Ascendis Pharma Stock Price, News & Analysis

Ascendis Pharma (ASND) provided a business update highlighting strong revenue growth from its two marketed Endocrinology Rare Disease medicines. SKYTROFA achieved ~€202 million in full-year 2024 revenue, with an 84% year-over-year volume increase and 6.5% U.S. market share. YORVIPATH generated ~€29 million in 2024 revenue, with ~700 patients in Europe and 324 patients enrolled in the U.S. program.

The company plans to submit an NDA for TransCon CNP for achondroplasia in Q1 2025 and expand to additional European markets. Total preliminary 2024 revenue is estimated at ~€364 million, including a $100 million Novo Nordisk milestone payment. The company reported a pro forma cash balance of ~€655 million as of December 31, 2024.

Ascendis Pharma A/S (Nasdaq: ASND) has announced its participation in the 43rd Annual J.P. Morgan Healthcare Conference. The event will take place on Monday, January 13, 2025, at 11:15 a.m. Eastern Time / 8:15 a.m. Pacific Time in San Francisco, California.

Company executives will be presenting at the conference, and interested parties can access a live webcast of the presentation through the Investors & News section of the Ascendis Pharma website at investors.ascendispharma.com. The webcast recording will remain available for 30 days following the event.

Ascendis Pharma (Nasdaq: ASND) has announced the commercial availability of YORVIPATH® (palopegteriparatide) in the United States for treating hypoparathyroidism in adults. YORVIPATH is the first and only FDA-approved medicine for this condition, designed as a once-daily prodrug of parathyroid hormone providing 24-hour continuous exposure to active PTH.

The company has established a dedicated YORVIPATH team within the U.S. Ascendis Signature Access Program® to support patients, offering services including clinical education, prior authorization assistance, injection training, and co-pay support for eligible patients.

Ascendis Pharma (ASND) announced positive Week 26 topline results from its Phase 2 New InsiGHTS trial, evaluating TransCon hGH (lonapegsomatropin) in Turner syndrome patients. The trial compared three different weekly doses of TransCon hGH against daily somatropin in 49 prepubertal children aged 1-10 years.

The study achieved its primary objective, demonstrating that once-weekly TransCon hGH provided similar growth benefits to daily somatropin, with comparable safety and tolerability profiles. The trial showed improved growth across all three TransCon hGH starting dose cohorts (0.24, 0.30, or 0.36 mg/kg/week), matching the performance of daily somatropin (0.35 mg/kg/week).

Ascendis Pharma (NASDAQ: ASND) announced FDA acceptance of its supplemental Biologics License Application (sBLA) for TransCon hGH to treat adult growth hormone deficiency (GHD), with a PDUFA date set for July 27, 2025. The application is supported by the foresiGHt Phase 3 trial, which evaluated 259 adults with GHD aged 23-80 years.

The trial demonstrated TransCon hGH's superiority in primary and key secondary efficacy endpoints at Week 38, showing significant reduction in trunk fat and increased total body lean mass compared to placebo. The treatment was generally safe and well-tolerated, with no discontinuations related to study drug and comparable safety to daily hGH treatment.

Ascendis Pharma reported Q3 2024 financial results with total revenue of €57.8 million, including SKYTROFA revenue of €47.2 million and YORVIPATH ex-U.S. revenue of €8.5 million. The company plans U.S. YORVIPATH launch with product availability in mid-January 2025. TransCon CNP NDA submission for achondroplasia is planned for Q1 2025. A new collaboration with Novo Nordisk was announced for metabolic and cardiovascular diseases. Full-year 2024 SKYTROFA revenue guidance is €200-220 million, with operating expenses projected at €600 million. Cash position stands at €626 million as of September 30, 2024.

Ascendis Pharma (Nasdaq: ASND) has scheduled its third quarter 2024 financial results announcement and business update for November 14, 2024, after U.S. market close. The company will host a conference call and webcast at 4:30 p.m. Eastern Time on the same day. Investors can access the live webcast or register for the teleconference through provided links. A replay will be available on the company's investor relations website for 30 days following the event.

Ascendis Pharma (ASND) has entered into a licensing agreement with Novo Nordisk for the exclusive worldwide rights to its TransCon technology platform. The collaboration focuses on developing products for metabolic and cardiovascular diseases, with a lead program targeting a once-monthly GLP-1 receptor agonist for obesity and type 2 diabetes. Ascendis will receive up to $285 million in upfront, development, and regulatory milestone payments for the lead program, plus sales-based milestones and tiered royalties. Additional product candidates could earn up to $77.5 million each in milestone payments plus royalties. Ascendis will handle early development while Novo Nordisk will manage clinical development, regulatory affairs, manufacturing, and commercialization.

Ascendis Pharma A/S (Nasdaq: ASND) presented 3-year results from their ongoing Phase 2 PaTH Forward Trial at ASBMR 2024. The study, involving 57 adults with hypoparathyroidism, showed that long-term treatment with TransCon™ PTH (palopegteriparatide; marketed as YORVIPATH®) through Week 162 normalized bone remodeling.

Hypoparathyroidism is associated with low bone remodeling rates, accumulation of overly mature bone, and higher-than-average bone mineral density, potentially indicating poorer overall bone quality. The results suggest that long-term palopegteriparatide treatment promotes skeletal health parameters similar to those in parathyroid sufficiency.

TransCon PTH is a once-daily prodrug of parathyroid hormone (PTH [1-34]), designed to provide continuous PTH exposure over 24 hours. Dr. Mishaela Rubin, Associate Professor of Medicine at Columbia University, presented the findings in an oral presentation titled 'Palopegteriparatide Improves Skeletal Dynamics in Adults with Chronic Hypoparathyroidism: 3 Year Results from the Phase 2 PaTH Forward Trial' (#1091).