{"success":true,"data":{"pressRelease":{"id":"170057","rtpr_id":"nPnRBVg6a-20261015","ticker":"INSM","exchange":"NASDAQ","all_tickers":["INSM"],"title":"Insmed Features the Global Phase 3 PALM Clinical Development Program Evaluating Treprostinil Palmitil Inhalation Powder (TPIP) at CHEST 2026","author":"PR Newswire","published_at":"2026-10-15T11:00:04.426Z","article_body":"Insmed Features the Global Phase 3 PALM Clinical Development Program Evaluating Treprostinil Palmitil Inhalation Powder (TPIP) at CHEST 2026\nPR Newswire\n\nBRIDGEWATER, N.J., Oct. 15, 2026\n\n—Insmed's Largest Parallel-Running Clinical Effort to Date With Four Pivotal\nPhase 3 Studies Advancing Across Four Progressive Pulmonary Diseases:\nPALM-PAH, PALM-ILD, PALM-PPF, and PALM-IPF—\n\n—One of the Broadest Active Global Clinical Programs in the Pulmonary Space,\nWith the Potential to Redefine Prostanoid Therapy for These Patient\nPopulations—\n\nBRIDGEWATER, N.J., Oct. 15, 2026 /PRNewswire/ -- Insmed Incorporated\n(Nasdaq: INSM), a people-first global biopharmaceutical company striving to\ndeliver first- and best-in-class therapies to transform the lives of patients\nfacing serious diseases, will feature the global PALM Clinical Development\nProgram at the American College of Chest Physicians(® )Annual Meeting 2026\n(CHEST 2026), which is investigating treprostinil palmitil inhalation powder\n(TPIP) in a range of serious pulmonary diseases. The PALM Clinical Development\nProgram includes four pivotal, parallel-running Phase 3 studies evaluating\nTPIP as a once-daily therapy for patients with pulmonary arterial hypertension\n(PAH), pulmonary hypertension associated with interstitial lung disease\n(PH-ILD), progressive pulmonary fibrosis (PPF), and idiopathic pulmonary\nfibrosis (IPF). Three PALM Phase 3 studies (PALM-PAH, PALM-ILD, PALM-PPF) have\nnow been initiated, with the fourth study (PALM-IPF) expected to begin in the\nfirst half of 2027. This program aims to enroll more than 2,000 patients\nacross these four studies.\n\n\"People living with debilitating pulmonary diseases often face substantial\nburdens as their disease progresses, compounded by complex treatment regimens\nand systemic side effects that can make the demands of everyday life\nincreasingly difficult,\" said Raymond Benza, MD, Chair of Cardiology, Sentara\nHealth and Section Chief of Cardiology at the Macon & Joan Brock Virginia\nHealth Sciences, Eastern Virginia Medical School at Old Dominion University.\n\"As clinicians, we see firsthand the need to address the progressive nature of\nthese diseases while considering the demands of long-term therapy. The PALM\nClinical Development Program has the potential to demonstrate the impact of a\nnovel, once-daily inhaled prostanoid therapy for patients across four serious\npulmonary diseases.\"\n\nBuilding on clinically meaningful Phase 2 efficacy and safety data evaluating\nTPIP in PAH and PH-ILD, the PALM Clinical Development Program is driven by the\nurgency to address treatment challenges and advance the standard of care for\npatients living with these serious diseases. The program is designed to\nestablish investigational TPIP as a highly differentiated, purposefully\ndesigned, once-daily therapy with the potential to deliver meaningful outcomes\nacross a broad range of patients. Background on each of the studies is as\nfollows:\n\n * PALM-PAH is a Phase 3, randomized, double-blind, placebo-controlled,\nmulticenter, parallel-group study evaluating the efficacy and safety of\nonce-daily TPIP in patients with PAH (World Health Organization [WHO] Group 1\npulmonary hypertension) over 24 weeks. The primary endpoint is change from\nbaseline in 6-minute walk distance (6MWD) at Week 24. Secondary endpoints\nassess functional status, disease severity, patient-reported outcomes, time to\nfirst clinical worsening, and pharmacokinetics (ClinicalTrials.gov ID:\nNCT07481981\n(https://edge.prnewswire.com/c/link/?t=0&l=en&o=4798149-1&h=3670847323&u=https%3A%2F%2Fclinicaltrials.gov%2Fstudy%2FNCT07481981%3Fterm%3DTPIP%26viewType%3DCard%26aggFilters%3Dphase%3A3%26rank%3D5&a=NCT07481981)\n\n).\n * PALM-ILD is a Phase 3, randomized, double-blind, placebo-controlled,\nmulticenter, parallel-group study evaluating the efficacy and safety of\nonce-daily TPIP in patients with PH-ILD (WHO Group 3 pulmonary hypertension)\nover 24 weeks. The primary endpoint is change from baseline in 6MWD at Week\n24, with time to first major morbidity or mortality event over the 24-week\ntreatment period as a secondary endpoint (ClinicalTrials.gov ID:\nNCT07179380\n(https://edge.prnewswire.com/c/link/?t=0&l=en&o=4798149-1&h=2383264456&u=https%3A%2F%2Fclinicaltrials.gov%2Fstudy%2FNCT07179380%3Fterm%3DTPIP%26viewType%3DCard%26aggFilters%3Dphase%3A3%26rank%3D6&a=NCT07179380)\n\n).\n * PALM-PPF is a Phase 3, randomized, double-blind, placebo-controlled,\nmulticenter, parallel-group study evaluating the safety and efficacy of\nonce-daily TPIP in adult patients with PPF over 52 to 104 weeks. The study's\nprimary endpoint is change from baseline in absolute forced vital capacity\n(FVC) at Week 52, with secondary endpoints assessing disease progression,\nfunctional and physiological decline, patient-reported impact,\npharmacokinetics, and safety (ClinicalTrials.gov ID:\nNCT07805785\n(https://edge.prnewswire.com/c/link/?t=0&l=en&o=4798149-1&h=2998057752&u=https%3A%2F%2Fclinicaltrials.gov%2Fstudy%2FNCT07805785%3Fterm%3DNCT07805785%26viewType%3DCard%26rank%3D1&a=NCT07805785)\n\n).\n * PALM-IPF will be a Phase 3, randomized, double-blind, placebo-controlled,\nmulticenter, parallel-group study evaluating the safety and efficacy of\nonce-daily TPIP in adult patients with IPF over 52 to 104 weeks. The study's\nprimary endpoint will be change from baseline in absolute FVC at Week 52, with\nsecondary endpoints assessing disease progression, functional and\nphysiological decline, and patient-reported impact, pharmacokinetics, and\nsafety (ClinicalTrials.gov listing forthcoming).\n\"As TPIP continues into the next stage of clinical development, this\nmulti-indication PALM Clinical Development Program — the most ambitious\nclinical effort we are undertaking to date — is designed to break through\ntreatment barriers that have historically limited innovation of prostanoid\ntreatment for these complex pulmonary disorders,\" said Martina Flammer, M.D.,\nMBA, Chief Medical Officer of Insmed. \"These four Phase 3 studies further\nevaluate TPIP's potential to meaningfully improve care and, if successful,\nemerge as the prostanoid of choice for clinicians and patients.\"\n\nAbout TPIP\n\nTreprostinil palmitil inhalation powder (TPIP) is an investigational dry\npowder formulation of treprostinil palmitil, a next-generation pro-drug\nformulation of inhaled treprostinil consisting of treprostinil linked by an\nester bond to a 16-carbon chain. Designed entirely in Insmed's laboratories,\nTPIP is a potentially highly differentiated prostanoid being developed as a\nonce-daily therapy for the treatment of patients with pulmonary arterial\nhypertension (PAH), pulmonary hypertension associated with interstitial lung\ndisease (PH-ILD), progressive pulmonary fibrosis (PPF), and idiopathic\npulmonary fibrosis (IPF). TPIP is administered in a capsule-based inhalation\ndevice. TPIP is an investigational drug product that has not been approved for\nany indication in any jurisdiction.\n\nAbout Pulmonary Arterial Hypertension\n\nPulmonary arterial hypertension (PAH), classified as WHO Group 1 Pulmonary\nHypertension, is a serious, progressive, rare disease in which the blood\nvessels in the lungs narrow or become obstructed, leading to high blood\npressure in the pulmonary arteries. The most common symptoms include shortness\nof breath, chest pain, dizziness or fainting, fatigue, and weakness. Untreated\nPAH can be debilitating and often fatal.\n\nAbout Pulmonary Hypertension Associated With Interstitial Lung Disease\n\nPulmonary hypertension associated with interstitial lung disease (PH-ILD),\nalso known as WHO Group 3 Pulmonary Hypertension, is a common and serious\ncomplication of several interstitial lung diseases (ILDs), a group of more\nthan 200 chronic lung disorders marked by inflammation and fibrosis of the\nlung tissue. PH-ILD is strongly associated with impaired quality of life,\ndecreased functional capacity, greater supplemental oxygen requirements,\nincreased risk of hospitalizations, and higher mortality.\n\nAbout Progressive Pulmonary Fibrosis\n\nProgressive pulmonary fibrosis (PPF) is a clinical phenotype that can occur\nacross multiple interstitial lung diseases (ILDs) and is characterized by\nworsening lung fibrosis over time despite treatment of the underlying disease.\nAs fibrosis progresses, patients may experience decline in lung function\naccompanied by worsening breathlessness during exercise and daily activities.\nOver time, disease progression can lead to significant disability, respiratory\nfailure, and premature death.\n\nAbout Idiopathic Pulmonary Fibrosis\n\nIdiopathic pulmonary fibrosis (IPF) is a chronic, progressive lung disease\ncharacterized by irreversible scarring of the lungs and a continual decline in\nlung function. Patients commonly experience worsening shortness of breath and\npersistent cough, which can significantly impact daily activities and quality\nof life.\n\nAbout Insmed\n\nInsmed Incorporated is a people-first global biopharmaceutical company\nstriving to deliver first- and best-in-class therapies to transform the lives\nof patients facing serious diseases. The Company is advancing a diverse\nportfolio of approved and mid- to late-stage investigational medicines —\nincluding two approved therapies to treat chronic, debilitating lung diseases\n— as well as cutting-edge drug discovery focused on serving patient\ncommunities where the need is greatest. Insmed's commercial portfolio and\nclinical pipeline are organized around three therapeutic areas: Respiratory,\nImmunology & Inflammation, and Neuro & Other Rare. The Company's\nresearch engine is advancing a wide range of technologies and modalities,\nincluding gene therapy, AI-driven protein engineering, RNA end-joining, and\nsynthetic rescue, in the pursuit of future pipeline candidates.\n\nHeadquartered in Bridgewater, New Jersey, Insmed has offices and research\nlocations throughout the United States, Europe, and Japan.\nVisit www.insmed.com\n(https://edge.prnewswire.com/c/link/?t=0&l=en&o=4798149-1&h=4030962026&u=https%3A%2F%2Fedge.prnewswire.com%2Fc%2Flink%2F%3Ft%3D0%26l%3Den%26o%3D4703288-1%26h%3D1989777388%26u%3Dhttp%253A%252F%252Fwww.insmed.com%252F%26a%3Dwww.insmed.com&a=www.insmed.com)\n to learn more or follow us on LinkedIn\n(https://edge.prnewswire.com/c/link/?t=0&l=en&o=4798149-1&h=3545815671&u=https%3A%2F%2Fedge.prnewswire.com%2Fc%2Flink%2F%3Ft%3D0%26l%3Den%26o%3D4703288-1%26h%3D3771540838%26u%3Dhttps%253A%252F%252Fwww.linkedin.com%252Fcompany%252Finsmed%26a%3DLinkedIn&a=LinkedIn)\n, Instagram\n(https://edge.prnewswire.com/c/link/?t=0&l=en&o=4798149-1&h=1350479662&u=https%3A%2F%2Fedge.prnewswire.com%2Fc%2Flink%2F%3Ft%3D0%26l%3Den%26o%3D4703288-1%26h%3D3370096843%26u%3Dhttps%253A%252F%252Fwww.instagram.com%252FInsmed%252F%26a%3DInstagram&a=Instagram)\n, YouTube\n(https://edge.prnewswire.com/c/link/?t=0&l=en&o=4798149-1&h=1924790851&u=https%3A%2F%2Fedge.prnewswire.com%2Fc%2Flink%2F%3Ft%3D0%26l%3Den%26o%3D4703288-1%26h%3D2114749782%26u%3Dhttps%253A%252F%252Fwww.youtube.com%252F%2540insmed%26a%3DYouTube&a=YouTube)\n, and X\n(https://edge.prnewswire.com/c/link/?t=0&l=en&o=4798149-1&h=3406878555&u=https%3A%2F%2Fedge.prnewswire.com%2Fc%2Flink%2F%3Ft%3D0%26l%3Den%26o%3D4703288-1%26h%3D3482314689%26u%3Dhttps%253A%252F%252Fx.com%252FInsmed%26a%3DX&a=X)\n.\n\nForward-looking Statements\n\nThis press release contains forward-looking statements that involve\nsubstantial risks and uncertainties. \"Forward-looking statements,\" as that\nterm is defined in the Private Securities Litigation Reform Act of 1995, are\nstatements that are not historical facts and involve a number of risks and\nuncertainties. Words herein such as \"may,\" \"will,\" \"should,\" \"could,\" \"would,\"\n\"expects,\" \"plans,\" \"anticipates,\" \"believes,\" \"estimates,\" \"projects,\"\n\"predicts,\" \"intends,\" \"potential,\" \"continues,\" and similar expressions (as\nwell as other words or expressions referencing future events, conditions or\ncircumstances) may identify forward-looking statements.\n\nThe forward-looking statements in this press release are based upon the\nCompany's current expectations and beliefs, and involve known and unknown\nrisks, uncertainties and other factors, which may cause the Company's actual\nresults, performance and achievements and the timing of certain events to\ndiffer materially from the results, performance, achievements or timings\ndiscussed, projected, anticipated or indicated in any forward-looking\nstatements. Such risks, uncertainties and other factors include, among others,\nthe following: failure to successfully conduct the Company's current and\nfuture clinical trials for TPIP, including due to the Company's potential\ninability to enroll or retain sufficient patients to conduct and complete the\ntrials or generate data necessary for regulatory approval, among other things;\ndevelopment of unexpected safety or efficacy concerns related to TPIP; failure\nof third parties on which the Company is dependent to manufacture sufficient\nquantities of TPIP for clinical needs, to conduct the Company's clinical\ntrials, or to comply with the Company's agreements or laws and regulations\nthat impact the Company's business or agreements with the Company; failure to\nobtain regulatory approval for TPIP in any or all of the indications for which\napproval is being sought; inaccuracies in the Company's estimates of the size\nof the potential markets for TPIP or in data the Company has used to identify\nphysicians; expected rates of patient uptake, duration of expected treatment,\nor expected patient adherence or discontinuation rates, if TPIP is approved;\ninability of the Company or the Company's third-party manufacturers to comply\nwith regulatory requirements related to TPIP; the Company's inability to\nobtain adequate reimbursement from government or third-party payors for TPIP\nor acceptable prices for TPIP, if approved; restrictions or other obligations\nimposed on the Company by agreements related to TPIP and failure to comply\nwith the Company's obligations under such agreements; risks that the Company's\nclinical studies will be delayed or that serious side effects will be\nidentified during drug development; the strength and enforceability of the\nCompany's intellectual property rights or the rights of third parties; and the\ncost and potential reputational damage resulting from litigation to which the\nCompany may become a party, including product liability claims.\n\nThe Company may not actually achieve the results, plans, intentions or\nexpectations indicated by the Company's forward-looking statements because, by\ntheir nature, forward-looking statements involve risks and uncertainties\nbecause they relate to events and depend on circumstances that may or may not\noccur in the future. For additional information about the risks and\nuncertainties that may affect the Company's business, please see the factors\ndiscussed in Item 1A, \"Risk Factors,\" in the Company's Annual Report on Form\n10-K for the year ended December 31, 2025 and any subsequent Company filings\nwith the Securities and Exchange Commission (SEC).\n\nThe Company cautions readers not to place undue reliance on any such\nforward-looking statements, which speak only as of the date of this press\nrelease. The Company disclaims any obligation, except as specifically required\nby law and the rules of the SEC, to publicly update or revise any such\nstatements to reflect any change in expectations or in events, conditions or\ncircumstances on which any such statements may be based, or that may affect\nthe likelihood that actual results will differ from those set forth in the\nforward-looking statements.\n\nContact:\n\nInvestors:\nGianna De Palma\nAssociate Director, Investor Relations\ninvestor.relations@insmed.com (mailto:investor.relations@insmed.com)\n\nMedia:\nClaire Mulhearn\nVice President, Corporate Communications\nmedia@insmed.com (mailto:media@insmed.com)\n\n \n\nView original content to download\nmultimedia:https://www.prnewswire.com/news-releases/insmed-features-the-global-phase-3-palm-clinical-development-program-evaluating-treprostinil-palmitil-inhalation-powder-tpip-at-chest-2026-302909246.html\n(https://www.prnewswire.com/news-releases/insmed-features-the-global-phase-3-palm-clinical-development-program-evaluating-treprostinil-palmitil-inhalation-powder-tpip-at-chest-2026-302909246.html)\n\nSOURCE Insmed Incorporated\n\n\n\nPhoto: \nhttps://mmx.prnewswire.com/media/MS1109455/Insmed-Incorporated-Logo.jpg?id=OA3019554\n\nCopyright (c) 2026 PR Newswire Association,LLC. All Rights Reserved.","article_body_html":"","raw_payload":{"data":{"id":"nPnRBVg6a-20261015","title":"Insmed Features the Global Phase 3 PALM Clinical Development Program Evaluating Treprostinil Palmitil Inhalation Powder (TPIP) at CHEST 2026","author":"PR Newswire","ticker":"INSM","created":"2026-10-15T11:00:04.426Z","tickers":["INSM"],"exchange":"NASDAQ","article_body":"Insmed Features the Global Phase 3 PALM Clinical Development Program Evaluating Treprostinil Palmitil Inhalation Powder (TPIP) at CHEST 2026\nPR Newswire\n\nBRIDGEWATER, N.J., Oct. 15, 2026\n\n—Insmed's Largest Parallel-Running Clinical Effort to Date With Four Pivotal\nPhase 3 Studies Advancing Across Four Progressive Pulmonary Diseases:\nPALM-PAH, PALM-ILD, PALM-PPF, and PALM-IPF—\n\n—One of the Broadest Active Global Clinical Programs in the Pulmonary Space,\nWith the Potential to Redefine Prostanoid Therapy for These Patient\nPopulations—\n\nBRIDGEWATER, N.J., Oct. 15, 2026 /PRNewswire/ -- Insmed Incorporated\n(Nasdaq: INSM), a people-first global biopharmaceutical company striving to\ndeliver first- and best-in-class therapies to transform the lives of patients\nfacing serious diseases, will feature the global PALM Clinical Development\nProgram at the American College of Chest Physicians(® )Annual Meeting 2026\n(CHEST 2026), which is investigating treprostinil palmitil inhalation powder\n(TPIP) in a range of serious pulmonary diseases. The PALM Clinical Development\nProgram includes four pivotal, parallel-running Phase 3 studies evaluating\nTPIP as a once-daily therapy for patients with pulmonary arterial hypertension\n(PAH), pulmonary hypertension associated with interstitial lung disease\n(PH-ILD), progressive pulmonary fibrosis (PPF), and idiopathic pulmonary\nfibrosis (IPF). Three PALM Phase 3 studies (PALM-PAH, PALM-ILD, PALM-PPF) have\nnow been initiated, with the fourth study (PALM-IPF) expected to begin in the\nfirst half of 2027. This program aims to enroll more than 2,000 patients\nacross these four studies.\n\n\"People living with debilitating pulmonary diseases often face substantial\nburdens as their disease progresses, compounded by complex treatment regimens\nand systemic side effects that can make the demands of everyday life\nincreasingly difficult,\" said Raymond Benza, MD, Chair of Cardiology, Sentara\nHealth and Section Chief of Cardiology at the Macon & Joan Brock Virginia\nHealth Sciences, Eastern Virginia Medical School at Old Dominion University.\n\"As clinicians, we see firsthand the need to address the progressive nature of\nthese diseases while considering the demands of long-term therapy. The PALM\nClinical Development Program has the potential to demonstrate the impact of a\nnovel, once-daily inhaled prostanoid therapy for patients across four serious\npulmonary diseases.\"\n\nBuilding on clinically meaningful Phase 2 efficacy and safety data evaluating\nTPIP in PAH and PH-ILD, the PALM Clinical Development Program is driven by the\nurgency to address treatment challenges and advance the standard of care for\npatients living with these serious diseases. The program is designed to\nestablish investigational TPIP as a highly differentiated, purposefully\ndesigned, once-daily therapy with the potential to deliver meaningful outcomes\nacross a broad range of patients. Background on each of the studies is as\nfollows:\n\n * PALM-PAH is a Phase 3, randomized, double-blind, placebo-controlled,\nmulticenter, parallel-group study evaluating the efficacy and safety of\nonce-daily TPIP in patients with PAH (World Health Organization [WHO] Group 1\npulmonary hypertension) over 24 weeks. The primary endpoint is change from\nbaseline in 6-minute walk distance (6MWD) at Week 24. Secondary endpoints\nassess functional status, disease severity, patient-reported outcomes, time to\nfirst clinical worsening, and pharmacokinetics (ClinicalTrials.gov ID:\nNCT07481981\n(https://edge.prnewswire.com/c/link/?t=0&l=en&o=4798149-1&h=3670847323&u=https%3A%2F%2Fclinicaltrials.gov%2Fstudy%2FNCT07481981%3Fterm%3DTPIP%26viewType%3DCard%26aggFilters%3Dphase%3A3%26rank%3D5&a=NCT07481981)\n\n).\n * PALM-ILD is a Phase 3, randomized, double-blind, placebo-controlled,\nmulticenter, parallel-group study evaluating the efficacy and safety of\nonce-daily TPIP in patients with PH-ILD (WHO Group 3 pulmonary hypertension)\nover 24 weeks. The primary endpoint is change from baseline in 6MWD at Week\n24, with time to first major morbidity or mortality event over the 24-week\ntreatment period as a secondary endpoint (ClinicalTrials.gov ID:\nNCT07179380\n(https://edge.prnewswire.com/c/link/?t=0&l=en&o=4798149-1&h=2383264456&u=https%3A%2F%2Fclinicaltrials.gov%2Fstudy%2FNCT07179380%3Fterm%3DTPIP%26viewType%3DCard%26aggFilters%3Dphase%3A3%26rank%3D6&a=NCT07179380)\n\n).\n * PALM-PPF is a Phase 3, randomized, double-blind, placebo-controlled,\nmulticenter, parallel-group study evaluating the safety and efficacy of\nonce-daily TPIP in adult patients with PPF over 52 to 104 weeks. The study's\nprimary endpoint is change from baseline in absolute forced vital capacity\n(FVC) at Week 52, with secondary endpoints assessing disease progression,\nfunctional and physiological decline, patient-reported impact,\npharmacokinetics, and safety (ClinicalTrials.gov ID:\nNCT07805785\n(https://edge.prnewswire.com/c/link/?t=0&l=en&o=4798149-1&h=2998057752&u=https%3A%2F%2Fclinicaltrials.gov%2Fstudy%2FNCT07805785%3Fterm%3DNCT07805785%26viewType%3DCard%26rank%3D1&a=NCT07805785)\n\n).\n * PALM-IPF will be a Phase 3, randomized, double-blind, placebo-controlled,\nmulticenter, parallel-group study evaluating the safety and efficacy of\nonce-daily TPIP in adult patients with IPF over 52 to 104 weeks. The study's\nprimary endpoint will be change from baseline in absolute FVC at Week 52, with\nsecondary endpoints assessing disease progression, functional and\nphysiological decline, and patient-reported impact, pharmacokinetics, and\nsafety (ClinicalTrials.gov listing forthcoming).\n\"As TPIP continues into the next stage of clinical development, this\nmulti-indication PALM Clinical Development Program — the most ambitious\nclinical effort we are undertaking to date — is designed to break through\ntreatment barriers that have historically limited innovation of prostanoid\ntreatment for these complex pulmonary disorders,\" said Martina Flammer, M.D.,\nMBA, Chief Medical Officer of Insmed. \"These four Phase 3 studies further\nevaluate TPIP's potential to meaningfully improve care and, if successful,\nemerge as the prostanoid of choice for clinicians and patients.\"\n\nAbout TPIP\n\nTreprostinil palmitil inhalation powder (TPIP) is an investigational dry\npowder formulation of treprostinil palmitil, a next-generation pro-drug\nformulation of inhaled treprostinil consisting of treprostinil linked by an\nester bond to a 16-carbon chain. Designed entirely in Insmed's laboratories,\nTPIP is a potentially highly differentiated prostanoid being developed as a\nonce-daily therapy for the treatment of patients with pulmonary arterial\nhypertension (PAH), pulmonary hypertension associated with interstitial lung\ndisease (PH-ILD), progressive pulmonary fibrosis (PPF), and idiopathic\npulmonary fibrosis (IPF). TPIP is administered in a capsule-based inhalation\ndevice. TPIP is an investigational drug product that has not been approved for\nany indication in any jurisdiction.\n\nAbout Pulmonary Arterial Hypertension\n\nPulmonary arterial hypertension (PAH), classified as WHO Group 1 Pulmonary\nHypertension, is a serious, progressive, rare disease in which the blood\nvessels in the lungs narrow or become obstructed, leading to high blood\npressure in the pulmonary arteries. The most common symptoms include shortness\nof breath, chest pain, dizziness or fainting, fatigue, and weakness. Untreated\nPAH can be debilitating and often fatal.\n\nAbout Pulmonary Hypertension Associated With Interstitial Lung Disease\n\nPulmonary hypertension associated with interstitial lung disease (PH-ILD),\nalso known as WHO Group 3 Pulmonary Hypertension, is a common and serious\ncomplication of several interstitial lung diseases (ILDs), a group of more\nthan 200 chronic lung disorders marked by inflammation and fibrosis of the\nlung tissue. PH-ILD is strongly associated with impaired quality of life,\ndecreased functional capacity, greater supplemental oxygen requirements,\nincreased risk of hospitalizations, and higher mortality.\n\nAbout Progressive Pulmonary Fibrosis\n\nProgressive pulmonary fibrosis (PPF) is a clinical phenotype that can occur\nacross multiple interstitial lung diseases (ILDs) and is characterized by\nworsening lung fibrosis over time despite treatment of the underlying disease.\nAs fibrosis progresses, patients may experience decline in lung function\naccompanied by worsening breathlessness during exercise and daily activities.\nOver time, disease progression can lead to significant disability, respiratory\nfailure, and premature death.\n\nAbout Idiopathic Pulmonary Fibrosis\n\nIdiopathic pulmonary fibrosis (IPF) is a chronic, progressive lung disease\ncharacterized by irreversible scarring of the lungs and a continual decline in\nlung function. Patients commonly experience worsening shortness of breath and\npersistent cough, which can significantly impact daily activities and quality\nof life.\n\nAbout Insmed\n\nInsmed Incorporated is a people-first global biopharmaceutical company\nstriving to deliver first- and best-in-class therapies to transform the lives\nof patients facing serious diseases. The Company is advancing a diverse\nportfolio of approved and mid- to late-stage investigational medicines —\nincluding two approved therapies to treat chronic, debilitating lung diseases\n— as well as cutting-edge drug discovery focused on serving patient\ncommunities where the need is greatest. Insmed's commercial portfolio and\nclinical pipeline are organized around three therapeutic areas: Respiratory,\nImmunology & Inflammation, and Neuro & Other Rare. The Company's\nresearch engine is advancing a wide range of technologies and modalities,\nincluding gene therapy, AI-driven protein engineering, RNA end-joining, and\nsynthetic rescue, in the pursuit of future pipeline candidates.\n\nHeadquartered in Bridgewater, New Jersey, Insmed has offices and research\nlocations throughout the United States, Europe, and Japan.\nVisit www.insmed.com\n(https://edge.prnewswire.com/c/link/?t=0&l=en&o=4798149-1&h=4030962026&u=https%3A%2F%2Fedge.prnewswire.com%2Fc%2Flink%2F%3Ft%3D0%26l%3Den%26o%3D4703288-1%26h%3D1989777388%26u%3Dhttp%253A%252F%252Fwww.insmed.com%252F%26a%3Dwww.insmed.com&a=www.insmed.com)\n to learn more or follow us on LinkedIn\n(https://edge.prnewswire.com/c/link/?t=0&l=en&o=4798149-1&h=3545815671&u=https%3A%2F%2Fedge.prnewswire.com%2Fc%2Flink%2F%3Ft%3D0%26l%3Den%26o%3D4703288-1%26h%3D3771540838%26u%3Dhttps%253A%252F%252Fwww.linkedin.com%252Fcompany%252Finsmed%26a%3DLinkedIn&a=LinkedIn)\n, Instagram\n(https://edge.prnewswire.com/c/link/?t=0&l=en&o=4798149-1&h=1350479662&u=https%3A%2F%2Fedge.prnewswire.com%2Fc%2Flink%2F%3Ft%3D0%26l%3Den%26o%3D4703288-1%26h%3D3370096843%26u%3Dhttps%253A%252F%252Fwww.instagram.com%252FInsmed%252F%26a%3DInstagram&a=Instagram)\n, YouTube\n(https://edge.prnewswire.com/c/link/?t=0&l=en&o=4798149-1&h=1924790851&u=https%3A%2F%2Fedge.prnewswire.com%2Fc%2Flink%2F%3Ft%3D0%26l%3Den%26o%3D4703288-1%26h%3D2114749782%26u%3Dhttps%253A%252F%252Fwww.youtube.com%252F%2540insmed%26a%3DYouTube&a=YouTube)\n, and X\n(https://edge.prnewswire.com/c/link/?t=0&l=en&o=4798149-1&h=3406878555&u=https%3A%2F%2Fedge.prnewswire.com%2Fc%2Flink%2F%3Ft%3D0%26l%3Den%26o%3D4703288-1%26h%3D3482314689%26u%3Dhttps%253A%252F%252Fx.com%252FInsmed%26a%3DX&a=X)\n.\n\nForward-looking Statements\n\nThis press release contains forward-looking statements that involve\nsubstantial risks and uncertainties. \"Forward-looking statements,\" as that\nterm is defined in the Private Securities Litigation Reform Act of 1995, are\nstatements that are not historical facts and involve a number of risks and\nuncertainties. Words herein such as \"may,\" \"will,\" \"should,\" \"could,\" \"would,\"\n\"expects,\" \"plans,\" \"anticipates,\" \"believes,\" \"estimates,\" \"projects,\"\n\"predicts,\" \"intends,\" \"potential,\" \"continues,\" and similar expressions (as\nwell as other words or expressions referencing future events, conditions or\ncircumstances) may identify forward-looking statements.\n\nThe forward-looking statements in this press release are based upon the\nCompany's current expectations and beliefs, and involve known and unknown\nrisks, uncertainties and other factors, which may cause the Company's actual\nresults, performance and achievements and the timing of certain events to\ndiffer materially from the results, performance, achievements or timings\ndiscussed, projected, anticipated or indicated in any forward-looking\nstatements. Such risks, uncertainties and other factors include, among others,\nthe following: failure to successfully conduct the Company's current and\nfuture clinical trials for TPIP, including due to the Company's potential\ninability to enroll or retain sufficient patients to conduct and complete the\ntrials or generate data necessary for regulatory approval, among other things;\ndevelopment of unexpected safety or efficacy concerns related to TPIP; failure\nof third parties on which the Company is dependent to manufacture sufficient\nquantities of TPIP for clinical needs, to conduct the Company's clinical\ntrials, or to comply with the Company's agreements or laws and regulations\nthat impact the Company's business or agreements with the Company; failure to\nobtain regulatory approval for TPIP in any or all of the indications for which\napproval is being sought; inaccuracies in the Company's estimates of the size\nof the potential markets for TPIP or in data the Company has used to identify\nphysicians; expected rates of patient uptake, duration of expected treatment,\nor expected patient adherence or discontinuation rates, if TPIP is approved;\ninability of the Company or the Company's third-party manufacturers to comply\nwith regulatory requirements related to TPIP; the Company's inability to\nobtain adequate reimbursement from government or third-party payors for TPIP\nor acceptable prices for TPIP, if approved; restrictions or other obligations\nimposed on the Company by agreements related to TPIP and failure to comply\nwith the Company's obligations under such agreements; risks that the Company's\nclinical studies will be delayed or that serious side effects will be\nidentified during drug development; the strength and enforceability of the\nCompany's intellectual property rights or the rights of third parties; and the\ncost and potential reputational damage resulting from litigation to which the\nCompany may become a party, including product liability claims.\n\nThe Company may not actually achieve the results, plans, intentions or\nexpectations indicated by the Company's forward-looking statements because, by\ntheir nature, forward-looking statements involve risks and uncertainties\nbecause they relate to events and depend on circumstances that may or may not\noccur in the future. For additional information about the risks and\nuncertainties that may affect the Company's business, please see the factors\ndiscussed in Item 1A, \"Risk Factors,\" in the Company's Annual Report on Form\n10-K for the year ended December 31, 2025 and any subsequent Company filings\nwith the Securities and Exchange Commission (SEC).\n\nThe Company cautions readers not to place undue reliance on any such\nforward-looking statements, which speak only as of the date of this press\nrelease. The Company disclaims any obligation, except as specifically required\nby law and the rules of the SEC, to publicly update or revise any such\nstatements to reflect any change in expectations or in events, conditions or\ncircumstances on which any such statements may be based, or that may affect\nthe likelihood that actual results will differ from those set forth in the\nforward-looking statements.\n\nContact:\n\nInvestors:\nGianna De Palma\nAssociate Director, Investor Relations\ninvestor.relations@insmed.com (mailto:investor.relations@insmed.com)\n\nMedia:\nClaire Mulhearn\nVice President, Corporate Communications\nmedia@insmed.com (mailto:media@insmed.com)\n\n \n\nView original content to download\nmultimedia:https://www.prnewswire.com/news-releases/insmed-features-the-global-phase-3-palm-clinical-development-program-evaluating-treprostinil-palmitil-inhalation-powder-tpip-at-chest-2026-302909246.html\n(https://www.prnewswire.com/news-releases/insmed-features-the-global-phase-3-palm-clinical-development-program-evaluating-treprostinil-palmitil-inhalation-powder-tpip-at-chest-2026-302909246.html)\n\nSOURCE Insmed Incorporated\n\n\n\nPhoto: \nhttps://mmx.prnewswire.com/media/MS1109455/Insmed-Incorporated-Logo.jpg?id=OA3019554\n\nCopyright (c) 2026 PR Newswire Association,LLC. All Rights Reserved."},"type":"article","timestamp":"2026-10-15T11:00:04.479556145Z","server_sent_at_ms":1792062004479},"received_at":"2026-10-15T11:00:04.533Z","source_url":"https://www.prnewswire.com/news-releases/insmed-features-the-global-phase-3-palm-clinical-development-program-evaluating-treprostinil-palmitil-inhalation-powder-tpip-at-chest-2026-302909246.html"},"analysis":{"id":"158266","press_release_id":"170057","analysis_json":{"industry":{"label":"Pharmaceuticals, Biotechnology & Life Sciences","sector":"Health Care"},"redFlags":["TPIP is not approved in any jurisdiction; binary Phase 3 outcomes lie ahead","PALM-IPF has not yet started"],"eventType":"clinical_trial","narrative":"Insmed is featuring its global Phase 3 PALM program for TPIP at CHEST 2026, with four pivotal studies spanning PAH, PH-ILD, PPF, and IPF.\n\nThree studies (PALM-PAH, PALM-ILD, PALM-PPF) are initiated, and PALM-IPF is expected to begin in the first half of 2027, with the program aiming to enroll more than 2,000 patients.\n\nTPIP remains investigational with no approval in any jurisdiction; the release contains no new clinical data, so the update is pipeline visibility rather than a value-changing event.","sentiment":"neutral","agentHooks":{"shouldPost":false,"suggestedAngle":"Program-status confirmation only -- no new data; watch for PALM-IPF initiation in 1H 2027."},"keyFigures":{"drugName":"TPIP (treprostinil palmitil inhalation powder)","phaseOfTrial":"Phase 3","customDimensions":{"palm_ipf_start":"first half of 2027","pivotal_studies":4,"studies_initiated":"PALM-PAH, PALM-ILD, PALM-PPF","planned_enrollment":"more than 2,000 patients"}},"quotedText":"These four Phase 3 studies further evaluate TPIP's potential to meaningfully improve care and, if successful, emerge as the prostanoid of choice for clinicians and patients.","namedEntities":{"people":[{"name":"Raymond Benza","role":"Chair of Cardiology, Sentara Health"},{"name":"Martina Flammer","role":"Chief Medical Officer of Insmed"}],"products":["TPIP (treprostinil palmitil inhalation powder)"],"companies":[{"name":"Insmed Incorporated","ticker":"INSM","relationship":"filer"}],"dollarAmounts":[]},"materialImpact":{"score":2,"reasoning":"Conference showcase of the already-announced four-study Phase 3 PALM program for TPIP; no new efficacy, safety, or regulatory data, but it confirms three of four studies are initiated and PALM-IPF is on track for 1H 2027."},"tickerRelevance":{"others":[],"primary":"INSM"},"globalImportance":25,"audienceRelevance":40,"eventTypeSecondary":[],"importanceComponents":{"tickerTier":"large-cap biotech","eventGravity":"conference-showcase-no-new-data","issuerAuthored":true,"retailFavoriteBoost":"moderate"}},"event_type":"clinical_trial","event_type_secondary":null,"sentiment":"neutral","material_impact_score":2,"narrative":"Insmed is featuring its global Phase 3 PALM program for TPIP at CHEST 2026, with four pivotal studies spanning PAH, PH-ILD, PPF, and IPF.\n\nThree studies (PALM-PAH, PALM-ILD, PALM-PPF) are initiated, and PALM-IPF is expected to begin in the first half of 2027, with the program aiming to enroll more than 2,000 patients.\n\nTPIP remains investigational with no approval in any jurisdiction; the release contains no new clinical data, so the update is pipeline visibility rather than a value-changing event.","key_figures":{"drugName":"TPIP (treprostinil palmitil inhalation powder)","phaseOfTrial":"Phase 3","customDimensions":{"palm_ipf_start":"first half of 2027","pivotal_studies":4,"studies_initiated":"PALM-PAH, PALM-ILD, PALM-PPF","planned_enrollment":"more than 2,000 patients"}},"named_entities":{"people":[{"name":"Raymond Benza","role":"Chair of Cardiology, Sentara Health"},{"name":"Martina Flammer","role":"Chief Medical Officer of Insmed"}],"products":["TPIP (treprostinil palmitil inhalation powder)"],"companies":[{"name":"Insmed Incorporated","ticker":"INSM","relationship":"filer"}],"dollarAmounts":[]},"model_name":"glm-5.3-flashx","prompt_hash":"sha256:5c812bd9e28b810d","schema_hash":"sha256:05005c02d9cffac9","created_at":"2026-10-15T11:00:23.644Z","global_importance":25,"audience_relevance":40,"importance_components":{"tickerTier":"large-cap biotech","eventGravity":"conference-showcase-no-new-data","issuerAuthored":true,"retailFavoriteBoost":"moderate"}},"durationMs":5809,"modelName":"glm-5.3-flashx"}}