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Yahoo
8 hours ago
- Business
- Yahoo
Insmed Announces Pricing of $750 Million Public Offering of Common Stock
BRIDGEWATER, N.J., June 11, 2025 /PRNewswire/ -- Insmed Incorporated (Nasdaq: INSM), a people-first global biopharmaceutical company striving to deliver first- and best-in-class therapies to transform the lives of patients facing serious diseases, today announced that it priced an underwritten public offering of 7,812,500 shares of its common stock at a price to the public of $96.00 per share. The gross proceeds to Insmed from the offering, before deducting underwriting discounts and commissions and other offering expenses payable by Insmed, are expected to be approximately $750 million. In addition, Insmed has granted the underwriters a 30-day option to purchase up to an additional 1,171,875 shares of common stock. Insmed intends to use the net proceeds from this offering to fund continued research and development of brensocatib as well as pre-commercial and, if approved, commercialization activities related to brensocatib, activities related to the further commercialization and development of ARIKAYCE® (amikacin liposome inhalation suspension), further research and development of treprostinil palmitil inhalation powder (TPIP), INS1201, and the Company's pre-clinical research product candidates, and for other general corporate purposes, including business expansion activities. Goldman Sachs & Co. LLC, Leerink Partners, BofA Securities, Jefferies and J.P. Morgan are acting as joint book-running managers for the offering. Stifel is acting as co-lead manager for the offering. The offering is expected to close on June 13, 2025, subject to the satisfaction of customary closing conditions. The public offering of common stock described above is being made pursuant to Insmed's shelf registration statement on Form S-3 (File No. 333-272088) that was previously filed with the Securities and Exchange Commission (SEC) and became automatically effective on May 19, 2023. A preliminary prospectus supplement relating to and describing the terms of the offering was filed with the SEC and is available on the SEC's website at Copies of the final prospectus supplement and the accompanying prospectus relating to this offering may be obtained, when available, from Goldman Sachs & Co. LLC, Prospectus Department, 200 West Street, New York, NY 10282, telephone: 1-866-471-2526, facsimile: 212-902-9316 or by emailing Prospectus-ny@ or Leerink Partners LLC, Attention: Syndicate Department, 53 State Street, 40th Floor, Boston, MA 02109, by telephone at (800) 808-7525, ext. 6105, or by email at syndicate@ This press release shall not constitute an offer to sell or a solicitation of an offer to buy, nor shall there be any sale of these securities in any jurisdiction in which such an offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such jurisdiction. About Insmed Insmed Incorporated is a people-first global biopharmaceutical company striving to deliver first- and best-in-class therapies to transform the lives of patients facing serious diseases. The Company is advancing a diverse portfolio of approved and mid- to late-stage investigational medicines as well as cutting-edge drug discovery focused on serving patient communities where the need is greatest. Insmed's most advanced programs are in pulmonary and inflammatory conditions, including a therapy approved in the United States, Europe, and Japan to treat a chronic, debilitating lung disease. The Company's early-stage programs encompass a wide range of technologies and modalities, including gene therapy, AI-driven protein engineering, protein manufacturing, RNA end-joining, and synthetic rescue. Headquartered in Bridgewater, New Jersey, Insmed has offices and research locations throughout the United States, Europe, and Japan. Forward-looking Statements This press release contains forward-looking statements that involve substantial risks and uncertainties. "Forward-looking statements," as that term is defined in the Private Securities Litigation Reform Act of 1995, are statements that are not historical facts and involve a number of risks and uncertainties. Words herein such as "may," "will," "should," "could," "would," "expects," "plans," "anticipates," "believes," "estimates," "projects," "predicts," "intends," "potential," "continues," and similar expressions (as well as other words or expressions referencing future events, conditions or circumstances) may identify forward-looking statements. The forward-looking statements in this press release are based upon the Company's current expectations and beliefs, and involve known and unknown risks, uncertainties and other factors, which may cause the Company's actual results, performance and achievements and the timing of certain events to differ materially from the results, performance, achievements or timings discussed, projected, anticipated or indicated in any forward-looking statements. Such risks, uncertainties and other factors include, among others, the following: the risks and uncertainties associated with market conditions and the satisfaction of customary closing conditions related to the public offering; failure to continue to successfully commercialize ARIKAYCE, our only approved product, in the United States ("U.S."), Europe or Japan (amikacin liposome inhalation suspension, Liposomal 590 mg Nebuliser Dispersion, and amikacin sulfate inhalation drug product, respectively), or to maintain U.S., European or Japanese approval for ARIKAYCE; our inability to obtain full approval of ARIKAYCE from the U.S. Food and Drug Administration, including the risk that we will not successfully or in a timely manner complete the confirmatory post-marketing clinical trial required for full approval of ARIKAYCE, or our failure to obtain regulatory approval to expand ARIKAYCE's indication to a broader patient population; failure to obtain, or delays in obtaining, regulatory approvals for brensocatib, TPIP or our other product candidates in the U.S., Europe or Japan or for ARIKAYCE outside the U.S., Europe or Japan, including separate regulatory approval for the Lamira® Nebulizer System in each market and for each usage; failure to successfully commercialize brensocatib, TPIP or our other product candidates, if approved by applicable regulatory authorities, or to maintain applicable regulatory approvals for brensocatib, TPIP or our other product candidates, if approved; uncertainties or changes in the degree of market acceptance of ARIKAYCE or, if approved, brensocatib, TPIP, or our other product candidates, by physicians, patients, third-party payors and others in the healthcare community; our inability to obtain and maintain adequate reimbursement from government or third-party payors for ARIKAYCE or, if approved, brensocatib, TPIP, or our other product candidates, or acceptable prices for ARIKAYCE or, if approved, brensocatib, TPIP, or our other product candidates; inaccuracies in our estimates of the size of the potential markets for ARIKAYCE, brensocatib, TPIP, or our other product candidates or in data we have used to identify physicians, expected rates of patient uptake, duration of expected treatment, or expected patient adherence or discontinuation rates; failure of third parties on which the Company is dependent to manufacture sufficient quantities of ARIKAYCE, brensocatib, or TPIP for commercial or clinical needs, to conduct the Company's clinical trials, or to comply with the Company's agreements or laws and regulations that impact the Company's business; the risks and uncertainties associated with, and the perceived benefits of, our senior secured loan with certain funds managed by Pharmakon Advisors, LP and our royalty financing with OrbiMed Royalty & Credit Opportunities IV, LP, including our ability to maintain compliance with the covenants in the agreements for the senior secured loan and royalty financing and the impact of the restrictions on our operations under these agreements; our inability to create or maintain an effective direct sales and marketing infrastructure or to partner with third parties that offer such an infrastructure for distribution of ARIKAYCE or any of our product candidates that are approved in the future; failure to successfully conduct future clinical trials for ARIKAYCE, brensocatib, TPIP, or our other product candidates and our potential inability to enroll or retain sufficient patients to conduct and complete the trials or generate data necessary for regulatory approval of our product candidates or to permit the use of ARIKAYCE in the broader population of patients with Mycobacterium avium complex lung disease, among other things; development of unexpected safety or efficacy concerns related to ARIKAYCE, brensocatib, TPIP, or our other product candidates; risks that our clinical studies will be delayed, that serious side effects will be identified during drug development, or that any protocol amendments submitted will be rejected; failure to successfully predict the time and cost of development, regulatory approval and commercialization for novel gene therapy products; the risk that the full data set from the TPIP study in pulmonary arterial hypertension ("PAH") or data generated in further clinical trials of TPIP will not be consistent with the topline results of the TPIP PAH study; risk that interim, topline or preliminary data from our clinical trials that we announce or publish from time to time may change as more patient data become available or may be interpreted differently if additional data are disclosed, or that blinded data will not be predictive of unblinded data; risk that our competitors may obtain orphan drug exclusivity for a product that is essentially the same as a product we are developing for a particular indication; our inability to attract and retain key personnel or to effectively manage our growth; our inability to successfully integrate our acquisitions and appropriately manage the amount of management's time and attention devoted to integration activities; risks that our acquired technologies, products and product candidates will not be commercially successful; inability to adapt to our highly competitive and changing environment; inability to access, upgrade or expand our technology systems or difficulties in updating our existing technology or developing or implementing new technology; risk that we are unable to maintain our significant customers; risk that government healthcare reform materially increases our costs and damages our financial condition; business or economic disruptions due to catastrophes or other events, including natural disasters or public health crises; risk that our current and potential future use of artificial intelligence and machine learning may not be successful; deterioration in general economic conditions in the U.S., Europe, Japan and globally, including the effect of prolonged periods of inflation, affecting us, our suppliers, third-party service providers and potential partners; the risk that we could become involved in costly intellectual property disputes, be unable to adequately protect our intellectual property rights or prevent disclosure of our trade secrets and other proprietary information, and incur costs associated with litigation or other proceedings related to such matters; restrictions or other obligations imposed on us by agreements related to ARIKAYCE, brensocatib or our other product candidates, including our license agreements with PARI Pharma GmbH and AstraZeneca AB, and failure to comply with our obligations under such agreements; the cost and potential reputational damage resulting from litigation to which we are or may become a party, including product liability claims; risk that our operations are subject to a material disruption in the event of a cybersecurity attack or issue; our limited experience operating internationally; changes in laws and regulations applicable to our business, including any pricing reform and laws that impact our ability to utilize certain third parties in the research, development or manufacture of our product candidates, and failure to comply with such laws and regulations; our history of operating losses, and the possibility that we never achieve or maintain profitability; goodwill impairment charges affecting our results of operations and financial condition; inability to repay our existing indebtedness and uncertainties with respect to our ability to access future capital; and delays in the execution of plans to build out an additional third-party manufacturing facility approved by the appropriate regulatory authorities and unexpected expenses associated with those plans. The Company may not actually achieve the results, plans, intentions or expectations indicated by the Company's forward-looking statements because, by their nature, forward-looking statements involve risks and uncertainties because they relate to events and depend on circumstances that may or may not occur in the future. For additional information about the risks and uncertainties that may affect the Company's business, please see the factors discussed in Item 1A, "Risk Factors," in the Company's Annual Report on Form 10-K for the year ended December 31, 2024 and any subsequent Company filings with the SEC. The Company cautions readers not to place undue reliance on any such forward-looking statements, which speak only as of the date of this press release. The Company disclaims any obligation, except as specifically required by law and the rules of the SEC, to publicly update or revise any such statements to reflect any change in expectations or in events, conditions or circumstances on which any such statements may be based, or that may affect the likelihood that actual results will differ from those set forth in the forward-looking statements. Contact: Investors: Bryan DunnVice President, Investor Relations(646) Media: Claire MulhearnVice President, Corporate Communications(862) 842-6819media@ View original content to download multimedia: SOURCE Insmed Incorporated Error in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
Yahoo
21-05-2025
- Health
- Yahoo
MAC Lung Disease Market Poised for Growth Across the 7MM During the Forecast Period (2025-2034) Amid Rising Prevalence and New Therapeutic Solutions
The MAC lung disease market is predicted to grow in the coming years. This growth is mainly driven by the launch of innovative therapies such as MNKD-101, Bedaquiline fumarate (TMC207), and SPR720, among others. Furthermore, the increasing prevalence of MAC lung disease, influenced by host factors like advanced age, COPD, thoracic abnormalities, and environmental exposure to MAC in soil, water, and aerosol-generating activities, is expected to expand the MAC lung disease market potential. LAS VEGAS, May 20, 2025 /PRNewswire/ -- Mycobacterium avium Complex (MAC) refers to a group of bacteria, primarily Mycobacterium avium and Mycobacterium intracellulare, that are responsible for MAC lung disease. Accurate identification typically requires genetic testing. MAC is the leading cause of nontuberculous mycobacterial (NTM) lung infections in the United States and can affect people of all ages, although it is more common in older adults, postmenopausal women, smokers, and individuals with weakened immune systems or pre-existing lung conditions such as bronchiectasis, COPD, cystic fibrosis, emphysema, or a prior history of tuberculosis. DelveInsight estimates that in 2023, there were around 119K diagnosed prevalent cases of MAC lung disease across the 7MM, with the United States accounting for approximately 64% of these cases. In 2023, there were an estimated 151K diagnosed prevalent cases of NTM lung disease across the 7MM, with the number expected to rise by 2034. Treatment for MAC lung disease typically involves a combination of multiple antibiotics, most often including a macrolide (such as azithromycin or clarithromycin), a rifamycin (such as rifampin or rifabutin), and ethambutol. This regimen works by inhibiting protein synthesis, disrupting the bacterial cell wall, and preventing replication of the mycobacteria. Therapy generally continues for 12 to 18 months, depending on the severity of the disease and the pathogen's drug susceptibility. Supportive therapies play an important role, especially for patients with preexisting lung conditions. Chest physiotherapy, mucolytic agents, and bronchodilators help clear mucus and alleviate airway obstruction. Additionally, devices like positive expiratory pressure (PEP) masks and high-frequency chest wall oscillation (HFCWO) devices can assist in reducing bacterial burden. Learn more about the MAC lung disease treatment @ New Treatment for MAC Lung Disease ARIKAYCE is the first FDA-approved therapy specifically for MAC lung disease. It is a once-daily inhaled formulation of amikacin, delivered using Insmed's proprietary PULMOVANCE technology to directly target the lungs while reducing systemic exposure. The treatment is administered through the Lamira Nebulizer System and was granted orphan drug status by the FDA in 2013. In May 2024, new data from the ARISE study were presented at ATS 2024, highlighting outcomes in MAC lung disease patients who had not previously received antibiotic therapy. ARIKAYCE is approved in the US, European Union, and Japan, and is currently being studied in the Phase III ENCORE trial, which focuses on newly diagnosed or relapsed MAC patients who have not begun antibiotic treatment. Topline results from this study are anticipated in the first quarter of 2026. Find out more on FDA-approved MAC lung disease drugs @ MAC Lung Disease Treatment Options The scarcity of FDA-approved therapies for MAC lung disease, with only ARIKAYCE being the only approved option, limits treatment options, complicates management of resistant strains, and highlights the need for new therapies. MannKind Corporation, Janssen Pharmaceutical, and Spero Therapeutics are progressing through various stages of clinical trials, driving innovation in the MAC lung disease market. This activity is creating a dynamic environment, offering significant opportunities for the MAC lung disease market expansion and growth. Among the emerging therapies, MNKD-101, a nebulized formulation of clofazimine, is currently in Phase III clinical development and is expected to launch in the market by 2027. Discover which therapies are expected to grab major MAC lung disease market share @ MAC Lung Disease Market Report MNKD-101 is a nebulized formulation of clofazimine being developed to treat severe, chronic, and recurrent lung infections, such as nontuberculous mycobacterial lung disease. This inhaled version is anticipated to provide therapeutic benefits over the existing oral form. MannKind is also working on a dry-powder variant using its proprietary Technosphere platform. In May 2024, the U.S. FDA granted Fast Track Designation to MNKD-101 for NTM lung disease, following its earlier designations as an orphan drug and a Qualified Infectious Disease Product (QIDP). The FDA approved the Investigational New Drug (IND) application for MNKD-101 in April 2024, paving the way for a Phase III clinical trial. Similarly, Japan's PMDA authorized the Phase III ICoN-1 trial in September 2024, enabling the global trial to move forward. Bedaquiline fumarate, marketed as SIRTURO, is a diarylquinoline antimycobacterial agent used in combination regimens to treat pulmonary tuberculosis caused by Mycobacterium tuberculosis strains resistant to both rifampin and isoniazid. It is approved for use in adults and children aged 5 years and older, weighing at least 15 kg. Bedaquiline is currently being studied in a Phase II/III clinical trial as part of a treatment regimen with clarithromycin and ethambutol for adults with treatment-refractory Mycobacterium avium complex lung disease (MAC-LD). Spero Therapeutics is developing SPR720, an oral therapy for NTM pulmonary disease. SPR720 is a stable prodrug that is rapidly converted into SPR719, which targets the ATPase subunits of gyrase and topoisomerase, mechanisms distinct from fluoroquinolones. Preclinical data have demonstrated SPR720's broad-spectrum activity against key NTM pathogens such as MAC, M. kansasii, and M. abscessus, in both treatment-refractory and treatment-naïve patients. The FDA has granted SPR720 Fast Track status, orphan drug designation, and QIDP designation. Discover more about drugs for MAC lung disease in development @ MAC Lung Disease Clinical Trials The anticipated launch of these emerging therapies for MAC lung disease are poised to transform the market landscape in the coming years. As these cutting-edge therapies continue to mature and gain regulatory approval, they are expected to reshape the MAC lung disease market landscape, offering new standards of care and unlocking opportunities for medical innovation and economic growth. DelveInsight estimates that the market size for MAC lung disease is expected to grow from USD 474 million in the 7MM in 2023 at a significant CAGR by 2034. The market growth across the 7MM is expected to be fueled by the introduction of novel treatments such as MNKD-101, Bedaquiline fumarate (TMC207), and SPR720, among others. Additionally, the rising incidence of MAC lung disease driven by factors like aging populations, COPD, structural lung abnormalities, and exposure to MAC through soil, water, and aerosol-generating activities will likely contribute to an expanding MAC lung disease market opportunity. DelveInsight's latest published market report, titled as MAC Lung Disease Market Insight, Epidemiology, and Market Forecast – 2034, will help you to discover which market leader is going to capture the largest market share. The report provides comprehensive insights into the MAC lung disease country-specific treatment guidelines, patient pool analysis, and epidemiology forecast to help understand the key opportunities and assess the market's underlying potential. The MAC lung disease market report proffers epidemiological analysis for the study period 2020–2034 in the 7MM segmented into: Total Diagnosed Prevalent Cases of NTM Lung Disease Gender-specific Diagnosed Prevalent Cases of NTM Lung Disease Species-specific Diagnosed Prevalent Cases of NTM Infection Total Diagnosed Prevalent Cases of MAC Lung Disease The report provides an edge while developing business strategies by understanding trends shaping and driving the 7MM MAC lung disease market. Highlights include: 10-year Forecast 7MM Analysis Epidemiology-based Market Forecasting Historical and Forecasted Market Analysis upto 2034 Emerging Drug Market Uptake Peak Sales Analysis Key Cross Competition Analysis Industry Expert's Opinion Access and Reimbursement Download this MAC lung disease market report to assess the epidemiology forecasts, understand the patient journeys, know KOLs' opinions about the upcoming treatment paradigms, and determine the factors contributing to the shift in the MAC lung disease market. Also, stay abreast of the mitigating factors to improve your market position in the MAC lung disease therapeutic space. Related Reports Nontuberculous Mycobacterial Infection Market Nontuberculous Mycobacterial Infection Market Insights, Epidemiology, and Market Forecast – 2034 report deliver an in-depth understanding of the disease, historical and forecasted epidemiology, market share of the individual therapies, and key NTM infections companies, including AN2 Therapeutics, Mannkind Corporation, Spero Therapeutics, Paratek Pharmaceuticals, Redhill Biopharma, among others. Nontuberculous Mycobacterial Infection Pipeline Nontuberculous Mycobacterial Infection Pipeline Insight – 2024 report provides comprehensive insights about the pipeline landscape, pipeline drug profiles, including clinical and non-clinical stage products, and the key nontuberculous mycobacterial infection companies, including MannKind Corporation, Matinas BioPharma, Spero Therapeutics, Crestone, Inc., Vast Therapeutics, among others. Chronic Obstructive Pulmonary Disease Market Chronic Obstructive Pulmonary Disease Market Insights, Epidemiology, and Market Forecast – 2034 report deliver an in-depth understanding of the disease, historical and forecasted epidemiology, market share of the individual therapies, and key chronic obstructive pulmonary disease companies, including Genentech, Inc., GlaxoSmithKline, Verona Pharma plc, Regeneron Pharmaceuticals, Sanofi, MedImmune LLC, EpiEndo Pharmaceuticals, Tetherex Pharmaceuticals, AstraZeneca, Chiesi Farmaceutici S.p.A., Synairgen Research Ltd., Mereo Biopharma, Organicell Regenerative Medicine, Pulmotect, Inc., Inmunotek S.L., PULMATRiX, GLENMARK PHARMACEUTICALS LTD, Dimerix Limited, ProterixBio, among others. Asthma Market Asthma Market Insights, Epidemiology, and Market Forecast – 2034 report delivers an in-depth understanding of the disease, historical and forecasted epidemiology, as well as the market trends, market drivers, market barriers, and key asthma companies including GlaxoSmithKline, 4D Pharma plc, AstraZeneca, Suzhou Connect Biopharmaceuticals, Avillion, Pearl Therapeutics, ARS Pharmaceuticals, Sinomab, Avalo Therapeutics, Kymab, Sanofi, Cumberland Pharmaceuticals, Genentech, Inc., among others. About DelveInsight DelveInsight is a leading Business Consultant and Market Research firm focused exclusively on life sciences. It supports pharma companies by providing comprehensive end-to-end solutions to improve their performance. Get hassle-free access to all the healthcare and pharma market research reports through our subscription-based platform PharmDelve. Contact UsShruti Thakur info@ +14699457679 Logo: View original content: SOURCE DelveInsight Business Research, LLP
Malaysian Reserve
20-05-2025
- Health
- Malaysian Reserve
MAC Lung Disease Market Poised for Growth Across the 7MM During the Forecast Period (2025-2034) Amid Rising Prevalence and New Therapeutic Solutions
The MAC lung disease market is predicted to grow in the coming years. This growth is mainly driven by the launch of innovative therapies such as MNKD-101, Bedaquiline fumarate (TMC207), and SPR720, among others. Furthermore, the increasing prevalence of MAC lung disease, influenced by host factors like advanced age, COPD, thoracic abnormalities, and environmental exposure to MAC in soil, water, and aerosol-generating activities, is expected to expand the MAC lung disease market potential. LAS VEGAS, May 20, 2025 /PRNewswire/ — Mycobacterium avium Complex (MAC) refers to a group of bacteria, primarily Mycobacterium avium and Mycobacterium intracellulare, that are responsible for MAC lung disease. Accurate identification typically requires genetic testing. MAC is the leading cause of nontuberculous mycobacterial (NTM) lung infections in the United States and can affect people of all ages, although it is more common in older adults, postmenopausal women, smokers, and individuals with weakened immune systems or pre-existing lung conditions such as bronchiectasis, COPD, cystic fibrosis, emphysema, or a prior history of tuberculosis. DelveInsight estimates that in 2023, there were around 119K diagnosed prevalent cases of MAC lung disease across the 7MM, with the United States accounting for approximately 64% of these cases. In 2023, there were an estimated 151K diagnosed prevalent cases of NTM lung disease across the 7MM, with the number expected to rise by 2034. Treatment for MAC lung disease typically involves a combination of multiple antibiotics, most often including a macrolide (such as azithromycin or clarithromycin), a rifamycin (such as rifampin or rifabutin), and ethambutol. This regimen works by inhibiting protein synthesis, disrupting the bacterial cell wall, and preventing replication of the mycobacteria. Therapy generally continues for 12 to 18 months, depending on the severity of the disease and the pathogen's drug susceptibility. Supportive therapies play an important role, especially for patients with preexisting lung conditions. Chest physiotherapy, mucolytic agents, and bronchodilators help clear mucus and alleviate airway obstruction. Additionally, devices like positive expiratory pressure (PEP) masks and high-frequency chest wall oscillation (HFCWO) devices can assist in reducing bacterial burden. Learn more about the MAC lung disease treatment @ New Treatment for MAC Lung Disease ARIKAYCE is the first FDA-approved therapy specifically for MAC lung disease. It is a once-daily inhaled formulation of amikacin, delivered using Insmed's proprietary PULMOVANCE technology to directly target the lungs while reducing systemic exposure. The treatment is administered through the Lamira Nebulizer System and was granted orphan drug status by the FDA in 2013. In May 2024, new data from the ARISE study were presented at ATS 2024, highlighting outcomes in MAC lung disease patients who had not previously received antibiotic therapy. ARIKAYCE is approved in the US, European Union, and Japan, and is currently being studied in the Phase III ENCORE trial, which focuses on newly diagnosed or relapsed MAC patients who have not begun antibiotic treatment. Topline results from this study are anticipated in the first quarter of 2026. Find out more on FDA-approved MAC lung disease drugs @ MAC Lung Disease Treatment Options The scarcity of FDA-approved therapies for MAC lung disease, with only ARIKAYCE being the only approved option, limits treatment options, complicates management of resistant strains, and highlights the need for new therapies. MannKind Corporation, Janssen Pharmaceutical, and Spero Therapeutics are progressing through various stages of clinical trials, driving innovation in the MAC lung disease market. This activity is creating a dynamic environment, offering significant opportunities for the MAC lung disease market expansion and growth. Among the emerging therapies, MNKD-101, a nebulized formulation of clofazimine, is currently in Phase III clinical development and is expected to launch in the market by 2027. Discover which therapies are expected to grab major MAC lung disease market share @ MAC Lung Disease Market Report MNKD-101 is a nebulized formulation of clofazimine being developed to treat severe, chronic, and recurrent lung infections, such as nontuberculous mycobacterial lung disease. This inhaled version is anticipated to provide therapeutic benefits over the existing oral form. MannKind is also working on a dry-powder variant using its proprietary Technosphere platform. In May 2024, the U.S. FDA granted Fast Track Designation to MNKD-101 for NTM lung disease, following its earlier designations as an orphan drug and a Qualified Infectious Disease Product (QIDP). The FDA approved the Investigational New Drug (IND) application for MNKD-101 in April 2024, paving the way for a Phase III clinical trial. Similarly, Japan's PMDA authorized the Phase III ICoN-1 trial in September 2024, enabling the global trial to move forward. Bedaquiline fumarate, marketed as SIRTURO, is a diarylquinoline antimycobacterial agent used in combination regimens to treat pulmonary tuberculosis caused by Mycobacterium tuberculosis strains resistant to both rifampin and isoniazid. It is approved for use in adults and children aged 5 years and older, weighing at least 15 kg. Bedaquiline is currently being studied in a Phase II/III clinical trial as part of a treatment regimen with clarithromycin and ethambutol for adults with treatment-refractory Mycobacterium avium complex lung disease (MAC-LD). Spero Therapeutics is developing SPR720, an oral therapy for NTM pulmonary disease. SPR720 is a stable prodrug that is rapidly converted into SPR719, which targets the ATPase subunits of gyrase and topoisomerase, mechanisms distinct from fluoroquinolones. Preclinical data have demonstrated SPR720's broad-spectrum activity against key NTM pathogens such as MAC, M. kansasii, and M. abscessus, in both treatment-refractory and treatment-naïve patients. The FDA has granted SPR720 Fast Track status, orphan drug designation, and QIDP designation. Discover more about drugs for MAC lung disease in development @ MAC Lung Disease Clinical Trials The anticipated launch of these emerging therapies for MAC lung disease are poised to transform the market landscape in the coming years. As these cutting-edge therapies continue to mature and gain regulatory approval, they are expected to reshape the MAC lung disease market landscape, offering new standards of care and unlocking opportunities for medical innovation and economic growth. DelveInsight estimates that the market size for MAC lung disease is expected to grow from USD 474 million in the 7MM in 2023 at a significant CAGR by 2034. The market growth across the 7MM is expected to be fueled by the introduction of novel treatments such as MNKD-101, Bedaquiline fumarate (TMC207), and SPR720, among others. Additionally, the rising incidence of MAC lung disease driven by factors like aging populations, COPD, structural lung abnormalities, and exposure to MAC through soil, water, and aerosol-generating activities will likely contribute to an expanding MAC lung disease market opportunity. DelveInsight's latest published market report, titled as MAC Lung Disease Market Insight, Epidemiology, and Market Forecast – 2034, will help you to discover which market leader is going to capture the largest market share. The report provides comprehensive insights into the MAC lung disease country-specific treatment guidelines, patient pool analysis, and epidemiology forecast to help understand the key opportunities and assess the market's underlying potential. The MAC lung disease market report proffers epidemiological analysis for the study period 2020–2034 in the 7MM segmented into: Total Diagnosed Prevalent Cases of NTM Lung Disease Gender-specific Diagnosed Prevalent Cases of NTM Lung Disease Species-specific Diagnosed Prevalent Cases of NTM Infection Total Diagnosed Prevalent Cases of MAC Lung Disease The report provides an edge while developing business strategies by understanding trends shaping and driving the 7MM MAC lung disease market. Highlights include: 10-year Forecast 7MM Analysis Epidemiology-based Market Forecasting Historical and Forecasted Market Analysis upto 2034 Emerging Drug Market Uptake Peak Sales Analysis Key Cross Competition Analysis Industry Expert's Opinion Access and Reimbursement Download this MAC lung disease market report to assess the epidemiology forecasts, understand the patient journeys, know KOLs' opinions about the upcoming treatment paradigms, and determine the factors contributing to the shift in the MAC lung disease market. Also, stay abreast of the mitigating factors to improve your market position in the MAC lung disease therapeutic space. Related Reports Nontuberculous Mycobacterial Infection Market Nontuberculous Mycobacterial Infection Market Insights, Epidemiology, and Market Forecast – 2034 report deliver an in-depth understanding of the disease, historical and forecasted epidemiology, market share of the individual therapies, and key NTM infections companies, including AN2 Therapeutics, Mannkind Corporation, Spero Therapeutics, Paratek Pharmaceuticals, Redhill Biopharma, among others. Nontuberculous Mycobacterial Infection Pipeline Nontuberculous Mycobacterial Infection Pipeline Insight – 2024 report provides comprehensive insights about the pipeline landscape, pipeline drug profiles, including clinical and non-clinical stage products, and the key nontuberculous mycobacterial infection companies, including MannKind Corporation, Matinas BioPharma, Spero Therapeutics, Crestone, Inc., Vast Therapeutics, among others. Chronic Obstructive Pulmonary Disease Market Chronic Obstructive Pulmonary Disease Market Insights, Epidemiology, and Market Forecast – 2034 report deliver an in-depth understanding of the disease, historical and forecasted epidemiology, market share of the individual therapies, and key chronic obstructive pulmonary disease companies, including Genentech, Inc., GlaxoSmithKline, Verona Pharma plc, Regeneron Pharmaceuticals, Sanofi, MedImmune LLC, EpiEndo Pharmaceuticals, Tetherex Pharmaceuticals, AstraZeneca, Chiesi Farmaceutici S.p.A., Synairgen Research Ltd., Mereo Biopharma, Organicell Regenerative Medicine, Pulmotect, Inc., Inmunotek S.L., PULMATRiX, GLENMARK PHARMACEUTICALS LTD, Dimerix Limited, ProterixBio, among others. Asthma Market Asthma Market Insights, Epidemiology, and Market Forecast – 2034 report delivers an in-depth understanding of the disease, historical and forecasted epidemiology, as well as the market trends, market drivers, market barriers, and key asthma companies including GlaxoSmithKline, 4D Pharma plc, AstraZeneca, Suzhou Connect Biopharmaceuticals, Avillion, Pearl Therapeutics, ARS Pharmaceuticals, Sinomab, Avalo Therapeutics, Kymab, Sanofi, Cumberland Pharmaceuticals, Genentech, Inc., among others. About DelveInsight DelveInsight is a leading Business Consultant and Market Research firm focused exclusively on life sciences. It supports pharma companies by providing comprehensive end-to-end solutions to improve their performance. Get hassle-free access to all the healthcare and pharma market research reports through our subscription-based platform PharmDelve. Contact UsShruti Thakur info@ +14699457679 Logo: View original content:
Yahoo
20-05-2025
- Health
- Yahoo
MAC Lung Disease Market Poised for Growth Across the 7MM During the Forecast Period (2025-2034) Amid Rising Prevalence and New Therapeutic Solutions
The MAC lung disease market is predicted to grow in the coming years. This growth is mainly driven by the launch of innovative therapies such as MNKD-101, Bedaquiline fumarate (TMC207), and SPR720, among others. Furthermore, the increasing prevalence of MAC lung disease, influenced by host factors like advanced age, COPD, thoracic abnormalities, and environmental exposure to MAC in soil, water, and aerosol-generating activities, is expected to expand the MAC lung disease market potential. LAS VEGAS, May 20, 2025 /PRNewswire/ -- Mycobacterium avium Complex (MAC) refers to a group of bacteria, primarily Mycobacterium avium and Mycobacterium intracellulare, that are responsible for MAC lung disease. Accurate identification typically requires genetic testing. MAC is the leading cause of nontuberculous mycobacterial (NTM) lung infections in the United States and can affect people of all ages, although it is more common in older adults, postmenopausal women, smokers, and individuals with weakened immune systems or pre-existing lung conditions such as bronchiectasis, COPD, cystic fibrosis, emphysema, or a prior history of tuberculosis. DelveInsight estimates that in 2023, there were around 119K diagnosed prevalent cases of MAC lung disease across the 7MM, with the United States accounting for approximately 64% of these cases. In 2023, there were an estimated 151K diagnosed prevalent cases of NTM lung disease across the 7MM, with the number expected to rise by 2034. Treatment for MAC lung disease typically involves a combination of multiple antibiotics, most often including a macrolide (such as azithromycin or clarithromycin), a rifamycin (such as rifampin or rifabutin), and ethambutol. This regimen works by inhibiting protein synthesis, disrupting the bacterial cell wall, and preventing replication of the mycobacteria. Therapy generally continues for 12 to 18 months, depending on the severity of the disease and the pathogen's drug susceptibility. Supportive therapies play an important role, especially for patients with preexisting lung conditions. Chest physiotherapy, mucolytic agents, and bronchodilators help clear mucus and alleviate airway obstruction. Additionally, devices like positive expiratory pressure (PEP) masks and high-frequency chest wall oscillation (HFCWO) devices can assist in reducing bacterial burden. Learn more about the MAC lung disease treatment @ New Treatment for MAC Lung Disease ARIKAYCE is the first FDA-approved therapy specifically for MAC lung disease. It is a once-daily inhaled formulation of amikacin, delivered using Insmed's proprietary PULMOVANCE technology to directly target the lungs while reducing systemic exposure. The treatment is administered through the Lamira Nebulizer System and was granted orphan drug status by the FDA in 2013. In May 2024, new data from the ARISE study were presented at ATS 2024, highlighting outcomes in MAC lung disease patients who had not previously received antibiotic therapy. ARIKAYCE is approved in the US, European Union, and Japan, and is currently being studied in the Phase III ENCORE trial, which focuses on newly diagnosed or relapsed MAC patients who have not begun antibiotic treatment. Topline results from this study are anticipated in the first quarter of 2026. Find out more on FDA-approved MAC lung disease drugs @ MAC Lung Disease Treatment Options The scarcity of FDA-approved therapies for MAC lung disease, with only ARIKAYCE being the only approved option, limits treatment options, complicates management of resistant strains, and highlights the need for new therapies. MannKind Corporation, Janssen Pharmaceutical, and Spero Therapeutics are progressing through various stages of clinical trials, driving innovation in the MAC lung disease market. This activity is creating a dynamic environment, offering significant opportunities for the MAC lung disease market expansion and growth. Among the emerging therapies, MNKD-101, a nebulized formulation of clofazimine, is currently in Phase III clinical development and is expected to launch in the market by 2027. Discover which therapies are expected to grab major MAC lung disease market share @ MAC Lung Disease Market Report MNKD-101 is a nebulized formulation of clofazimine being developed to treat severe, chronic, and recurrent lung infections, such as nontuberculous mycobacterial lung disease. This inhaled version is anticipated to provide therapeutic benefits over the existing oral form. MannKind is also working on a dry-powder variant using its proprietary Technosphere platform. In May 2024, the U.S. FDA granted Fast Track Designation to MNKD-101 for NTM lung disease, following its earlier designations as an orphan drug and a Qualified Infectious Disease Product (QIDP). The FDA approved the Investigational New Drug (IND) application for MNKD-101 in April 2024, paving the way for a Phase III clinical trial. Similarly, Japan's PMDA authorized the Phase III ICoN-1 trial in September 2024, enabling the global trial to move forward. Bedaquiline fumarate, marketed as SIRTURO, is a diarylquinoline antimycobacterial agent used in combination regimens to treat pulmonary tuberculosis caused by Mycobacterium tuberculosis strains resistant to both rifampin and isoniazid. It is approved for use in adults and children aged 5 years and older, weighing at least 15 kg. Bedaquiline is currently being studied in a Phase II/III clinical trial as part of a treatment regimen with clarithromycin and ethambutol for adults with treatment-refractory Mycobacterium avium complex lung disease (MAC-LD). Spero Therapeutics is developing SPR720, an oral therapy for NTM pulmonary disease. SPR720 is a stable prodrug that is rapidly converted into SPR719, which targets the ATPase subunits of gyrase and topoisomerase, mechanisms distinct from fluoroquinolones. Preclinical data have demonstrated SPR720's broad-spectrum activity against key NTM pathogens such as MAC, M. kansasii, and M. abscessus, in both treatment-refractory and treatment-naïve patients. The FDA has granted SPR720 Fast Track status, orphan drug designation, and QIDP designation. Discover more about drugs for MAC lung disease in development @ MAC Lung Disease Clinical Trials The anticipated launch of these emerging therapies for MAC lung disease are poised to transform the market landscape in the coming years. As these cutting-edge therapies continue to mature and gain regulatory approval, they are expected to reshape the MAC lung disease market landscape, offering new standards of care and unlocking opportunities for medical innovation and economic growth. DelveInsight estimates that the market size for MAC lung disease is expected to grow from USD 474 million in the 7MM in 2023 at a significant CAGR by 2034. The market growth across the 7MM is expected to be fueled by the introduction of novel treatments such as MNKD-101, Bedaquiline fumarate (TMC207), and SPR720, among others. Additionally, the rising incidence of MAC lung disease driven by factors like aging populations, COPD, structural lung abnormalities, and exposure to MAC through soil, water, and aerosol-generating activities will likely contribute to an expanding MAC lung disease market opportunity. DelveInsight's latest published market report, titled as MAC Lung Disease Market Insight, Epidemiology, and Market Forecast – 2034, will help you to discover which market leader is going to capture the largest market share. The report provides comprehensive insights into the MAC lung disease country-specific treatment guidelines, patient pool analysis, and epidemiology forecast to help understand the key opportunities and assess the market's underlying potential. The MAC lung disease market report proffers epidemiological analysis for the study period 2020–2034 in the 7MM segmented into: Total Diagnosed Prevalent Cases of NTM Lung Disease Gender-specific Diagnosed Prevalent Cases of NTM Lung Disease Species-specific Diagnosed Prevalent Cases of NTM Infection Total Diagnosed Prevalent Cases of MAC Lung Disease The report provides an edge while developing business strategies by understanding trends shaping and driving the 7MM MAC lung disease market. Highlights include: 10-year Forecast 7MM Analysis Epidemiology-based Market Forecasting Historical and Forecasted Market Analysis upto 2034 Emerging Drug Market Uptake Peak Sales Analysis Key Cross Competition Analysis Industry Expert's Opinion Access and Reimbursement Download this MAC lung disease market report to assess the epidemiology forecasts, understand the patient journeys, know KOLs' opinions about the upcoming treatment paradigms, and determine the factors contributing to the shift in the MAC lung disease market. Also, stay abreast of the mitigating factors to improve your market position in the MAC lung disease therapeutic space. 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