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Investing.com -- Insmed (NASDAQ:INSM) stock jumped 27% after the biopharmaceutical company announced positive topline results from its Phase 2b study of treprostinil palmitil inhalation powder (TPIP) as a once-daily therapy for patients with pulmonary arterial hypertension.
The study met its primary endpoint, showing a placebo-adjusted reduction from baseline in pulmonary vascular resistance of 35% with statistical significance (p<0.001). It also achieved all secondary efficacy endpoints, including a placebo-adjusted improvement in six-minute walk distance of 35.5 meters and a 60% reduction in NT-proBNP concentrations, a biomarker for cardiac stress.
These results are particularly significant as they demonstrate TPIP’s durability as a once-daily therapy, with efficacy measured approximately 24 hours after administration. Of patients treated with TPIP, 84% titrated to at least 480 μg once daily and 75% reached the maximum allowed dose of 640 μg.
"The statistically significant and clinically meaningful results shown with TPIP in pulmonary arterial hypertension mark a potential breakthrough for patients and the future of prostanoid therapy," said Gene Sullivan, Chief Product Strategy Officer of Insmed.
The treatment was generally well-tolerated, with cough (40.6% vs 21.2% for placebo), headache (31.9% vs 15.2%), and fatigue (10.1% vs 3.0%) being the most common side effects.
Based on these results, Insmed plans to engage with the FDA regarding Phase 3 trial design for PAH, with plans to initiate Phase 3 trials in pulmonary hypertension associated with interstitial lung disease before the end of 2025 and in PAH in early 2026.
Leerink Partners analyst Joseph P. Schwartz reiterated an Outperform rating with a $100 price target, stating: "Insmed (INSM, OP) disclosed topline data from the Ph.2b study with TPIP in PAH, with results exceeding our bestcase scenario; we expect the stock to trade back into the $80s or higher."
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