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Ascendis Pharma Says FDA Accepts Resubmitted NDA For TransCon PTH In Adults With Hypoparathyroidism
(RTTNews) - Ascendis Pharma A/S (ASND) announced Monday that the U.S. Food & Drug Administration (FDA) has accepted for review the Company's resubmitted New Drug Application (NDA) for TransCon PTH (palopegteriparatide) for the treatment of adult patients with hypoparathyroidism.
The agency considered the resubmission a complete, class 2 response and set a Prescription Drug User Fee Act (PDUFA) goal date of May 14, 2024.
In the United States, TransCon PTH (palopegteriparatide) is an investigational prodrug of parathyroid hormone (PTH [1-34]) for adult patients with hypoparathyroidism.
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Ascendis Pharma Says UK Approves YORVIPATH For Treatment Of Adults With Chronic Hypoparathyroidism
Danish pharmaceutical company Ascendis Pharma A/S (ASND) announced that the United Kingdom's Medicines & Healthcare products Regulatory Agency (MHRA) has granted marketing authorization for YORVIPATH (palopegteriparatide; developed as TransCon PTH) in Great Britain as a parathyroid hormone (PTH) replacement therapy indicated for the treatment of adults with chronic hypoparathyroidism
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Pred 508 dňami
Australian Market Slashes Early Losses In Mid-market
The Australian stock market is slashing its early losses in mid-market trading on Monday, giving up some of the gains in the previous session, following the mixed cues from Wall Street on Friday. The benchmark S&P/ASX 200 index is falling below the 8,850.00 level, with weakness in mining stocks and a mixed performance across other sectors.
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Pred 1 h 25 min
Asian Markets Trade Mostly Higher
Asian stock markets are trading mostly higher on Monday, following the mixed cues from Wall Street on Friday, as traders remain cautious ahead of the anticipated interest rate cut after recent US data signaled softer labor conditions and muted inflation. The escalating geopolitical concerns in the Middle East are also weighing on market sentiment. Asian markets closed mostly higher on Friday.
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Pred 1 h 37 min
Rally May Stall For Thai Stock Market
The Thai stock market has moved higher in six straight sessions, adding more than 40 points or 3.3 percent along the way. The Stock Exchange of Thailand now sits just beneath the 1,295-point plateau although it may be stuck in neutral on Monday.
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Pred 3 h 12 min
Lower Open Called For Indonesia Stock Market
The Indonesia stock market has moved higher in three straight sessions, advancing almost 225 points or 2.9 percent in that span. The Jakarta Composite Index now rests just above the 7,850-point plateau although it may spin its wheels on Monday.
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Pred 3 h 42 min
Hong Kong Shares Tipped To Open To The Downside On Monday
The Hong Kong stock market bounced higher again on Friday, one day after ending the four-day winning streak in which it had climbed almost 1,250 points or 4.9 percent. The Hang Seng Index now sits just beneath the 26,390-point plateau although it figures to find renewed selling pressure on Monday.
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Pred 3 h 57 min
Australian Market Notably Lower
The Australian stock market is notably lower on Monday, giving up the gains in the previous session, following the mixed cues from Wall Street on Friday. The benchmark S&P/ASX 200 index is falling below the 8,800.00 level, with weakness across all sectors lod by mining and technology stocks.
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Pred 4 h 6 min
China Shares May Take Further Damage On Monday
The China stock market on Friday wrote a finish to the two-day winning streak in which it had jumped almost 70 points or 2 percent. The Shanghai Composite Index now sits just above the 3,870-point plateau and it's likely to open under water again on Monday.
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Pred 4 h 12 min
