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 (NASDAQ: ASND) is a global biopharmaceutical company that develops therapies using its proprietary TransCon technology platform. This news page aggregates company announcements, clinical updates, financial results, and regulatory milestones that Ascendis discloses through press releases and regulatory channels.
Readers can follow developments related to Ascendis’ commercial products and pipeline, including YORVIPATH (TransCon PTH) for adults with hypoparathyroidism and SKYTROFA (TransCon hGH) for pediatric and adult growth hormone deficiency. News items also cover investigational programs such as TransCon CNP for children with achondroplasia, combination therapy with TransCon CNP and TransCon hGH in the COACH trial, and TransCon IL-2 β/γ in late-line platinum-resistant ovarian cancer.
Updates frequently include information on Phase 2 and Phase 3 clinical trial results, publication of pivotal data in peer-reviewed journals, submissions and reviews of New Drug Applications and Marketing Authorisation Applications, and presentations at major medical and investor conferences. Financial news, such as quarterly results, revenue contributions from YORVIPATH and SKYTROFA, and commentary on the company’s progress toward its long-term vision, is also reported.
Investors and observers can use this page to monitor how Ascendis advances its TransCon-based portfolio across endocrinology, rare diseases, and oncology, as well as to track collaboration news involving partners in regions such as Greater China and Japan. For those following ASND stock, the news flow provides context on the company’s operational performance, regulatory interactions, and clinical milestones over time.
Ascendis Pharma A/S (Nasdaq: ASND) reported promising Week 110 data from the Phase 2 PaTH Forward Trial for TransCon PTH, an investigational treatment for hypoparathyroidism. The results demonstrated sustained normalization of serum calcium levels, with 93% of participants achieving independence from conventional therapy. The therapy was well-tolerated, and there were no discontinuations due to adverse events. Additionally, there was a notable improvement in bone mineral density, trending toward age- and sex-matched norms. Ascendis plans to submit a Marketing Authorisation Application to the EMA in Q4 2022.
Ascendis Pharma A/S (Nasdaq: ASND) will participate in three investor conferences in September 2022. The events include Citi's 17th Annual BioPharma Conference on September 7 in Boston, the Wells Fargo Healthcare Conference on September 8 in Boston, and the Morgan Stanley 20th Annual Global Healthcare Conference on September 13 in New York. Scott Smith, CFO, will speak at the first two conferences, while both Scott Smith and CEO Jan Mikkelsen will present at the last conference. Live webcasts will be available on Ascendis' website.
Ascendis Pharma has submitted a New Drug Application (NDA) for TransCon PTH to the FDA, targeting hypoparathyroidism. If approved, it could be the first hormone replacement therapy addressing the root cause of this condition affecting approximately 70,000-90,000 adults in the U.S. The NDA is based on positive Phase 2 and Phase 3 trial data showing that treated patients achieved normalization of serum calcium levels and reported improved quality of life. The company also plans to submit a Marketing Authorisation Application to the European Medicines Agency in Q4 2022.
Ascendis Pharma (ASND) announced Q2 2022 financial results, reporting total revenue of €6.2 million, a significant increase from €1.0 million year-over-year, driven by €4.4 million in SKYTROFA sales. The company holds €995 million in cash and equivalents, positioning it to achieve its Vision 3x3 strategy. The anticipated U.S. launch of TransCon PTH is set for mid-2023, with EU submissions planned shortly after. Although net loss for Q2 was €81.3 million, a decrease from €134.4 million in 2021, R&D and SG&A expenses rose due to increased operations. A conference call is scheduled for 4:30 PM ET.
Ascendis Pharma A/S (Nasdaq: ASND) will host a conference call and live webcast on August 10, 2022, at 4:30 p.m. ET to discuss its second quarter 2022 financial results and provide a business update. The event aims to showcase the company's commitment to transparency and investor engagement. Participants can access the webcast via the link provided, with a replay available for 30 days post-event. Ascendis Pharma is focused on developing innovative therapies using its TransCon technologies to improve patient outcomes.
Ascendis Pharma A/S (Nasdaq: ASND) announced significant advancements in its investigational product candidate TransCon PTH for adult hypoparathyroidism, showcasing Phase 2 and Phase 3 trial data at ENDO 2022. Dr. Aliya Khan reported that the PaTHway Trial highlighted a majority of treated patients achieving disease control, including normalized serum calcium and independence from conventional therapy. The treatment was well-tolerated. These presentations aim to reshape the treatment paradigm for hypoparathyroidism and underline Ascendis' commitment to innovative therapies.
Ascendis Pharma has announced new leadership appointments in its Endocrinology commercial team. Joe Kelly is appointed Head of U.S. Commercial, while Scott A. Holmes takes on the role of Head of Global Commercial Strategy. This follows the retirement of Jesper Høiland, who will continue as a senior advisor. The team aims to enhance U.S. market leadership for SKYTROFA and prepare for upcoming TransCon product launches. Despite the leadership change, the company focuses on leveraging its TransCon technologies to develop innovative therapies.
Ascendis Pharma A/S announced positive results from VISEN Pharmaceuticals' Phase 3 trial of TransCon™ hGH for pediatric growth hormone deficiency (GHD) in China. The trial met its primary endpoint, demonstrating significantly greater annualized height velocity at 52 weeks (p=0.0010) compared to daily growth hormone treatment. This result aligns with previous multinational trial outcomes, confirming the safety and efficacy of TransCon hGH. The treatment is now approved in the U.S. and EU. The CEO praised VISEN for its achievement, underscoring TransCon technology's global applicability.
Ascendis Pharma (ASND) reported strong Phase 3 trial results for its TransCon PTH therapy, potentially positioning it as the first replacement therapy for adults with hypoparathyroidism. The company anticipates U.S. FDA submission by Q3 2022 and EU MAA submission by Q4 2022. First-quarter revenue surged to €6.8 million, up from €0.7 million, mainly driven by SKYTROFA sales. However, the net loss widened to €125.5 million, or €2.21 per share. Ascendis ended Q1 2022 with €1,065 million in cash, bolstering its investment potential for growth and sustainability.
Ascendis Pharma A/S (Nasdaq: ASND) will attend the BofA Securities 2022 Healthcare Conference on May 12, 2022, in Las Vegas, NV. Company executives are set to participate in a fireside chat from 1:40-2:10 p.m. ET. A live webcast will be accessible on their website, with a replay available for 30 days post-event. Ascendis aims to leverage its platform technology to develop new therapies, focusing on making a significant impact in patients' lives.
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