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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 (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.
Ascendis Pharma A/S (Nasdaq: ASND) will participate in the 40th Annual J.P. Morgan Healthcare Conference on January 10, 2022. The event is virtual and begins at 3:00 p.m. Eastern Time. Company executives will provide updates on its pipeline programs and business overview. A live webcast will be available on the Ascendis Pharma website, with a replay accessible for 30 days following the event. This presentation highlights Ascendis' commitment to innovative therapies using its TransCon technologies.
Ascendis Pharma A/S (Nasdaq: ASND) announced significant updates on its investigational products during a virtual R&D Program Update. Key highlights include:
- Phase 3 topline results for TransCon PTH expected in Q1 2022, with NDA and MAA submissions planned for Q3 and Q4 2022, respectively.
- Enrollment completed in Phase 2 ACcomplisH Trial for TransCon CNP, with promising preliminary data guiding dose selection for future trials.
- Early clinical activity observed in cancer patients treated with TransCon TLR7/8 Agonist, indicating potential for further development.
Ascendis Pharma A/S (Nasdaq: ASND) will host a virtual R&D Program Update on December 14, 2021, from 9:00 a.m. to 11:30 a.m. Eastern Time. The event will provide updates on the company's endocrinology rare disease programs and its oncology product, TransCon TLR7/8 Agonist. Key speakers include senior management and Dr. Aliya Khan, a recognized expert in parathyroid disease. Investors can access the live webcast on the company's website, with a replay available for 30 days afterward.
Ascendis Pharma (ASND) announced encouraging results from Week 84 of its Phase 2 PaTH Forward Trial for TransCon PTH, an investigational treatment for hypoparathyroidism. The trial observed that 58 out of 59 participants remained in the study, with stable mean serum calcium levels and most participants free from active vitamin D supplementation. TransCon PTH was well-tolerated, with no serious treatment-related adverse events reported. The company expects to release Phase 3 data in Q1 2022, with plans for a potential New Drug Application (NDA) submission if results are positive.
Ascendis Pharma A/S (Nasdaq: ASND) announced its participation in the Evercore ISI 4th Annual HealthCONx Conference, scheduled for December 1, 2021. The event is set to be held virtually, with company executives participating in a fireside chat from 3:55 to 4:15 p.m. Eastern Time. A live audio webcast will be available on the company’s website, with a replay accessible for 30 days post-event. Ascendis Pharma focuses on innovating therapies through its TransCon technologies, aiming to enhance patient outcomes.
Ascendis Pharma A/S (Nasdaq: ASND) announced the completion of its $25 million ADS Share Repurchase Program executed from November 1 to November 9, 2021. The company repurchased a total of 154,837 ADS at a weighted average price of $161.43, totaling $24,999,884. This buyback aims to enhance shareholder value by reducing the number of outstanding shares. The program was conducted under U.S. Securities regulations 10b-18 and 10b5-1.
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.