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Ascendis Pharma A/S reports developments as a global biopharmaceutical company applying its TransCon technology platform to new therapies in endocrinology, rare disease and oncology. News commonly centers on TransCon CNP, also known as navepegritide, including YUVIWEL for pediatric achondroplasia, as well as TransCon hGH combination data and growth-disorder clinical programs.
Recurring company updates also include financial results and business updates, U.S. regulatory and commercialization milestones, patient-access programs, and capital-structure actions such as convertible senior note activity. Corporate news also documents the completed transition from American Depositary Shares to ordinary shares trading on Nasdaq under ASND.
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.
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. 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.