FDA expands approval of BioCryst's rare disease drug for use in young children

The U.S. Food and Drug Administration has expanded the use of BioCryst Pharmaceuticals' drug to include an oral pellet formulation for preventing hereditary angioedema attacks in children aged 2 to under 12 years, the company said on Friday.

Reuters • Dec 12, 2025

BioCryst Announces FDA Approval of ORLADEYO® (berotralstat) Oral Pellets, First and Only Oral Prophylactic Treatment for Patients with HAE Aged 2 to

– 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

GlobeNewsWire • Dec 12, 2025

BioCryst Reports Inducement Grants Under Nasdaq Listing Rule 5635(c)(4)

RESEARCH TRIANGLE PARK, N.C., Dec. 04, 2025 (GLOBE NEWSWIRE) -- BioCryst Pharmaceuticals, Inc. (Nasdaq: BCRX) today announced that the compensation committee of BioCryst's board of directors granted four newly-hired employees stock options to purchase an aggregate of 57,100 shares, and restricted stock units (RSUs) covering an aggregate of 46,400 shares, of BioCryst common stock.

GlobeNewsWire • Dec 4, 2025

BioCryst Receives Early Termination of HSR Waiting Period for Astria Acquisition

RESEARCH TRIANGLE PARK, N.C., Dec. 03, 2025 (GLOBE NEWSWIRE) -- BioCryst Pharmaceuticals, Inc. (Nasdaq: BCRX) today announced that it has received early termination of the waiting period under the Hart-Scott-Rodino Antitrust Improvements Act of 1976, as amended (the “HSR Act”), with respect to BioCryst's proposed acquisition of Astria Therapeutics, Inc. (the “Merger”).

GlobeNewsWire • Dec 3, 2025

BioCryst Pharmaceuticals, Inc. (BCRX) Presents at Jefferies London Healthcare Conference 2025 Transcript

BioCryst Pharmaceuticals, Inc. ( BCRX ) Jefferies London Healthcare Conference 2025 November 19, 2025 12:00 PM EST Company Participants Jon Stonehouse - CEO & Executive Director Charles Gayer - President & Chief Commercial Officer Babar Ghias - CFO & Head of Corporate Development Conference Call Participants Maurice Raycroft - Jefferies LLC, Research Division Presentation Maurice Raycroft Jefferies LLC, Research Division Hi, everyone. My name is Maury Raycroft, and I'm one of the biotech analysts at Jefferies.

Seeking Alpha • Nov 24, 2025

BioCryst Presents New Data at ACAAI Highlighting Burden of HAE on Pediatric Patients and Caregivers and Sustained Reduction of Attacks in Children Treated with One Year of ORLADEYO® (berotralstat)

–   Findings highlight negative psychosocial impact of HAE attacks and resulting ED/hospital visits on pediatric patients and their caregivers – –  ORLADEYO oral granules demonstrated early and sustained reduction in HAE attacks over one year of treatment in second interim analysis of APeX-P – –  ORLADEYO oral granules are currently under review with U.S. FDA for ages 2 to

GlobeNewsWire • Nov 6, 2025

BioCryst to Present at Upcoming Investor Conference

RESEARCH TRIANGLE PARK, N.C., Nov. 05, 2025 (GLOBE NEWSWIRE) -- BioCryst Pharmaceuticals, Inc. (Nasdaq: BCRX) today announced that the company plans to present at the Jefferies Global Healthcare Conference in London on Wednesday, November 19, 2025, at 12:00 p.m.

GlobeNewsWire • Nov 5, 2025

BioCryst Pharmaceuticals, Inc. (BCRX) Q3 2025 Earnings Call Transcript

BioCryst Pharmaceuticals, Inc. ( BCRX ) Q3 2025 Earnings Call November 3, 2025 8:30 AM EST Company Participants Nick Wilder Jon Stonehouse - CEO & Executive Director Charles Gayer - President & Chief Commercial Officer William Sheridan - Chief Development Officer Babar Ghias - CFO & Head of Corporate Development Conference Call Participants Laura Chico - Wedbush Securities Inc., Research Division Stacy Ku - TD Cowen, Research Division Steven Seedhouse - Cantor Fitzgerald & Co., Research Division Maurice Raycroft - Jefferies LLC, Research Division Brian Abrahams - RBC Capital Markets, Research Division Jonathan Wolleben - Citizens JMP Securities, LLC, Research Division John Todaro - Needham & Company, LLC, Research Division Huidong Wang - Barclays Bank PLC, Research Division Presentation Operator Good day, and welcome to BioCryst Third Quarter 2025 Earnings Conference Call. [Operator Instructions] Please note this event is being recorded.

Seeking Alpha • Nov 3, 2025

BioCryst Reports Third Quarter 2025 Financial Results and Provides Business Update

—Q3 2025 ORLADEYO net revenue of $159.1 million (+37 percent y-o-y)—  —Q3 2025 operating profit of $29.6 million (+285 percent y-o-y); non-GAAP operating profit of $51.7 million (+107 percent y-o-y); continued improvement in non-GAAP operating profit margin from strong operating leverage— —ORLADEYO FY 2025 revenue guidance raised to between $590 to $600 million; FY 2025 non-GAAP operating expense guidance lowered to between $430 to $440 million— —Sale of European ORLADEYO business completed; proceeds used to retire all remaining Pharmakon term debt— —Definitive agreement signed to acquire Astria Therapeutics; transaction expected to close Q1 2026— RESEARCH TRIANGLE PARK, N.C., Nov. 03, 2025 (GLOBE NEWSWIRE) -- BioCryst Pharmaceuticals, Inc. (Nasdaq:BCRX) today reported financial results for the third quarter ended September 30, 2025, and provided a business update.

GlobeNewsWire • Nov 3, 2025

BioCryst Pharmaceuticals (BCRX) Earnings Expected to Grow: Should You Buy?

BioCryst (BCRX) possesses the right combination of the two key ingredients for a likely earnings beat in its upcoming report. Get prepared with the key expectations.

Zacks Investment Research • Oct 27, 2025