Biocryst Pharmaceuticals Inc Stock Price, News & Analysis

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.

BioCryst Pharmaceuticals (Nasdaq: BCRX) will announce its third quarter 2020 financial results on November 5, 2020. The management team plans to host a conference call and webcast at 8:30 a.m. ET to discuss the results and provide an update on corporate developments.

Investors can join the call at 877-303-8027 for domestic callers and 760-536-5165 for international callers, using conference ID # 3766784. A live webcast will be accessible on the company’s website.

BioCryst Pharmaceuticals has reported significant efficacy results from the APeX-2 trial of berotralstat, a potential oral treatment for hereditary angioedema (HAE). Over 24 weeks, both 110 mg and 150 mg doses of berotralstat notably reduced HAE attack rates compared to placebo, with the 150 mg dose showing superior results. The findings, published in the Journal of Allergy and Clinical Immunology, highlight berotralstat's safety and tolerability. The FDA is set to decide on the new drug application by December 3, 2020.

BioCryst Pharmaceuticals (BCRX) announced the grant of inducement stock options to 12 new employees totaling 213,000 shares. The options, exercisable at $3.44 per share, were awarded on September 30, 2020, in line with Nasdaq Listing Rule 5635(c)(4). They will vest in four annual installments, subject to continued employment, and have a 10-year term. This initiative highlights BioCryst's commitment to attracting talent necessary for advancing its drug development programs, including treatments for rare diseases and COVID-19.

BioCryst Pharmaceuticals (BCRX) announced the grant of inducement stock options to 22 new employees. A total of 333,000 shares were allocated at an exercise price of $4.15, equal to the stock's closing price prior to the grant date. The options will vest over four years, starting one year after the grant, and have a 10-year term. This initiative aligns with Nasdaq Listing Rule 5635(c)(4) and aims to attract and retain talent critical for BioCryst's growth, particularly as it advances its novel treatments for rare diseases.

BioCryst Pharmaceuticals (BCRX) announced the U.S. Department of Health and Human Services (HHS) will purchase 10,000 additional doses of RAPIVAB (peramivir injection) for approximately $7 million. This order supports the Strategic National Stockpile amid concerns over the influenza season during the COVID-19 pandemic. The purchase is part of a broader $34.7 million contract from 2018, allowing procurement of up to 50,000 doses over five years. RAPIVAB is approved for treating acute uncomplicated influenza in patients aged 2 and older.

BioCryst Pharmaceuticals (BCRX) announced a $44 million contract from NIAID and an additional $3 million to further develop galidesivir, a broad-spectrum antiviral. The funds will support ongoing clinical trials, including a phase 2 trial for non-hospitalized COVID-19 patients and a trial assessing dosing for patients with renal impairment. Galidesivir has shown effectiveness against various RNA viruses, and the company is accelerating its manufacturing to increase supply. The contract reflects continued government investment in combating COVID-19 and future viral threats.

BioCryst Pharmaceuticals (BCRX) has received Orphan Drug designation from the FDA for its oral Factor D inhibitor, BCX9930, aimed at treating paroxysmal nocturnal hemoglobinuria (PNH), a rare and severe blood disorder. This designation qualifies BCX9930 for development incentives like tax credits and market exclusivity. Additionally, BCX9930 has also been granted Fast Track designation. Dr. William Sheridan highlighted the unmet medical need BCX9930 addresses, signaling a commitment to advancing this treatment efficiently.