BioCryst Pharmaceuticals Reports Q4, Full Year 2024 Results and Faces Generic ANDA Challenge

BioCryst Pharmaceuticals, Inc. disclosed in a Form 8‑K filing dated February 24, 2025 that it issued a press release detailing its corporate developments and financial results for the fourth quarter and full year ended December 31, 2024. The update also mentioned that the company scheduled a conference call and webcast to discuss these results.

In addition to reporting its financial performance, BioCryst noted a significant development regarding its flagship product, ORLADEYO. In January 2025, the company received a Paragraph IV notice of certification from Annora Pharma Private Limited. According to the notice, Annora has submitted an Abbreviated New Drug Application to the U.S. Food and Drug Administration seeking approval to manufacture, use or sell a generic version of ORLADEYO in the United States. The notice alleges that three patents covering ORLADEYO—U.S. Patent Nos. 10,662,160; 11,117,867; and 11,618,733, which expire in 2039—are invalid, unenforceable and/or will not be infringed by the proposed generic product. BioCryst emphasized that the notice does not challenge six other patents related to ORLADEYO. The company intends to vigorously defend its intellectual property rights protecting the product.

A copy of the press release, furnished as an exhibit to the Form 8‑K, is incorporated by reference. While the exhibit text contains details regarding financial performance and operational matters of another entity, the filing confirms that BioCryst’s announcement covers its own results and corporate developments.

BioCryst’s filing underscores its commitment to transparency amid evolving market challenges and highlights its readiness to address regulatory and legal issues that could impact its portfolio.

This article was generated by an automated content engine and was reviewed by a human editor prior to publication. For additional information, read BioCryst Pharmaceuticals’s 8K filing here.

BioCryst Pharmaceuticals Company Profile

BioCryst Pharmaceuticals, Inc, a biotechnology company, develops oral small-molecule and protein therapeutics to treat rare diseases. The company markets peramivir injection, an intravenous neuraminidase inhibitor for the treatment of acute uncomplicated influenza under the RAPIVAB, RAPIACTA, and PERAMIFLU names; and ORLADEYO, an oral serine protease inhibitor to treat hereditary angioedema.