Ascendis Pharma Stock Price, News & Analysis

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.

Ascendis Pharma and Royalty Pharma have entered into a $150 million capped synthetic royalty funding agreement based on U.S. net sales of YORVIPATH. This deal supports the development and commercialization of Ascendis' Endocrine Rare Disease products, including the U.S. launch of YORVIPATH, the first FDA-approved treatment for hypoparathyroidism in adults.

Key terms of the agreement include:

• Ascendis receives a $150 million upfront payment
• Royalty Pharma gets a 3% royalty on U.S. net sales of YORVIPATH
• Royalty payments cease upon reaching a 2.0x multiple, or 1.65x if achieved by December 31, 2029

This transaction highlights YORVIPATH's value and Ascendis' strategy to reduce capital costs while maintaining flexibility in their global commercial capabilities.

Ascendis Pharma reported Q2 2024 financial results and provided a business update. Key highlights:

1. YORVIPATH approved by FDA for hypoparathyroidism in adults
2. TransCon CNP pivotal trial results expected soon
3. SKYTROFA Q2 revenue of €26 million, 134% YoY volume growth
4. Full year 2024 SKYTROFA revenue outlook revised to €220-240 million
5. Q2 total revenue: €36 million, down from €47.4 million in Q2 2023
6. Net loss of €109.4 million or €1.91 per share
7. Cash position of €259 million as of June 30, 2024

The company expects to be operating cash flow breakeven on a quarterly basis in 2024 or 2025, pending YORVIPATH launch timing in the U.S.

Ascendis Pharma A/S (Nasdaq: ASND) has announced its plans to release second quarter 2024 financial results and provide a business update on Tuesday, September 3, 2024, after the U.S. financial markets close. The company will host a conference call and live webcast at 4:30 p.m. Eastern Time on the same day to discuss the results. Interested parties can access the live webcast or register for the teleconference in advance. The webcast link will also be available on the Investors & News section of the Ascendis Pharma website. A replay of the webcast will be accessible on the company's website for 30 days following the event.

Ascendis Pharma (Nasdaq: ASND) announced FDA approval of YORVIPATH® (palopegteriparatide) for treating hypoparathyroidism in adults. YORVIPATH is the first and only treatment for this rare endocrine disease affecting 70,000 to 90,000 people in the US. It's a once-daily prodrug of parathyroid hormone designed to provide continuous 24-hour exposure.

The approval is based on data from Phase 2 PaTH Forward and Phase 3 PaTHway trials. Ascendis plans to launch YORVIPATH with patient support services through its A.S.A.P. program. Commercial product is expected to be available in Q1 2025, with potential earlier introduction in Q4 2024 pending FDA approval of existing manufactured product.