Every 8-K that Insmed, Inc. (INSM) has filed with the SEC in the last 24 months is listed below, newest first, and each one links through to the document itself with the summary and the scores our analysis gives it.
A 8-K covers material events a company has to report between its quarterly reports, so if you follow INSM and want that one kind of document rather than the whole filing history, this is the page to keep. The company's other filings, of every form, are on the full INSM filings page.
Insmed Incorporated reported second-quarter 2026 total revenues of $425.5 million, up from $107.4 million a year earlier. Growth was led by BRINSUPRI, which generated $309.2 million and grew 49% over the first quarter of 2026, and ARIKAYCE, which delivered $116.3 million, up 8% versus the 2025 quarter.
Operating loss for the quarter was $1.5 million, and net loss narrowed to $13.2 million (or $0.06 per share) compared with $321.7 million (or $1.70 per share) a year earlier. At June 30, 2026, cash, cash equivalents and marketable securities totaled approximately $1.2 billion, with shareholders’ equity of $757.5 million.
Insmed raised its 2026 BRINSUPRI revenue guidance to $1.25 billion–$1.40 billion and reiterated ARIKAYCE guidance of $450 million–$470 million. The company now estimates combined peak revenue of more than $14 billion for BRINSUPRI, TPIP and ARIKAYCE, and states it expects to reach cash flow positivity in 2027 without raising additional capital while advancing multiple late-stage and early-stage programs.
Insmed Incorporated reported 12‑month results from a 24‑month open‑label extension study of once‑daily treprostinil palmitil inhalation powder (TPIP) in 91 patients with pulmonary arterial hypertension who had completed prior TPIP trials. The study is single‑arm and uses baseline values from the Phase 2b lead‑in study.
Patients continuing TPIP and those crossing over from placebo both showed sustained improvements at Month 12, including mean six‑minute walk distance gains of 55.7 meters and 54.1 meters from baseline, and an approximately 60% reduction in NT‑proBNP levels by Month 6 that was maintained at Month 12. About 80% of patients achieved World Health Organization Functional Class I or II, and roughly 65% reached Refined Low Risk status on the REVEAL Lite 2.0 mortality risk score.
Once‑daily TPIP was generally well tolerated through Month 12 at doses up to 1,280 µg. Treatment‑emergent adverse events occurred in 89.0% of patients, serious events in 18.7%, severe events in 16.5%, and adverse events led to discontinuation in 7.7%. There were four deaths, none considered related to TPIP. Insmed states that these findings support continued TPIP development and the ongoing Phase 3 PALM‑PAH trial.
Insmed Incorporated reported results from its annual shareholder meeting held on May 13, 2026. Shareholders elected Elizabeth McKee Anderson and Clarissa Desjardins, Ph.D., as Class II directors to serve until the 2029 annual meeting. Anderson received 153,734,471 votes for and 32,130,980 withheld, while Desjardins received 164,437,828 votes for and 21,427,623 withheld; each had 11,564,082 broker non-votes.
Shareholders also approved, on an advisory and non-binding basis, the 2025 compensation of the company’s named executive officers, with 162,133,728 votes for, 23,657,325 against, 74,398 abstentions and 11,564,082 broker non-votes. In addition, shareholders ratified the appointment of Ernst & Young LLP as independent registered public accounting firm for the year ending December 31, 2026, by 190,386,612 votes for, 6,997,613 against and 45,308 abstentions.
Insmed reported strong first-quarter 2026 growth, with total revenues of $306.0 million, up from $92.8 million a year earlier, driven by the U.S. launch of BRINSUPRI and continued ARIKAYCE demand. BRINSUPRI generated $207.9 million, while ARIKAYCE contributed $98.1 million and remained in growth eight years post-launch.
The company still posted a net loss of $163.6 million, though this narrowed from $256.6 million in 2025 as operating leverage improved. Management reiterated 2026 revenue guidance of at least $1 billion for BRINSUPRI and $450–$470 million for ARIKAYCE, and highlighted a goal of reaching cash-flow positivity in 2027 supported by roughly $1.2 billion in cash and marketable securities.
Insmed Incorporated reported that its Phase 2b CEDAR trial of brensocatib in moderate to severe hidradenitis suppurativa did not meet its primary or secondary efficacy endpoints, and the company will discontinue development of brensocatib for HS.
The randomized, double-blind, placebo-controlled study enrolled 214 patients across 72 global sites. At Week 16, abscess and inflammatory nodule counts fell 45.5% and 40.3% in the 10 mg and 40 mg brensocatib arms, compared with a 57.1% reduction on placebo, indicating no efficacy advantage. Safety was consistent with prior studies, with similar rates of treatment-emergent adverse events and no new safety signals at either dose.
Insmed Incorporated reported positive topline results from its Phase 3b ENCORE study of ARIKAYCE in patients with newly diagnosed MAC lung infection not previously treated with antibiotics. ARIKAYCE plus multidrug therapy improved Respiratory Symptom Score at Month 13 by 17.77 points versus 14.66 with placebo, a 3.11‑point advantage (p=0.0299), and achieved culture conversion by Month 6 in 87.8% of patients versus 57.0% with placebo. By Month 15, a significantly greater proportion of ARIKAYCE patients maintained durable culture conversion, and overall study completion exceeded 90% in both arms, with a safety profile consistent with known risks such as dysphonia, cough and bronchospasm. These results fulfill the U.S. FDA post‑marketing requirement, and Insmed plans a supplemental NDA in the second half of 2026 to seek U.S. label expansion and conversion of ARIKAYCE’s existing refractory indication to traditional approval, as well as a parallel submission to Japan’s PMDA.
Insmed Incorporated reported strong growth for the fourth quarter and full year 2025 while remaining deeply loss-making and setting ambitious 2026 revenue goals. Total revenue reached $606.4 million in 2025, up from $363.7 million, driven by the U.S. launch of BRINSUPRI and continued ARIKAYCE expansion.
BRINSUPRI generated $144.6 million in Q4 and $172.7 million for 2025, while ARIKAYCE delivered $119.2 million in Q4 and $433.8 million for the year, representing 19% annual growth. Despite this, Insmed posted a 2025 net loss of $1.28 billion, as operating expenses rose to $1.85 billion. The company ended 2025 with approximately $1.4 billion in cash, cash equivalents, and marketable securities and guides for at least $1 billion in 2026 BRINSUPRI revenue and $450–$470 million from ARIKAYCE. Insmed also highlighted Orphan Drug Designation for TPIP in pulmonary arterial hypertension and ongoing late-stage studies. Separately, director David W.J. McGirr will not stand for re-election at the 2026 annual meeting but will continue serving until then.
Insmed Incorporated reported that its management will present at the 44th Annual J.P. Morgan Healthcare Conference on January 12, 2026, at 3:00 p.m. Pacific Time (6:00 p.m. Eastern Time). The company will provide a live webcast of the presentation through the investor relations section of its website, allowing broader access for interested stakeholders. In connection with this conference appearance, Insmed issued a press release and prepared a slide presentation, which are included as Exhibits 99.1 and 99.2, respectively, and are incorporated by reference for informational purposes but are not deemed filed under securities laws.
Insmed Incorporated reported topline results from its Phase 2b BiRCh study of brensocatib in patients with chronic rhinosinusitis without nasal polyps (CRSsNP) and announced that it has discontinued development of brensocatib for this indication. The 24‑week, randomized, double‑blind, placebo‑controlled study enrolled 288 patients across 104 global sites, comparing once‑daily brensocatib 10 mg, brensocatib 40 mg, and placebo, all on top of mometasone furoate nasal spray.
The primary endpoint was change from baseline in the 28‑day average daily Sinus Total Symptom Score at Week 24. Least squares mean changes were -2.44 for placebo, -2.21 for brensocatib 10 mg, and -2.33 for brensocatib 40 mg. Brensocatib was observed to be well tolerated, with similar rates of treatment‑emergent and serious adverse events across arms. Insmed also disclosed it has acquired INS1148, an investigational monoclonal antibody it plans to develop for respiratory, immunological, and inflammatory diseases with high unmet need.
Insmed Incorporated announced that the European Commission has approved its drug BRINSUPRI (brensocatib 25 mg tablets) to treat non-cystic fibrosis bronchiectasis in certain younger and adult patients. The approval covers patients 12 years of age and older who have experienced two or more exacerbations in the prior 12 months, addressing a population with recurrent respiratory flare-ups. Insmed disclosed the news in connection with a press release, which is included as an exhibit to the report.
Insmed Incorporated announced it has furnished a press release detailing its financial results for the third quarter ended September 30, 2025. The company also provided a slide presentation to accompany its conference call.
Both materials are included as Exhibits 99.1 and 99.2. The information is furnished under Item 2.02 and Item 9.01 and is not deemed “filed” for purposes of Section 18 of the Exchange Act.
Insmed announced FDA approval of BRINSUPRI (brensocatib) 10 mg and 25 mg tablets, an oral once-daily treatment for non-cystic fibrosis bronchiectasis in adults and children 12 years and older. The company attached a press release and an approval presentation as Exhibits 99.1 and 99.2 and will host a conference call with a live webcast to discuss the approval. The filing notes the Item 7.01 materials are not deemed "filed" for purposes of Section 18. The report does not include financial results, revenue guidance, launch timing, or other commercial details.