On Wednesday, BofA Securities maintained a Buy rating on shares of Ascendis Pharma (NASDAQ:ASND) with a steady price target of $165.00.
This affirmation comes after Ascendis Pharma provided a strategic mid-year update, focusing on the upcoming TransCon PTH August 14th Prescription Drug User Fee Act (PDUFA) action date. The company is in active discussions with the FDA regarding labeling but has chosen not to disclose details on the New Drug Application (NDA) review process at this stage.
Ascendis Pharma's management remains confident in the potential approval of TransCon PTH, emphasizing the strength of clinical trial data and the positive real-world evidence from the early access program and commercial launch in Germany. The FDA's extension of the PDUFA date by three months is believed to be a logistical step, as no additional information was requested from Ascendis, suggesting a straightforward review process involving multiple FDA divisions.
Historically, Ascendis has seen a similar extension with its Skytrofa filing, which was followed by an approval seven weeks later. The firm's confidence is bolstered by a survey in which 100% of key opinion leaders (KOLs) anticipated U.S. approval of TransCon PTH, with projections of about 32% of patients being on therapy within six months of its launch, and nearly 46% at peak.
Financial projections by BofA Securities estimate fiscal year 2024 U.S. sales for Ascendis Pharma at $46.9 million, with a peak worldwide risk-adjusted sales figure of $2.3 billion by 2033, assuming an 80% likelihood of success in the U.S. market. The firm's reiteration of the Buy rating and the $165 price target reflects an optimistic outlook for Ascendis Pharma as the market awaits further updates on the TransCon PTH review process.
In other recent news, Ascendis Pharma has been making significant strides in the medical field. The firm reported promising results from its ongoing Phase 1/2 IL-Believe Trial. The trial, evaluating TransCon IL-2 β/γ therapy for melanoma patients, showed that 40% of efficacy-evaluable patients responded positively to the treatment.
In the realm of financial analysis, Ascendis has drawn attention from Stifel and Morgan Stanley (NYSE:MS). Stifel initiated coverage of Ascendis with a 'Buy' rating and a price target of $200. The firm's assessment is based on the potential of Ascendis's product for Hypoparathyroidism, which could significantly bolster the company's existing growth hormone business.
Meanwhile, Morgan Stanley adjusted its price target for Ascendis, raising it to $140 from the previous $116, while maintaining an Equal-weight rating on the stock.
Lastly, Ascendis announced significant findings from a two-year post-hoc analysis of its Phase 3 PaTHway Trial. The trial, which involved TransCon PTH treatment for adults with chronic hypoparathyroidism, showed sustained improvements in kidney function.
These are some of the recent developments for Ascendis Pharma, a company that continues to make its mark in the biopharmaceutical industry.
InvestingPro Insights
As Ascendis Pharma (NASDAQ:ASND) anticipates the FDA's decision on TransCon PTH, the latest data from InvestingPro provides a snapshot of the company's financial health and market performance. With a substantial market capitalization of $7.57 billion, Ascendis is trading at a high revenue valuation multiple, reflecting investor expectations for future growth. Despite this optimism, analysts have flagged concerns, noting that Ascendis is not expected to be profitable this year and operates with a moderate level of debt. Moreover, with short-term obligations exceeding liquid assets, financial prudence may be critical in the near term.
On the brighter side, the company's revenue growth has been impressive, with a staggering 322.18% increase over the last twelve months as of Q1 2024. This is complemented by a solid gross profit margin of 85.61%. The InvestingPro Tips suggest that two analysts have revised their earnings upwards for the upcoming period, possibly indicating a positive outlook on the company's financial trajectory. However, it's worth noting that Ascendis does not pay a dividend, which might be a consideration for income-focused investors.
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