RESEARCH TRIANGLE PARK, N.C., Jan. 23, 2026 (GLOBE NEWSWIRE) -- BioCryst Pharmaceuticals, Inc. (Nasdaq: BCRX) today announced that it has completed its acquisition of Astria Therapeutics, Inc., initially announced on October 14, 2025. The transaction strengthens its position as a leader in hereditary angioedema (HAE) and enhances the company’s long-term growth trajectory. BioCryst adds navenibart, a late-stage, long-acting plasma kallikrein inhibitor currently in Phase 3 clinical development, to its HAE por ...

Revenue Performance - Preliminary, unaudited ORLADEYO net revenue for Q4 2025 was $151 million, representing a 22% year-over-year increase and a 36% increase on a comparable basis, excluding European ORLADEYO revenue for Q4 2024[12] - Preliminary, unaudited ORLADEYO net revenue for the full year 2025 was $601 million, reflecting a 37% year-over-year growth; excluding European ORLADEYO revenue, the net revenue was $563 million, marking a 43% increase on a comparable basis[12] Financial Position - As of December 31, 2025, the company reported preliminary, unaudited cash, cash equivalents, restricted cash, and investments totaling $338 million[12]

Core Insights - BioCryst is undergoing significant transformation and is positioned for exciting developments in the near future [1] Company Performance - The company reported substantial growth in new patient prescriptions for ORLADEYO in 2025, marking a pivotal year for BioCryst [2]

BioCryst Pharmaceuticals FY Conference Summary Company Overview - **Company**: BioCryst Pharmaceuticals (NasdaqGS: BCRX) - **Event**: FY Conference held on January 12, 2026 - **Key Speakers**: Charlie Gayer (CEO), Babar Ghias (CFO), Dr. Bill Sheridan (Chief Development Officer) Core Industry and Company Insights Industry: Rare Disease Pharmaceuticals - BioCryst focuses on developing treatments for rare diseases, particularly hereditary angioedema (HAE) Key Developments in 2025 - **ORLADEYO Growth**: Achieved the highest number of new patient prescriptions in the U.S. since its launch, with a paid rate improvement ending Q1 at 84% and the year at 81% compared to a long-term goal of 85% [3][4] - **European Business Sale**: Sold the European business for $250 million to streamline operations and focus on U.S. growth [3][4] - **Profitability**: Achieved profitability for the first time in company history, with expectations to maintain profitability moving forward [4] - **New Approval**: Received approval for ORLADEYO for children as young as two years old, expanding the market potential [4] Financial Performance - **2025 Preliminary Results**: - ORLADEYO revenue: $601 million, exceeding guidance of $590-$600 million - Ongoing business revenue (excluding European business): $563 million - Cash position: Nearly $340 million [5] - **2026 Revenue Guidance**: Anticipating ORLADEYO revenue of $625-$645 million and total revenue (including RAPIVAB) of $635-$660 million [5] Growth Strategy - **Three Pillars for Growth**: 1. **ORLADEYO**: Expected to reach $1 billion in peak sales by 2029 with a contribution margin over 80% [6] 2. **Novanavart**: Acquired through Astria Therapeutics, expected to enhance the portfolio with a differentiated injectable product [4][12] 3. **Netherton Syndrome Program**: Aiming to develop a transformative therapy for a high-need rare disease with no current treatments [20][21] Market Dynamics - **HAE Market**: Competitive landscape with 10-11 approved products, but ORLADEYO remains the only oral prophylaxis option, which is a significant differentiator [28][29] - **Patient Retention**: Approximately 50% of patients remain on ORLADEYO after five years, indicating strong efficacy and satisfaction [9] Future Outlook - **Revenue Growth**: Projected 15% year-over-year CAGR for ORLADEYO through 2029, with additional contributions from Novanavart and international markets [11][30] - **Acquisition of Astria**: Expected to close soon, enhancing BioCryst's capabilities in the HAE space [12][26] - **Netherton Syndrome**: Initial proof of concept trial expected to provide data by the end of 2026, with potential for pivotal study thereafter [26][43] R&D and Pipeline - **BCX 17725 for Netherton Syndrome**: Entering initial proof of concept trials, with a focus on safety and efficacy in patients [20][24] - **Avoralstat for Diabetic Macular Edema**: Currently in phase 1 study, with plans to out-license post-study completion [31][48] Conclusion - BioCryst Pharmaceuticals is positioned for significant growth in the rare disease market, with a strong focus on innovative therapies and strategic acquisitions. The company aims to leverage its successful commercialization strategies and maintain profitability while expanding its product offerings.

Financial Performance and Outlook - BioCryst achieved its first full year of profitability in 2025[13] - Preliminary ORLADEYO revenue for 2025 reached $601 million, with $563 million excluding European revenue[14] - The company anticipates ORLADEYO revenue between $625 million and $645 million in 2026[14] - Total revenue for 2026 is projected to be in the range of $635 million to $660 million[14] - Non-GAAP operating expenses for 2026 are expected to be between $380 million and $390 million, and $450 million to $470 million including the Astria acquisition[14] - BioCryst expects to have a cash balance of over $1 billion by 2029[37,52] Strategic Initiatives and Pipeline - BioCryst is acquiring Astria Therapeutics for approximately $700 million TEV to strengthen its HAE portfolio with navenibart[35] - ORLADEYO has a sustainable peak revenue opportunity of $1 billion, with IP protection extending into 2040[20] - The company received FDA approval for ORLADEYO pellet formulation for pediatric patients aged 2 to under 12 with HAE[13] - BCX17725 is being developed as a targeted KLK5 inhibitor for Netherton syndrome, with Phase 1 data from Part 4 expected by the end of 2026[54,69]

Core Insights - BioCryst Pharmaceuticals reported a transformative year in 2025, driven by strong demand for ORLADEYO and successful business maneuvers, including the sale of its European ORLADEYO business and the proposed acquisition of Astria Therapeutics [2] Financial Performance - Preliminary, unaudited ORLADEYO net revenue for full year 2025 was $601 million, reflecting a 37% year-over-year increase, surpassing prior guidance of $590 million to $600 million [4] - Excluding European ORLADEYO revenue, the net revenue for 2025 was $563 million, marking a 43% year-over-year growth on a comparable basis [4] - For the fourth quarter of 2025, ORLADEYO net revenue was $151 million, representing a 22% year-over-year increase, and a 36% increase on a comparable basis [3] Revenue Guidance - The company anticipates full year 2026 global net ORLADEYO revenue to be between $625 million and $645 million [5] - Total revenue for 2026, including RAPIVAB®, is expected to range from $635 million to $660 million [5] Operating Expenses - BioCryst expects full year 2026 non-GAAP operating expenses to be between $380 million and $390 million, excluding stock-based compensation and other costs [6] - After the expected acquisition of Astria, additional non-GAAP operating expenses in 2026 are projected to be between $70 million and $80 million [7] Cash Position - As of December 31, 2025, the company reported preliminary cash, cash equivalents, restricted cash, and investments totaling $338 million [5]

Core Viewpoint - The proposed sale of Astria Therapeutics, Inc. to BioCryst Pharmaceuticals, Inc. is under investigation to assess whether the offered consideration adequately values Astria [1] Group 1: Transaction Details - Shareholders of Astria will receive $8.55 in cash and 0.59 shares of BioCryst common stock for each share of Astria they own [1] - The law firm Kahn Swick & Foti, LLC is investigating the adequacy of this consideration and the process leading to the proposed sale [1] Group 2: Legal Rights and Contact Information - Individuals who believe the transaction undervalues Astria can contact KSF Managing Partner Lewis S. Kahn for discussions regarding their legal rights [2] - KSF offers a no-obligation consultation for those interested in the proposed sale [2]

Group 1 - BioCryst Pharmaceuticals will present at the 44th Annual J.P. Morgan Healthcare Conference on January 12, 2026, at 1:30 p.m. ET [1] - The presentation will be accessible via a live audio webcast on BioCryst's website [1] Group 2 - BioCryst is a global biotechnology company focused on developing and commercializing medicines for hereditary angioedema (HAE) and other rare diseases [2] - The company has commercialized ORLADEYO® (berotralstat), the first oral, once-daily plasma kallikrein inhibitor [2] - BioCryst is advancing a pipeline of potential first-in-class or best-in-class oral small-molecule and injectable protein therapeutics for a range of rare diseases [2]

Core Viewpoint - BioCryst Pharmaceuticals Inc. (NASDAQ:BCRX) is highlighted as a promising small-cap stock with significant upside potential, particularly following the FDA approval of Orladeyo for pediatric patients with hereditary angioedema [1][2]. Group 1: FDA Approval and Product Details - On December 12, BioCryst Pharmaceuticals announced that the FDA approved its New Drug Application for an oral pellet formulation of ORLADEYO (berotralstat) for pediatric patients aged 2 to <12 years with hereditary angioedema [2]. - ORLADEYO is noted as the first and only targeted oral prophylactic therapy for this age group, which previously had limited treatment options that were burdensome [2]. - The company also reported that a capsule formulation of ORLADEYO was approved in December 2020 for patients aged 12 years and older, and it is now approved in over 45 countries [3]. Group 2: Investment Outlook - H.C. Wainwright raised the price target for BioCryst Pharmaceuticals from $30 to $32 and reaffirmed a Buy rating, citing the approval of Orladeyo as a significant factor for this update [1]. - The company is recognized for its innovative approach in biotechnology, focusing on structure-guided drug design to develop therapies for rare diseases [3].

Core Insights - BioCryst Pharmaceuticals is focused on developing oral treatments for rare diseases, particularly with its drug ORLADEYO® targeting hereditary angioedema (HAE) [1] - H.C. Wainwright maintains a "Buy" rating for BioCryst, raising its price target from $30 to $32, reflecting confidence in the company's future performance [2] - The FDA's approval of ORLADEYO in an oral pellet formulation is a significant milestone, especially for children, as it addresses a critical need in managing HAE [3] Company Performance - BioCryst's stock is currently priced at $7.60, with a slight increase of 0.33% today, and has fluctuated between $7.57 and $7.92 [4] - The company's market capitalization is approximately $1.6 billion, with a trading volume of 1,923,583 shares today [4] Market Impact - The expanded approval of ORLADEYO is expected to enhance BioCryst's market presence by targeting a younger demographic, positioning the company to capture a larger share of the HAE market [5]