$33.320
-0.933 (-2.80%)終値時点
AGIO のニュース
AGIO のイベント
Stock Futures Rise as Tech Shares Lead Gains
Stock futures are pointing higher as investors attempt to build on Monday's rebound, with technology shares leading premarket gains ahead of a stretch of earnings from some of the market's largest companies.The focus this week is on corporate earnings, with Alphabet, Tesla, IBM and Intel all set to report in the coming days. Investors are looking for signs that spending on artificial intelligence continues to translate into revenue growth and profitability after recent volatility in chip stocks raised questions about lofty valuations across the sector.Hopes for a potential ceasefire proposal between the United States and Iran have eased some pressure on oil prices, improving risk appetite, but Brent crude remains near $90 a barrel as uncertainty persists and renewed threats to shipping routes in the Middle East keep energy markets on edge.In pre-market trading, S&P 500 futures rose 0.40%, Nasdaq futures rose 1.36% and Dow futures rose 0.24%.Check out this morning's top movers from around Wall Street, compiled by The Fly.HIGHER -Nebiusup 6% after Nvidiadisclosed a 9.3% stake in the companyTSMCup 3% after Nikkei AsiaTSMC plans to raise chipmaking prices by up to 10% from 2027 to offset rising costsUP AFTER EARNINGS -3M (MMM) up 5%Novartisup 2%General Motorsup 1%D.R. Hortonup 1%Synchronyup 1%DOWN AFTER EARNINGS -Equifaxdown 13%Calixdown 11%Danaherdown 10%Northrop Grummandown 4%Charles Schwabdown 3%Steel Dynamicsdown 1%LOWER -Agios Pharmaceuticalsdown 14% after announcing it has decided not to advance tebapivat in sickle cell disease following trial results
Agios Pharmaceuticals Down 13% to $34.75 on Tebapivat Trial Results
Agios Pharmaceuticals down 13% at $34.75 on topline results from tebapivat trial
Agios Pharmaceuticals Halts Tebapivat Development in Sickle Cell Disease
Agios Pharmaceuticals announced topline results from the Phase 2 trial of tebapivat, an oral pyruvate kinase activator, in patients aged 16 years or older with sickle cell disease. The Phase 2 trial was designed to characterize the dose-response relationship of tebapivat in sickle cell disease and evaluate whether its profile was meaningfully differentiated relative to other PK activators. The trial included a 12-week, double-blind, placebo-controlled period in which 59 participants were randomized 2:2:2:1 to receive one of three once-daily tebapivat doses or placebo. Over the 12-week treatment period, improvements in hemoglobin levels and hemolysis were observed across all tebapivat dose levels, consistent with the established PK activation mechanism. The trial's primary endpoint of hemoglobin response was achieved by 43.8%, 47.1%, and 29.4% in the 2.5 mg QD, 5.0 mg QD, and 7.5 mg QD tebapivat arms, respectively, and 33.3% in the placebo arm. The safety and tolerability of tebapivat in the Phase 2 trial were consistent with that observed in prior sickle cell disease trials. The trial did not demonstrate the level of differentiation required to support continued development; therefore, Agios has decided not to advance tebapivat in sickle cell disease.
Agios Pharmaceuticals Stock Rises 13.5% to $42.43
Agios Pharmaceuticals is up 13.5%, or $5.04 to $42.43.
Leerink: Agios mitapivat Receives FDA Priority Review
Leerink notes that Agios Pharmaceuticals announced the FDA granted Priority Review for the sNDA for mitapivat in sickle cell disease with a PDUFA date of 11/1/26 suggesting imminent approval. The Phase 3 REIGNITE trial is the confirmatory study required under the accelerated approval pathway and the agency requires that the trial be "underway" at the time of accelerated approval, with the definition of "underway" agreed upon by the agency and Agios. The firm sees the Priority Review designation as a positive sign given that Priority Review is granted to applications which, if approved, would demonstrate significant improvements of serious conditions. Leerink models peak U.S. sales of $554M for mitapivat in SCD with a 60% probability of success. The firm has an Outperform rating on the shares.
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