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Tuesday, Ascendis Pharma (NASDAQ:ASND), currently trading near its 52-week high at $173.15 with a market capitalization of $10.45 billion, maintained its Hold rating and $84.00 price target by Canaccord Genuity following the release of new clinical trial data. According to InvestingPro data, the company has shown impressive momentum with a 33.5% return over the past six months. The company reported strong 26-week efficacy results from its TransCon hGH+TransCon CNP COACH trial. The study demonstrated an annualized growth increase of 4.23 cm/year in patients who had not previously received CNP treatment, compared to 1.71 cm/year with competitor drug vosoritide.
Despite the positive data, Canaccord Genuity noted that there are still valid concerns regarding the durability of the treatment’s effects and the potential for longer-term side effects associated with human Growth Hormone (hGH), similar to those noted with Ascendis Pharma’s product Skytrofa. These concerns align with InvestingPro analysis, which shows the company is not currently profitable, with a negative EBITDA of $355.8 million in the last twelve months. Get access to 10+ additional ProTips and comprehensive financial analysis with InvestingPro. The firm emphasized that while the combination therapy offers an additional growth acceleration option for achondroplasia patients, it is not necessarily a permanent replacement for CNP monotherapy.
Ascendis Pharma management highlighted that the treatment presents a therapeutic choice, ultimately leaving the decision to patients and caregivers. Canaccord Genuity does not view the combination hGH+CNP product as a significant threat to BioMarin Pharmaceutical (TADAWUL:2070)’s (NASDAQ:BMRN) Voxzogo franchise, as competition had already been factored into their projections.
In conclusion, Canaccord Genuity stated that the recent trial data does not alter their thesis or financial model for BioMarin Pharmaceutical, reaffirming their Hold stance on Ascendis Pharma shares. The analyst’s comments reflect a cautious optimism about the new data, acknowledging its potential while also considering the broader competitive landscape and long-term implications. Notably, while Canaccord maintains a Hold rating, the broader analyst consensus on InvestingPro leans more bullish with a Strong Buy recommendation and price targets ranging from $193 to $289, suggesting significant potential upside. Discover the complete financial health analysis and detailed Pro Research Report, available exclusively on InvestingPro.
In other recent news, Ascendis Pharma has announced that the U.S. Food and Drug Administration (FDA) has accepted its New Drug Application for TransCon CNP, granting it a priority review with a goal date set for November 30, 2025. This development follows clinical trials showing significant benefits in annualized growth velocity and other health improvements for children with achondroplasia. The FDA’s decision to prioritize the review is seen as a positive step, with no advisory committee meeting planned, potentially expediting the approval process. Ascendis Pharma also reported positive interim results from its Phase 2 COACH trial, evaluating a combination treatment for children with achondroplasia. The company plans to release 52-week data in the fourth quarter, which will inform the design of a forthcoming Phase 3 trial. Analysts at BofA Securities and Stifel have maintained their "Buy" ratings on Ascendis Pharma, with price targets set at $216 and $212, respectively. Both firms have expressed optimism about Ascendis Pharma’s market potential, particularly with the anticipated launch of TransCon CNP and the company’s strategy to enhance patient access to treatments. Ascendis Pharma’s ongoing efforts to address unmet medical needs continue to garner attention from investors and analysts alike.
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