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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 A/S (Nasdaq: ASND) announced new clinical data presentations at four medical meetings in May 2022. Key highlights include Phase 3 results for children with growth hormone deficiency treated with TransCon hGH for 2.5 years, and findings on comorbidities in adults with growth hormone deficiency. At the PES 2022 meeting, an oral presentation will detail the efficacy and safety of lonapegsomatropin in children. Additionally, the company’s FDA-approved treatment, SKYTROFA, will be showcased. This data signifies the expansion of Ascendis’ endocrinology portfolio.
Ascendis Pharma A/S (Nasdaq: ASND) has announced the pricing of a private offering of US$500 million in 2.25% convertible senior notes due 2028, set to settle on March 29, 2022. An additional US$75 million may be purchased by initial buyers within 13 days. The notes will accrue interest semi-annually and are convertible into ADSs at a rate of 6.0118 ADSs per US$1,000 principal. The net proceeds, estimated at approximately US$485 million, will support various developmental activities including commercialization of TransCon hGH and clinical development of other products.
Ascendis Pharma A/S (Nasdaq: ASND) has announced a private offering of US$500,000,000 in convertible senior notes due 2028. The offering is aimed at qualified institutional buyers under Rule 144A and includes an option for initial purchasers to buy an additional US$75,000,000 in notes. The notes will accrue interest semi-annually and are convertible into Ascendis Pharma's American Depositary Shares (ADSs). Proceeds will fund the repurchase of up to 1 million ADSs and support the development of various therapeutics, including TransCon hGH and oncology programs.
Spruce Biosciences, Inc. (NASDAQ: SPRB) has appointed Dr. Will Charlton as Chief Medical Officer following the departure of Dr. Rosh Dias. Dr. Charlton, with over 15 years in clinical research and experience in rare disease drug development, will lead Spruce's clinical strategies, particularly focusing on tildacerfont, aimed at treating classic congenital adrenal hyperplasia and polycystic ovary syndrome.
CEO Javier Szwarcberg expressed confidence in Dr. Charlton's expertise, anticipating significant advancements in therapies for rare endocrine disorders, which have seen no new treatments in nearly 50 years.
Ascendis Pharma announced significant results from the Phase 3 PaTHway Trial of TransCon PTH for adults with hypoparathyroidism. The primary endpoint was achieved by 78.7% of treated patients, compared to 4.8% in the control group (p-value < 0.0001). Key secondary endpoints also showed statistically significant improvements in patient-reported symptoms. TransCon PTH was well-tolerated, with no discontinuations due to the drug. An NDA is planned for submission in Q3 2022.
Ascendis Pharma announced its full-year financial results for 2021, reporting total revenue of €7.8 million, an increase from €7.0 million in 2020. The company incurred a net loss of €383.6 million, or €7.00 per share, improving from €419.0 million, or €8.28 per share, in the prior year. With cash reserves of €789.6 million, Ascendis continues to advance its pipeline, including TransCon PTH, with Phase 3 results expected soon. The company remains optimistic about a strong 2022, driven by the success of SKYTROFA and a robust oncology pipeline.
Ascendis Pharma A/S (Nasdaq: ASND) announced a conference call on March 2, 2022 at 4:30 p.m. ET to discuss its 2021 financial results and provide a business update. Investors can join via the company’s website, where a replay will be available afterward. The company aims to build a leading biopharma firm using its TransCon technologies to deliver potentially best-in-class therapies. However, the release includes forward-looking statements that highlight substantial risks and uncertainties in achieving their operational goals.
Ascendis Pharma A/S (Nasdaq: ASND) announced its participation in the 11th Annual SVB Leerink Global Healthcare Conference. The virtual fireside chat will take place on February 16, 2022, from 3:00 to 3:30 p.m. Eastern Time. A live webcast will be accessible through the Investors and News section on Ascendis Pharma's website, with a replay available for 30 days post-event. Ascendis Pharma focuses on innovative therapies through its TransCon technologies, aiming to enhance patient lives.
Ascendis Pharma announced that the European Commission has granted marketing authorization for TransCon hGH, branded as Lonapegsomatropin, aimed at treating pediatric patients aged 3 to 18 with growth hormone deficiency (GHD). This once-weekly injection offers a sustained release of somatropin, improving treatment adherence. The approval is based on positive results from the Phase 3 trials involving over 300 pediatric patients. The company plans to leverage this approval to enhance its market presence in Europe and develop further products for GHD.
Ascendis Pharma (Nasdaq: ASND) provided updates on its Vision 3x3 and upcoming milestones at the J.P. Morgan Healthcare Conference. CEO Jan Mikkelsen reported strong initial demand for SKYTROFA, the FDA-approved treatment for pediatric growth hormone deficiency, noting a 10% prescription rate among targeted prescribers. In 2022, the company anticipates significant clinical data readouts across its endocrinology and oncology pipeline, alongside the introduction of a third therapeutic area by year-end.
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