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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.
Ascendis Pharma (Nasdaq: ASND) has announced the commercial availability of YORVIPATH® (palopegteriparatide) in the United States for treating hypoparathyroidism in adults. YORVIPATH is the first and only FDA-approved medicine for this condition, designed as a once-daily prodrug of parathyroid hormone providing 24-hour continuous exposure to active PTH.
The company has established a dedicated YORVIPATH team within the U.S. Ascendis Signature Access Program® to support patients, offering services including clinical education, prior authorization assistance, injection training, and co-pay support for eligible patients.
Ascendis Pharma (ASND) announced positive Week 26 topline results from its Phase 2 New InsiGHTS trial, evaluating TransCon hGH (lonapegsomatropin) in Turner syndrome patients. The trial compared three different weekly doses of TransCon hGH against daily somatropin in 49 prepubertal children aged 1-10 years.
The study achieved its primary objective, demonstrating that once-weekly TransCon hGH provided similar growth benefits to daily somatropin, with comparable safety and tolerability profiles. The trial showed improved growth across all three TransCon hGH starting dose cohorts (0.24, 0.30, or 0.36 mg/kg/week), matching the performance of daily somatropin (0.35 mg/kg/week).
Ascendis Pharma (NASDAQ: ASND) announced FDA acceptance of its supplemental Biologics License Application (sBLA) for TransCon hGH to treat adult growth hormone deficiency (GHD), with a PDUFA date set for July 27, 2025. The application is supported by the foresiGHt Phase 3 trial, which evaluated 259 adults with GHD aged 23-80 years.
The trial demonstrated TransCon hGH's superiority in primary and key secondary efficacy endpoints at Week 38, showing significant reduction in trunk fat and increased total body lean mass compared to placebo. The treatment was generally safe and well-tolerated, with no discontinuations related to study drug and comparable safety to daily hGH treatment.
Ascendis Pharma reported Q3 2024 financial results with total revenue of €57.8 million, including SKYTROFA revenue of €47.2 million and YORVIPATH ex-U.S. revenue of €8.5 million. The company plans U.S. YORVIPATH launch with product availability in mid-January 2025. TransCon CNP NDA submission for achondroplasia is planned for Q1 2025. A new collaboration with Novo Nordisk was announced for metabolic and cardiovascular diseases. Full-year 2024 SKYTROFA revenue guidance is €200-220 million, with operating expenses projected at €600 million. Cash position stands at €626 million as of September 30, 2024.
Ascendis Pharma (Nasdaq: ASND) has scheduled its third quarter 2024 financial results announcement and business update for November 14, 2024, after U.S. market close. The company will host a conference call and webcast at 4:30 p.m. Eastern Time on the same day. Investors can access the live webcast or register for the teleconference through provided links. A replay will be available on the company's investor relations website for 30 days following the event.
Ascendis Pharma (ASND) has entered into a licensing agreement with Novo Nordisk for the exclusive worldwide rights to its TransCon technology platform. The collaboration focuses on developing products for metabolic and cardiovascular diseases, with a lead program targeting a once-monthly GLP-1 receptor agonist for obesity and type 2 diabetes. Ascendis will receive up to $285 million in upfront, development, and regulatory milestone payments for the lead program, plus sales-based milestones and tiered royalties. Additional product candidates could earn up to $77.5 million each in milestone payments plus royalties. Ascendis will handle early development while Novo Nordisk will manage clinical development, regulatory affairs, manufacturing, and commercialization.
Ascendis Pharma A/S (Nasdaq: ASND) presented 3-year results from their ongoing Phase 2 PaTH Forward Trial at ASBMR 2024. The study, involving 57 adults with hypoparathyroidism, showed that long-term treatment with TransCon™ PTH (palopegteriparatide; marketed as YORVIPATH®) through Week 162 normalized bone remodeling.
Hypoparathyroidism is associated with low bone remodeling rates, accumulation of overly mature bone, and higher-than-average bone mineral density, potentially indicating poorer overall bone quality. The results suggest that long-term palopegteriparatide treatment promotes skeletal health parameters similar to those in parathyroid sufficiency.
TransCon PTH is a once-daily prodrug of parathyroid hormone (PTH [1-34]), designed to provide continuous PTH exposure over 24 hours. Dr. Mishaela Rubin, Associate Professor of Medicine at Columbia University, presented the findings in an oral presentation titled 'Palopegteriparatide Improves Skeletal Dynamics in Adults with Chronic Hypoparathyroidism: 3 Year Results from the Phase 2 PaTH Forward Trial' (#1091).
Ascendis Pharma A/S (Nasdaq: ASND) has submitted a supplemental Biologics License Application (sBLA) to the FDA for TransCon hGH to treat adults with growth hormone deficiency (GHD). This submission aims to expand the label of SKYTROFA®, currently approved for pediatric GHD in the U.S. The sBLA is based on results from the foresiGHt Phase 3 trial, which compared weekly TransCon hGH with weekly placebo and daily hGH in 259 adults with GHD aged 23-80.
The trial demonstrated that TransCon hGH was superior to placebo in reducing trunk fat and increasing total body lean mass at Week 38. It was generally safe and well-tolerated, with no discontinuations related to the study drug and comparable safety to daily hGH. This submission supports Ascendis Pharma's strategy to develop SKYTROFA into a blockbuster product and address the unmet medical need in adult GHD treatment.
Ascendis Pharma A/S (Nasdaq: ASND) has announced the pricing of its public offering of 2,000,000 American Depositary Shares (ADSs) at $150.00 per ADS. The offering is expected to close around September 23, 2024. Ascendis has also granted underwriters a 30-day option to purchase up to 300,000 additional ADSs. The company estimates net proceeds of approximately $281.3 million, which will be used for commercial preparations, launch activities, clinical development, regulatory approvals, and general corporate purposes.
J.P. Morgan, Morgan Stanley, Evercore ISI, and Goldman Sachs & Co. are acting as joint book-running managers. BofA Securities, Wells Fargo Securities, and Citigroup are lead managers, while Oppenheimer & Co. is co-manager for the offering. A shelf registration statement has been filed with the SEC, and the offering is being made through a prospectus.
Ascendis Pharma A/S (Nasdaq: ASND) has announced a proposed public offering of $300 million in American Depositary Shares (ADSs). Each ADS represents one ordinary share of Ascendis. The company plans to grant underwriters a 30-day option to purchase up to an additional $45 million of ADSs at the public offering price, less underwriting commissions.
The offering is subject to market conditions, with no assurance of completion or final terms. J.P. Morgan, Morgan Stanley, Evercore ISI, and Goldman Sachs & Co. are acting as joint book-running managers. A shelf registration statement has been filed with the SEC, and the offering will be made through a prospectus.
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