On Friday, the U.S. Food and Drug Administration (FDA) approved BioMarin Pharmaceutical Inc.’s (NASDAQ:BMRN) supplemental application for Palynziq (pegvaliase-pqpz), a treatment for phenylketonuria (PKU) in adolescents aged 12 and older.
FDA’s Expanded Approval
The FDA approved BioMarin’s supplemental Biologics License Application for Palynziq, making it the only enzyme substitution therapy approved for PKU management in pediatric patients aged 12 and older.
Phenylketonuria is a rare inherited disorder that causes an amino acid called phenylalanine (phe) to build up in the body.
The approval is based on the results from the Phase 3 PEGASUS study, which demonstrated statistically significant reductions in blood phenylalanine levels compared to diet alone.
Individuals in the Palynziq arm showed a significant mean reduction from baseline in blood Phe levels at Week 72 compared to those in the diet-only arm.
The company is also pursuing approval from the European Medicines Agency to expand treatment options for adolescents in the EU.
Technical Analysis
The stock is currently trading 4.5% below its 20-day simple moving average (SMA) and 8.2% below its 100-day SMA, indicating some short-term weakness. Over the past 12 months, shares have decreased by approximately 19%, and they are currently positioned closer to their 52-week lows than highs, reflecting a challenging market environment.
The RSI is at 50.00, suggesting a neutral position, while the MACD is at -0.10, below its signal line at 0.05, indicating bearish pressure on the stock. The combination of neutral RSI and bearish MACD suggests mixed momentum.
- Key Resistance: $73.50
- Key Support: $50.00
Analyst Consensus & Recent Actions: The stock carries a Buy Rating with an average price target of $88.80. Recent analyst moves include:
- Canaccord Genuity: Buy (Raises Target to $104.00) (Feb. 26)
- Bernstein: Outperform (Raises Target to $94.00) (Feb. 25)
- Guggenheim: Buy (Lowers Target to $86.00) (Feb. 25)
BMRN Price Action: BioMarin Pharmaceutical shares were down 3.92% at $59.30 during premarket trading on Monday, according to Benzinga Pro data.
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