Biocryst Pharmaceuticals Inc Stock Price, News & Analysis

BioCryst Pharmaceuticals (Nasdaq: BCRX) announced promising preclinical data for BCX9930, an oral Factor D inhibitor aimed at treating paroxysmal nocturnal hemoglobinuria (PNH) and other complement-mediated diseases. The data, presented at the 62nd ASH Annual Meeting, showed complete in vitro blockade of hemolysis in PNH erythrocytes. BCX9930 demonstrated specificity for the alternative pathway, with significant suppression observed in primates. The FDA has granted Fast Track status and Orphan Drug designation for BCX9930.

BioCryst Pharmaceuticals (BCRX) announced FDA approval for ORLADEYO™ (berotralstat), an oral, once-daily prophylactic treatment for hereditary angioedema (HAE) in patients aged 12 and older. The pivotal Phase 3 APeX-2 trial showed a significant reduction in HAE attacks, from 2.9 to 1.0 per month after 48 weeks. With EMPOWER Patient Services, access to therapy is streamlined, providing dedicated support for patients. ORLADEYO represents a critical advancement, reducing treatment burden compared to existing injectable therapies.

BioCryst Pharmaceuticals (BCRX) announced the granting of inducement stock options to 13 newly-hired employees on November 30, 2020. The total of 260,500 shares were awarded at an exercise price of $5.11, equal to the closing price on the grant date. These options vest in four equal annual installments starting one year from the grant date and have a 10-year term. This grant complies with Nasdaq Listing Rule 5635(c)(4) and is part of BioCryst's Inducement Equity Incentive Plan.

BioCryst Pharmaceuticals (BCRX) announced that the APeX-J trial results, published in the journal Allergy, showed berotralstat significantly reduces the rate of hereditary angioedema (HAE) attacks compared to placebo. The trial's primary endpoint was met with a p-value of 0.003, confirming the drug's safety and tolerability. Berotralstat is set to be the first approved prophylactic therapy for HAE in Japan, with its new drug application currently under review and a decision expected in December 2020.

BioCryst Pharmaceuticals (Nasdaq:BCRX) announced its participation in the Evercore ISI HealthCONx and Piper Sandler Healthcare Conferences, both held virtually. The Evercore presentation is scheduled for December 2, 2020, at 12:35 p.m. ET. Investors can access a pre-recorded presentation on November 23, 2020, via the company’s website. BioCryst is focused on developing innovative treatments for rare diseases, including ORLADEYO for hereditary angioedema and BCX9930 for complement-mediated diseases.

BioCryst Pharmaceuticals presented new clinical data on berotralstat for hereditary angioedema (HAE) at the 2020 ACAAI meeting. The APeX-2 trial showed a significant reduction in attack rates over 48 weeks, with patients reporting a mean monthly attack rate drop from 2.5 to 0.6. Additionally, treatment improved patient satisfaction, reflected by a 26-point increase in the Treatment Satisfaction Questionnaire scores. Quality of life also improved, with 77% of patients exceeding the minimal clinically important difference. Berotralstat is an investigational oral treatment pending FDA approval.

BioCryst Pharmaceuticals (Nasdaq:BCRX) shared data at the 2020 ACAAI meeting, highlighting the significant treatment burden faced by hereditary angioedema (HAE) patients. Key findings indicated that 86% of patients desire easier medication administration, with 58% expressing fatigue over injections. A majority of caregivers identified challenges in learning to administer treatments, while 94% of physicians acknowledged the need for novel therapies. This data emphasizes an unmet need for improved HAE management and the potential for enhanced patient-physician dialogue to address treatment concerns.

BioCryst Pharmaceuticals (BCRX) announced that preclinical data on BCX9930, an oral Factor D inhibitor, will be presented at the 62nd American Society of Hematology (ASH) Annual Meeting on December 6, 2020. The abstract is available on the ASH website. BCX9930 is a novel oral treatment for complement-mediated diseases, currently in Phase 1 clinical development for Paroxysmal Nocturnal Hemoglobinuria (PNH). The FDA has granted Fast Track and Orphan Drug designations for the drug. Preliminary results show that BCX9930 has been safe and well tolerated with significant biomarker improvements in PNH patients.

BioCryst Pharmaceuticals (BCRX) announced its Q3 2020 financial results, reporting revenues of $6.1 million, up from $1.8 million in Q3 2019. The increase was primarily attributed to higher collaboration revenue and peramivir sales. R&D expenses rose to $30.2 million, and SG&A expenses increased to $17.2 million, reflecting costs associated with the upcoming launch of ORLADEYO. The net loss for the quarter was $46.1 million, or $0.26 per share, compared to a loss of $37.6 million or $0.34 per share a year earlier. The company expects full-year 2020 net operating cash use between $150 million and $165 million.