BCRX
- Q1 GAAP EPS of -$0.24 beats by $0.01.Revenue of $4.82M (-18.2% Y/Y) beats by $0.53M.
- BioCryst expects three regulatory approvals for berotralstat in 2020 and early 2021
- Early clinical data supports BCX9930 as oral monotherapy for complement-mediated diseases
- Patient dosing underway in galidesivir trial in COVID-19 patients in Brazil
- Patient dosing is underway in Brazil in a randomized, double-blind, placebo-controlled clinical trial to assess the safety, clinical impact and antiviral effects of galidesivir in patients with COVID-19. The trial (NCT03891420) is being funded by the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health.
- Part 1 of the trial is enrolling 24 hospitalized adults diagnosed with moderate to severe COVID-19 confirmed by PCR. Three cohorts of eight patients will be randomized to receive intravenous (IV) galidesivir (n=6) or placebo (n=2) every 12 hours for seven days. Upon completion of part 1 of the trial, an optimized dosing regimen of galidesivir will be selected for part 2 of the trial, based on part 1 results. In part 2 of the trial, up to 42 hospitalized patients with COVID-19 will be randomized 2:1 to receive IV galidesivir or placebo.
- In vitro testing of galidesivir against SARS-CoV-2, the virus that causes COVID-19, is underway. Galidesivir has been shown to be active against more than 20 RNA viruses in nine different families, including coronaviruses.
- The company also is working closely with the government to increase the supply of galidesivir.
- The company remains on track to report data in 2H 2020 from its ongoing Phase 1 clinical trial of BCX9250, an oral ALK-2 kinase inhibitor for treatment of fibrodysplasia ossificans progressiva (FOP), in healthy subjects.
Así a primera vista, no le veo motivos para bajar, sino más bien para subir. Cierto es que no hay resultados del trial de COVID19, pero ya se menciona, y se dice que están en curso, por lo que los resultados no pueden tardar.
Habrá que ver qué dicen luego en la conference call...
Un saludo
