Insmed reports positive 12-month OLE results for TPIP showing sustained 6MWD, ~60% NT-proBNP drop

Insmed announced positive 12-month OLE data for TPIP showing sustained efficacy and favorable tolerability.

Key Highlights:

• 12-month OLE: continued TPIP showed mean 6MWD improvement +55.7m; placebo-crossed group +54.1m, aligning by Month 12.
• NT-proBNP fell ~60% vs baseline in both continued and placebo-crossed groups, maintained at Month 12.
• ~80% of patients achieved WHO Functional Class I or II; >25% reached Class I by Month 12.
• REVEAL Lite 2.0 score improved (TPIP continued +2.0 pts; placebo-crossed +1.4 pts); ~65% achieved Refined Low Risk status.
• Safety: TPIP generally well tolerated through Month 12; TEAEs in 89.0%, serious TEAEs 18.7%, 4 deaths not considered treatment related; doses up to 1,280 µg permitted.

Original SEC Filing:

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