Welcome to our dedicated page for Biocryst Pharmaceuticals news (Ticker: BCRX), a resource for investors and traders seeking the latest updates and insights on Biocryst Pharmaceuticals stock.
BioCryst Pharmaceuticals, Inc. (Nasdaq: BCRX) is a global biotechnology company focused on hereditary angioedema (HAE) and other rare diseases, and its news flow reflects this specialization. Company press releases frequently highlight regulatory milestones, clinical data, commercial performance, and strategic transactions related to its flagship product ORLADEYO® (berotralstat) and its broader rare disease pipeline.
Investors following BCRX news can expect regular updates on ORLADEYO, described as the first oral, once-daily plasma kallikrein inhibitor for prophylaxis to prevent HAE attacks. Recent announcements have covered U.S. Food and Drug Administration approval of an oral pellet formulation for pediatric patients aged 2 to <12 years, interim data from the APeX-P pediatric trial showing early and sustained reductions in attack rates, and presentations at major allergy and immunology congresses on the burden of HAE in children and caregivers.
BioCryst also issues news on its financial outlook and operating performance, including preliminary ORLADEYO net revenue, total revenue guidance that incorporates RAPIVAB® (peramivir injection), and non-GAAP operating expense expectations. These releases often explain how structural changes, such as the sale of the European ORLADEYO business, affect the company’s revenue mix and cost base.
Strategic and corporate developments are another major theme in BCRX news. The company has announced a definitive agreement to acquire Astria Therapeutics, Inc., with updates on regulatory clearances such as early termination of the Hart-Scott-Rodino waiting period and expected closing timelines. Additional news items include leadership changes, inducement equity grants under Nasdaq Listing Rule 5635(c)(4), and planned presentations at high-profile investor conferences.
For readers tracking BCRX, this news stream offers insight into BioCryst’s commercial execution in HAE, progress of its rare disease pipeline, evolving capital allocation, and key corporate events. Regularly reviewing these updates can help contextualize movements in BCRX stock and provide a clearer picture of the company’s strategic direction.
BioCryst Pharmaceuticals (BCRX) announced it will report its Q3 2022 financial results on November 1, 2022. A conference call and webcast will be held at 8:30 a.m. ET to discuss the results and provide a corporate update. The call can be accessed by dialing 866-374-5140 domestically or 404-400-0571 internationally, using conference ID 28663801#. Additionally, a live webcast will be available on the BioCryst website, along with a replay post-call.
BioCryst Pharmaceuticals (Nasdaq: BCRX) announced on October 4, 2022, that its compensation committee granted stock options and restricted stock units (RSUs) to 33 new employees. The total of 522,808 shares in options and 166,916 shares in RSUs were issued as inducements to employment, effective as of September 30, 2022. The options have an exercise price of $12.60 per share, matching the stock's closing price on the grant date, and will vest in four annual installments. This initiative aligns with Nasdaq Listing Rule 5635(c)(4).
BioCryst Pharmaceuticals announced executive appointments on September 14, 2022. Dr. Bill Sheridan will take on the role of Chief Development Officer, focusing on the company's pipeline, while Dr. Ryan Arnold has been named the new Chief Medical Officer. Dr. Sheridan brings 15 years of experience from Amgen, with a strong background in medical affairs and product development. Dr. Arnold, who joined BioCryst in March 2022, has over 20 years in the industry, specializing in medical affairs across rare disease indications. This leadership change aims to enhance the company’s development efforts in treating unmet medical needs.
On September 6, 2022, BioCryst Pharmaceuticals (BCRX) announced the granting of stock options and restricted stock units to 17 new employees, totaling 161,500 options and 64,250 RSUs. The options have an exercise price of $13.90, matching the stock's closing price on the grant date. These compensation incentives are part of Nasdaq's compliance and will vest over four years. BioCryst focuses on developing oral medicines for rare diseases, including approved products like ORLADEYO and ongoing projects such as BCX9930.
BioCryst Pharmaceuticals (BCRX) announced its participation in two upcoming healthcare conferences. The company will present at the 2022 Wells Fargo Healthcare Conference on September 7, 2022, at 11:35 a.m. ET, and will also take part in the H.C. Wainwright 24th Annual Global Investment Conference. A pre-recorded fireside chat for this latter event will be available on September 12, 2022, at 7:00 a.m. ET. Links to live webcasts and replays will be accessible on BioCryst's website.
BioCryst Pharmaceuticals (BCRX) has received FDA orphan drug designation for BCX9250, aimed at treating fibrodysplasia ossificans progressiva (FOP), a rare genetic disorder. This designation offers benefits like tax credits, user fee exemptions, and potential market exclusivity. BioCryst is also preparing for trials in FOP patients next year following earlier Fast Track and EMA PRIME designations for BCX9250. The drug demonstrated safety and tolerability in Phase 1 trials, supporting once-daily dosing. The upcoming American Society for Bone and Mineral Research meeting will feature data from BCX9250 studies.
BioCryst Pharmaceuticals announced promising results for its oral Factor D inhibitor, BCX9930, in patients with C3 glomerulopathy (C3G). The study demonstrated over 99% suppression of the alternative pathway (AP) of the complement system, maintained for 24 hours after dosing. The drug achieved rapid suppression of C3a levels and was generally safe and well-tolerated. These findings support further development of BCX9930 for treating C3G and other complement-mediated diseases. The data will be presented at the 18th European Meeting on Complement in Human Disease in Bern, Switzerland.
On August 25, 2022, BioCryst Pharmaceuticals (BCRX) announced a contract extension with the U.S. Department of Health and Human Services (HHS) to supply an additional 10,000 doses of its antiviral drug, RAPIVAB (peramivir injection), valued at approximately $7 million. This order fulfills the final requirement under a $34.7 million contract for 50,000 doses over five years, aimed at enhancing pandemic preparedness. RAPIVAB is approved for treating acute influenza in patients over six months old, with administration via intravenous infusion.
BioCryst Pharmaceuticals (BCRX) announced that the Saudi Food and Drug Authority has approved ORLADEYO® (berotralstat) for the prevention of hereditary angioedema attacks in patients aged 12 and older. This approval highlights the demand for new HAE treatment options in Saudi Arabia. ORLADEYO is the first oral therapy specifically designed for HAE prophylaxis. BioCryst also has distribution agreements with NewBridge Pharmaceuticals for the GCC region. The drug demonstrated safety and tolerability in clinical trials, with some common adverse reactions noted.
BioCryst Pharmaceuticals (BCRX) reported Q2 2022 net revenue of $65.2 million, a 129% increase year-over-year. The company anticipates FY 2022 ORLADEYO net revenue of $255 million to $265 million and projects peak global sales of ORLADEYO nearing $1 billion. Growth continues in patient prescriptions, with a significant portion from key HAE treaters. However, R&D expenses rose to $62.0 million, and net losses increased to $58.9 million. The company has lifted the clinical hold on BCX9930 and expects increased focus on its development.