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...
Ascendis Presents TransCon™ PTH Data at the American Thyroid Association Annual Meeting
October 02, 2023 08:00 ET
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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
September 23, 2023 07:00 ET
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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 ...
Ascendis Pharma Launches SKYTROFA® (lonapegsomatropin) in Germany for the Once-Weekly Treatment of Children and Adolescents with Growth Hormone Deficiency
September 15, 2023 08:00 ET
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Ascendis Pharma
COPENHAGEN, Denmark, Sept. 15, 2023 (GLOBE NEWSWIRE) -- Ascendis Pharma A/S (Nasdaq: ASND) today announced the launch in Germany of SKYTROFA® (lonapegsomatropin), its growth hormone approved in the...
Ascendis Pharma Receives Positive CHMP Opinion for TransCon™ PTH (palopegteriparatide) for Adults with Chronic Hypoparathyroidism
September 14, 2023 12:22 ET
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Ascendis Pharma
- Final European Commission decision expected within 67 days after positive opinion; if approved, first European Union launch planned in Germany in early 2024 COPENHAGEN, Denmark, Sept. 14, 2023...
Ascendis Pharma Reports Second Quarter 2023 Financial Results
September 05, 2023 16:03 ET
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Ascendis Pharma
Expect to resubmit NDA to FDA for TransCon™ PTH in October 2023; EC decision on MAA for TransCon PTH expected during the fourth quarter of 2023U.S. and EU regulatory authorities endorsed ApproaCH as a...
New Post Hoc Analysis Showed Substantial Improvement in Observed Estimated Glomerular Filtration Rate (eGFR), in TransCon PTH-Treated Adults with Hypoparathyroidism
September 05, 2023 16:01 ET
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Ascendis Pharma
- Approximately 50% of Phase 3 PaTHway Trial patients with eGFR < 60 mL/min/1.73m2, the threshold for kidney dysfunction, receiving TransCon PTH experienced eGFR improvement to above 60...