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BioCryst ( (BCRX) ) has provided an announcement.
On December 12, 2025, BioCryst Pharmaceuticals announced the FDA approval of its new drug application for an oral pellet formulation of ORLADEYO® (berotralstat) for prophylactic therapy in pediatric patients with hereditary angioedema (HAE) aged 2 to less than 12 years. This approval marks a significant milestone as it introduces the first and only oral prophylactic treatment for this age group, offering a more convenient administration method compared to previous intravenous or subcutaneous options. The approval was supported by positive interim data from the APeX-P clinical trial, which demonstrated early and sustained reductions in monthly attack rates. The new formulation aims to alleviate the treatment burden for young patients and their caregivers, potentially transforming the management of HAE in children.
The most recent analyst rating on (BCRX) stock is a Hold with a $8.00 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 overall stock score reflects significant financial challenges, despite positive strategic moves and technical indicators. The company’s high leverage and negative equity weigh heavily on its financial performance, but strong earnings call sentiment and corporate events provide a positive outlook.
To see Spark’s full report on BCRX stock, click here.
More about BioCryst
BioCryst Pharmaceuticals is a global biotechnology company focused on developing and commercializing medicines for hereditary angioedema (HAE) and other rare diseases. The company has commercialized ORLADEYO® (berotralstat), the first oral, once-daily plasma kallikrein inhibitor, and is advancing a pipeline of potential first-in-class or best-in-class oral small-molecule and injectable protein therapeutics for a range of rare diseases.
Average Trading Volume: 4,962,823
Technical Sentiment Signal: Strong Sell
Current Market Cap: $1.61B
For detailed information about BCRX stock, go to TipRanks’ Stock Analysis page.