Biocryst Pharmaceuticals Inc Stock Price, News & Analysis

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.

BioCryst Pharmaceuticals announced the FDA has lifted the partial clinical hold on its BCX9930 program. Enrollment in pivotal trials for paroxysmal nocturnal hemoglobinuria (PNH) and other kidney diseases will resume with a reduced dose of 400 mg twice daily. Previous doses of 500 mg showed elevated serum creatinine levels in some patients. The change aims to prevent crystal formation in kidneys. If successful, BioCryst plans to invest more in BCX9930; if not, they will shift focus to other pipeline candidates.

BioCryst Pharmaceuticals, Inc. (BCRX) will announce its second quarter 2022 financial results on August 4, 2022, followed by a conference call at 8:30 a.m. ET for a corporate update. The live call can be accessed at 866-374-5140 (domestic) or 404-400-0571 (international) using conference ID 68509725#. A webcast and slides will be available on the company's investor website, with a replay accessible afterward.

BioCryst focuses on developing oral treatments for rare diseases, including ORLADEYO (berotralstat) and other pipeline candidates.

BioCryst Pharmaceuticals (Nasdaq: BCRX) will present at the H.C. Wainwright 1st Annual Hereditary Angioedema Virtual Conference on July 20, 2022, at 10:00 a.m. ET. The presentation is accessible via a live audio webcast on the company’s website.

BioCryst focuses on developing oral medicines for rare diseases. Their approved product ORLADEYO (berotralstat) is already available in the U.S. and globally. The company is also advancing several programs, including BCX9930 and galidesivir.

BioCryst Pharmaceuticals (Nasdaq: BCRX) announced promising long-term efficacy and safety results for ORLADEYO (berotralstat) in treating hereditary angioedema (HAE). Data from the APeX-2 and APeX-S clinical trials highlight sustained reductions in HAE attack rates and improved quality of life. Notably, patients switching from injectable therapies reported 98 percent attack-free days. Presenting at the EAACI Congress 2022, these findings bolster ORLADEYO's position as a preferred oral prophylactic therapy for HAE.

BioCryst Pharmaceuticals (Nasdaq: BCRX) announced that it will present data at the EAACI Hybrid Congress 2022 in Prague from July 1-3. Key abstract presentations include:

• Attack-free Status: Patients switching from Lanadelumab to Berotralstat.
• Quality of Life Improvement: Observed in long-term Berotralstat treatment.
• Decreased Injectable Medication Use: After 96 weeks of Berotralstat treatment.

ORLADEYO (berotralstat) is designed to prevent hereditary angioedema attacks in patients aged 12 and older.

BioCryst Pharmaceuticals, Inc. (Nasdaq: BCRX) has formed an exclusive partnership with Pint Pharma GmbH to promote ORLADEYO^® (berotralstat) across the pan-Latin America (LATAM) region. This agreement aims to address the needs of hereditary angioedema (HAE) patients seeking new treatment options. Pint Pharma will handle marketing authorizations and commercialization in LATAM. ORLADEYO, the only oral therapy for HAE prevention, has been successful in several global markets, indicating strong potential for market acceptance in the LATAM region.

BioCryst Pharmaceuticals (BCRX) announced FDA has granted Fast Track designation for BCX9250 aimed at preventing heterotopic ossification in fibrodysplasia ossificans progressiva (FOP) patients. This designation expedites drug development and review for serious conditions with unmet medical needs. BCX9250 targets the ALK-2 enzyme, crucial for FOP, with positive Phase 1 trial results indicating good safety and tolerability. This follows recent PRIME eligibility from EMA, reflecting significant progress in the drug’s development, addressing a critical need in an ultra-rare disease community.

BioCryst Pharmaceuticals (BCRX) announced that Swissmedic has authorized the marketing of ORLADEYO (berotralstat) for preventing recurrent hereditary angioedema (HAE) attacks in patients aged 12 and older in Switzerland. The drug is the first oral, non-steroidal therapy for HAE, enhancing treatment options. Following its European approval last year, BioCryst anticipates launching ORLADEYO in Switzerland after finalizing reimbursement plans. Clinical trials reported gastrointestinal issues which were generally mild and self-resolving.