COPENHAGEN, Denmark, May 09, 2024 (GLOBE NEWSWIRE) -- Ascendis Pharma A/S (Nasdaq: ASND) today announced that new TransCon PTH (palopegteriparatide) data supporting clinical and quality-of-life benefits in adult patients with chronic hypoparathyroidism will be presented at the European Congress of Endocrinology being held May 11-14, 2024, in Stockholm.
Key Points:
- COPENHAGEN, Denmark, May 09, 2024 (GLOBE NEWSWIRE) -- Ascendis Pharma A/S (Nasdaq: ASND) today announced that new TransCon PTH (palopegteriparatide) data supporting clinical and quality-of-life benefits in adult patients with chronic hypoparathyroidism will be presented at the European Congress of Endocrinology being held May 11-14, 2024, in Stockholm.
- Topics include an oral presentation of new 2-year results from a post-hoc analysis of the Phase 3 PaTHway Trial demonstrating sustained improvements in kidney function in adults with chronic hypoparathyroidism treated with TransCon PTH, as well as a symposium presentation on health and quality-of-life improvements in patients switching from rhPTH(1-84) to TransCon PTH as part of a compassionate use program.
- “We are pleased to partner with leading experts in endocrinology to present this new, groundbreaking data showing the health and quality-of-life benefits of initiating or switching to TransCon PTH treatment,” said Aimee Shu, M.D., Ascendis Pharma’s Senior Vice President of Clinical Development, Endocrine Medical Sciences.
- The full schedule of Ascendis presentations during ECE 2024 follow:
Retrieved on:
Wednesday, April 24, 2024
Hypoparathyroidism,
United,
Parathyroid hormone,
European Commission,
Marketing,
PTH,
Health care,
European,
Commission,
MHRA,
European Medicines Agency,
Pharmaceutical industry YORVIPATH is a prodrug of parathyroid hormone (PTH 1-34) administered once daily.
Key Points:
- YORVIPATH is a prodrug of parathyroid hormone (PTH 1-34) administered once daily.
- “With today’s MHRA approval of YORVIPATH, we are expanding our global geographic reach to meet the needs of adults with chronic hypoparathyroidism in Great Britain,” said Camilla Harder Harvig, Executive Vice President and Chief Commercial Officer at Ascendis Pharma.
- Orphan status provides 10 years of market exclusivity in Great Britain with respect to similar medicinal products in the approved orphan indication of chronic adult hypoparathyroidism.
- TransCon PTH is also in development for the treatment of adults with chronic hypoparathyroidism in the United States, Japan, and other countries.
Retrieved on:
Wednesday, January 31, 2024
COPENHAGEN, Denmark, Jan. 31, 2024 (GLOBE NEWSWIRE) -- Ascendis Pharma A/S (Nasdaq: ASND) today announced that YORVIPATH® (palopegteriparatide, developed as TransCon PTH), a parathyroid hormone (PTH) replacement therapy indicated for the treatment of adults with chronic hypoparathyroidism, is now available in Germany and Austria.
Key Points:
- COPENHAGEN, Denmark, Jan. 31, 2024 (GLOBE NEWSWIRE) -- Ascendis Pharma A/S (Nasdaq: ASND) today announced that YORVIPATH® (palopegteriparatide, developed as TransCon PTH), a parathyroid hormone (PTH) replacement therapy indicated for the treatment of adults with chronic hypoparathyroidism, is now available in Germany and Austria.
- YORVIPATH is the second product developed with Ascendis Pharma’s TransCon technology platform to be launched commercially.
- “We are pleased to initiate the launch of YORVIPATH to address the needs expressed within the hypoparathyroidism community for a new PTH-based treatment option,” said Jan Mikkelsen, Ascendis Pharma’s President and Chief Executive Officer.
- With an increasingly broad commercial infrastructure in place, we are well positioned to accomplish this by expanding the availability of YORVIPATH and our other approved products to meet the needs of physicians and patients around the world.”
BUCHAREST, Romania, Jan. 09, 2024 (GLOBE NEWSWIRE) -- Er-Kim , an international pharmaceutical company specializing in the commercialization of novel therapies, today announced it has entered into an exclusive distribution agreement with Danish Company Ascendis Pharma A/S (Nasdaq: ASND) for its endocrinology portfolio.
Key Points:
- BUCHAREST, Romania, Jan. 09, 2024 (GLOBE NEWSWIRE) -- Er-Kim , an international pharmaceutical company specializing in the commercialization of novel therapies, today announced it has entered into an exclusive distribution agreement with Danish Company Ascendis Pharma A/S (Nasdaq: ASND) for its endocrinology portfolio.
- Under the agreement, Er-Kim is appointed as the exclusive Ascendis A/S endocrinology distributor in Albania, Bosnia and Herzegovina, Bulgaria, Croatia, Cyprus, Czechia, Estonia, Greece, Hungary, Kosovo, Latvia, Lithuania, Malta, Montenegro, North Macedonia, Poland, Romania, Serbia, Slovakia, Slovenia, and Türkiye.
- He added, “Leveraging our exceptional expertise in rare diseases and our preeminent status in endocrinology throughout the region, we eagerly anticipate collaborating with Ascendis and the healthcare community.
- “We are therefore very pleased to partner with Er-Kim, a company that shares this commitment, to broaden and accelerate access to our innovative Endocrinology Rare Disease treatment options across Central and Eastern Europe and Turkey.”
Growth hormone,
Hypoparathyroidism,
Quality of life,
Partnership,
Achondroplasia,
Vitamin D,
ACH,
European,
Disease,
Osteochondrodysplasia,
Therapy,
PTH,
Endocrinology,
CNP,
Patient,
Phase II,
Pharmaceutical industry Under the terms of the agreement, ST will commercialise Ascendis Pharma's weekly injectable paediatric human growth hormone treatment SKYTROFATM (lonapegsomatropin), hypoparathyroidism treatment YORVIPATHTM (palopegteriparatide) and investigational achondroplasia therapy TransCon™ CNP (navepegritide).
Key Points:
- Under the terms of the agreement, ST will commercialise Ascendis Pharma's weekly injectable paediatric human growth hormone treatment SKYTROFATM (lonapegsomatropin), hypoparathyroidism treatment YORVIPATHTM (palopegteriparatide) and investigational achondroplasia therapy TransCon™ CNP (navepegritide).
- The agreement spans ST's key regions of Australia, New Zealand, Singapore, Malaysia, Brunei, Thailand, and Vietnam.
- Announcing the partnership, ST Chief Executive Officer Carlo Montagner said this agreement was an important company milestone, signalling ST's expansion into both endocrinology and paediatric medicine.
- "We are delighted to partner with Specialised Therapeutics to broaden the reach of our endocrinology rare disease portfolio, contributing to our shared goal of making a meaningful difference for patients facing unmet medical needs," she said.
Retrieved on:
Monday, November 20, 2023
Hypoparathyroidism,
European Commission,
Science,
Physician,
EMA,
Parathyroid hormone,
Health,
Disease,
Civil service commission,
PTH,
TU Dresden,
European Medicines Agency,
Committee,
Patient,
Diagnosis,
Institute of technology,
CHMP COPENHAGEN, Denmark, Nov. 20, 2023 (GLOBE NEWSWIRE) -- Ascendis Pharma A/S (Nasdaq: ASND) today announced that the European Commission (EC) has granted marketing authorization for YORVIPATH® (palopegteriparatide) as replacement therapy indicated for the treatment of adults with chronic hypoparathyroidism. YORVIPATH is a prodrug of parathyroid hormone (PTH 1-34) administered once daily. Ascendis plans its first European Union (EU) launch of YORVIPATH in January 2024 in Germany.
Key Points:
- COPENHAGEN, Denmark, Nov. 20, 2023 (GLOBE NEWSWIRE) -- Ascendis Pharma A/S (Nasdaq: ASND) today announced that the European Commission (EC) has granted marketing authorization for YORVIPATH® (palopegteriparatide) as replacement therapy indicated for the treatment of adults with chronic hypoparathyroidism.
- Ascendis plans its first European Union (EU) launch of YORVIPATH in January 2024 in Germany.
- Treatment should be initiated and monitored by physicians or qualified healthcare professionals experienced in the diagnosis and management of patients with hypoparathyroidism.
- TransCon PTH is in development for adults with hypoparathyroidism in the United States, Japan, and other countries.
Retrieved on:
Thursday, November 16, 2023
LYON, France and CAMBRIDGE, Mass., Nov. 16, 2023 (GLOBE NEWSWIRE) -- Amolyt Pharma, a global company specialized in developing therapeutic peptides for rare endocrine and related diseases, has been awarded ‘Biotech Company of the Year 2023’ at the annual LSX, European Lifestars Awards Ceremony, held on November 13th in London, U.K.
Key Points:
- LYON, France and CAMBRIDGE, Mass., Nov. 16, 2023 (GLOBE NEWSWIRE) -- Amolyt Pharma, a global company specialized in developing therapeutic peptides for rare endocrine and related diseases, has been awarded ‘Biotech Company of the Year 2023’ at the annual LSX, European Lifestars Awards Ceremony, held on November 13th in London, U.K.
- The European Lifestars Awards (ELAs) are an annual event that acknowledges and celebrates the significant achievements within the life sciences sector across Europe.
- These awards recognize the innovation and ground-breaking achievements of the life sciences industry's most distinguished executive leaders, investors, partners, and dealmakers for their outstanding contributions to the advancement of the industry.
- Together, we've cultivated a culture of excellence and commitment towards patients, advancing our clinical pipeline of therapeutic peptides for rare endocrine diseases.
Annual general meeting,
Calcium,
Hypoparathyroidism,
McMaster University,
Bone fracture,
Bone disease,
Society,
American Society for Bone and Mineral Research,
PTHR1,
Homeostasis,
Fracture,
Phase 3,
Osteoporosis,
Medicine,
DXA,
Patient,
PMF,
Metabolic bone disease,
Woman,
Osteopenia,
Quality of life,
Medical imaging,
Dietary supplement LYON, France, and CAMBRDIGE, Mass., Oct. 16, 2023 (GLOBE NEWSWIRE) -- Amolyt Pharma, a global company specialized in developing therapeutic peptides for rare endocrine and related diseases, today announced data from two posters that were presented at the American Society for Bone and Mineral Research (ASBMR) 2023 Annual Meeting, which is being held October 13-16, 2023, in Vancouver, BC, Canada. The data include a prospective analysis of bone disease in patients with hypoparathyroidism from the Canadian National Hypoparathyroidism Registry with evidence of significant bone disease burden in postmenopausal females (PMF). In addition, data from both pre-clinical and clinical studies of eneboparatide continue to demonstrate its ability to restore balanced bone turnover, preserving bone integrity, while maintaining calcium homeostasis and normalizing urinary calcium.
Key Points:
- The data include a prospective analysis of bone disease in patients with hypoparathyroidism from the Canadian National Hypoparathyroidism Registry with evidence of significant bone disease burden in postmenopausal females (PMF).
- In addition, data from both pre-clinical and clinical studies of eneboparatide continue to demonstrate its ability to restore balanced bone turnover, preserving bone integrity, while maintaining calcium homeostasis and normalizing urinary calcium.
- “We’re very pleased to have a strong presence at this year’s ASBMR Annual Meeting.
- These data increase our understanding of the relationship between hypoparathyroidism and bone strength.
Annual general meeting,
HP,
Hypoparathyroidism,
Pharmacokinetics,
Food,
MBX,
PTH,
Therapy,
Society,
PK,
Death,
Safety,
American Society for Bone and Mineral Research,
MAD,
Disease,
Participation,
SC,
SAD,
Regulation of food and dietary supplements by the U.S. Food and Drug Administration,
PD,
Volunteering,
Pharmacology,
Patient,
Pharmaceutical industry,
Vaccine CARMEL, Ind., Oct. 16, 2023 (GLOBE NEWSWIRE) -- MBX Biosciences, Inc., a clinical stage biopharmaceutical company developing Precision Endocrine Peptide™ (PEP™) therapeutics to treat an array of endocrine disorders, today announced the presentation of positive results from its Phase 1 single and multiple ascending dose trial of MBX 2109 in healthy adults, as a late-breaking oral presentation at the American Society for Bone and Mineral Research (ASBMR) Annual Meeting, held in Vancouver, Canada from October 13-16, 2023. MBX 2109 is the company’s long-acting parathyroid hormone (PTH) peptide prodrug in development for the treatment of hypoparathyroidism (HP).
Key Points:
- MBX 2109 is the company’s long-acting parathyroid hormone (PTH) peptide prodrug in development for the treatment of hypoparathyroidism (HP).
- Single and repeat doses of MBX 2109 were generally well-tolerated, and the majority of treatment emergent adverse events were mild in severity.
- The observed PK parameters following single and repeat doses of MBX 2109 reflected the intended prodrug design and support once-weekly dosing.
- MBX Biosciences is preparing for an End-of-Phase 1 meeting with the U.S. Food and Drug Administration this quarter, and the company anticipates initiating its Phase 2 trial of MBX 2109 in patients with HP thereafter.
CARMEL, Ind., Oct. 03, 2023 (GLOBE NEWSWIRE) -- MBX Biosciences, Inc. , a clinical stage biopharmaceutical company developing Precision Endocrine Peptide™ (PEP™) therapeutics to treat an array of endocrine disorders, today announced that results from the Phase 1 Study of MBX 2109, the company’s long-acting parathyroid hormone (PTH) peptide prodrug in development for the treatment of hypoparathyroidism (HP), will be featured in a late-breaking oral presentation at the American Society for Bone and Mineral Research (ASBMR) Annual Meeting being held in Vancouver, Canada October 13-16, 2023.
Key Points:
- CARMEL, Ind., Oct. 03, 2023 (GLOBE NEWSWIRE) -- MBX Biosciences, Inc. , a clinical stage biopharmaceutical company developing Precision Endocrine Peptide™ (PEP™) therapeutics to treat an array of endocrine disorders, today announced that results from the Phase 1 Study of MBX 2109, the company’s long-acting parathyroid hormone (PTH) peptide prodrug in development for the treatment of hypoparathyroidism (HP), will be featured in a late-breaking oral presentation at the American Society for Bone and Mineral Research (ASBMR) Annual Meeting being held in Vancouver, Canada October 13-16, 2023.
- Preliminary Data From a First-in-Human, Randomized, Double-blind, Placebo-Controlled, Phase 1 Study of MBX 2109, a Once-Weekly Parathyroid Hormone Replacement Therapy, in Healthy Adults
