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FDA Extends BioCryst’s ORLADEYO Review Deadline

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FDA Extends BioCryst’s ORLADEYO Review Deadline

Confident Investing Starts Here:

BioCryst ( (BCRX) ) has provided an announcement.

On June 23, 2025, the FDA extended the PDUFA goal date for BioCryst‘s new drug application for ORLADEYO® oral granules for pediatric HAE patients aged 2 to 11. This extension, moving the target action date to December 12, 2025, was due to the submission of additional reports and data, which the FDA considered a major amendment requiring a full review.

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 strong technical momentum and positive earnings call drive the score higher, despite financial instability. Regulatory successes and strategic leadership changes also support the score, but persistent net losses and negative equity pose significant risks.

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

More about BioCryst

BioCryst Pharmaceuticals, Inc. operates in the biotechnology industry, focusing on the development of oral and small-molecule medicines for rare diseases. The company’s primary product, ORLADEYO® (berotralstat), targets hereditary angioedema (HAE).

Average Trading Volume: 4,514,466

Technical Sentiment Signal: Buy

Current Market Cap: $2.07B

For detailed information about BCRX stock, go to TipRanks’ Stock Analysis page.

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