Ascendis Pharma Stock Price, News & Analysis

Ascendis Pharma A/S (Nasdaq: ASND) announced three presentations for its TransCon PTH program at the ASBMR 2020 Annual Meeting, highlighting a significant phase 2 trial showing that TransCon PTH eliminated standard vitamin D treatment in 82% of participants. This investigational treatment aims to address hypoparathyroidism symptoms effectively. Additionally, a survey revealed that over two-thirds of HP patients experience calcium crashes, demonstrating the need for better treatment options. The meeting runs from September 11-15, with key presentations scheduled for September 15.

Ascendis Pharma A/S (Nasdaq: ASND) has submitted a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) seeking approval for TransCon hGH, a once-weekly treatment for pediatric growth hormone deficiency (GHD). This submission follows the EMA's approval of Ascendis' Paediatric Investigation Plan. The MAA includes data from eight clinical trials involving over 400 subjects. Currently, no long-acting growth hormone treatments are approved in Europe for pediatric GHD. TransCon hGH has orphan designation in both the U.S. and Europe.

Ascendis Pharma A/S announced that the FDA accepted its BLA for TransCon hGH, a long-acting prodrug of human growth hormone for treating pediatric growth hormone deficiency (GHD). The PDUFA target date is set for June 25, 2021. Notably, the FDA is not planning to hold an Advisory Committee Meeting regarding this application. TransCon hGH aims to provide a once-weekly injection option, enhancing treatment for clinicians and children. The BLA is backed by results from eight clinical trials involving over 400 subjects. The investigational therapy has received orphan designation in both the U.S. and Europe.

Ascendis Pharma A/S (Nasdaq: ASND) announced two presentations related to its TransCon PTH program for adult hypoparathyroidism at the 22nd European Congress of Endocrinology (e-ECE) 2020. The phase 2 PaTH Forward Trial results showed that 82% of subjects were able to discontinue standard treatments after four weeks of TransCon PTH. The oral presentation is scheduled for September 8, 2020. TransCon PTH is designed as a long-acting hormone replacement therapy, addressing complications from the rare endocrine disorder HP, affecting about 200,000 patients globally.

Ascendis Pharma A/S (Nasdaq: ASND) announced its participation in the 2020 Wells Fargo Virtual Healthcare Conference on September 10, 2020, at 4:00 p.m. ET. The conference will showcase a business overview and updates on the company's pipeline programs, focusing on their innovative TransCon™ technologies aimed at addressing unmet medical needs. A live webcast will be available on the company’s website, with a replay accessible for 30 days post-event. Ascendis Pharma is actively developing therapies for rare endocrine diseases and expanding into oncology.

Ascendis Pharma A/S (Nasdaq: ASND) has submitted a Biologics License Application (BLA) for TransCon™ hGH to the FDA for pediatric growth hormone deficiency, with a European Marketing Authorisation Application (MAA) planned for Q3 2020 after EMA approval of the Pediatric Investigation Plan. New trial data showed TransCon PTH significantly improved quality of life for hypoparathyroidism patients. The company reported a Q2 2020 net loss of €94.9 million, a decline from €58.9 million in Q2 2019, with revenue decreasing to €1.4 million from €3.2 million. Cash reserves total €471.6 million.

Ascendis Pharma A/S (Nasdaq: ASND) announced a conference call on August 27, 2020, at 4:30 PM ET to discuss its Q2 2020 financial results and provide a business update. The live webcast will be accessible on the company’s website, with a replay available for 30 days post-event. Ascendis is focused on developing therapies using its TransCon™ technologies, currently advancing three endocrinology product candidates and expanding into oncology. The company emphasizes patient needs and scientific innovation in its mission.

Ascendis Pharma A/S (Nasdaq: ASND) announced that the European Commission has granted Orphan Designation to its investigational drug, TransCon C-Type Natriuretic Peptide (CNP), for treating achondroplasia. This designation highlights the urgency for effective therapies for this condition, which affects about 250,000 people globally. TransCon CNP received similar status in the U.S. in February 2019. The company's ongoing Phase 2 ACcomplisH Trial aims to develop new treatment options, emphasizing the significance of CNP in promoting bone growth affected by the FGFR3 mutation.

Ascendis Pharma A/S (Nasdaq: ASND) announced the pricing of a public offering of 4,225,352 American Depositary Shares (ADSs) at $142.00 each, aiming to raise approximately $569.2 million. The funds will support clinical development and regulatory approval for TransCon hGH and other endocrinology programs, as well as working capital. The offering is expected to close on or about July 10, 2020, with an option for underwriters to purchase an additional 633,802 ADSs. J.P. Morgan, Morgan Stanley, and others are managing the offering.