BioCryst Announces FDA Approval of ORLADEYO® (berotralstat) Oral Pellets, First and Only Oral Prophylactic Treatment for Patients with HAE Aged 2 to <12 Years
BioCryst Pharmaceuticals, Inc. (BCRX)
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Source: GlobeNewswire
–ORLADEYO now first and only targeted oral prophylactic therapy for patients with HAE aged 2 and older–-Oral pellet formulation provides child-friendly method of administration- –Showed early and sustained reductions in monthly attack rates in APeX-P– RESEARCH TRIANGLE PARK, N.C., Dec. 12, 2025 (GLOBE NEWSWIRE) -- BioCryst Pharmaceuticals, Inc. (Nasdaq: BCRX) today announced that the U.S. Food and Drug Administration (FDA) has approved its New Drug Application (NDA) for the use of an oral pellet formulation of once-daily ORLADEYO® (berotralstat) for prophylactic therapy in pediatric patients with hereditary angioedema (HAE) aged 2 to HAE often presents during childhood, with approximately 40% of children with HAE having their first attack by age 5. HAE can significantly impair normal daily living due to the physical manifestations and psychosocial impact resulting from the disease’s unpredictable, debilitating, and potentially life-threatening nature. Until now, the only targeted
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News
- Does The Market Misread BioCryst Pharmaceuticals After DCF Upside And Low Sales Multiple In 2025? [Yahoo! Finance]Yahoo! Finance
- BioCryst Pharmaceuticals (NASDAQ:BCRX) had its price target raised by analysts at HC Wainwright from $30.00 to $32.00. They now have a "buy" rating on the stock.MarketBeat
- BioCryst Announces FDA Approval of ORLADEYO® (berotralstat) Oral Pellets, First and Only Oral Prophylactic Treatment for Patients with HAE Aged 2 to <12 Years [Yahoo! Finance]Yahoo! Finance
- BioCryst Reports Inducement Grants Under Nasdaq Listing Rule 5635(c)(4)GlobeNewswire
- BioCryst Pharmaceuticals (NASDAQ:BCRX) had its "sell (e+)" rating reaffirmed by analysts at <a style="font-weight:bold" href="https://weissratings.com/">Weiss Ratings</a>.MarketBeat
BCRX
Earnings
- 11/3/25 - Beat
BCRX
Sec Filings
- 12/15/25 - Form 144
- 12/15/25 - Form S-4/A
- 12/12/25 - Form 8-K
- BCRX's page on the SEC website