ORLADEYO® (berotralstat)
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BioCryst Pharmaceuticals' Significant Strides in Rare Disease Treatment
Financial Modeling Prep· 2025-12-15 21:00
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]
BioCryst Announces FDA Approval of ORLADEYO® (berotralstat) Oral Pellets, First and Only Oral Prophylactic Treatment for Patients with HAE Aged 2 to
Globenewswire· 2025-12-12 12:00
–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 ...
BioCryst Receives Early Termination of HSR Waiting Period for Astria Acquisition
Globenewswire· 2025-12-03 12:00
Core Viewpoint - BioCryst Pharmaceuticals has received early termination of the waiting period under the Hart-Scott-Rodino Antitrust Improvements Act for its proposed acquisition of Astria Therapeutics, indicating progress towards the merger [1][2]. Group 1: Merger Details - The termination of the waiting period satisfies one of the conditions for the merger, with BioCryst expecting the merger to close in the first quarter of 2026, pending other customary closing conditions [2]. - BioCryst has filed a registration statement with the SEC, which includes a preliminary proxy statement of Astria and a preliminary prospectus of BioCryst regarding the merger [5][6]. Group 2: Company Overview - BioCryst Pharmaceuticals is a global biotechnology company focused on developing and commercializing medicines for hereditary angioedema and other rare diseases, with a commitment to improving the lives of affected individuals [3]. - The company has commercialized ORLADEYO® (berotralstat), the first oral, once-daily plasma kallikrein inhibitor, and is advancing a pipeline of potential first-in-class or best-in-class oral small-molecule and injectable protein therapeutics for various rare diseases [3].
BioCryst Reports Inducement Grants Under Nasdaq Listing Rule 5635(c)(4) - BioCryst Pharma (NASDAQ:BCRX)
Benzinga· 2025-11-05 12:01
Company Overview - BioCryst Pharmaceuticals, Inc. is a global biotechnology company focused on developing and commercializing medicines for hereditary angioedema (HAE) and other rare diseases [3] - The company has commercialized ORLADEYO® (berotralstat), the first oral, once-daily plasma kallikrein inhibitor, and 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 [3] Stock Compensation - The compensation committee of BioCryst's board of directors granted three newly-hired employees restricted stock units (RSUs) covering an aggregate of 30,700 shares of BioCryst common stock as inducements for employment [1] - The RSUs were granted as of November 3, 2025, and will vest in four equal annual installments beginning on the one-year anniversary of the grant date, subject to the new employee's continued service with the company [2] - The RSUs are subject to the terms and conditions of BioCryst's Inducement Equity Incentive Plan and a restricted stock unit agreement covering the grant [2]
BioCryst Pharmaceuticals(BCRX) - 2025 Q1 - Earnings Call Presentation
2025-05-05 12:06
First Quarter 2025 Results Call Corporate Update & Financial Results May 5, 2025 CONFIDENTIAL & PROPRIETARY Forward-looking statements President and Chief Executive Officer ORLADEYO® update Charlie Gayer Chief Commercial Officer BioCryst's presentation contains forward-looking statements, including, but not limited to, statements regarding future results and forward-looking financial information, company performance, achievements, future market share or size, and expectations regarding pipeline development. ...