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 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.
Ascendis Pharma A/S (Nasdaq: ASND) has scheduled a conference call for May 11, 2022, at 4:30 p.m. ET to discuss its first quarter financial results. The event will provide an update on the company's operations and financial performance. Interested parties can join via a live webcast on Ascendis Pharma's website, with a replay available afterward for 30 days. Ascendis Pharma focuses on using its TransCon technologies to develop innovative therapies aimed at improving patient outcomes.
Ascendis Pharma A/S (Nasdaq: ASND) announced new clinical data presentations at four medical meetings in May 2022. Key highlights include Phase 3 results for children with growth hormone deficiency treated with TransCon hGH for 2.5 years, and findings on comorbidities in adults with growth hormone deficiency. At the PES 2022 meeting, an oral presentation will detail the efficacy and safety of lonapegsomatropin in children. Additionally, the company’s FDA-approved treatment, SKYTROFA, will be showcased. This data signifies the expansion of Ascendis’ endocrinology portfolio.
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