Insmed Reports Positive Topline Results From Phase 3 ARISE Study Of ARIKAYCE

RTTNews | il y a 695
Insmed Reports Positive Topline Results From Phase 3 ARISE Study Of ARIKAYCE

(RTTNews) - Biopharmaceutical company Insmed Inc. (INSM) announced Tuesday positive topline results from its Phase 3 ARISE study of ARIKAYCE in patients with newly diagnosed or recurrent nontuberculous mycobacterial (NTM) lung infection caused by Mycobacterium avium complex (MAC) who had not started antibiotics.

The study met its primary objective of demonstrating that the Quality of Life - Bronchiectasis (QOL-B) respiratory domain works effectively as a patient-reported outcome (PRO) instrument in patients with MAC lung disease.

Based on these results, Insmed plans to propose to the U.S. Food and Drug Administration (FDA) that the QOL-B respiratory domain PRO be the primary endpoint for the ENCORE study without any modifications.

Patients in ARISE were randomized 1:1 to treatment with ARIKAYCE plus macrolide-based background regimen (ARIKAYCE arm) or placebo plus macrolide-based background regimen (comparator arm) for six months, followed by one month off treatment.

Based on the results of ARISE, Insmed plans to explore with global regulators accelerating the filing for approval of ARIKAYCE in newly infected patients with MAC lung disease.

In parallel, the Company continues to enroll patients in ENCORE, which will use the PRO tool that has been validated in ARISE, with 250 patients expected to be enrolled by the end of 2023.

Enrollment in ENCORE is expected to continue into 2024 to ensure a high degree of statistical powering and Insmed anticipates reporting topline data from ENCORE in 2025.

read more
Japanese Market Notably Lower

Japanese Market Notably Lower

Reversing the gains in the previous session, the Japanese market is notably lower on Friday, following the broadly negative cues from Wall Street overnight. The Nikkei 225 is falling below the 40,700 level, with weakness in financial and technology stocks partially offset by gains in exporters and automaker stocks.
RTTNews | il y a 42 minutes
Australian Market Notably Lower

Australian Market Notably Lower

The Australian stock market is trading notably lower on Friday, extending the losses in the previous session, following the broadly negative cues from Wall Street overnight. The benchmark S&P/ASX 200 is falling below the 8,700 level, with weakness across most sectors led by energy and technology stocks.
RTTNews | il y a 44 minutes
Swiss Market Ends Moderately Lower

Swiss Market Ends Moderately Lower

Despite a decent spell in positive territory till about an hour before noon, the Switzerland market turned weak and kept drifting lower as the session progressed on Thursday to eventually settle with a moderate loss.
RTTNews | il y a 8h 31min
U.S. Consumer Price Growth Matches Estimates In June

U.S. Consumer Price Growth Matches Estimates In June

A closely watched report released by the Commerce Department on Thursday showed consumer prices in the U.S. increased in line with economist estimates in the month of June. The Commerce Department said its personal consumption expenditures (PCE) price index rose by 0.3 percent in June after inching up by an upwardly revised 0.2 percent in May.
RTTNews | il y a 11h 50min
German Unemployment Rises In July

German Unemployment Rises In July

Germany's unemployment increased less than expected in July but the overall number of people out of work remained close to the 3 million mark due to the prolonged period of economic slowdown, official data revealed on Thursday. The number of unemployed rose by less-than-expected 2,000 from June, the Federal Employment Agency said. For July, economists had forecast an increase of 15,000.
RTTNews | il y a 12h 33min
U.S. Jobless Claims Inch Up Less Than Expected To 218,000

U.S. Jobless Claims Inch Up Less Than Expected To 218,000

First-time claims for U.S. unemployment benefits edged slightly higher in the week ended July 26th, according to a report released by the Labor Department on Thursday. The report said initial jobless claims crept up to 218,000, an increase of 1,000 from the previous week's unrevised level of 217,000. Economists had expected jobless claims to rise to 224,000.
RTTNews | il y a 12h 40min