BioCryst Pharmaceuticals Inc. (NASDAQ:BCRX) has announced its Q3 2020 results and also offered a corporate update.
BioCryst ready to launch ORLADEYO
Jon Stonehouse, the CEO and president of BioCryst, said that the company is 28 days from its PDUFA date. The company is ready to launch ORLADEYO to deliver an oral, once-daily treatment to HAE patients that they need to prevent attacks, minimize the burden of therapy, and more quality of life. Stonehouse added that in addition to the commercial transformation of BioCryst and the revenue it generates, the company’s pipeline of discovered molecules continues to advance its several upcoming short-term data readouts.
The company is expecting three ORLADEYO regulatory approvals in Q4 2020 and early next year. The FDA reviews an NDA for ORLADEYO and has set an action date under the PDUFA of December 3, 2020. In Japan, ORLADEYO is under the Sakigake designation review with the Pharmaceutical and Medical Devices has confirmed a regulatory review schedule with the company expecting a decision on approval next month.
On March 30, 2020, The EMA validated BioCryst’s MAA submission for ORLADEYO and commenced a formal review of the application under centralized procedure. BioCryst expects an opinion from the EMA’s Committee of Medicinal Products for Human Use after 12 months following MAA validation.
Also, the company recently announced that the UK Medicines and Healthcare Products Regulatory Agency gave oral, once per day berotralstat, a positive scientific opinion via the Early Access to Medicines Scheme. As per the EAMS, UK HAE patients aged 12 years and above will access berotralsat for routine prevention of recurrent HAE attacks before the drug receives marketing authorization by the European Commission.
BioCryst’s completes enrolment in a COVID-19 trial
The company completed enrolment in Part 1 clinical study of galidesivir in coronavirus patients in Brazil. Clinical data from the trial will be out in Q4 2020. The primary endpoint is safety and secondary endpoints data being collected, including virology and patient outcomes. Data from the first part is a gating component for the program, and clinical evidence is vital for the program’s progress.