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BioCryst Pharmaceuticals reported Q3 2022 revenues of $75.8 million, a 85% year-over-year increase, driven mainly by $66.0 million from ORLADEYO. The patient base for ORLADEYO grew by 9% in Q3. The company is advancing its pipeline with new Factor D inhibitors, BCX10013 entering clinical trials, while screening for BCX9930 continues, with data expected mid-2023. The company anticipates full-year ORLADEYO revenue of $255 million and operating expenses between $365 million and $370 million.
BioCryst Pharmaceuticals (BCRX) announced presentations at the American College of Allergy, Asthma & Immunology's meeting from November 10-14, 2022, in Louisville, Kentucky. They will showcase two abstracts on ORLADEYO® (berotralstat) for hereditary angioedema treatment. Dr. Ryan Arnold emphasized ORLADEYO's effectiveness in reducing attack rates, making it a convenient option. The Distinguished Industry Oral Presentation will discuss real-world outcomes of berotralstat, while a poster will highlight consistently low attack rates irrespective of prior therapies.
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.