Welcome to our dedicated page for Ascendis Pharma news (Ticker: ASND), a resource for investors and traders seeking the latest updates and insights on Ascendis Pharma stock.
Ascendis Pharma A/S (ASND) delivers innovative biopharmaceutical solutions through its proprietary TransCon platform, focusing on rare endocrine disorders, oncology, and growth-related conditions. This news hub provides investors and healthcare professionals with essential updates on clinical advancements, regulatory milestones, and strategic initiatives.
Access timely reports on ASND's product pipeline including TransCon PTH for hypoparathyroidism and TransCon CNP for achondroplasia. Our curated news collection covers earnings announcements, partnership developments, and European Medicines Agency (EMA)/FDA regulatory interactions, offering critical context for understanding the company's growth trajectory.
Key updates include progress in global clinical trials, manufacturing expansions, and analyses of commercial strategies for approved therapies. Bookmark this page for consolidated access to verified press releases and objective third-party analyses of ASND's position in the competitive biopharma landscape.
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.
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.