Significant Health and Quality of Life Improvements Achieved in Children with Achondroplasia Treated for One Year with TransCon™ CNP (Navepegritide) at 100 µg/kg/week
December 20, 2023 08:30 ET
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Ascendis Pharma
TransCon CNP is the first investigational product to demonstrate improvements in health-related quality of life and disease impacts in children with achondroplasia COPENHAGEN, Denmark, Dec. 20,...
TransCon™ hGH (lonapegsomatropin) Achieved Statistically Superior Outcomes Compared to Placebo in Phase 3 foresiGHt Trial of Adults with Growth Hormone Deficiency
December 19, 2023 08:30 ET
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Ascendis Pharma
– On primary efficacy and key secondary endpoints, TransCon hGH demonstrated statistically significant reduction from baseline in trunk fat and increase in total body lean mass at Week 38 compared...
FDA Accepts for Review Resubmitted NDA for TransCon PTH (Palopegteriparatide) in Adult Patients with Hypoparathyroidism
December 11, 2023 08:30 ET
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Ascendis Pharma
– PDUFA goal date is May 14, 2024 COPENHAGEN, Denmark, Dec. 11, 2023 (GLOBE NEWSWIRE) -- Ascendis Pharma A/S (Nasdaq: ASND) today announced that the U.S. Food & Drug Administration (FDA) has...
Ascendis Pharma Announces Strategic Partnership with Teijin Limited in Japan
November 29, 2023 04:30 ET
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Ascendis Pharma
– Teijin to receive exclusive license to further develop and commercialize TransCon™ hGH, TransCon™ PTH, and TransCon™ CNP in Japan – Ascendis Pharma is eligible to receive $70 million upfront,...
Ascendis Pharma Announces European Commission Approval of YORVIPATH® (palopegteriparatide) for the Treatment of Adults with Chronic Hypoparathyroidism
November 20, 2023 08:00 ET
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Ascendis Pharma
- YORVIPATH (developed as TransCon PTH) is a parathyroid hormone (PTH) replacement therapy indicated for the treatment of adults with chronic hypoparathyroidism - Ascendis plans its first EU launch...
Ascendis Pharma Resubmits NDA for TransCon™ PTH to the U.S. FDA
November 15, 2023 08:00 ET
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Ascendis Pharma
COPENHAGEN, Denmark, Nov. 15, 2023 (GLOBE NEWSWIRE) -- Ascendis Pharma A/S (Nasdaq: ASND) today announced that it has resubmitted its New Drug Application (NDA) for TransCon PTH...
Ascendis Pharma Reports Third Quarter 2023 Financial Results
November 07, 2023 16:01 ET
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Ascendis Pharma
European Commission decision for TransCon™ PTH expected this month; if approved, first European Union launch planned in Germany in January 2024TransCon PTH NDA resubmission to FDA expected before...
Ascendis Pharma Announces Timing of Third Quarter 2023 Financial Results and TransCon PTH NDA Resubmission
October 31, 2023 08:30 ET
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Ascendis Pharma
• Third Quarter financial results and business update conference call to be held onNovember 7, 2023 • Resubmission of TransCon PTH NDA for adults with hypoparathyroidism expected...
Ascendis Presents Updated and New TransCon™ IL-2 β⁄γ Monotherapy and Combination Therapy Data Confirming Clinical Activity Across Tumor Types at ESMO 2023
October 26, 2023 08:30 ET
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Ascendis Pharma
— Clinical responses with TransCon IL-2 β⁄γ demonstrated as monotherapy or in combination with checkpoint inhibitor, including in two of three small cell lung cancer patients treated with combination...
Ascendis Pharma Presents TransCon™ PTH (palopegteriparatide) Phase 3 52-Week Skeletal Dynamics Data at ASBMR 2023
October 16, 2023 16:01 ET
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Ascendis Pharma
— 52-week results from the Phase 3 PaTHway Trial showed that the skeletal dynamics of adult patients with chronic hypoparathyroidism treated with TransCon PTH trended toward a new steady state closer...