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Noticias de INSM
Eventos de INSM
Insmed's Brinsupri Approved in Japan for Non-Cystic Fibrosis Bronchiectasis
Insmed announced that Japan's Ministry of Health, Labour and Welfare has approved Brinsupri, an oral, once-daily treatment for non-cystic fibrosis bronchiectasis in adults and pediatric patients 12 years and older. Brinsupri, the first and only MHLW-approved treatment for NCFB, finally gives patients with NCFB and clinicians who treat the disease an option to manage this chronic and progressive disease that can lead to permanent lung damage and lung function decline. With this approval, Brinsupri is now approved for use in the U.S., Europe, and Japan.
Insmed Stock Rises 31.9% to $130.63
Insmed is up 31.9%, or $31.61 to $130.63.
Insmed Stock Rises 37.1% to $135.75
Insmed is up 37.1%, or $36.73 to $135.75.
Insmed Reports Q2 Revenue of $425.5M, Beating Expectations
Reports Q2 revenue $425.5M, consensus $393.36M. "Our team delivered tremendous results in the second quarter of the year, reflecting our operational excellence and positioning for the future," said Will Lewis, Chair and Chief Executive Officer of Insmed. "The U.S. BRINSUPRI launch continues to be met with significant enthusiasm and demand from patients and physicians. Additionally, we were pleased to report positive data from our ongoing open-label extension study of TPIP in PAH, reinforcing TPIP's potential to become the prostanoid of choice. Looking ahead, our focus is on building upon the early success of the BRINSUPRI launch, preparing to execute on the potential ARIKAYCE label expansion in the U.S. and Japan, progressing our Phase 3 TPIP programs across four large indications, and advancing our multiple early-stage pipeline candidates. As a result of our team's significant efforts, we are raising our peak revenue estimates for both BRINSUPRI and TPIP. We now expect that our three lead programs will generate more than $14 billion in combined peak sales. This ambitious yet achievable objective reflects our team's proven ability to execute and the opportunity to improve the lives of hundreds of thousands of patients worldwide."
Insmed Reports Positive 12-Month Data for TPIP
Insmed announced positive 12-Month data from the ongoing open-label extension study evaluating treprostinil palmitil inhalation powder, or TPIP, administered once daily in patients with pulmonary arterial hypertension, or PAH. The OLE study is a non-placebo-controlled trial and was designed to evaluate the long-term safety, tolerability, and effectiveness of TPIP over 24 months in patients who completed the lead-in TPIP PAH studies. Results for secondary efficacy endpoints demonstrated sustained improvement with TPIP in six-minute walk distance, N-terminal fragment pro-B-type natriuretic peptide concentration, and World Health Organization Functional Class, as well as a clinically meaningful improvement in REVEAL Lite 2.0 score at Month 12. Patients in the Placebo Crossed group showed similar outcomes to patients in the TPIP Continued group across all efficacy measures at Month 12. Mean improvement from baseline for 6MWD was +55.7 meters for the TPIP Continued group and +54.1 meters for the Placebo Crossed group. Mean REVEAL Lite 2.0 score improved 2.0-points from baseline for the TPIP Continued group and 1.4-points from baseline for the Placebo Crossed group. Approximately 65% of all patients achieved Refined Low Risk status, which is associated with a less than 5% estimated risk of mortality at three years and an approximately 7% risk of clinical worsening at one year.
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