Welcome to our dedicated page for Biocryst Pharmaceuticals SEC filings (Ticker: BCRX), a comprehensive resource for investors and traders seeking official regulatory documents including 10-K annual reports, 10-Q quarterly earnings, 8-K material events, and insider trading forms.
BioCryst Pharmaceuticals, Inc. (Nasdaq: BCRX) files a range of documents with the U.S. Securities and Exchange Commission that shed light on its operations as a biotechnology company focused on hereditary angioedema (HAE) and other rare diseases. On this page, you can review BioCryst’s SEC filings alongside AI-generated summaries that help explain complex disclosures in clear language.
Current Reports on Form 8-K are especially important for tracking material events at BioCryst. Recent 8-K filings describe key regulatory milestones, such as U.S. Food and Drug Administration approval of the New Drug Application for an oral pellet formulation of once-daily ORLADEYO® (berotralstat) for prophylactic therapy in pediatric HAE patients aged 2 to <12 years. Other 8-Ks cover quarterly financial results, preliminary revenue updates, and guidance for ORLADEYO net revenue, total revenue including RAPIVAB® (peramivir injection), and non-GAAP operating expenses.
Filings also document strategic transactions that shape BioCryst’s business model. One set of 8-Ks details the Stock Purchase Agreement and subsequent closing of the sale of BioCryst Ireland Limited, which held certain assets and rights related to the European ORLADEYO business, along with associated IP license, supply, brand support, transition services, and trademark license agreements. Another 8-K outlines the Agreement and Plan of Merger under which a BioCryst subsidiary will merge with Astria Therapeutics, Inc., including the cash-and-stock merger consideration, closing conditions, and potential delisting of Astria’s stock.
Governance and compensation developments also appear in BioCryst’s filings. Recent 8-Ks describe the planned retirement of the company’s President and Chief Executive Officer, the appointment of a new President and future CEO, the hiring of a new Chief Financial Officer, and related employment and separation agreements. Additional filings report inducement equity grants to new employees in accordance with Nasdaq Listing Rule 5635(c)(4).
Alongside these 8-Ks, investors can use this page to access BioCryst’s periodic reports on Forms 10-K and 10-Q (when available), which provide detailed discussions of risk factors, business strategy, and financial statements. Stock Titan’s AI tools highlight key sections of lengthy documents such as annual reports (10-K), quarterly reports (10-Q), and insider transaction filings (Form 4), helping you quickly understand revenue drivers, major agreements, executive changes, and other disclosures that may affect BCRX.
BioCryst Pharmaceuticals (NASDAQ:BCRX) announced that the FDA has extended the PDUFA goal date for their NDA regarding ORLADEYO oral granules for pediatric HAE patients aged 2-11 years. The 3-month extension moves the target action date to December 12, 2025. The extension was triggered by the company's submission of additional final reports and formulation data, which the FDA classified as a major amendment requiring full review.
The delay affects the potential expansion of ORLADEYO, currently approved for other age groups, into the pediatric hereditary angioedema market segment. The FDA requires additional time to review the supplementary data for safety and efficacy in young patients.