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ASCENDIS PHARMA A/S

(ASND)
  Report
Delayed Nasdaq  -  04:00 2022-12-05 pm EST
119.42 USD   -4.76%
11:22aAfter Seesaw Opening, European Equities Little Changed in Monday Trading
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08:12aAscendis Pharma A/s : INCORPORATION BY REFERENCE - Form 6-K
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08:01aAscendis Pharma to Initiate TransCon™ PTH U.S. Expanded Access Program for Adult Patients with Hypoparathyroidism
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Ascendis Pharma A/S announces new Week 110 data from the Phase 2 PaTH Forward Trial

09/12/2022 | 08:00am EST

Ascendis Pharma A/S announced new Week 110 data from the Phase 2 PaTH Forward Trial showing that long-term therapy with TransCon PTH, an investigational prodrug designed to provide sustained release of active parathyroid hormone at stable levels in the physiological range for 24 hours/day, provided a durable response in adults with hypoparathyroidism, as seen in continued normalization of mean serum calcium levels and 93% of patients achieving independence from conventional therapy with active vitamin D and therapeutic levels of calcium. Data on the skeletal effects of TransCon PTH were presented by Mishaela Rubin, M.D., Associate Professor of Medicine, Columbia University, at ASBMR 2022, the annual meeting of the American Society for Bone and Mineral Research, held September 9-12 in Austin, Texas. The data also showed continued restoration of skeletal bone mineral density toward sex- and age-expected norms for study participants treated with TransCon PTH, which augments turnover of stagnant bone.

Participants with more years of hypoparathyroidism duration had higher mean baseline bone mineral density Z-scores and larger decreases in BMD Z-scores through Week 110, trending toward age- and sex-matched norms. PTH replacement therapy with TransCon PTH was well-tolerated through Week 110, with continued normalization of mean urine calcium and no discontinuations from the trial due to adverse events. On August 31, 2022, Ascendis Pharma submitted a New Drug Application for TransCon PTH in adult hypoparathyroidism to the U.S. Food & Drug Administration. During the fourth quarter of this year, the Company plans to submit a Marketing Authorisation Application (MAA) for TransCon PTH in hypoparathyroidism to the European Medicines Agency.

Also, during the fourth quarter, Ascendis expects to announce topline results for PaTHway Japan, the Phase 3 trial of TransCon PTH in adult hypoparathyroidism in Japan. A separate Phase 3 trial of TransCon PTH in hypoparathyroidism is ongoing in Greater China through VISEN Pharmaceuticals. About Hypoparathyroidism (1,) (2) (,) (3,) (4,) (5,) (6) Hypoparathyroidism is a rare endocrine disorder characterized by insufficient levels of parathyroid hormone, resulting in low calcium and elevated phosphate levels in the blood.

Hypoparathyroidism affects approximately 200,000 patients in the United States, Europe, and Japan, most of whom develop the condition following damage to or accidental removal of the parathyroid glands during thyroid surgery. Conventional treatment with calcium supplements and active vitamin D (also called calcitriol) does not effectively address the short-term symptoms, long-term complications, or quality-of-life impacts of hypoparathyroidism. Short-term symptoms include weakness, severe muscle cramps (tetany), abnormal sensations such as tingling, burning and numbness (paresthesia), memory loss, impaired judgment, and headache.

Patients often experience decreased quality of life, and, over the long term, this complex disorder can increase risk of major complications, such as calcium deposits in the brain, blood vessels, eye, and other soft tissues -- including the kidneys, which can lead to impaired renal function. Hypoparathyroidism remains among the few hormonal insufficiency states without a replacement therapy that restores the missing hormone at physiologic levels. Current standard of care with high doses of calcium and active vitamin D does not fully control the disease or address its underlying cause and may contribute to risk of renal disease.

Patients with hypoparathyroidism have an estimated 4- to 8-fold greater risk of renal disease compared to healthy populations. Hypoparathyroidism is also associated with a 2-fold increased risk of depression or bipolar disorder compared to healthy populations.


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All news about ASCENDIS PHARMA A/S
11:22aAfter Seesaw Opening, European Equities Little Changed in Monday Trading
MT
08:12aAscendis Pharma A/s : INCORPORATION BY REFERENCE - Form 6-K
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Financials
Sales 2022 47,3 M 49,7 M 49,7 M
Net income 2022 -528 M -555 M -555 M
Net cash 2022 374 M 393 M 393 M
P/E ratio 2022 -11,9x
Yield 2022 -
Capitalization 6 667 M 7 006 M 7 006 M
EV / Sales 2022 133x
EV / Sales 2023 44,6x
Nbr of Employees 639
Free-Float 10,3%
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Number of Analysts 15
Last Close Price 113,64 €
Average target price 153,42 €
Spread / Average Target 35,0%
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Managers and Directors
Jan M°ller Mikkelsen President, CEO & Executive Director
Scott Thomas Smith Chief Financial Officer & Senior Vice President
Albert Cha Chairman
Birgitte Volck SVP, Head-Clinical Development & Medical Affairs
Kennett Sprog°e Senior Vice President, Head-Innovation & Research
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