Ascendis Pharma A/S (NASDAQ:ASND) shares are up during Monday’s premarket session following the FDA’s approval of Yuviwel (navepegritide; developed as TransCon CNP), the first and only once-weekly treatment for children with achondroplasia.
FDA Approval
The FDA approved Yuviwel, a prodrug designed to increase linear growth in children aged two years and older with achondroplasia, based on data from three randomized clinical trials.
Achondroplasia is a rare genetic disorder causing dwarfism, characterized by short limbs, a normal-sized torso, and a large head.
Ascendis Pharma plans to make Yuviwel available through prescribing physicians in the U.S. during the early part of the second quarter of 2026.
In November, Ascendis Pharma announced that pivotal week 52 results from its ApproaCH Trial of investigational once-weekly TransCon CNP (navepegritide) in children with achondroplasia have been published in JAMA Pediatrics, a journal of the American Medical Association.
The authors report that treatment with TransCon CNP led to significantly higher annualized growth velocity (AGV) at week 52 compared to placebo (primary endpoint), as well as improved lower-limb alignment and body proportionality and positive changes in health-related quality of life, with a safety and tolerability profile similar to placebo.
Additionally, the approval includes a Rare Pediatric Disease Priority Review Voucher, which could expedite future drug applications. This development marks a significant advancement in treatment options for a condition that affects many children, providing a new avenue for growth in Ascendis Pharma’s portfolio.
Technical Analysis
The stock is currently trading 0.42% below its 20-day simple moving average (SMA) and 2.45% above its 100-day SMA, indicating some short-term weakness but longer-term strength. Over the past 12 months, shares have increased significantly and are currently positioned closer to their 52-week highs than lows.
The RSI is at 50.00, which is considered neutral territory, suggesting that the stock is neither overbought nor oversold at this time. Meanwhile, MACD is at 0.15, below its signal line at 0.22, indicating bearish pressure on the stock. The combination of neutral RSI and bearish MACD suggests mixed momentum.
- Key Resistance: $242.00
- Key Support: $230.00
Analyst Consensus & Recent Actions: The stock carries a Buy Rating with an average price target of $261.21. Recent analyst moves include:
- Oppenheimer: Outperform (Raises Target to $262.00) (Feb. 12)
- Wedbush: Outperform (Raises Target to $273.00) (Feb. 12)
- B of A Securities: Buy (Raises Target to $260.00) (Jan. 30)
ASND Price Action: Ascendis Pharma shares were up 3.21% at $241.00 during premarket trading on Monday, according to Benzinga Pro data.
Photo by Tada Images via Shutterstock
