What happened Shares of BioCryst Pharmaceuticals (NASDAQ: BCRX) were soaring 16.8% higher as of 11:44 a.m. EST on Friday. The big jump came after the drugmaker announced Food and Drug Administration (FDA) approval of Orladeyo (berotralstat) to prevent hereditary angioedema (HAE) attacks in adults and children ages 12 and up. So what Was the size of today's gain justified? Probably so. Orladeyo could potentially generate peak annual sales in the ballpark of $500 million. BioCryst's market cap stood at close to $900 million before the FDA approval was announced. Image source: Getty Images. There are other FDA-approved HAE drugs on the market. However, Anthony Castaldo, CEO of the U.S. Hereditary Angioedema Association, noted that Orladeyo is "the first orally administered non-steroidal option for preventing HAE attacks." He added that the approval of the drug "represents an important and welcome step in making more treatment options available to physicians and patients." The FDA's approval decision was based on overwhelmingly positive results from a late-stage study of Orladeyo. Patients receiving the drug experienced a significant reduction in HAE attacks at 24 weeks with the improvement carrying over through 48 weeks. Now what BioCryst has already built a sales team ready to launch Orladeyo in the U.S. market. What's the next potential catalyst for the biotech stock? The company expects two other key approvals for its HAE drug soon: Japanese regulators should make an approval decision this month, and the European Medicines Agency could approve Orladeyo early in 2021. 10 stocks we like better than BioCryst PharmaceuticalsWhen investing geniuses David and Tom Gardner have a stock tip, it can pay to listen. After all, the newsletter they have run for over a decade, Motley Fool Stock Advisor, has tripled the market.* David and Tom just revealed what they believe are the ten best stocks for investors to buy right now… and BioCryst Pharmaceuticals wasn't one of them! That's right -- they think these 10 stocks are even better buys. See the 10 stocks *Stock Advisor returns as of November 20, 2020 Keith Speights has no position in any of the stocks mentioned. The Motley Fool has no position in any of the stocks mentioned. The Motley Fool has a disclosure policy.Source