On Friday, TD Cowen reiterated its Buy rating on shares of Ascendis Pharma (NASDAQ:ASND), maintaining a price target of $157.00. The firm's analysis suggests that the upcoming Phase 3 ApproaCH data for TransCon CNP is expected to show results similar to competitor drug Voxzogo, though not superior.
The Phase 2 trials indicated that TransCon CNP's efficacy is comparable to Voxzogo, but the interpretation of these results is complicated by the small sample size and the absence of baseline Annualized Height Velocity (AHV) data.
The primary endpoint (EP) for the Phase 3 trial of TransCon CNP is also slightly different compared to the endpoints used in trials by BioMarin Pharmaceutical (NASDAQ:BMRN) and BridgeBio Pharma (NASDAQ:BBIO) for their drug AGV. It was highlighted that TransCon CNP is approximately four years behind Voxzogo in development.
Additionally, Ascendis Pharma's infigratinib, an oral once-daily medication, is seen as a potential "dark horse" by the firm. This drug is currently in Phase 3 trials, with data expected to be released in late 2025 or the first half of 2026. The anticipation around this drug adds to the company's prospects, as the market awaits the forthcoming results.
In other recent news, Ascendis Pharma has made significant strides in their drug development and financial growth. The company received approval from the U.S. for YORVIPATH, a treatment for adult hypoparathyroidism, and secured a $150 million funding agreement with Royalty Pharma.
While the company experienced a decline in SKYTROFA revenue due to adjustments and higher sales deductions, Ascendis Pharma is looking to gain approval for all three of its product candidates by the end of 2025.
The company's R&D costs saw a decrease of 21% year-over-year, while SG&A expenses rose due to higher employee costs. Ascendis Pharma ended the quarter with EUR259 million in cash and equivalents, and forecasts for SKYTROFA revenue are set at EUR220 million to EUR240 million for the full year of 2024.
Oppenheimer, an investment firm, recently upgraded Ascendis Pharma from Perform to Outperform. The upgrade comes as Oppenheimer anticipates the upcoming U.S. launch of Ascendis Pharma's hypoparathyroidism treatment, Yorvipath, and the release of top-line results from the Phase 3 trial of TransCon CNP for achondroplasia.
The firm's optimism is fueled by strong demand signals for Yorvipath and the potential for robust sales growth towards a 2029 estimate of €1.7 billion in global revenue.
InvestingPro Insights
As Ascendis Pharma (NASDAQ:ASND) navigates through its Phase 3 trials, investors are keeping a close eye on the company's financial metrics and analyst projections. According to InvestingPro data, Ascendis currently holds a market cap of $6.82 billion, with a revenue growth of an impressive 166.54% over the last twelve months as of Q2 2024. Despite this growth, the company faces challenges, as reflected by a negative P/E ratio of -14.15 and an operating income margin of -111.27% for the same period.
InvestingPro Tips suggest that Ascendis Pharma's stock is presently in oversold territory, indicating potential buying opportunities for investors who believe in the company's long-term value. However, it's important to note that analysts have revised their earnings expectations downwards for the upcoming period, which could impact short-term stock performance. For those considering an investment, there are additional insights available on InvestingPro, with 9 more tips to help inform your decision-making process.
With the next earnings date set for November 6, 2024, and the fair value estimated at $127.38 by InvestingPro, compared to the analyst target of $176.11, investors may want to weigh the current price against these valuations. As the market anticipates the results of the Phase 3 trials for both TransCon CNP and infigratinib, these financial metrics and expert tips can provide valuable context for Ascendis Pharma's potential future performance.
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