Annuncio • Apr 30
MannKind Corporation to Report Q1, 2026 Results on May 06, 2026 MannKind Corporation announced that they will report Q1, 2026 results at 4:00 PM, US Eastern Standard Time on May 06, 2026 Annuncio • Apr 09
MannKind Corporation, Annual General Meeting, May 20, 2026 MannKind Corporation, Annual General Meeting, May 20, 2026. Annuncio • Feb 18
MannKind Corporation to Report Q4, 2025 Results on Feb 26, 2026 MannKind Corporation announced that they will report Q4, 2025 results Pre-Market on Feb 26, 2026 Annuncio • Feb 10
Mannkind Corporation Announces First Patient Enrolled in Inhale-1St Pediatric Study Evaluating Afrezza®? for Youth with Newly-Diagnosed Type 1 Diabetes (T1d) MannKind Corporation announced that the first patient has been enrolled in INHALE-1ST, a clinical study evaluating the initiation of Afrezza (insulin human) Inhalation Powder shortly after a type 1 diabetes diagnosis in pediatric patients. INHALE-1ST is designed to assess the safety and efficacy of Afrezza used in combination with subcutaneously injected basal insulin once-daily in youth aged 10 to In October 2025, the FDA accepted for review a supplemental Biologics License Application (sBLA) for Afrezza Inhalation Powder in children and adolescents living with type 1 or type 2 diabetes, with a PDUFA target action date of May 29, 2026. If approved, it would be the first needle-free insulin option for pediatric patients in 100+ years of insulin therapy. Afrezza (ins insulin human) Inhalation Powder is a rapid-acting inhaled human insulin indicated to improve glycemic control in adults with diabetes mellitus. Limitations of Use: Not recommended for the treatment of diabetic ketoacidosis or in patients that smoke or have recently stopped smoking. Acute bronchospasm has been observed in Afrezza-treated patients with asthma and chronic obstructive pulmonary disease (COPD); Afrezza is contraindicated in patients with chronic lung disease such as asthma or COPD; Before initiating Afrezza, perform a detailed medical history, physical examination, and spirometry (FEV1) to identify potential lung disease in all patients. Most common adverse reactions are hypoglycemia, cough, and throat pain or irritation. Annuncio • Jan 26
MannKind Corporation Announces FDA Approval of Updated Afrezza Label Providing Starting Dose Guidance When Switching from Multiple Daily Injections (MDI) or Insulin Pump Mealtime Therapy MannKind Corporation announced that the U.S. Food and Drug Administration (FDA) has approved an update to the Prescribing Information for Afrezza®? (insulin human) Inhalation Powder, revising recommendations for the starting mealtime dosage when patients switch from subcutaneous mealtime insulin regimens. The updated labeling was supported by modeling data and in vivo results from the Dose Optimization study and the INHALE-3 trial that demonstrated improved postprandial glucose outcomes following conversion to inhaled insulin using the now-approved conversion dose. The revised dosing recommendations, provided in the table below, include recommended dose conversions from injected mealtime insulin or insulin pump bolus dosing to the appropriate mealtime dosage of Afrezza and are intended to support a clinically appropriate and safe transition for adult patients initiating Afrezza. Please see the Full Prescribing Information for additional details. Afrezza (pronouncedUh-frezz-uh) Inhalation Powder is the only ultra rapid-acting inhaled insulin approved by the U.S. food and Drug Administration to improve glycemic control in adult patients with diabetes mellitus. Administration at the beginning of meals using a small, portable inhaler, Afrezza delivers insulin via MannKind's proprietary Technosphere®? technology, enabling ultra-rapid absorption through the lungs. Afrezza causes a decline in lung pulmonary function over time as measured by FEV1. In clinical trials excluding patients with chronic lung disease and lasting up to 2 years, Afrezza-treated patients experienced a small (40mL) but greater FEV1 decline than comparator-treated patients. Assess pulmonary function with spirometry at baseline, after the first 6 mon ths of therapy and annually thereafter even in the absence of pulmonary symptoms. If symptoms persist, discontinue Afrezza. In clinical trials, 2 cases of lung cancer were observed in patients exposed to Afrezza while no cases were reported for the comparators. In both cases, a prior history of heavy tobacco use was identified as a risk factor for lung cancer. In patients with active lung cancer, a prior history of lung cancer, or in patients at risk of lung cancer, consider whether the benefits of Afrezza use outweigh this potential risk. In clinical trials enrolling patients with type 1 diabetes, diabetic ketoacidosis (DKA) was more common in Afrezza-treated patients (0.43%; n=13) than in comparator-treated patients (0.14%; n=3). Patients with type 1 diabetes should always use Afrezza concomitantly with basal insulin. These forward-looking statements are based upon MannKind's current expectations. Actual results and the timing of events could differ materially from those anticipated in such forward-looking statements as a result of various risks and uncertainties, which include, without limitation, risks associated with developing and commercializing product candidates and other risks detailed in MannKind's filings with the Securities and Exchange Commission ("SEC"), including under the "R Securities and Exchange Commission ("SEC"). Annuncio • Dec 24
MannKind Corporation Shares FUROSCIX®? Business Updates MannKind Corporation announced two business updates--approval of the FUROSCIX®? (furosemide) On-body Infusor for pediatric patients and issuance of additional intellectual property protection for the investigational-stage FUROSCIX ReadyFlow™? Autoinjector, which is currently under review by the U.S. FDA. The U.S. Food and Drug Administration (FDA) has approved a supplemental New Drug Application (sNDA) for FUROSCIX (furosemide) on-body Infusor, expanding the indication of this product to include pediatric patients weighing 43 kg or more. FUROSCIX was previously approved for the treatment of edema associated with chronic heart failure (CHF) and chronic kidney disease (CKD) in adults. This additional approval fulfills all post-marketing requirements outlined in the original approval letter under the Pediatric Research Equity Act. The U.S. Patent and Trademark Office (USPTO) issued five patents with claims that protect the FUROSCIX Ready flow Autoinjector. These patents cover the high-concentration liquid compositions of furosemide and associated methods of treatment potentially through 2040, further reinforcing MannKind's intellectual property position around this innovative drug-device combination. The patents would be listed in the FDA's Orange Book, if the FUROSCIX readyFlow Autoinjector is approved by the FDA. The newly issued patents complement previously issued patents supporting FUROSCIX and the FUROSCIXReadyFlow Autoinjector, creating a robust IP portfolio that is designed to protect the formulation and delivery approach for years to come. Annuncio • Dec 02
MannKind Corporation Announces U.S. FDA Accepts for Review its Supplemental New Drug Application of FUROSCIX ReadyFlow Autoinjector for the Treatment of Edema in Adults with Chronic Kidney Disease MannKind Corporation announced that the U.S. Food and Drug Administration (FDA) has accepted the sNDA seeking approval for FUROSCIX ReadyFlow™? Autoinjector (SCP-111), developed to deliver a subcutaneous furosemide injection in under 10 seconds as an investigational alternative to the FDA-approved FUROSCIX®? (furosemide) On-body Infusor for treatment of edema in adult patients with chronic heart failure (CHF) or chronic kidney disease (CKD). The application has been assigned a Prescription Drug User Fee Act (PDUFA) target action date of July 26, 2026. If approved, FUROSCIX Ready flow Autoinjector would provide a new option for patients with CHF or CKD to manage fluid buildup episodes from the convenience of their home rather than in a hospital setting. The FDA-approved FUROScIX On-body Infusor was approved for adult patients with edema in chronic heart failure in 2022 and in chronic kidney disease in 2025. The ReadyFlow Autoinjector would reduce administration time from five hours to under 10 seconds. The sNDA is supported by positive study results announced in August 2024. Furosemide via the ReadyFlow Autoinjector demonstrated a bioavailability of 107.3% (90% CI: 103.9 - 110.8), achieving the 90% confidence interval limit of 80 to 125%. Additionally, participants who utilized ReadyFlow Autoinjector had similar fluids, urinary sodium excretion and urinary potassium excretion at 6, 8, and 12 hours compared to IV furosemide, and was generally well tolerated with respect to injection site pain. Contact with water or other fluids and certain patient movements during treatment may cause the On-body Infusor to prematurely terminate infusion. Ensure patients can detect and respond to alarms. The most common adverse reactions with FUROSCIX administration in clinical trials were site and skin reactions including erythema, bruising, edema, and injection site pain. Annuncio • Nov 11
MannKind Corporation Announces Discontinuing its Phase 3 Clinical Trial Evaluating Nebulized Inhalation Suspension of Clofazimine On November 10, 2025, MannKind Corporation announced that it is discontinuing its Phase 3 clinical trial evaluating nebulized inhalation suspension of clofazimine (MNKD-101") for the treatment of refractory nontuberculous mycobacterial (NTM) lung disease (the ICoN-1 Study). The decision to discontinue the trial follows an analysis of sputum culture conversion data, conducted as part of routine study monitoring and in accordance with the trial protocol, for the first 46 participants who had completed the double-blind treatment phase of the study. None of these 46 participants showed evidence of sputum culture conversion, raising concerns regarding the likelihood of achieving the study's key primary endpoint. Following an ad hoc meeting of the data safety monitoring board ("DSMB") for the ICoN-1 Study on November 8, 2025, the DSMB reviewed the data and agreed with the decision to discontinue the trial due to futility. In this meeting and in all pastDSMB meetings, no safety issues were found. The Company intends to investigate the reasons for this outcome and use the findings to help guide the ongoing development of MNKD-102, the dry powder formulation of clofazimine, which is in the process of advancing from pre-clinical development towards Phase 1. Annuncio • Oct 30
MannKind Corporation to Report Q3, 2025 Results on Nov 05, 2025 MannKind Corporation announced that they will report Q3, 2025 results Pre-Market on Nov 05, 2025 Annuncio • Oct 14
Mannkind Corporation Announces U.S. Fda Accepts for Review Its Supplemental Biologics License Application for Inhaled Insulin (Afrezza) in Children and Adolescents Aged 4-17 Years Living with Diabetes MannKind Corporation announced that the U.S. Food and Drug Administration (FDA) has accepted the supplemental biologics license application (sBLA) seeking approval for Afrezza (insulin human) Inhalation Powder in children and adolescents living with type 1 or type 2 diabetes. The application has been assigned a Prescription Drug User Fee Act (PDUFA) target action date of May 29, 2026. The sBLA is based on results from the Phase 3 INHALE-1 study in children and adolescents between the ages of 4-17 who are living with either type 1 or type2 diabetes. The 26-week open-label, randomized clinical trial evaluated Afrezza in combination with basal insulin vs. multiple daily injections (MDI) with basal insulin. Six-month topline results from INHALE-1 were reported in December 2024. The submission also included safety data from the study's 26-week extension phase in which all remaining MDI patients switched to Afrezza. Full results will be shared at the International Society for Pediatric and Adolescent Diabetes (ISPAD) in early November. Afrezza was first approved by the FDA for adults (age 18+) in June 2014 and is also approved in India and Brazil. It is recognized as part of the American Diabetes Association's Standards of Care. Afrezza (insulinhuman) Inhalation Powder is a rapid-acting inhaled human insulin indicated to improve glycemic control in adults with diabetes mellitus. Limitations of Use: Not recommended for the treatment of diabetic ketoacidosis or in patients that smoke or have recently stopped smoking. Annuncio • Oct 08
MannKind Corporation (NasdaqGM:MNKD) completed the acquisition of scPharmaceuticals Inc. (NasdaqGS:SCPH). MannKind Corporation (NasdaqGM:MNKD) entered into a definitive Agreement to acquire scPharmaceuticals Inc. (NasdaqGS:SCPH) for approximately $290 million on August 24, 2025. As part of agreement, MannKind Corporation will commence a tender offer to acquire all of the outstanding shares of scPharmaceuticals's common stock, at a price per share of (i) $5.35 in cash, without interest, subject to any applicable withholding taxes and (ii) one non-tradeable contingent value right (CVR), which represents the right to receive certain milestone payments of up to an aggregate of $1.00 in cash, payable upon achieving specific regulatory and net sales milestones. In case of termination of transaction, scPharmaceuticals will pay a termination fee of $9.48 million. Under the terms of the definitive merger agreement, MannKind will promptly commence a tender offer to acquire all of the outstanding shares of scPharmaceuticals. MannKind and Blackstone amended their recently announced strategic financing agreement to provide $175 million of additional funding to support the acquisition.
The transaction is subject to approval by regulatory board / committee, minimum tender and all applicable waiting periods under the HSR Act and the Required Antitrust Approvals shall have expired or been terminated and any approvals or clearances required thereunder shall have been obtained. The board of directors of the scPharmaceuticalst unanimously recommends that stockholders accept the Offer. The deal has been unanimously approved by the boards of MannKind Corporation and scPharmaceuticals. The transaction is expected to complete in fourth quarter of 2025. As on October 6, 2025, the tender offer expired and pursuant to the offer 73.47% shares where validly tendered.
Jefferies LLC acted as financial advisor for MannKind Corporation. The team of Cooley LLP led by Barbara Borden, Rowook Park, Julia Kim, Mischi a Marca and Adam Longenbach acted as legal advisor for MannKind Corporation. Leerink Partners LLC acted as financial advisor for scPharmaceuticals Inc. The team of Latham & Watkins LLP led by Wesley Holmes, Scott Shean, Bret Stancil, Elisabeth Martin, Peter Handrinos, Alexandra McArthur, Josh Friedman, Katharine Moir, Betty Pang, Chad Jennings, Elizabeth Ohacted, Heather Deixler, Patrick English, Kristin Murphy and Steven Chinowsky as legal advisor for scPharmaceuticals Inc.
MannKind Corporation (NasdaqGM:MNKD) completed the acquisition of scPharmaceuticals Inc. (NasdaqGS:SCPH) on October 7, 2025. Annuncio • Sep 30
MannKind Corporation Appoints Dr. Ajay Ahuja as Executive Vice President and Chief Medical Officer, Effective September 29, 2025 MannKind Corporation announced the appointment of Ajay Ahuja, MD, MBA, as Chief Medical Officer, effective September 29, 2025. Dr. Ahuja will report directly to Michael Castagna, PharmD, Chief Executive Officer, and will serve on the company’s executive leadership team. Dr. Ahuja brings to MannKind more than two decades of leadership experience across the biopharmaceutical industry, spanning development-stage companies and global pharmaceutical firms since 2003. Most recently, he served as the Development and Launch Leader for a late-stage DNA-based therapeutic at Kardigan Bio, a cardiology-focused biopharmaceutical company. Previously, Dr. Ahuja held senior leadership roles at Idorsia Pharmaceuticals, where he built out the US Medical department and launched multiple novel compounds. At Allergan, he served as Global Head of Medical Affairs, overseeing all therapeutic areas and a team of over 100 professionals across the U.S. and international markets. Earlier in his career, he was Global Medical Head for Takeda Pharmaceuticals’ cardiometabolic franchise, with a focus on diabetes and cardiovascular disease. Dr. Ahuja also held impactful roles at Pfizer, Novartis, and Tepha Inc. Dr. Ahuja earned his Doctor of Medicine from Washington University School of Medicine and completed his residency and fellowship training at Northwestern University and Harvard Medical School, respectively. As a board-certified physician, Dr. Ahuja practiced medicine on staff at Boston Children’s Hospital for over a decade. He also earned an MBA from Harvard Business School before embarking on his industry career. Annuncio • Aug 25
MannKind Corporation (NasdaqGM:MNKD) entered into a definitive agreement to acquire scPharmaceuticals Inc. (NasdaqGS:SCPH) for approximately $290 million. MannKind Corporation (NasdaqGM:MNKD) entered into a definitive agreement to acquire scPharmaceuticals Inc. (NasdaqGS:SCPH) for approximately $290 million on August 24, 2025. As part of agreement, MannKind Corporation will commence a tender offer to acquire all of the outstanding shares of scPharmaceuticals's common stock, at a price per share of (i) $5.35 in cash, without interest, subject to any applicable withholding taxes and (ii) one non-tradeable contingent value right (CVR), which represents the right to receive certain milestone payments of up to an aggregate of $1.00 in cash, payable upon achieving specific regulatory and net sales milestones. In case of termination of transaction, scPharmaceuticals will pay a termination fee of $9.48 million. Under the terms of the definitive merger agreement, MannKind will promptly commence a tender offer to acquire all of the outstanding shares of scPharmaceuticals. MannKind and Blackstone amended their recently announced strategic financing agreement to provide $175 million of additional funding to support the acquisition.
The transaction is subject to approval by regulatory board / committee, minimum tender and all applicable waiting periods under the HSR Act and the Required Antitrust Approvals shall have expired or been terminated and any approvals or clearances required thereunder shall have been obtained. The board of directors of the scPharmaceuticalst unanimously recommends that stockholders accept the Offer. The deal has been unanimously approved by the boards of MannKind Corporation and scPharmaceuticals. The transaction is expected to complete in fourth quarter of 2025.
Jefferies LLC acted as financial advisor for MannKind Corporation. Barbara Borden and Rowook Park of Cooley LLP acted as legal advisor for MannKind Corporation. Leerink Partners LLC acted as financial advisor for scPharmaceuticals Inc. Scott Shean, Wesley Holmes and Bret Stancil of Latham & Watkins LLP acted as legal advisor for scPharmaceuticals Inc. Annuncio • Aug 07
MannKind Corporation announced that it expects to receive $200 million in funding MannKind Corp. announced a private placement of its senior secured term loans for gross proceeds of $200 million from new lender, Blackstone Alternative Credit Advisors LP on August 6, 2025. The company will raise $75 million in first tranche from initial term loan and $125 million in delayed draw term loan commitments, which the Company may draw at its option during the 24 months immediately following the closing date, subject to customary conditions set forth in the credit agreement. The Blackstone Credit Facility will mature on the fifth anniversary of the closing date. The loans thereunder bear interest at a rate per annum equal to 1, 3 or 6 month term SOFR, subject to a 2% floor, plus a margin of 4.75%. Interest is paid quarterly or, if the Company elects 1-month SOFR, monthly. The interest rate margin will increase to 5.00% at any time the Company’s ratio of indebtedness to adjusted EBITDA is greater than or equal to 5.00:1.00 as of the most recent fiscal quarter for which the Company has delivered financial statements.
On the same date, the company has raised $75 in first tranche. Annuncio • Jul 31
MannKind Corporation to Report Q2, 2025 Results on Aug 06, 2025 MannKind Corporation announced that they will report Q2, 2025 results Pre-Market on Aug 06, 2025 Annuncio • Jun 10
Mannkind Corporation to Highlight Data from Recent Pediatric and Adult Studies of Inhaled Insulin (Afrezza®) At American Diabetes Association's 85Th Scientific Sessions in Chicago, June 20-23 MannKind Corporation will showcase inhaled insulin at the American Diabetes Association's (ADA) 85th Scientific Sessions from June 20-23 in Chicago. Dr. Michael J. Haller, Professor and Chief of Pediatric Endocrinology at the University of Florida, will present the results from the randomized period of the INHALE-1 clinical trial during a "Future Ready" symposium. Dr. Haller is the Chair for MannKind's Phase 3 INHALE-1 study of Afrezza (insulin human) Inhalation Powder in children and adolescents (aged 4-17 years of age). The presentation/posters planned at ADA's 85th Scientific Sessions regarding the most recent advances in inhaled insulin treatment include: Symposium - Future Ready - Breakthrough in Pediatric Type 1 Diabetes Care Sunday, June 22 - 1:30 to 3:00 p.m. (Central) in Room W 181(A-C). Additionally, MannKind will host booth #1617 in the Exhibit Hall throughout the ADA's Scientific Sessions. Members of MannKind's Medical Education Team will be available for scientific exchange in the medical section of the booth. MannKind expects to issue the topline results from the full study pediatric data set with safety extension in second quarter of 2025 and anticipates submitting a Supplemental Biologics License Application in mid-2025 for a potential pediatric indication for Afrezza. Annuncio • May 02
MannKind Corporation to Report Q1, 2025 Results on May 08, 2025 MannKind Corporation announced that they will report Q1, 2025 results Pre-Market on May 08, 2025 Annuncio • Apr 03
MannKind Corporation, Annual General Meeting, May 14, 2025 MannKind Corporation, Annual General Meeting, May 14, 2025. Annuncio • Mar 10
MannKind Corporation Showcases Efficacy, Safety, and Mealtime Control Data from Recent Pediatric and Adult Studies of Afrezza at the ATTD Conference, March 19-22 MannKind Corporation will showcase data from recent studies of inhaled insulin across five presentations at the 18thInternational Conference on Advanced Technologies and Treatments for Diabetes to be held March 19-22 in Amsterdam. In addition to the planned presentations, MannKind will host booth #40 in the exhibit hall (Hall I) throughout ATTD. Members of MannKind's Clinical Education Team will be available for scientific exchange in the medical section of the booth. INHALE-1 is a Phase 3, randomized controlled trial in children and teenagers aged 4-17 with type 1 or type 2 diabetes to evaluate the efficacy and safety of inhaled insulin in combination with basal insulin versus multiple daily injections of rapid acting insulin in combination with basal insulin. The 26-week, open-label clinical trial randomized 230 pediatric subjects to one of two groups: Afrezza or multiple daily injections (MDI) of rapid acting insulin analog (RAA) in combination with basal insulin. the primary endpoint was a non-inferior change in HbA1c levels after 26 weeks. The 17-week results shared that the study met its primary efficacy endpoint of a non-inferior Change in HbA1c between baseline and week 17 compared to the usual care group. The 30-week results from the study expanded upon the positive 17-week data and showed that more people living with T1D were able to reach target A1c levels when they remain on Afrezza (plus basal insulin) or switch to Afrezza from usual care. The signature technologies - dry- powder formulations and inhalation devices - offer rapid and convenient delivery of medicines to the deep lung where they can exert an effect locally or enter the systemic circulation, depending on the target indication. Actual results and the timing of events could differ materially from those anticipated in such forward-looking statements as a result of various risks and uncertainties, which include, without limitation, the risk that issues that develop in the review by the FDA may subject to unanticipated delays or prevent from obtaining the expanded indication as well as other risks detailed in MannKind's filings with the Securities and Exchange Commission, including under the "Risk Factors" heading of its Annual Report on Form 10-K for the year ended December 31, 2025. Annuncio • Feb 27
MannKind Corporation has filed a Follow-on Equity Offering in the amount of $200 million. MannKind Corporation has filed a Follow-on Equity Offering in the amount of $200 million.
Security Name: Common Stock
Security Type: Common Stock Annuncio • Feb 20
MannKind Corporation to Report Q4, 2024 Results on Feb 26, 2025 MannKind Corporation announced that they will report Q4, 2024 results After-Market on Feb 26, 2025 Annuncio • Dec 16
MannKind Announces Six-Month Results From Phase 3 INHALE-1 Pediatric Diabetes Trial Utilizing Inhaled Insulin (Afrezza®) MannKind Corporation announced six-month results from its Phase 3 INHALE-1 study of Afrezza (insulin human) Inhalation Powder in children and adolescents (aged 4-17 years of age). MannKind expects to submit a request for a supplemental new drug application (sNDA) meeting with the U.S. Food and Drug Administration (FDA) in 1H 2025 to discuss the data and filing timeline. The INHALE-1 study is a 26-week, open-label clinical trial that randomized 230 subjects to one of two groups: Afrezza or multiple daily injections (MDI) of rapid acting insulin analog (RAA) in combination with basal insulin. The primary endpoint was a non-inferior change in HbA1c levels after 26 weeks. A 26-week extension phase in which all remaining MDI patients switched to Afrezza is still ongoing. Results were as follows: mITT analysis excludes one outlier from the primary ITT endpoint who failed to adhere to the study protocol. An analysis of the full intent-to-treat population (ITT) found that the between-group difference in mean HbA1c change over 26 weeks exceeded the prespecified non-inferiority margin of 0.4% (0.435%), largely driven by the variability of a single patient who did not adhere to the study protocol. A modified ITT (mITT) analysis, which excluded this subject, did not exceed the predetermined threshold of 0.4% (0.370%), thereby establishing the non-inferiority of Afrezza to MDI, which was the primary endpoint of the study. Over 26 weeks of treatment, no difference in lung function parameters were seen between the treatment groups. The Afrezza-treated patients had a mean FEV1 of 2.901 liters (99.6% of predicted) at baseline and 2.934 liters (96.6% of predicted) at 26 weeks. MDI-treated patients had corresponding mean FEV1 values of 2.948 liters (102.3% of predicted) and 2.957 liters (98% of predicted), respectively. Additional safety findings, including for hypoglycemia, did not show any significant concerns or differences between the treatment groups. Annuncio • Nov 05
MannKind Corporation Successfully Completes Phase 1 Trial of Nintedanib DPI for Pulmonary Fibrotic Diseases MannKind Corporation announced the successful completion of its first-in-human Phase 1 study of nintedanib DPI (MNKD-201) for pulmonary fibrotic diseases, including idiopathic pulmonary fibrosis (IPF). The key highlights of the study included: Nintedanib DPI was shown to be safe and well tolerated in healthy volunteers with the tested doses and study duration; Participants did not experience typical adverse events seen with oral nintedanib; specifically, no GI or neurologic adverse events (AEs) were reported; Two types of AEs noted - cough and drop in FEV-1; These AEs were mild, transient, and fully recovered; These AEs were not dose-dependent and there was no pattern of recurrence or worsening with repeated dosing; No bronchospasm, wheezing, other symptoms, or change in vital signs were reported; No serious adverse events or study drug discontinuation. The completed Phase 1 was a single-site, randomized, placebo-controlled, single- (n=24) and multiple-ascending dose (n=16) study in healthy adult (older than 40 years old) participants. The primary objective of the study was to evaluate the safety and tolerability of nintedanib DPI. The secondary study objective was to evaluate the pharmacokinetics (PK) of MNKD-201. Additionally, the preclinical chronic toxicology study did not show any adverse findings and supports further development of nintedanib DPI. Annuncio • Nov 01
MannKind Corporation to Report Q3, 2024 Results on Nov 07, 2024 MannKind Corporation announced that they will report Q3, 2024 results After-Market on Nov 07, 2024 Annuncio • Oct 01
Mannkind Corporation Announces Top-Level 30-Week Results from Its Phase 4 Inhale-3 Study MannKind Corporation announced top-level 30-week results from its Phase 4 INHALE-3 study, in which additional patients living with type 1 diabetes achieved target A1c levels during the extension phase. The completer analysis which included all people on inhaled insulin, evaluated two separate groups - one that utilized Afrezza®? (plus basal insulin) over 30 weeks, and a second group of patients who switched to Afrezza at week 17 from usual care, defined as multiple daily injections (MDI), an automated insulin delivery system, (AID) or a pump without automation. There was continued improvement in the Afrezza (plus degludec)-treated group, with additional subjects achieving A1c 1) to identify potential lung disease in all patients. Most common adverse reactions are hypoglycemia, cough, and throat pain or irritation. Annuncio • Sep 19
MannKind Corporation Announces Clearance from PMDA to Initiate Phase 3 Clinical Trial in Japan Evaluating Clofazimine Inhalation Suspension for the Treatment of Nontuberculous Mycobacterial (NTM) Lung Disease MannKind Corporation announced that it has received clearance from Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) to initiate the Phase 3 study (ICoN-1) of Clofazimine Inhalation Suspension for the treatment of NTM lung disease. The global study is now cleared by health authorities to proceed in four countries (U.S., Japan, South Korea and Australia) with a fifth (Taiwan) expected in Fourth Quarter 2024. The ICoN-1 study was initiated in the United States in June 2024 and had its first patient randomized in September. In all, approximately 230 eligible participants will be enrolled and randomized at more than 100 sites across the U.S. and globally to ensure a minimum of 180 participants are evaluable for efficacy. Details of the ICoN-1 study and sites can be found at: ClinicalTrials.gov (NCT06418711). Annuncio • Aug 14
Mannkind Corporation Announces Board Changes, September 30, 2024 MannKind Corporation announced that Kent Kresa has decided to retire from MannKind’s Board of Directors effective September 30, 2024. In addition, the Board of Directors has appointed Steven B. Binder to the Board, also effective September 30, 2024. Kresa, who has served on MannKind’s Board of Directors since June 2004, was Chairman from 2016 until December 2020. Upon his retirement from the MannKind Board, Mr. Kresa will continue to be associated with the company in the capacity of Chairman Emeritus. Binder previously served as MannKind’s Chief Financial Officer from July 2017 until April 2024 and currently serves as Executive Vice President, Special Projects. Mr. Binder will remain in that role until he joins the Board of Directors on September 30, 2024, after which he will no longer be an employee of the Company. With the addition of Binder, there will remain nine total members of the MannKind Board of Directors. Reported Earnings • Aug 08
Second quarter 2024 earnings released: US$0.007 loss per share (vs US$0.02 loss in 2Q 2023) Second quarter 2024 results: US$0.007 loss per share (improved from US$0.02 loss in 2Q 2023). Revenue: US$72.4m (up 49% from 2Q 2023). Net loss: US$2.01m (loss narrowed 62% from 2Q 2023). Revenue is forecast to grow 13% p.a. on average during the next 3 years, compared to a 20% growth forecast for the Biotechs industry in Europe. 
