FDA Accepts for Review Resubmitted NDA for TransCon PTH (Palopegteriparatide) in Adult Patients with Hypoparathyroidism
11 déc. 2023 08h30 HE
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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
29 nov. 2023 04h30 HE
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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
20 nov. 2023 08h00 HE
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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
15 nov. 2023 08h00 HE
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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
07 nov. 2023 16h01 HE
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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
31 oct. 2023 08h30 HE
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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
26 oct. 2023 08h30 HE
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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
16 oct. 2023 16h01 HE
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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...
Ascendis Presents TransCon™ PTH Data at the American Thyroid Association Annual Meeting
02 oct. 2023 08h00 HE
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Ascendis Pharma
– At Week 26, 81% of patients in Phase 3 PaTHway Trial with chronic post-surgical hypoparathyroidism, the most common cause of this disease, achieved independence from conventional therapy while...
Ascendis Pharma Presents Results from Long-Term enliGHten Trial of TransCon™ hGH in Pediatric Growth Hormone Deficiency
23 sept. 2023 07h00 HE
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Ascendis Pharma
- The majority of children and adolescents treated once weekly with TransCon hGH (lonapegsomatropin) met or exceeded average parental height SDS at time of treatment completion or last visit ...