership. Currently the CEO of Fremont Private Investments, she has successfully managed several companies and is involved in numerous philanthropic initiatives. With Dr. Kay's appointment, MannKind aims to enhance its strategic vision and leadership as it continues to develop its inhaled therapeutic products, including Afrezza.
MannKind Corporation (NASDAQ:MNKD) has successfully achieved the final development milestone under its collaboration with United Therapeutics for their dry powder formulation of treprostinil, a treatment for pulmonary arterial hypertension (PAH). All clinical trials are fully enrolled, including the BREEZE study and pivotal pharmacokinetics study. MannKind's stability program has met the requirements for a regulatory filing, paving the way for an FDA submission in early 2021. With all milestone payments received, MannKind will also earn royalties and manufacturing margins from TreT sales.
MannKind Corporation (NASDAQ:MNKD) reported third quarter 2020 results showing a net revenue of $15.4 million, comprising $7.3 million from Afrezza, an increase of 27% year-over-year. The company achieved a gross profit of $3.7 million, a significant recovery from a loss of $0.7 million in the same quarter of 2019. Cash and cash equivalents stood at $52.4 million as of September 30, 2020. The net loss for the quarter was $11.3 million or $0.05 per share, slightly higher than $10.4 million in Q3 2019. The company is on track to finalize Treprostinil Technosphere development by year-end.