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Ascendis Pharma A/S reports developments as a global biopharmaceutical company applying its TransCon technology platform to new therapies in endocrinology, rare disease and oncology. News commonly centers on TransCon CNP, also known as navepegritide, including YUVIWEL for pediatric achondroplasia, as well as TransCon hGH combination data and growth-disorder clinical programs.
Recurring company updates also include financial results and business updates, U.S. regulatory and commercialization milestones, patient-access programs, and capital-structure actions such as convertible senior note activity. Corporate news also documents the completed transition from American Depositary Shares to ordinary shares trading on Nasdaq under ASND.
Ascendis Pharma (ASND) announced a positive opinion from the European Medicines Agency’s CHMP for its growth hormone therapy, TransCon hGH, designed for pediatric patients with growth hormone deficiency. This recommendation supports the marketing authorization application (MAA) with a final decision expected within 67 days. The CHMP's opinion is based on data from three Phase 3 trials involving over 300 patients. Earlier this year, TransCon hGH was also approved by the U.S. FDA under the brand name SKYTROFA.
Ascendis Pharma announced the FDA approval of SKYTROFA® (lonapegsomatropin-tcgd) as a once-weekly treatment for pediatric growth hormone deficiency, launched in October 2021. The company reported a net loss of €80.3 million for Q3 2021, improved from €121.7 million in Q3 2020. Revenue fell to €1.1 million from €2.8 million in the previous year due to decreased sales of clinical supplies. R&D costs decreased to €58.8 million, while selling expenses rose significantly to €39.3 million. Ascendis ended Q3 with cash and equivalents of €929.9 million and plans upcoming clinical updates in December.
Ascendis Pharma (ASND) announced compelling non-clinical results for its investigational TransCon TLR7/8 Agonist at SITC 2021. The results indicate that a single dose activated key immune mechanisms and modulated tumor microenvironments with minimal systemic exposure. The company plans to release initial clinical data for the monotherapy later this quarter. The TransCon TLR7/8 Agonist utilizes innovative hydrogel technology, aimed at sustained immune response, ultimately advancing its ongoing Phase 1/2 study to assess the treatment's safety and efficacy.
Ascendis Pharma A/S (ASND) has announced an update on its $25 million ADS Share Repurchase Program, initiated on November 1, 2021. Under this program, the company has authorized repurchases of up to 300,000 ADSs, with total repurchased shares reaching 122,422 for a total value of approximately $19.76 million. The program will run until December 31, 2021, aiming to enhance shareholder value. The average purchase price per ADS stands at $161.41.
Ascendis Pharma A/S (Nasdaq: ASND) announced a conference call on November 10, 2021, at 4:30 p.m. ET to discuss its Q3 2021 financial results and provide a business update. The call will feature insights into the company's progress and performance metrics, with participation via U.S. and international dial-in options. A live webcast will be accessible on the Ascendis Pharma website, with a replay available for 30 days post-event. The company is committed to delivering innovative therapies aimed at improving patient lives using its TransCon technologies.
Ascendis Pharma A/S (Nasdaq: ASND) has launched SKYTROFA (lonapegsomatropin-tcgd), a once-weekly treatment for pediatric patients aged 1 year and older with growth failure due to inadequate secretion of endogenous growth hormone. This FDA-approved therapy replaces daily injections, representing a significant innovation in pediatric care. The company has also introduced the Ascendis Signature Access Program™, providing personalized patient support services. SKYTROFA is expected to enhance the company's growth trajectory as part of its strategic roadmap.
Ascendis Pharma A/S (Nasdaq: ASND) announced significant findings at the ASBMR 2021 Annual Meeting regarding its TransCon PTH product. In a late-breaking presentation, results from the 58-week PaTH Forward Trial were shared, indicating positive trends in calcium homeostasis and improvements in health-related quality of life for hypoparathyroidism patients. The study involved 58 subjects, showing normalization of key biomarkers with mild adverse events reported. The company also highlighted its sponsorship of two CME programs related to hypoparathyroidism and achondroplasia.
Ascendis Pharma A/S (NASDAQ: ASND) has announced a $25 million share repurchase program aimed at enhancing shareholder value. The program will take place from November 1, 2021, through December 31, 2021, and is managed independently by J.P. Morgan Securities LLC. A maximum of 300,000 American Depositary Shares (ADS) will be repurchased, with a daily limit of 10% of the average trading volume over the last four weeks. Funding will come from existing cash resources, emphasizing the company's commitment to utilizing its financial flexibility for shareholder benefit.
Ascendis Pharma A/S (Nasdaq: ASND) announced positive results from the 58-week Bone Mineral Density (BMD) analysis of the PaTH Forward Trial, a global Phase 2 study of its investigational drug TransCon PTH for adult hypoparathyroidism (HP) patients. Data showed stabilization of BMD Z-scores, indicating potential normalization of calcium metabolism. TransCon PTH, a once-daily injection, aims to restore physiological PTH levels. The trial results align with previous findings on bone turnover markers, reinforcing the therapeutic potential of TransCon PTH in managing HP, a condition affecting approximately 400,000 patients globally.
Ascendis Pharma A/S (Nasdaq: ASND), a biopharmaceutical company, announced its participation in two investor conferences: the Wells Fargo Healthcare Conference on September 10, 2021, at 2:40 p.m. ET and the Morgan Stanley Global Healthcare Conference on September 15, 2021, at 12:30 p.m. ET. Executives will discuss the company's innovative TransCon™ technologies and provide a business overview. Live webcasts will be available on the Ascendis Pharma website, with replays accessible for 30 days post-event.
Ascendis recently received FDA approval for its product SKYTROFA®.