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 operates in the rare disease biotechnology sector, where news frequently centers on clinical trial results, regulatory decisions, and product commercialization milestones. The company's focus on pediatric and adult endocrine disorders means that FDA approvals, European Medicines Agency decisions, and clinical data readouts constitute particularly significant news events for investors tracking ASND.
Key news categories for Ascendis Pharma include regulatory milestones such as FDA acceptance of New Drug Applications, priority review designations, and marketing authorization decisions. Clinical trial results from pivotal studies testing the company's TransCon-based therapies provide critical insights into product viability and commercial potential. Quarterly financial reports reveal commercialization progress for approved products like SKYTROFA, including prescription trends and revenue growth in key markets.
Investors following Ascendis Pharma also monitor news about pipeline advancement, including initiation of clinical trials for new indications, enrollment progress in ongoing studies, and publication of clinical data in medical journals. Regulatory interactions, such as FDA Advisory Committee meetings or responses to Complete Response Letters, can significantly impact development timelines. Partnership announcements, manufacturing agreements, and expansion into new geographic markets represent additional news categories relevant to the company's growth strategy.
Conference presentations at major endocrinology and rare disease medical meetings often provide detailed clinical data and expert physician perspectives on Ascendis Pharma's therapies. Investor conferences and earnings calls offer management commentary on commercial execution, competitive dynamics, and strategic priorities. For a biotechnology company with multiple programs in different stages of development and commercialization, tracking this diverse news flow helps investors understand both near-term catalysts and long-term value drivers.
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.
Ascendis Pharma A/S (Nasdaq: ASND) has announced the pricing of a private offering of US$500 million in 2.25% convertible senior notes due 2028, set to settle on March 29, 2022. An additional US$75 million may be purchased by initial buyers within 13 days. The notes will accrue interest semi-annually and are convertible into ADSs at a rate of 6.0118 ADSs per US$1,000 principal. The net proceeds, estimated at approximately US$485 million, will support various developmental activities including commercialization of TransCon hGH and clinical development of other products.
Ascendis Pharma A/S (Nasdaq: ASND) has announced a private offering of US$500,000,000 in convertible senior notes due 2028. The offering is aimed at qualified institutional buyers under Rule 144A and includes an option for initial purchasers to buy an additional US$75,000,000 in notes. The notes will accrue interest semi-annually and are convertible into Ascendis Pharma's American Depositary Shares (ADSs). Proceeds will fund the repurchase of up to 1 million ADSs and support the development of various therapeutics, including TransCon hGH and oncology programs.
Spruce Biosciences, Inc. (NASDAQ: SPRB) has appointed Dr. Will Charlton as Chief Medical Officer following the departure of Dr. Rosh Dias. Dr. Charlton, with over 15 years in clinical research and experience in rare disease drug development, will lead Spruce's clinical strategies, particularly focusing on tildacerfont, aimed at treating classic congenital adrenal hyperplasia and polycystic ovary syndrome.
CEO Javier Szwarcberg expressed confidence in Dr. Charlton's expertise, anticipating significant advancements in therapies for rare endocrine disorders, which have seen no new treatments in nearly 50 years.
Ascendis Pharma announced significant results from the Phase 3 PaTHway Trial of TransCon PTH for adults with hypoparathyroidism. The primary endpoint was achieved by 78.7% of treated patients, compared to 4.8% in the control group (p-value < 0.0001). Key secondary endpoints also showed statistically significant improvements in patient-reported symptoms. TransCon PTH was well-tolerated, with no discontinuations due to the drug. An NDA is planned for submission in Q3 2022.
Ascendis Pharma announced its full-year financial results for 2021, reporting total revenue of €7.8 million, an increase from €7.0 million in 2020. The company incurred a net loss of €383.6 million, or €7.00 per share, improving from €419.0 million, or €8.28 per share, in the prior year. With cash reserves of €789.6 million, Ascendis continues to advance its pipeline, including TransCon PTH, with Phase 3 results expected soon. The company remains optimistic about a strong 2022, driven by the success of SKYTROFA and a robust oncology pipeline.
Ascendis Pharma A/S (Nasdaq: ASND) announced a conference call on March 2, 2022 at 4:30 p.m. ET to discuss its 2021 financial results and provide a business update. Investors can join via the company’s website, where a replay will be available afterward. The company aims to build a leading biopharma firm using its TransCon technologies to deliver potentially best-in-class therapies. However, the release includes forward-looking statements that highlight substantial risks and uncertainties in achieving their operational goals.
Ascendis Pharma A/S (Nasdaq: ASND) announced its participation in the 11th Annual SVB Leerink Global Healthcare Conference. The virtual fireside chat will take place on February 16, 2022, from 3:00 to 3:30 p.m. Eastern Time. A live webcast will be accessible through the Investors and News section on Ascendis Pharma's website, with a replay available for 30 days post-event. Ascendis Pharma focuses on innovative therapies through its TransCon technologies, aiming to enhance patient lives.
Ascendis Pharma announced that the European Commission has granted marketing authorization for TransCon hGH, branded as Lonapegsomatropin, aimed at treating pediatric patients aged 3 to 18 with growth hormone deficiency (GHD). This once-weekly injection offers a sustained release of somatropin, improving treatment adherence. The approval is based on positive results from the Phase 3 trials involving over 300 pediatric patients. The company plans to leverage this approval to enhance its market presence in Europe and develop further products for GHD.
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