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Ascendis Pharma A/S - ASND STOCK NEWS

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Ascendis Pharma A/S (NASDAQ: ASND) is a pioneering biotechnology company located at 12 Tuborg Blvd., Hellerup, Capital Region of Denmark, Denmark. Specializing in the development of prodrug therapies, Ascendis Pharma is leveraging its proprietary TransCon technology to create therapies with improved efficacy and safety profiles that address significant unmet medical needs. The company’s diverse product pipeline includes TransCon growth hormone, TransCon peptides, TransCon PTH, and TransCon CNP, among others.

Ascendis Pharma operates across North America, China, and Europe, with the majority of its revenue derived from North American markets. The firm’s flagship product, SKYTROFA, has become the leading growth hormone product by value in the U.S. Ascendis is also rolling out YORVIPATH in Europe, starting with Germany and Austria. In addition, the company is advancing its clinical program for TransCon CNP.

In 2023, Ascendis undertook a significant restructuring to streamline its operations, processes, and expense allocations. President and CEO Jan Mikkelsen maintains that Ascendis is on track to achieve its ambitious Vision 3x3 and Vision 2030 goals, which include achieving blockbuster status for each of its three independent Endocrinology Rare Disease products and expanding its engine for future innovation.

Financially, Ascendis Pharma reported substantial revenue growth in 2023, with total revenue reaching €266.7 million compared to €51.2 million in 2022. This growth was primarily driven by higher SKYTROFA revenue and an upfront payment from Teijin. Research and development (R&D) expenses also increased to €413.5 million in 2023, reflecting ongoing development activities in their TransCon programs. Despite a net loss for the year, the company's financial health remains robust, with cash, cash equivalents, and marketable securities totaling €399.4 million as of December 31, 2023.

Looking ahead, Ascendis Pharma has several key milestones slated for 2024, including the expected commercial launch of TransCon PTH in the U.S. and advancing its oncology and ophthalmology programs. The company also plans to achieve operating cash flow breakeven on a quarterly basis by the end of the year.

Ascendis continues to focus on leveraging its TransCon technology to develop therapies that can make a meaningful difference in patients’ lives. Guided by its core values of Patients, Science, and Passion, Ascendis Pharma is committed to becoming a leading, fully integrated biopharma company.

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Ascendis Pharma's Phase 2 ACcomplisH Trial data on TransCon CNP for children with achondroplasia was presented at ICCBH 2024. The trial showed significant improvements in well-being and physical functioning compared to placebo at the 100μg/kg/week dose, suggesting benefits beyond linear growth. Conducted in 57 children aged 2-10, the trial's results highlighted TransCon CNP's potential to enhance health-related quality of life. Statistically significant improvements were noted in daily living functioning and emotional well-being, with no serious adverse events reported.

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Ascendis Pharma A/S (Nasdaq: ASND) announced its participation in the Goldman Sachs 45th Annual Global Healthcare Conference. Company executives will engage in a fireside chat on June 11, 2024, at 8:00 a.m. ET in Miami, Florida. The event will be webcast live on the Ascendis Pharma website, with a replay available for 30 days post-event.

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Ascendis Pharma (Nasdaq: ASND) presented new data from the ongoing Phase 1/2 IL-Believe Trial at ASCO 2024. The study evaluates TransCon IL-2 β⁄γ, alone and in combination with TransCon TLR7/8 Agonist, in patients with anti-PD-1 refractory melanoma and other solid tumors.

Key findings include clinical responses in 40% of efficacy-evaluable patients in the initial cohort and 45% in patients with prior disease progression on checkpoint inhibitors. Notably, no new safety signals were reported.

Biomarker analysis linked clinical benefits to CD8+ T cell expansion and activation. The recommended Phase 2 dose is 120 µg/kg administered every three weeks.

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Ascendis Pharma announced its participation in ENDO 2024, the annual meeting of the Endocrine Society from June 1-4, 2024, in Boston. They will present their TransCon technology for conditions including growth hormone deficiency (GHD), hypoparathyroidism, achondroplasia, and Turner syndrome.

Key events include the sharing of data from the pivotal foresiGHt trial of TransCon hGH in adults with GHD and an informational booth on hypoparathyroidism coinciding with World Hypoparathyroidism Day. Presentations feature efficacy and safety data for once-weekly Lonapegsomatropin in adults with GHD, pediatric perspectives on once-weekly growth hormone treatments, and baseline demographics from the SkybriGHt Registry Study.

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Ascendis Pharma has announced that the FDA has extended the Prescription Drug User Fee Act (PDUFA) goal date for TransCon PTH (palopegteriparatide), a treatment for adults with hypoparathyroidism, by three months to August 14, 2024. This extension follows a major amendment to the New Drug Application (NDA) submitted by Ascendis Pharma. CEO Jan Mikkelsen stated that they have responded to all FDA requests and are committed to working with the agency. Patients currently in clinical trials and the Expanded Access Program (EAP) will continue to receive their medication, and the EAP remains open for enrollment.

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Ascendis Pharma A/S (Nasdaq: ASND) announced significant and sustained improvements in renal function for adults with chronic hypoparathyroidism treated with TransCon PTH (palopegteriparatide) in a Phase 3 trial. The results showed a mean eGFR increase of 8.9 mL/min/1.73m2 at Week 52 and 9.0 mL/min/1.73m2 at Week 104, with well-tolerated treatment and no new safety concerns.

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Ascendis Pharma A/S (Nasdaq: ASND) will present new TransCon PTH data at the European Congress of Endocrinology, showcasing benefits in chronic hypoparathyroidism patients. Key topics include sustained kidney function improvements and quality of life enhancements. The company's presentations highlight the positive impact of TransCon PTH treatment, emphasizing its clinical and quality-of-life benefits.

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Ascendis Pharma reported strong financial results for the first quarter of 2024, with notable achievements including the initiation of YORVIPATH® rollout, significant revenue growth for SKYTROFA®, and key milestones for TransCon PTH and TransCon CNP.

Despite positive revenue growth and operational progress, Ascendis Pharma reported increased operating expenses, a net loss, and a decline in net finance income compared to the same period in 2023.

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Ascendis Pharma A/S (Nasdaq: ASND) will report its first quarter 2024 financial results and provide a business update on May 2, 2024. The company will host a conference call and live webcast to discuss the results.
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Ascendis Pharma A/S receives MHRA approval for YORVIPATH® in Great Britain for adults with chronic hypoparathyroidism, expanding global reach and gaining orphan drug status.
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FAQ

What is Ascendis Pharma A/S's primary focus?

Ascendis Pharma A/S focuses on developing prodrug therapies using its proprietary TransCon technology to meet significant unmet medical needs.

Where is Ascendis Pharma A/S located?

Ascendis Pharma A/S is located at 12 Tuborg Blvd., Hellerup, Capital Region of Denmark, Denmark.

What are some of Ascendis Pharma's key products?

Key products include SKYTROFA, YORVIPATH, TransCon growth hormone, TransCon peptides, TransCon PTH, and TransCon CNP.

In which regions does Ascendis Pharma operate?

Ascendis Pharma operates in North America, China, and Europe.

What were Ascendis Pharma's total revenues for 2023?

In 2023, Ascendis Pharma reported total revenues of €266.7 million.

What major milestones does Ascendis Pharma plan to achieve in 2024?

In 2024, Ascendis Pharma plans to launch TransCon PTH in the U.S. and continue advancing its oncology and ophthalmology programs.

What is the Vision 2030 goal for Ascendis Pharma?

The Vision 2030 goal includes achieving blockbuster status for each of its three independent Endocrinology Rare Disease products and expanding its engine for future innovation.

How much cash and marketable securities did Ascendis Pharma have at the end of 2023?

As of December 31, 2023, Ascendis Pharma had cash, cash equivalents, and marketable securities totaling €399.4 million.

What technology platform does Ascendis Pharma use for developing its therapies?

Ascendis Pharma uses its innovative TransCon technology platform to develop its therapies.

What are Ascendis Pharma's core values?

Ascendis Pharma's core values are Patients, Science, and Passion.

Ascendis Pharma A/S

Nasdaq:ASND

ASND Rankings

ASND Stock Data

7.89B
57.71M
0.76%
107.66%
6.06%
Pharmaceutical Preparation Manufacturing
Manufacturing
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United States of America
Tuborg Boulevard 5