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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 announced FDA approval of SKYTROFA (lonapegsomatropin-tcgd), a once-weekly treatment for pediatric growth hormone deficiency. The company exceeded enrollment targets for the Phase 3 PaTHway Trial for TransCon PTH and plans to reveal top-line results in Q1 2022. For Q2 2021, Ascendis reported a net loss of €134.4 million, an increase from €94.9 million in Q2 2020, with revenues falling to €1 million. R&D expenses rose to €83.3 million due to higher external development costs. Cash reserves decreased to €641.3 million as of June 30, 2021.
Ascendis Pharma announced the FDA approval of SKYTROFA (lonapegsomatropin-tcgd), the first long-acting growth hormone treatment for pediatric patients aged one year and older with growth failure due to inadequate secretion of endogenous growth hormone. This once-weekly injection demonstrated a higher annualized height velocity (AHV) at week 52 in comparison to daily treatments, potentially reducing the treatment burden for families. The product will soon be available in the U.S. with a suite of patient support programs.
Ascendis Pharma A/S (Nasdaq: ASND) announced a conference call scheduled for August 25, 2021, at 4:30 p.m. ET to discuss its second quarter 2021 financial results and provide a business update. The call reflects the company's commitment to transparency and communication regarding its performance and strategic direction. Ascendis Pharma focuses on innovative TransCon technologies, enhancing patient outcomes in endocrinology and oncology. The call will be accessible via dial-in and a live webcast on their website.
Ascendis Pharma A/S (Nasdaq: ASND) announced participation in two investor conferences this August, providing updates on its pipeline and company overview. The key events are:
- Wedbush PacGrow Healthcare Conference on August 11, 2021, at 9:10 a.m. ET (Virtual)
- Canaccord Genuity 41st Annual Growth Conference on August 12, 2021, at 11:00 a.m. ET (Virtual)
Live webcasts will be accessible on the Ascendis Pharma website, with replays available for 30 days post-event. The company focuses on innovative therapies addressing unmet medical needs.
Ascendis Pharma (ASND) has reached target enrollment for its phase 3 PaTHway Trial, evaluating TransCon PTH for hypoparathyroidism (HP). Top-line data is expected in Q1 2022, with a New Drug Application (NDA) submission planned for mid-2022. The company has received Orphan Drug Designation for TransCon PTH in Japan and established a pathway for global regulatory filings. The trial aims to assess the drug's safety and efficacy in adults with HP, impacting over 400,000 patients across multiple regions.
Ascendis Pharma announced the extension of the PDUFA goal date for its lonapegsomatropin application by three months to September 25, 2021. This extension follows the FDA's classification of the recent submissions as a major amendment to the Biologics License Application (BLA) for treating pediatric growth hormone deficiency (GHD). The company's CEO expressed confidence in the submitted materials, anticipating that the application meets FDA requirements for a thorough review.
VISEN Pharmaceuticals has received IND approval from the CDE of NMPA for the Phase III PaTHway China Trial of TransCon PTH, targeting patients with hypoparathyroidism (HP). This trial aims to evaluate the efficacy of this once-daily hormone replacement therapy, which mimics continuous PTH infusion, to maintain normal serum calcium levels. The study will also collect patient-reported data to enhance understanding of HP's impact on quality of life. Over 200,000 patients globally suffer from HP, and this development marks a significant step in addressing unmet clinical needs in China.
Ascendis Pharma (Nasdaq: ASND) will host an online event on June 1, 2021, to raise awareness for World Hypopara Awareness Day. The event will feature a live reading by bestselling children's author Ariana Feiner, known for her short film documentary, A Story of Courage, which has won 24 international awards. This initiative aims to inspire and support those affected by hypoparathyroidism, a rare condition affecting approximately 200,000 patients in the US and other countries. The event is accessible via www.astoryofcourage.live.
Ascendis Pharma (ASND) announced Q1 2021 results, reporting a net loss of €62.8 million, or €1.17 per share, with revenue decreasing to €0.7 million from €2.2 million year-on-year. The decline in revenue was attributed to lower license revenue and clinical supplies sales. R&D expenses surged to €88.1 million, up from €57.5 million, driven by increased personnel costs and ongoing product development. Cash reserves stood at €771.1 million. The PDUFA date for TransCon hGH is set for June 25, 2021, with a commercial launch anticipated in Q3 2021.
Ascendis Pharma A/S (ASND) announced a conference call on May 27, 2021, at 4:30 p.m. ET to discuss Q1 2021 financial results and provide a business update. The conference will be accessible via a live webcast on the company's website. Ascendis is focused on developing therapies using its TransCon technology for rare diseases and oncology. The company aims to address unmet medical needs and is expanding into new therapeutic areas. The press release highlights Ascendis' commitment to impactful patient care.