Company Announcements

—Abstracts Include the Phase 3 PALM-PAH Study Design, a Presentation of the Previously Disclosed Topline Phase 2b PAH Data, a Functional Respiratory Imaging Analysis from the Phase 2b Study in Pulmonary Arterial Hypertension (PAH), and Pulmonary Vasodilation Data in Rat Models—

BRIDGEWATER, N.J. , Jan. 28, 2026 /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 will present four abstracts on treprostinil palmitil inhalation powder (TPIP) at the Pulmonary Vascular Research Institute (PVRI) 2026 congress in Dublin from January 28 – February 1, 2026.

Presentations will feature the Phase 3 PALM-PAH study design and an encore presentation of the topline results from the Phase 2b study of TPIP in pulmonary arterial hypertension (PAH). Additionally, a new Functional Respiratory Imaging analysis from the Phase 2b PAH study, as well as data evaluating the pulmonary vasodilatory effect of TPIP in rat models will be presented.

"We are pleased that TPIP will have a significant presence at this year's PVRI 2026 congress, reflecting the growing body of evidence supporting its potential to become the prostanoid of choice," said Martina Flammer, M.D., MBA, Chief Medical Officer, Insmed. "Collectively, these Phase 2b clinical, advanced imaging, and translational preclinical data provide a strong foundation as we initiate multiple Phase 3 programs, including the PALM-PAH study, with the goal of improving outcomes for patients."

Presentations:

• Presentation Details, Moderated Poster Discussion – Robinson, Friday, January 30, 2026, 15:10 – 16:15, Robinson Suite, Poster Board: 41
  • Lead Author and Presenter: Tam Nguyen
  • Title: Pulmonary Vasodilation with TPIP in Rat Isolated Perfused Lungs
• Presentation Details, Moderated Poster Discussion – Higgins, Saturday, January 31, 2026, 09:55 - 11:00, Higgins Suite, Poster Board: 7
  • Lead Author: Ekkehard Grünig, Presenter:Raymond Benza
  • Title: Study Design of a Phase 3 Trial of Treprostinil Palmitil Inhalation Powder (TPIP) in Patients With Pulmonary Arterial Hypertension (PAH)
• Presentation Details, Moderated Poster Discussion – Higgins, Saturday, Jan 31, 2026, 09:55 - 11:00, Higgins Suite, Poster Board: 8 
  • Lead Author and Presenter: Ioana Preston
  • Title: Novel Insights from Functional Respiratory Imaging (FRI) Analysis in a Phase 2 Randomized, Double-blind, Placebo-controlled Study of Treprostinil Palmitil Inhalation Powder (TPIP) in Patients with Pulmonary Arterial Hypertension (PAH)
• Presentation Details, Moderated Poster Discussion – Higgins, Saturday, Jan 31, 2026, 09:55 - 11:00, Higgins Suite, Poster Board: 6
  • Lead Author: Ekkehard Grünig, Presenter: Amy Boutet
  • Title: Encore Presentation: A Randomized, Double-blind, Placebo-controlled Study of Treprostinil Palmitil Inhalation Powder (TPIP) in Patients (pts) with Pulmonary Arterial Hypertension (PAH)

About TPIP

Treprostinil palmitil inhalation powder (TPIP) is a dry powder formulation of treprostinil palmitil, a treprostinil prodrug consisting of treprostinil linked by an ester bond to a 16-carbon chain. Developed entirely in Insmed's laboratories, TPIP is being evaluated as a once-daily therapy for the treatment of patients with PAH, PH-ILD, and other rare and serious pulmonary disorders. TPIP is administered in a capsule-based inhalation device. TPIP is an investigational drug product that has not been approved for any indication in any jurisdiction. 

About the Phase 2b Study

The Phase 2b study of treprostinil palmitil inhalation powder (TPIP) in patients with PAH was a randomized, double-blind, multicenter, placebo-controlled study designed to evaluate the efficacy, safety, and pharmacokinetics of TPIP, administered once daily, in patients diagnosed with PAH (World Health Organization Group 1). The study was conducted at 44 sites and enrolled 102 adult participants. Patients started at a dose of 80 µg once daily (TPIP or matching placebo) and were titrated up to their maximum tolerated dose, or to the maximum allowable dose of 640 µg, once daily over a three-week period, with the possibility of a final dose increase occurring at Week 5. Patients self-administered TPIP or placebo using a capsule-based inhalation device. The primary endpoint was change from baseline in pulmonary vascular resistance (PVR) versus placebo at Week 16. Secondary endpoints were six-minute walk distance (6MWD), N-terminal pro b-type natriuretic peptide (NT-proBNP) concentrations, pharmacokinetics, and safety/tolerability. Patients who completed the study could enroll in a long-term open-label extension, with the option to titrate up to a maximum tolerated dose of 1,280 µg once daily. 

About PAH

PAH is a serious, progressive, rare disease in which the blood vessels in the lungs narrow or become obstructed, leading to high blood pressure in the pulmonary arteries. The most common symptoms include shortness of breath, chest pain, dizziness or fainting, fatigue, and weakness. It is estimated that approximately 35,000 patients in the U.S., 40,000 patients in the EU5 (France, Germany, Italy, Spain and the UK), and 15,000 patients in Japan have been diagnosed with the disease. Untreated, PAH can be debilitating and often fatal.

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 two approved therapies to treat chronic, debilitating lung diseases. 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. Insmed is proud to be recognized as one of the best employers in the biopharmaceutical industry, including spending five consecutive years as the No. 1 Science Top Employer. Visit www.insmed.com to learn more or follow us on LinkedIn, Instagram, YouTube, and X.

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 risk that the full data set from the TPIP PAH study or data generated in further clinical trials of TPIP will not be consistent with the topline results of the TPIP PAH study; failure to successfully conduct future clinical trials for TPIP, such as the Company's planned Phase 3 program for TPIP, including due to the Company's potential inability to enroll or retain sufficient patients to conduct and complete the trials or generate data necessary for regulatory approval, among other things; development of unexpected safety or efficacy concerns related to TPIP; failure of third parties on which the Company is dependent to manufacture sufficient quantities of TPIP for 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 or agreements with the Company; failure to obtain regulatory approval for TPIP; inaccuracies in the Company's estimates of the size of the potential markets for TPIP or in data the Company has used to identify physicians; expected rates of patient uptake, duration of expected treatment, or expected patient adherence or discontinuation rates, if TPIP is approved; inability of the Company or the Company's third-party manufacturers to comply with regulatory requirements related to TPIP; the Company's inability to obtain adequate reimbursement from government or third-party payors for TPIP or acceptable prices for TPIP, if approved; restrictions or other obligations imposed on us by agreements related to TPIP and failure to comply with our obligations under such agreements; risks that the Company's clinical studies will be delayed or that serious side effects will be identified during drug development; the strength and enforceability of the Company's intellectual property rights or the rights of third parties; and the cost and potential reputational damage resulting from litigation to which the Company may become a party, including product liability claims.

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 Securities and Exchange Commission (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 Dunn
Vice President, Investor Relations
(732) 487-7043
investor.relations@insmed.com

Media:

Claire Mulhearn
Vice President, Corporate Communications
(862) 842-6819
media@insmed.com

 

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SOURCE Insmed Incorporated