Insmed's Supplemental New Drug Application (sNDA) for ARIKAYCE, an inhaled antibiotic for Mycobacterium avium complex (MAC) lung disease, has been accepted by the FDA with Priority Review and a target decision date of January 28, 2027. The full approval application is based on positive Phase 3b ENCORE study results showing significant improvements in respiratory symptoms and culture conversion compared to standard therapy. Full approval could allow ARIKAYCE to be used earlier in the disease course, benefiting more patients. Insmed also plans to seek label expansion in Japan based on these data.
The FDA's Priority Review of Insmed's sNDA for ARIKAYCE provides context for healthcare sector interest. For readers following health-sector stocks, 46 of 92 US stocks traded on Pluang rose and 29 fell today. Notable movers include Novo Nordisk A/S (NVO) at USD 41.22 with a -4.67% change, Summit Therapeutics Inc (SMMT) at USD 18.61 up 4.26%, and AbCellera Biologics Inc (ABCL) at USD 13.07 up 3.48%, as of Sep 21, 2026 17:21 WIB.
Accenture's stock fell 4.73% to $181.29 after Guggenheim reiterated a Neutral rating, citing that the stock price has outpaced the company's actual business performance. Analysts point to weak customer demand, fewer job postings, and a cautious mid-m...
Thryv Holdings is selling its traditional print directory business for $142 million to focus on business automation software for small and medium businesses. CEO Walsh Joe bought 25,000 shares at $1.80 each, increasing his stake to 788,099 shares, si...
Bitcoin surged more than 5% to surpass $85,000, its highest level since January, following the failure of the CLARITY Act in the US Senate. The bill, aimed at regulating crypto markets, did not receive enough votes to avoid a filibuster, leaving digi...
Midnight Sun Mining Corp has entered an earn-in agreement to acquire up to an 80% interest in the Mulundu Licence, a 62 square kilometre property adjacent to its Solwezi Project in Zambia. Geophysical data suggests the Dumbwa mineralized trend may ex...
MSTR shares surged about 7% in premarket trading following Bitcoin's rise above $85,000, its highest since late January. Strategy acquired 950 Bitcoin last week for $75.7 million, increasing its total holdings to 846,000 BTC valued at roughly $72 bil...
