Ascendis Pharma A/S American Depositary Shares - ASND STOCK NEWS

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).

Ascendis Pharma A/S (Nasdaq: ASND) has submitted a supplemental Biologics License Application (sBLA) to the FDA for TransCon hGH to treat adults with growth hormone deficiency (GHD). This submission aims to expand the label of SKYTROFA®, currently approved for pediatric GHD in the U.S. The sBLA is based on results from the foresiGHt Phase 3 trial, which compared weekly TransCon hGH with weekly placebo and daily hGH in 259 adults with GHD aged 23-80.

The trial demonstrated that TransCon hGH was superior to placebo in reducing trunk fat and increasing total body lean mass at Week 38. It was generally safe and well-tolerated, with no discontinuations related to the study drug and comparable safety to daily hGH. This submission supports Ascendis Pharma's strategy to develop SKYTROFA into a blockbuster product and address the unmet medical need in adult GHD treatment.

Ascendis Pharma A/S (Nasdaq: ASND) has announced the pricing of its public offering of 2,000,000 American Depositary Shares (ADSs) at $150.00 per ADS. The offering is expected to close around September 23, 2024. Ascendis has also granted underwriters a 30-day option to purchase up to 300,000 additional ADSs. The company estimates net proceeds of approximately $281.3 million, which will be used for commercial preparations, launch activities, clinical development, regulatory approvals, and general corporate purposes.

J.P. Morgan, Morgan Stanley, Evercore ISI, and Goldman Sachs & Co. are acting as joint book-running managers. BofA Securities, Wells Fargo Securities, and Citigroup are lead managers, while Oppenheimer & Co. is co-manager for the offering. A shelf registration statement has been filed with the SEC, and the offering is being made through a prospectus.

Ascendis Pharma A/S (Nasdaq: ASND) has announced a proposed public offering of $300 million in American Depositary Shares (ADSs). Each ADS represents one ordinary share of Ascendis. The company plans to grant underwriters a 30-day option to purchase up to an additional $45 million of ADSs at the public offering price, less underwriting commissions.

The offering is subject to market conditions, with no assurance of completion or final terms. J.P. Morgan, Morgan Stanley, Evercore ISI, and Goldman Sachs & Co. are acting as joint book-running managers. A shelf registration statement has been filed with the SEC, and the offering will be made through a prospectus.

Ascendis Pharma announced positive topline data from the pivotal ApproaCH Trial of TransCon CNP (navepegritide) for children with achondroplasia. The trial met its primary objective, demonstrating superior annualized growth velocity (AGV) compared to placebo:

- Overall AGV difference: 1.49 cm/year (p<0.0001)
- Ages 5-11: 1.78 cm/year difference (p<0.0001)
- Ages 2-<5: 1.02 cm/year difference (p=0.0084)

TransCon CNP also showed improvements in height Z-scores and quality of life measures. The treatment was generally well-tolerated with a safety profile comparable to placebo. Ascendis plans to submit an NDA to the FDA in Q1 2025 and an MAA to the EMA in Q3 2025.

Ascendis Pharma A/S (Nasdaq: ASND) has announced initial data from its Phase 1/2 IL-Believe Trial of TransCon IL-2 β/γ in platinum-resistant ovarian cancer (PROC) patients. The study showed anti-tumor clinical responses in 29% (4/14) of efficacy-evaluable patients treated with TransCon IL-2 β/γ in combination with chemotherapy. These results suggest clinical activity in heavily pre-treated PROC patients, including those who had previously progressed on Elahere®. The treatment was generally well-tolerated, with most treatment-emergent adverse events being grade 1 or 2. The data will be presented at ESMO 2024 in Barcelona. This follows promising results in melanoma announced at ASCO 2024, indicating potential efficacy across multiple cancer types.

Ascendis Pharma A/S (Nasdaq: ASND) has received Orphan Drug exclusivity from the U.S. FDA for YORVIPATH® (palopegteriparatide) in treating hypoparathyroidism in adults. This grants seven years of market exclusivity in the United States. YORVIPATH, a once-daily prodrug of parathyroid hormone, is designed to provide continuous PTH exposure over 24 hours.

Hypoparathyroidism, affecting an estimated 70,000 to 90,000 people in the U.S., is a rare endocrine disease caused by insufficient parathyroid hormone levels. YORVIPATH is the first and only FDA-approved treatment for adult hypoparathyroidism, addressing the underlying disease.