what is the percent chance ascendis pharma transcon hgh is approved on July 27? Predict stock price following approval.
7/24/2025 01:16pm
The likelihood of Ascendis Pharma's TransCon hGH being approved on July 27, 2025, is **high**. Here's why:
1. **FDA Acceptance of sBLA**: The FDA has accepted the supplemental Biologics License Application (sBLA) for TransCon hGH in adult growth hormone deficiency (GHD), with a Prescription Drug User Fee Act (PDUFA) goal date of July 27, 2025.
2. **Positive Trial Results**: The Phase 3 foresiGHt trial showed TransCon hGH's superiority on primary and key secondary efficacy endpoints, with a statistically significant reduction in trunk fat and increase in total body lean mass compared to placebo.
3. **Safety and Tolerability**: TransCon hGH was generally safe and well-tolerated, with no discontinuations related to study drug.
Considering these factors, it is reasonable to predict that TransCon hGH will be approved on July 27, 2025.
**Predicted Stock Price Following Approval**:
1. **Market Potential**: TransCon hGH has the potential to capture a significant market share in the growth hormone deficiency treatment landscape, especially with its weekly subcutaneous administration.
2. **Pricing and Revenue**: The therapy is expected to generate substantial revenue, potentially exceeding $1 billion annually, due to its innovative formulation and high price point.
3. **Analyst Sentiment**: Analysts have a positive outlook on Ascendis Pharma, with price targets indicating significant upside potential, such as the $200 target mentioned earlier.
4. **Stock Performance**: Assuming approval, the stock price of ASND could experience a significant upward movement, potentially doubling or even tripling its current price, considering the high unmet medical need and breakthrough therapy potential of TransCon hGH.
While it's impossible to predict an exact stock price, considering the factors above, a **50-75% increase** in ASND's stock price following approval seems reasonable.