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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) 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.
MannKind Corporation (NASDAQ:MNKD) will announce its 2020 third quarter financial results on November 4, 2020, at 5:00 PM ET. CEO Michael Castagna and CFO Steven Binder will discuss the results and corporate updates during a conference call. Interested parties can listen live via the company's website or join a telephone replay available for 14 days post-call. MannKind specializes in inhaled therapeutic products, notably the FDA-approved Afrezza® inhalation powder, the only inhaled ultra-rapid acting mealtime insulin available in the U.S. and Brazil.
MannKind Corporation (Nasdaq: MNKD) announced its participation in several upcoming conferences where CEO Michael Castagna will speak. Key events include the H.C. Wainwright 22nd Annual Global Investment Conference on September 14 at 3:30 pm EDT, the Cantor Global Virtual Healthcare Conference on September 15 at 8:40 am EDT, and the Oppenheimer Fall Healthcare Summit on September 21 at 10:50 am EDT. The presentations will be accessible through a live webcast on the company's website, with replays available for 14 days.
MannKind Corporation (Nasdaq: MNKD) announced that CEO Michael Castagna will present at the BTIG Virtual Biotechnology Conference on August 11, 2020, at 2:00 pm ET. The live webcast will be accessible via the company's website, with a replay available for 14 days after the event. MannKind focuses on inhaled therapeutic products for diabetes and orphan lung diseases, with its flagship product, Afrezza® (inhaled insulin), being the only FDA-approved inhaled ultra-rapid-acting mealtime insulin available in the U.S.
MannKind Corporation (NASDAQ:MNKD) reported 2Q 2020 Afrezza net revenue of $7.0 million, up 15% from 2Q 2019, contributing to a total revenue of $15.1 million. For 1H 2020, net revenue was $15.0 million, a 35% increase year-over-year. Gross profit surged 90% to $3.3 million, boosting gross margin from 29% to 47%. The company reported a net loss of $10.3 million, an improvement from $12.4 million in 2Q 2019. Cash reserves stood at $63.2 million. New Chief Commercial Officer Alejandro Galindo joined to enhance growth.
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