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Agios Says CHMP Adopts Positive Opinion For PYRUKYND To Treat Pyruvate Kinase Deficiency In Adults

RTTNews | vor 970 Tagen

Agios Says CHMP Adopts Positive Opinion For PYRUKYND To Treat Pyruvate Kinase Deficiency In Adults

(RTTNews) - Agios Pharmaceuticals, Inc. (AGIO) announced Friday that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) adopted a positive opinion on September 15, 2022, recommending the granting of a marketing authorization for PYRUKYND (mitapivat) for the treatment of pyruvate kinase (PK) deficiency in adult patients.

PK deficiency is a rare, debilitating, lifelong hemolytic anemia. PYRUKYND is a first-in-class, oral PK activator that was recently approved by the U.S. Food and Drug Administration (FDA).

If approved by the European Commission (EC), PYRUKYND will be the first approved disease-modifying therapy for European patients with PK deficiency.

PYRUKYND was previously granted orphan drug designation by the EMA.

The positive CHMP opinion was based on results from two pivotal studies, ACTIVATE and ACTIVATE-T, conducted in not regularly transfused and regularly transfused adults with PK deficiency, respectively.

Tags: AGIO

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Australian Market Slightly Lower

Australian Market Slightly Lower

Australian shares are trading slightly lower on Wednesday, snapping a five-session winning streak, with the benchmark S&P/ASX 200 staying well below the 8,300 level, following the mixed cues from Wall Street overnight, with a mixed performance across most sectors. Traders are also booking some profits following the recent upside in the markets.

RTTNews | vor 5 Minuten

China Bourse Tipped To Open In The Green

China Bourse Tipped To Open In The Green

The China stock market has moved higher in consecutive trading days, improving almost 35 points or 1 percent along the way. The Shanghai Composite Index now rests just beneath the 3,375-point plateau and it's looking at a higher open again on Wednesday.

RTTNews | vor 14 Minuten

Tech Shares May Boost Taiwan Stock Market

Tech Shares May Boost Taiwan Stock Market

The Taiwan stock market has moved higher in three straight sessions, collecting almost 800 points or 4 percent in that span. The Taiwan Stock Exchange now sits just above the 21,330-point plateau and it's likely to open to the upside again on Wednesday.

RTTNews | vor 44 Minuten

Japan Producer Prices Rise 0.2% In April

Japan Producer Prices Rise 0.2% In April

Producer prices in Japan were up 0.2 percent on month in April, the Bank of Japan said on Wednesday - slowing from 0.4 percent in March.

RTTNews | vor 48 Minuten

Singapore Bourse May Crack Resistance At 3,900 Points

Singapore Bourse May Crack Resistance At 3,900 Points

The Singapore stock market has tracked higher in back-to-back sessions, gathering more than 30 points or 0.8 percent along the way. The Straits Times Index now sits just above the 3,880-point plateau and it may see additional support on Wednesday.

RTTNews | vor 1Std 14 Minuten

Malaysia Shares Expected To Open To The Upside On Wednesday

Malaysia Shares Expected To Open To The Upside On Wednesday

The Malaysia stock market has moved higher in two straight sessions, advancing almost 40 points or 2.7 percent in that span. The Kuala Lumpur Composite Index now sits just above the 1,580-point plateau and it may extend its gains again on Wednesday.

RTTNews | vor 1Std 44 Minuten

Japan Bourse May Add To Its Winnings On Wednesday

Japan Bourse May Add To Its Winnings On Wednesday

The Japanese stock market has moved higher in four straight sessions, rallying more than 1,400 points or 3.7 percent along the way. The Nikkei 225 now sits just above the 39,180-point plateau and it may open in the green again on Wednesday.

RTTNews | vor 1Std 59 Minuten

South Korea Shares May Extend Winning Streak

South Korea Shares May Extend Winning Streak

The South Korea stock market has finished higher in back-to-back sessions, collecting almost 30 points or 1.2 percent in that span. The KOSPI now sits just shy of the 2,610-point plateau and it's tipped to open to the upside again on Wednesday.

RTTNews | vor 2Std 14 Minuten

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