BioCryst Pharmaceuticals Inc - BCRX STOCK NEWS

BioCryst Pharmaceuticals (BCRX) announced that its oral Factor D inhibitor, BCX9930, has shown significant efficacy in increasing hemoglobin levels and reducing transfusion requirements in treatment-naïve and C5 inhibitor inadequate response patients with paroxysmal nocturnal hemoglobinuria (PNH). In the trial, 100% of treatment-naïve patients and 83% of C5 inadequate response patients were transfusion-free. The mean hemoglobin levels increased significantly, and the drug was well-tolerated. Pivotal trials are expected to commence in the second half of 2021.

BioCryst Pharmaceuticals (BCRX) appointed Helen Thackray, M.D., FAAP, as chief research and development officer, a newly created position. Dr. Thackray will enhance BioCryst's R&D strategy, focusing on rare disease medicines. She brings extensive experience from GlycoMimetics, Inc. and a strong background in clinical development. CEO Jon Stonehouse expressed confidence in her ability to accelerate their programs. Dr. Thackray is excited about BioCryst's innovative pipeline of oral compounds targeting multiple rare diseases.

BioCryst Pharmaceuticals (Nasdaq:BCRX) will host a virtual R&D day on March 22, 2021, from 9:00 am to 11:00 am ET. The event will detail the company's innovative approach to developing oral medicines for rare diseases, highlighting BCX9930, an oral Factor D inhibitor for complement-mediated diseases.

New data from a trial with 16 paroxysmal nocturnal hemoglobinuria (PNH) patients will be presented. Attendees can access the live webcast at biocryst.com.

BioCryst Pharmaceuticals (BCRX) announced that the French National Agency for Medicines and Health Products Safety has granted a cohort ATU (Temporary Authorization for Use) for berotralstat, allowing its use in hereditary angioedema (HAE) patients aged 12 and older in France. This authorization enables earlier access to the drug prior to full EU marketing approval. The EU review is ongoing, with a decision anticipated in Q2 2021. Berotralstat, the first oral treatment for HAE, aims to prevent attacks effectively.

BioCryst Pharmaceuticals (BCRX) has submitted a marketing authorization application (MAA) to the UK's Medicines and Healthcare products Regulatory Agency for ORLADEYO™ (berotralstat), aimed at preventing recurrent hereditary angioedema (HAE) attacks in patients aged 12 and older. This submission follows a positive opinion from the European Medicines Agency's CHMP. If approved, ORLADEYO will be the first oral, once-daily therapy for HAE in the UK. The drug is already approved in the U.S. and Japan, with expectations for a decision from the European Commission in Q2 2021.

BioCryst Pharmaceuticals (Nasdaq: BCRX) announced a positive opinion from the CHMP of the EMA recommending approval for ORLADEYO™ (berotralstat) for preventing recurrent attacks of hereditary angioedema (HAE) in patients aged 12 and older. If approved by the European Commission, ORLADEYO would be the first oral, once-daily treatment for HAE in the EU. The CHMP's recommendation was based on positive results from pivotal clinical trials. ORLADEYO is already approved in the U.S. and Japan, with an Early Access Scheme approved in the UK.

BioCryst Pharmaceuticals (BCRX) reported its Q4 and full-year 2020 financial results, revealing total revenues of $4.0 million for Q4 and $17.8 million for the full year, down from $39.7 million and $48.8 million in 2019 respectively. The company launched ORLADEYO in the U.S. after FDA approval and received marketing approval in Japan. The financing raised $325 million in December 2020 aids the launch and ongoing development of BCX9930, with cash totaling $303 million expected to last into 2023. The net loss increased to $60.5 million in Q4, reflecting higher R&D and SG&A expenses.

BioCryst Pharmaceuticals (Nasdaq:BCRX) announces its participation in two upcoming virtual healthcare conferences. The first is the Cowen 41st Annual Healthcare Conference on March 4, 2021, at 12:10 p.m. ET, followed by the Barclays Annual Healthcare Conference on March 11, 2021, at 8:00 a.m. ET. Interested investors can access live audio webcasts and replays via the investors section of BioCryst’s website.

BioCryst focuses on developing novel oral medicines for rare diseases, with key products like ORLADEYO™ and RAPIVAB® for treating various conditions.

BioCryst Pharmaceuticals (Nasdaq: BCRX) will announce its fourth quarter and full year 2020 financial results on February 25, 2021. Management will host a conference call at 8:30 a.m. ET to discuss these results and provide a corporate update. The call can be accessed by dialing 877-303-8027 for domestic and 760-536-5165 for international callers. Additionally, BioCryst's lead product, ORLADEYO™, is under regulatory review in the European Union, while ongoing developments include treatments for rare diseases and viral infections.