On Monday, Goldman Sachs raised the price target for Ascendis Pharma (NASDAQ:ASND) to $195 from $170, while keeping a Buy rating on the stock. This adjustment follows the U.S. Food and Drug Administration's approval of Ascendis Pharma's TransCon PTH, now branded as Yorvipath. The company's shares have seen a modest uptick, slightly outperforming the biotech sector, following the approval news.
Ascendis Pharma recently announced that Yorvipath received FDA approval, but the company's readiness for the U.S. market launch is under scrutiny. The firm's management disclosed that the pricing for Yorvipath is still to be determined, and the commercial supply won't be available until the first quarter of 2025. This comes as a surprise since the initial Complete Response Letter (CRL) from the FDA was issued over a year ago in 2023.
Despite the delay, Ascendis Pharma plans to seek FDA approval to market the already manufactured product, potentially allowing commercial efforts to commence in the fourth quarter of 2024. The Yorvipath label does not present new safety concerns, and Ascendis Pharma's expertise in marketing for rare endocrinology diseases is expected to fill in any data gaps, including information on urinary calcium levels.
The company estimates that there are between 70,000 and 90,000 patients in the U.S. with chronic hypoparathyroidism who are actively treated with calcium and active vitamin D. An additional 5,000 to 6,000 patients have previously received parathyroid hormone treatments.
Despite the delay in commercial launch to the first quarter of 2025, Goldman Sachs remains positive about Yorvipath's market potential, forecasting peak sales of EUR 1.6 billion. The firm maintains its Buy rating and has increased the price target for Ascendis Pharma to $195.
In other recent news, Ascendis Pharma's drug YORVIPATH® has gained approval from the U.S. Food & Drug Administration for treating hypoparathyroidism in adults. The company plans to make the drug commercially available in the first quarter of 2025.
In addition, Ascendis Pharma has reported encouraging results from its ongoing Phase 1/2 IL-Believe Trial for melanoma patients. The company's stock rating has been upgraded from Hold to Buy by TD Cowen, and its price target has been increased to $175.
Stifel has also initiated coverage on Ascendis Pharma with a Buy rating and a $200 price target. Morgan Stanley has raised its price target on the company's shares to $140. These are recent developments for Ascendis Pharma.
InvestingPro Insights
Following Goldman Sachs' updated price target for Ascendis Pharma, a look at InvestingPro data and tips provides further context for investors. Ascendis Pharma's market capitalization stands at $7.28 billion, indicating a significant presence in the biotech industry. Despite the optimism from Goldman Sachs, InvestingPro Tips suggest caution; analysts do not expect the company to be profitable this year, and its short-term obligations exceed its liquid assets. Additionally, the company operates with a moderate level of debt and has not been profitable over the last twelve months.
InvestingPro Data reveals a striking revenue growth of 322.18% over the last twelve months as of Q1 2024, with a quarterly growth of 185.49% in Q1 2024. This growth is a positive sign for the company's future prospects. However, the P/E ratio is negative at -12.74, reflecting the market's current expectations of future earnings. With a high gross profit margin of 85.61%, the company demonstrates strong profitability on its products, though this has yet to translate into net profitability.
For investors seeking more in-depth analysis, there are additional InvestingPro Tips available at https://www.investing.com/pro/ASND, which can provide further guidance on Ascendis Pharma's financial health and market position.
This article was generated with the support of AI and reviewed by an editor. For more information see our T&C.