BioCryst’s ORLADEYO Receives FDA Priority Review

An update from BioCryst ( (BCRX) ) is now available.

On May 14, 2025, BioCryst Pharmaceuticals announced that the FDA accepted its new drug application for ORLADEYO® oral granules for pediatric patients with hereditary angioedema aged 2 to 11 years, granting it priority review with a target action date of September 12, 2025. If approved, ORLADEYO would be the first targeted oral prophylactic therapy for this age group, potentially improving disease management and reducing acute attacks, with additional regulatory filings planned in Europe, Japan, and Canada.

The most recent analyst rating on (BCRX) stock is a Buy with a $13.00 price target. To see the full list of analyst forecasts on BioCryst stock, see the BCRX Stock Forecast page.

Spark’s Take on BCRX Stock

According to Spark, TipRanks’ AI Analyst, BCRX is a Neutral.

BioCryst’s stock score reflects its strong revenue growth and upward price momentum, countered by challenges in profitability and financial stability. Technical indicators suggest caution due to potential overbought conditions, while valuation concerns persist with a negative P/E ratio. The company’s strategic advancements and positive earnings call sentiment provide optimism, but financial restructuring remains critical.

To see Spark’s full report on BCRX stock, click here.

More about BioCryst

BioCryst Pharmaceuticals is a global biotechnology company focused on improving the lives of people with hereditary angioedema and other rare diseases. The company specializes in structure-guided drug design to develop small-molecule and protein therapeutics, including ORLADEYO®, the first oral, once-daily plasma kallikrein inhibitor.

Average Trading Volume: 4,616,648

Technical Sentiment Signal: Buy

Current Market Cap: $2.16B

For a thorough assessment of BCRX stock, go to TipRanks’ Stock Analysis page.