01—Abstract
Summary
Summary of the 8-K filed July 16, 2026. Cited figures are marked; the original filing is the authoritative source.
Insmed Incorporated (Nasdaq: INSM) reported 12-month safety and efficacy data from its ongoing open-label extension (OLE) study of treprostinil palmitil inhalation powder (TPIP), a once-daily inhaled investigational therapy in pulmonary arterial hypertension (PAH), in a press release and accompanying slide presentation filed under Item 7.01 on July 16, 2026.
The study enrolled 91 patients, 60 in the TPIP Continued group and 31 in the Placebo Crossed group, and the company says both groups showed sustained or similar improvements at Month 12 in six-minute walk distance (6MWD), NT-proBNP, WHO Functional Class and REVEAL Lite 2.0 score. Mean 6MWD improvement from baseline was +55.7 meters for the TPIP Continued group and +54.1 meters for the Placebo Crossed group, and NT-proBNP was reduced by approximately 60%a in both groups. On safety, the company reported that TPIP was generally well tolerated with no newly identified safety signals through Month 12 at doses up to 1,280 µg once daily.
Treatment-emergent adverse events occurred in 89.0%b of patients, serious TEAEs in 18.7%, and severe TEAEs in 16.5%, and TEAEs led to discontinuation in 7.7%. Four deaths occurred, none considered related to TPIP. The filing notes the study is single-arm and open-label for the TPIP Continued group, and that the efficacy endpoints are secondary and exploratory.
The company stated that these data support continued development of TPIP and the recently initiated Phase 3 PALM-PAH trial, a randomized, double-blind, placebo-controlled study with 6MWD as its primary endpoint. Insmed plans to publish the 12-month OLE results in the future. The filing also states that TPIP is investigational and has not been approved for any indication in any jurisdiction.
02—Key points
Key Highlights
- Insmed reported 12-month OLE data for TPIP in 91 PAH patients (60 TPIP Continued, 31 Placebo Crossed).
- Mean 6MWD improvement from baseline was +55.7 meters (TPIP Continued) and +54.1 meters (Placebo Crossed) at Month 12.
- NT-proBNP was reduced by approximately 60% in both groups; GMR to baseline was 0.40 and 0.41, respectively.
- Approximately 65% of all patients achieved Refined Low Risk status on REVEAL Lite 2.0 by Month 12; mean score improved 2.0 points (Continued) and 1.4 points (Placebo Crossed).
- Safety: no newly identified safety signals through Month 12; TEAEs in 89.0% of patients, serious TEAEs in 18.7%, TEAEs leading to discontinuation in 7.7%; four deaths, none considered related to TPIP.
- Phase 3 PALM-PAH, a randomized, double-blind, placebo-controlled trial with 6MWD as primary endpoint, has recently been initiated.
- The OLE study is single-arm and open-label for the TPIP Continued group, and efficacy endpoints are secondary and exploratory, per the filing's forward-looking statements.
03—Questions
Frequently Asked Questions
What did the 12-month OLE study show for efficacy?
Patients who continued TPIP showed sustained improvement in 6MWD, NT-proBNP and WHO Functional Class and a clinically meaningful REVEAL Lite 2.0 score improvement at Month 12. Patients who crossed from placebo to TPIP achieved similar outcomes across efficacy measures.
Was TPIP safe over 12 months?
The company reported TPIP was generally well tolerated with no newly identified safety signals through Month 12 at doses up to 1,280 µg once daily. Four deaths occurred, none of which were considered related to TPIP treatment.
What comes next for TPIP's development?
The company cited the recent initiation of PALM-PAH, a Phase 3, randomized, double-blind, placebo-controlled trial of once-daily TPIP in PAH over 24 weeks with change in 6MWD as the primary endpoint. Insmed plans to publish the 12-month OLE results in the future.
Is TPIP approved for use?
No. The filing states TPIP is an investigational drug product that has not been approved for any indication in any jurisdiction.
04—Continue