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BioCryst (NASDAQ:BCRX) announced FDA approval (Dec 12, 2025) of ORLADEYO oral pellets (berotralstat) for prophylactic treatment of hereditary angioedema (HAE) in patients aged 2 to <12 years. ORLADEYO becomes the first and only targeted oral prophylactic therapy for HAE patients aged 2 and older. Approval was supported by interim data from the APeX-P pediatric trial showing ORLADEYO was well tolerated and produced early, sustained reductions in monthly attack rates; the most common TEAE was nasopharyngitis. The pellet formulation is sprinkle-like for easy administration. Regulatory filings are underway in Europe, Japan, and other territories.
BioCryst (Nasdaq: BCRX) announced that its compensation committee granted inducement equity to four newly hired employees effective Dec 1, 2025. The grants consist of stock options to purchase an aggregate of 57,100 shares and restricted stock units covering 46,400 shares, totaling 103,500 shares.
The options have an exercise price of $7.13 per share, equal to the closing price on the grant date, a 10-year term, and the options and RSUs vest in four equal annual installments beginning on the one-year anniversary, subject to continued service. Grants were made under BioCryst’s Inducement Equity Incentive Plan in accordance with Nasdaq Listing Rule 5635(c)(4).
BioCryst (Nasdaq: BCRX) announced early termination of the Hart-Scott-Rodino (HSR) waiting period for its proposed acquisition of Astria Therapeutics.
Termination of the HSR waiting period satisfies one regulatory condition for the Merger. BioCryst expects the Merger to close in Q1 2026, subject to other customary closing conditions.
Astria Therapeutics (NASDAQ: ATXS) reported Q3 2025 results and provided a corporate update on November 12, 2025. Key corporate items include a definitive agreement for BioCryst to acquire Astria for $8.55 cash plus 0.59 BCRX shares per Astria share, with closing expected in Q1 2026 pending stockholder approval. Clinical highlights: final ALPHA-STAR data in 29 HAE patients showed a 84–92% mean and 93–100% median reduction in attack rate through six months; ALPHA-ORBIT Phase 3 topline results expected in early 2027. Financials: cash of $227.7M at 9/30/25, runway into 2028 assuming standalone operations; Q3 net loss $31.6M (-$0.55/share).
BioCryst (Nasdaq: BCRX) reported APeX-P second interim data and psychosocial findings at ACAAI on Nov 6, 2025. An oral granule formulation of ORLADEYO (berotralstat) for ages 2 to <12 is under FDA review with a target action date of Dec 12, 2025. In 29 pediatric participants (mean exposure 63.9 weeks), ORLADEYO produced early and sustained reductions in attacks: 65.5% attack-free at month 1, 70.4% attack-free at month 12, and a median monthly attack rate of 0 for 11 of 12 months. Continuation was high (93.1% completed ≥48 weeks). Safety findings reported no new signals; most common TEAE was nasopharyngitis. Separate posters documented early-onset HAE (median diagnosis age 2.0) and frequent, stressful ED/hospital visits for children and caregivers.
BioCryst (Nasdaq: BCRX) granted inducement restricted stock units covering an aggregate of 30,700 shares to three newly hired employees, effective November 3, 2025.
The awards were approved by the compensation committee as inducements under Nasdaq Listing Rule 5635(c)(4) and are governed by the company’s Inducement Equity Incentive Plan and individual RSU agreements. The RSUs vest in four equal annual installments beginning on the one‑year anniversary of the grant, each installment subject to the employee’s continued service.
BioCryst (Nasdaq:BCRX) will present at the Jefferies Global Healthcare Conference in London on Wednesday, November 19, 2025 at 12:00 p.m. ET.
The event will be available via a live audio webcast with a replay. Investors can access the live audio and replay in the Investors & Media section at www.biocryst.com.
BioCryst (Nasdaq:BCRX) reported strong Q3 2025 results driven by ORLADEYO: Q3 ORLADEYO net revenue $159.1M (+37% y-o-y), operating income $29.6M (+285% y-o-y) and non-GAAP operating income $51.7M (+107% y-o-y). The company raised FY2025 ORLADEYO revenue guidance to $590–$600M and lowered FY2025 non-GAAP operating expense guidance to $430–$440M. BioCryst completed the sale of its European ORLADEYO business and used proceeds to retire the Pharmakon term loan. A definitive agreement to acquire Astria Therapeutics was signed; the transaction is expected to close in Q1 2026. Pro forma cash at Sept 30, 2025 was $294M.
BioCryst (Nasdaq: BCRX) will present four abstracts at the American College of Allergy, Asthma & Immunology Annual Scientific Meeting in Orlando, Nov 6–10, 2025.
Planned presentations include a second interim analysis from the APeX-P trial evaluating long-term prophylaxis with once-daily oral granule ORLADEYO (berotralstat) in pediatric hereditary angioedema (HAE) patients aged 2 to <12 years, plus three ePosters on psychosocial burden, caregiver impact, and emergency department experiences for young HAE patients.
Individual ePoster sessions are scheduled Nov 7–9, 2025, and all ePosters will be available online on Nov 6, 2025 at 8:00 a.m. ET to registered attendees.
BioCryst (Nasdaq: BCRX) will report third quarter 2025 financial results on Monday, November 3, 2025. Management will host a conference call and live webcast at 8:30 a.m. ET to discuss results and provide a corporate update.
Dial-in numbers are 1-844-481-2942 (U.S.) and 1-412-317-1866 (international). A live webcast and replay will be available in the investors section of the company website at www.biocryst.com.
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