Anuncio • 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 Anuncio • Apr 09
MannKind Corporation, Annual General Meeting, May 20, 2026 MannKind Corporation, Annual General Meeting, May 20, 2026. Anuncio • 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 Anuncio • 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. Anuncio • 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"). Anuncio • 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. Anuncio • 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. Anuncio • 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. Anuncio • 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 Anuncio • 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. Anuncio • 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. Anuncio • 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. Anuncio • 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. Anuncio • 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. Anuncio • 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 Anuncio • 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. Anuncio • 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 Anuncio • Apr 03
MannKind Corporation, Annual General Meeting, May 14, 2025 MannKind Corporation, Annual General Meeting, May 14, 2025. Anuncio • 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. Anuncio • 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 Anuncio • 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 Anuncio • 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. Anuncio • 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. Anuncio • 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 Anuncio • 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. Anuncio • 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). Anuncio • 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. Anuncio • Jul 31
MannKind Corporation to Report Q2, 2024 Results on Aug 07, 2024 MannKind Corporation announced that they will report Q2, 2024 results Pre-Market on Aug 07, 2024 Anuncio • Jun 22
MannKind Corporation Announces Positive 17-Week Results from the INHALE-3 Study MannKind Corporation announced positive 17-week results from the INHALE-3 study, a Phase 4 U.S. clinical trial evaluating Afrezza® (plus basal insulin) vs. usual care (defined as multiple daily injections (MDI), an automated insulin delivery system, (AID) or a pump without automation) utilizing a higher initial conversion dose from mealtime injectable insulin to inhaled insulin. The study, which was presented by the INHALE-3 investigational team at the American Diabetes Association’s (ADA) 84th Scientific Sessions in Orlando, met its primary efficacy endpoint of a non-inferior change in HbA1c between baseline and week 17 compared to the usual care group. Key sub-analysis findings included: More subjects utilizing inhaled insulin achieved glycemic targets: 30% of inhaled insulin group reached <7% (HbA1c) at 17 weeks vs. 17% of the usual care group; 21% of inhaled insulin group vs. 0% of usual care group met A1c goal of <7% if baseline was >7%; 24% of the Afrezza group and 13% of the usual care group achieved TIR above 70% with no increased hypoglycemia in the inhaled insulin group. No difference in CGM-measured hypoglycemia between the groups; Study helps to establish a titrated basal-bolus ratio that is approximately 70/30 inhaled insulin to basal vs. 50/50 for usual care; While more people met the glycemic target of A1c (less than 7%) with Afrezza, some subjects worsened when switching from usual care to inhaled insulin, potentially due to missing doses of inhaled insulin during the day and/or underdosing going into bedtime; More than 50% of subjects at the end of the study expressed an interest in continuing to use Afrezza. The INHALE-3 study is a 17-week, randomized controlled trial with a 13-week extension conducted across 19 U.S. sites. The study, which enrolled 141 patients (123 randomized), assigned participants over 18 years of age with T1D who are using MDI, an automated insulin delivery system, or a pump without automation to either continue their standard of care or initiate an insulin regimen of a daily basal injection plus Afrezza for boluses (mealtime and corrections). Both arms utilized continuous glucose monitoring to assess glucose control. A1c levels were obtained at baseline, 17 and 30-weeks. The full 30-week results of INHALE-3 will be presented at future conferences. New Risk • May 09
New major risk - Financial position The company's interest payments are not well covered by earnings. Net interest cover: 1.5x This is considered a major risk. If the company is unable to fund interest repayments on its debt through profits, it may be forced into reducing its debt burden through selling assets, undertaking a potentially costly capital raising or even into bankruptcy in the worst case scenario. Currently, the following risks have been identified for the company: Major Risks Interest payments are not well covered by earnings (1.5x net interest cover). Negative equity (-US$230m). Minor Risk Shareholders have been diluted in the past year (3.0% increase in shares outstanding). Anuncio • May 08
MannKind Receives U.S. FDA Fast Track Designation for Clofazimine Inhalation Suspension for the Treatment of Nontuberculous Mycobacterial (NTM) Lung Disease MannKind Corporation announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation of Clofazimine Inhalation Suspension (MNKD-101) for the treatment of nontuberculous mycobacterial (NTM) lung disease. Fast track designation is intended to facilitate the development, and expedite the review, of medicines to treat serious conditions and fill an unmet medical need. ICoN-1 is a multi-national, randomized, double-blind, placebo-controlled trial to evaluate the efficacy and safety of Clofazimine Inhalation Suspension when added to guideline-based therapy in adults with refractory NTM lung disease caused by Mycobacterium Avium Complex (MAC), followed by an open-label extension. This single registrational study anticipates getting underway in June 2024 in the U.S., and internationally in the second half of 2024. The U.S. FDA previously designated Clofazimine Inhalation Suspension as both an orphan drug and a qualified infectious disease product (QIDP) for the treatment of pulmonary NTM infections. A drug that receives orphan drug exclusivity receives seven years of exclusivity, and one that also earns QIDP designation, may receive an additional five years of market exclusivity. Anuncio • May 03
MannKind Corporation to Report Q1, 2024 Results on May 08, 2024 MannKind Corporation announced that they will report Q1, 2024 results on May 08, 2024 Anuncio • Apr 06
MannKind Corporation, Annual General Meeting, May 15, 2024 MannKind Corporation, Annual General Meeting, May 15, 2024, at 10:00 US Eastern Standard Time. Agenda: To elect the nine nominees named herein as directors to serve for the upcoming year and until their successors are elected; to approve, on an advisory basis, the compensation of the named executive officers of company, as disclosed in company proxy statement for the Annual Meeting; and to discuss other matters. Anuncio • Mar 11
MannKind Corporation Announces INHALE-3 Study’s Initial Meal Challenge Results Comparing Afrezza® Head-To-Head With Multiple Daily Injections (MDI) and Insulin Pumps MannKind Corporation announced initial meal challenge data from INHALE-3 that was presented by Dr. Irl B. Hirsch at the 17thInternational Conference on Advanced Technologies and Treatments for Diabetes (ATTD) in Florence on March 8th. INHALE-3 is a Phase 4 U.S. clinical trial evaluating inhaled insulin (plus basal) vs. standard of care. The statistically significant findings included: Subjects utilizing inhaled insulin experienced significantly reduced post-meal hyperglycemia, compared with those who used subcutaneous rapid-acting analogues (RAA) delivered by MDI or pumps Area under the curve (AUC; 180 mg/dL) was reduced by 20%; Inhaled insulin subjects demonstrated significantly lower glucose excursions from baseline; Mean glucose excursions were reduced by 22%; In the inhaled insulin group, mean glucose levels peaked 15 minutes sooner than in the standard of care group despite inhaled insulin being given at start of the meal vs. RAA being administered 5-15 minutes prior to the meal. The 17-week endpoint results from INHALE-3 will be presented Saturday, June 22, during a symposium at the American Diabetes Association’s 84th Scientific Sessions in Orlando. INHALE-3 is a 17-week randomized controlled trial with a 13-week extension. The study, which enrolled 141 patients (123 randomized), assigned participants over 18 years of age with T1D who are using MDI, an automated insulin delivery system, or a pump without automation to either continue their standard of care or initiate an insulin regimen of a daily basal injection plus Afrezza for boluses (mealtime and corrections). Subjects utilizing inhaled insulin received a higher initial conversion dose than in the current label. Both arms utilized continuous glucose monitoring to assess glucose control. A1c levels were obtained at baseline, 17 and 30-weeks. For the meal challenge, the inhaled insulin group took an inhaled insulin dose immediately prior to a standardized meal (a 240 calorie nutritional shake) whereas those using usual care used RAA 5-15 minutes prior to the meal. Afrezza (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. Reported Earnings • Feb 29
Full year 2023 earnings: EPS and revenues exceed analyst expectations Full year 2023 results: US$0.045 loss per share (improved from US$0.34 loss in FY 2022). Revenue: US$199.0m (up 99% from FY 2022). Net loss: US$11.9m (loss narrowed 86% from FY 2022). Revenue exceeded analyst estimates by 2.8%. Earnings per share (EPS) also surpassed analyst estimates by 23%. Revenue is forecast to grow 16% p.a. on average during the next 3 years, compared to a 17% growth forecast for the Biotechs industry in the US. Over the last 3 years on average, earnings per share has increased by 23% per year but the company’s share price has only increased by 3% per year, which means it is significantly lagging earnings growth. Anuncio • Feb 21
MannKind Corporation to Report Q4, 2023 Results on Feb 27, 2024 MannKind Corporation announced that they will report Q4, 2023 results on Feb 27, 2024 Anuncio • Feb 15
MannKind Corporation Announces Enrollment Goal Completion of INHALE-1 Pediatric Diabetes Trial Utilizing Afrezza® MannKind Corporation announced that it has fully enrolled 305 patients living with Type 1 or type 2 diabetes in its INHALE-1 study assessing efficacy and safety of inhaled insulin in the pediatric population. INHALE-1 is a 26-week open-label, randomized clinical trial with a 26-week extension. The primary endpoint is change in HbA1c level after 26 weeks. Secondary endpoints include change in fasting plasma glucose after 26 weeks and rate of hypoglycemic events. The multi-center study evaluated Afrezza in combination with basal insulin vs. multiple daily injections (MDI) of insulin in children and adolescents aged 4-17 who are living with type 1 or type 2 diabetes. Recent Insider Transactions Derivative • Dec 17
CEO & Director notifies of intention to sell stock Michael Castagna intends to sell 100k shares in the next 90 days after lodging an Intent To Sell Form on the 14th of December. If the sale is conducted around the recent share price of US$4.00, it would amount to US$400k. For the year to December 2016, Michael's total compensation was 16% salary and 84% other compensation. This indicates that these sales could comprise a meaningful part of their income for the year. Since March 2023, Michael's direct individual holding has increased from 2.15m shares to 2.35m. There have been no trades via on-market transactions or options from company insiders in the last 12 months. Reported Earnings • Nov 09
Third quarter 2023 earnings: EPS and revenues exceed analyst expectations Third quarter 2023 results: EPS: US$0.006 (up from US$0.056 loss in 3Q 2022). Revenue: US$51.3m (up 56% from 3Q 2022). Net income: US$1.72m (up US$16.2m from 3Q 2022). Profit margin: 3.4% (up from net loss in 3Q 2022). The move to profitability was driven by higher revenue. Revenue exceeded analyst estimates by 1.0%. Earnings per share (EPS) also surpassed analyst estimates. Revenue is forecast to grow 21% p.a. on average during the next 3 years, compared to a 14% growth forecast for the Biotechs industry in the US. Over the last 3 years on average, earnings per share has increased by 6% per year whereas the company’s share price has increased by 9% per year. Anuncio • Nov 07
MannKind Corporation Announces Completion of Enrollment in U.S. Phase 4 Inhale-3 Clinical Trial in Patients Living with Type 1 Diabetes MannKind Corporation announced that it has fully enrolled patients in INHALE-3, a Phase 4 clinical trial evaluating inhaled insulin (combined with basal insulin) versus usual care in adults living with type 1 diabetes. INHALE-3 is a 17-week randomized controlled trial with a 13-week extension. The study will randomly assign participants over 18 years of age with T1D who are using Multiple Daily Injections (MDI), an automated insulin delivery (AID) system, or a pump without automation to either continue their usual care or adopt an insulin regimen of a daily basal injection plus Afrezza at mealtimes. Both arms will utilize continuous glucose monitoring to assess mealtime control and A1c levels. Anuncio • Nov 01
MannKind Corporation to Report Q3, 2023 Results on Nov 07, 2023 MannKind Corporation announced that they will report Q3, 2023 results on Nov 07, 2023 Price Target Changed • Oct 10
Price target increased by 9.8% to US$7.25 Up from US$6.60, the current price target is an average from 6 analysts. New target price is 71% above last closing price of US$4.24. Stock is up 34% over the past year. The company is forecast to post a net loss per share of US$0.082 next year compared to a net loss per share of US$0.34 last year. Reported Earnings • Aug 08
Second quarter 2023 earnings: EPS and revenues exceed analyst expectations Second quarter 2023 results: US$0.02 loss per share (improved from US$0.11 loss in 2Q 2022). Revenue: US$48.6m (up 157% from 2Q 2022). Net loss: US$5.27m (loss narrowed 82% from 2Q 2022). Revenue exceeded analyst estimates by 13%. Earnings per share (EPS) also surpassed analyst estimates by 53%. Revenue is forecast to grow 23% p.a. on average during the next 3 years, compared to a 15% growth forecast for the Biotechs industry in the US. Over the last 3 years on average, earnings per share has fallen by 6% per year but the company’s share price has increased by 50% per year, which means it is well ahead of earnings. Anuncio • Aug 01
MannKind Corporation to Report Q2, 2023 Results on Aug 07, 2023 MannKind Corporation announced that they will report Q2, 2023 results on Aug 07, 2023 Anuncio • Jun 23
Mannkind Corporation Launches Inhale-3 Study to Address the Most Important Unmet Need in Adults Living with Type 1 Diabetes (T1d) MannKind Corporation announced that it is launching the INHALE-3 study to address the most important unmet need in adults living with T1D. INHALE-3 is a 17-week randomized controlled trial with a 13-week extension. The study will randomly assign participants over 18 years of age with T1D who are using MDI, an automated insulin delivery (AID) system, or a pump without automation to either continue their usual care or adopt an insulin regimen of basal injections plus Afrezza. Both arms will utilize continuous glucose monitoring to assess mealtime control and A1c levels. Severe hypoglycemia can cause seizures, may be life-threatening, or cause death. Hypoglycemia can impair concentration ability and reaction time; this may place an individual and others at risk in situations where these abilities are important (e.g., driving or operating other machinery). Hypoglycemia can happen suddenly, and symptoms may differ across patients and change over time in the same patient. Patients and caregivers should be educated to recognize and manage hypoglycemia. Self-monitoring of blood glucose plays an essential role in the prevention and management of hypoglycemia. Decline in Pulmonary Function: 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 (40 mL) but greater FEV1 decline than comparator-treated patients. Assess pulmonary function with pulmonary function at baseline, after the first 6 months of therapy and annually thereafter even in the absence of pulmonary symptoms. In patients who have a decline of =20% in FEV1 from baseline, consider discontinuing AFREZZA. Consider more frequent lung function assessment in patients with pulmonary symptoms, e.g., wheezing, bronchospasm, breathing difficult, or persistent or recurring cough. 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. Two additional cases of lung cancer (squamous cell and lung blastoma) were reported in non-smokers exposed to AFREZZA after the trial completion. These data are insufficient to determine whether AFREZZA has an effect on lung or respiratory tract tumors. 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. Recent Insider Transactions Derivative • May 28
CEO & Director notifies of intention to sell stock Michael Castagna intends to sell 150k shares in the next 90 days after lodging an Intent To Sell Form on the 24th of May. If the sale is conducted around the recent share price of US$4.69, it would amount to US$703k. For the year to December 2016, Michael's total compensation was 16% salary and 84% other compensation. This indicates that these sales could comprise a meaningful part of their income for the year. Since September 2022, Michael's direct individual holding has decreased from 2.05m shares to 1.98m. There has only been one transaction (US$18k sale) from insiders over the last 12 months. Anuncio • May 25
Dr. Burkhard Blank Joins MannKind Corporation as Executive Vice President of Research & Development and Chief Medical Officer MannKind Corporation announced Burkhard Blank, MD, has joined the company as Executive Vice President, Research & Development and Chief Medical Officer, effective today. Blank will report directly to Michael Castagna, PharmD, Chief Executive Officer, and will serve on the company’s executive leadership team. Dr. Blank brings to MannKind more than 25 years of broad managerial experience and global drug development across all clinical, medical, and regulatory disciplines in multiple diseases areas. He has deep knowledge in the inhaled therapeutics space and has been instrumental in eight NDA and MAA submissions for small molecules, biologics, and drug-device combinations. Dr. Blank recently served as CMO/Head of R&D at Pharnext SA after serving seven years in the same position at Acorda Therapeutics. While at Acorda, he oversaw the Phase 3 development in North America and in Europe for Inbrija® (levodopa inhalation powder) for Parkinson’s disease with subsequent one-cycle approvals by the FDA and the EMA. Earlier in his career, Dr. Blank spent 20 years between Boehringer Ingelheim Pharmaceuticals in Ridgefield, CT, and Boehringer Ingelheim GmbH in Germany, serving in progressive leadership roles. Under his guidance, four products received approval including Spiriva® (for COPD) for which he oversaw development and led the presentation at the FDA advisory committee meeting. He has proven success in large and small organizations and will be based in Danbury. He received his medical degree from Universitaet Marburg, Germany, and is board-certified in internal medicine. Reported Earnings • May 10
First quarter 2023 earnings: EPS and revenues exceed analyst expectations First quarter 2023 results: US$0.037 loss per share (improved from US$0.10 loss in 1Q 2022). Revenue: US$40.6m (up 239% from 1Q 2022). Net loss: US$9.80m (loss narrowed 62% from 1Q 2022). Revenue exceeded analyst estimates by 8.6%. Earnings per share (EPS) also surpassed analyst estimates by 20%. Revenue is forecast to grow 24% p.a. on average during the next 3 years, compared to a 18% growth forecast for the Biotechs industry in the US. Over the last 3 years on average, earnings per share has fallen by 15% per year but the company’s share price has increased by 55% per year, which means it is well ahead of earnings. Major Estimate Revision • Mar 02
Consensus EPS estimates fall by 17%, revenue upgraded The consensus outlook for fiscal year 2023 has been updated. 2023 revenue forecast increased from US$167.0m to US$171.5m. Forecast EPS reduced from -US$0.12 to -US$0.14 per share. Biotechs industry in the US expected to see average net income decline 61% next year. Consensus price target up from US$6.17 to US$6.67. Share price fell 7.5% to US$4.83 over the past week. Price Target Changed • Feb 27
Price target increased by 8.1% to US$6.67 Up from US$6.17, the current price target is an average from 6 analysts. New target price is 24% above last closing price of US$5.38. Stock is up 105% over the past year. The company is forecast to post a net loss per share of US$0.14 next year compared to a net loss per share of US$0.34 last year. Reported Earnings • Feb 24
Full year 2022 earnings: EPS misses analyst expectations Full year 2022 results: US$0.34 loss per share (further deteriorated from US$0.33 loss in FY 2021). Revenue: US$99.8m (up 32% from FY 2021). Net loss: US$87.4m (loss widened 8.0% from FY 2021). Revenue was in line with analyst estimates. Earnings per share (EPS) missed analyst estimates by 5.7%. Revenue is forecast to grow 27% p.a. on average during the next 3 years, compared to a 14% growth forecast for the Biotechs industry in the US. Over the last 3 years on average, earnings per share has fallen by 18% per year but the company’s share price has increased by 62% per year, which means it is well ahead of earnings. Anuncio • Feb 17
MannKind Corporation to Report Q4, 2022 Results on Feb 23, 2023 MannKind Corporation announced that they will report Q4, 2022 results at 4:00 PM, US Eastern Standard Time on Feb 23, 2023 Anuncio • Jan 24
MannKind Corporation Announces its Inhaled Clofazimine Will Advance to an Adaptive Phase 2/3 Study For Potential Treatment of Rare Lung Disease MannKind Corporation announced clofazimine inhalation suspension (MNKD 101) will advance to an adaptive Phase 2/3 study. Additionally, a paper has been published in the American Society for Microbiology journal Antimicrobial Agents and Chemotherapy examining the potential for treatment of nontuberculous mycobacterial (NTM) infection through direct delivery of inhaled clofazimine to the lungs, overcoming the systemic toxicity witnessed in oral treatments. Pulmonary NTM infection is recognized as a major global health concern due to its rising prevalence worldwide. It is a serious infection that is caused by bacteria common in the environment that can lead to a reduction in lung function, cough, fatigue, and quality of life. It is estimated that approximately 86,000-180,000 people in the U.S. alone are living with NTM lung disease, and it is on the rise growing 8% each year with women, the elderly, and those with underlying lung conditions at greatest risk. MNKD-101 has been designated by the FDA as both an orphan lung and a qualified infectious disease product (QIDP) for the treatment of pulmonary NTM infections. The 28-day preclinical toxicology study included toxicokinetic analyses on days 29, 56, and 84. The findings indicated: Significant residual drug in lung tissue, and long lung residence post-dosing at all three dose levels. Drug concentrations in the lung remained well above the average NTM minimum inhibitory concentration (MIC, for MAC and Mabsc) at all time points, with measurable clofazimine levels at 28- and 56-days post-dosing. Study MKC-CI-001 was a Phase I randomized, double-blind, placebo-controlled, single- (SAD) and multiple-ascending dose (MAD) study to evaluate the safety, tolerability, and pharmacokinetics (PK) of MNKD-101. The dosing study evaluated low, mid, and high doses of clofazimine administered using a jet nebulizer. The key safety findings of the study included: Clofazimine inhalation solution found to be generally well tolerated at daily doses of up to 90 mg. No lab abnormalities, QT prolongation, or serious adverse events were identified. 
