Ascendis Pharma Stock Price, News & Analysis

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®.

Ascendis Pharma A/S (NASDAQ: ASND) has submitted an IND application to the FDA for the IL βelieγe trial, a phase 1/2 clinical study of TransCon IL-2 β/γ, aimed at enhancing cancer immunotherapy. This innovative long-acting prodrug is designed to provide sustained release of an IL-2 variant that selectively activates IL-2Rβ/γ while minimizing interaction with IL-2Rα. The company aims to address limitations of existing IL-2 drugs, potentially leading to a more effective cancer treatment.

Ascendis Pharma A/S (Nasdaq: ASND) announced a public offering of 2,500,000 American Depositary Shares (ADSs) at $160.00 each, expected to close around September 7, 2021. The company anticipates net proceeds of approximately $379.3 million, which will be allocated to commercial preparations and clinical development of its products, including lonapegsomatropin-tcgd, palopegteriparatide, and TransCon CNP. Additionally, Ascendis may use funds for working capital and general corporate purposes. Underwriters have a 30-day option to buy up to 375,000 more ADSs.

Ascendis Pharma A/S (Nasdaq: ASND) announced an underwritten public offering of $400,000,000 of American Depositary Shares (ADSs), each representing one ordinary share. The company may grant underwriters a 30-day option to purchase an additional $60,000,000 of ADSs. The offering is subject to market conditions, and there are no guarantees regarding its completion. J.P. Morgan, Morgan Stanley, Evercore, and SVB Leerink are acting as joint book-running managers. A shelf registration statement was filed with the SEC on May 27, 2021.

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.