Insmed Incorporated Presents 11 New Abstracts At Ats 2025 from Across Its Respiratory Portfolio

Published: 2025-05-21 17:05:48 ET INSM

Published on 05/21/2025 at 17:05

Insmed Incorporated presented 11 new abstracts at the American Thoracic Society (ATS) 2025 International Conference, which took place May 18-21 in San Francisco, including three prespecified subgroup analyses from the Phase 3 ASPEN trial of brensocatib in non-cystic fibrosis bronchiectasis (NCFBE), signaling the consistency of efficacy and safety outcomes across diverse clinical profiles. Such risks, uncertainties and other factors include, among others, the following: failure to continue to successfully commercialize ARIKAYCE, the company only approved product, in the 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; inability to obtain full approval of ARIKAYCE from the FDA, including the risk that the company will not successfully or in a timely manner complete the confirmatory post-marketing clinical trial required for full approval of ARIKayCE, or 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 or TPIP in the U.S, Europe or Japan or for ARIKAYCE outside the US, Europe or Japan, including separate regulatory approval for Lamira®? in each market and for each usage; failure to successfully commercialize brensocatib orTPIP, if approved by applicable regulatory authorities, or to maintain applicable regulatory approvals for brenSocatib or TPIP, if approved, brensocatib or CPIP, if approved, b Rensocatib or TPIP, or to maintain applicable regulatory approval for brensocatib and TPIP by physicians, patients, third-party payors and others in the healthcare community; inability to obtain and maintain adequate reimbursement from government or third-party payors for ARIKAYCE or, if approved, brenSocatib orTPIP, or acceptable prices for ARIKAYCE or.

inaccuracies in estimates of the size of the potential markets for ARIKAYCE, brensocatib and in data 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 brensocatib, 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, secured senior loan with certain funds managed by Pharmakon Advisors LP and royalty financing with OrbiMed Royalty & Credit Opportunities IV, LP, including 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 operations under these agreements; 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 product candidates that are approved in the future; failure to successfully conduct future clinical trials for ARIKAYCE,brensocatib or TP IP and potential inability to enroll or retain sufficient patients to conduct and complete the trials or generate data necessary for regulatory approval of product candidates or to permit the use of ARIKAYCE in the broader population of patients with MAC lung disease, among other things; development of unexpected safety or efficacy concerns related to ARIKAYCE, b Rensocatib, or TPIP; risks that the clinical studies will be delayed, that serious side effects will be identified during drug development, or that any protocol amendments will be identified during drug development.