Biocryst Pharmaceuticals Inc Stock Price, News & Analysis

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.

BioCryst Pharmaceuticals (Nasdaq: BCRX) announced the grant of inducement stock options to nine new employees, totaling 163,000 shares. The options, issued on October 30, 2020, have an exercise price of $3.82 per share, matching the closing stock price on the grant date. Vesting occurs in four equal annual installments starting after one year, subject to the employees' continued service. This issuance aligns with Nasdaq Listing Rule 5635(c)(4) and reflects BioCryst's commitment to attracting talent essential for its ongoing development programs targeting rare diseases.

BioCryst Pharmaceuticals (BCRX) announced that the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) granted a positive scientific opinion for berotralstat through the Early Access to Medicines Scheme (EAMS). This allows hereditary angioedema (HAE) patients aged 12 and older in the UK to access berotralstat for routine prevention before European Commission marketing authorization. The EAMS identifies medicines meeting high unmet needs, and berotralstat offers a significant advantage for HAE treatment. The European Medicines Agency is currently reviewing its marketing authorization application.

BioCryst Pharmaceuticals (BCRX) announced its participation in the Annual Scientific Meeting of the American College of Allergy, Asthma & Immunology (ACAAI) from November 13-15, 2020. The company will present five abstracts, including a Distinguished Industry Oral Abstract on the APeX-2 trial, highlighting berotralstat's effectiveness in reducing attacks in patients with Hereditary Angioedema (HAE).

Additional presentations will focus on patient-reported quality of life, satisfaction, and treatment burden related to HAE. E-posters will be available online on November 13.