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BioCryst (BCRX) Provides Updates on Galidesivir, Shares Fall

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Shares of BioCryst Pharmaceuticals, Inc. (BCRX - Free Report) fell about 8.6% after it provided an update on its galidesivir program. Data from part 1 of a study of its broad-spectrum antiviral, galidesivir, showed that the candidate was safe and generally well tolerated in patients infected with SARS-CoV-2, the virus that causes COVID-19. The study data did not show any clinical efficacy benefit with galidesivir treatment compared to placebo treatment. Per the company, the study was not designed or sized to demonstrate clinical efficacy.

Consequently, based on the company’s ongoing discussions with the NIAID, part of the National Institutes of Health, a major funding partner for the program, BioCryst expects NIAID to continue their support for the development of galidesivir with a focus on biodefense threats, such as Marburg virus disease, and not COVID-19.

Shares of BioCryst have soared 120% so far this year compared with the industry’s growth of 2.9%.

 

A separate study of galidesivir in a COVID-19 animal model showed that early administration of galidesivir reduced SARS-CoV-2 viral burden in lung tissue and was associated with a significant reduction in damage to lung tissue compared to vehicle control-treated animals.

This month, Pfizer Inc. (PFE - Free Report) and BioNTech SE (BNTX - Free Report) announced that the Medicines & Healthcare Products Regulatory Agency (MHRA) in the U.K. granted a temporary authorization for emergency use to their mRNA vaccine (BNT162b2) against COVID-19. This marks the first Emergency Use Authorization (EUA) following a worldwide phase III study of a vaccine to help fight the pandemic. On Dec 11, the FDA granted an EUA to BNT162b2. Later in the same month, the European Commission granted conditional marketing authorization (CMA) to BNT162b2, making it the first COVID-19 vaccine to be approved in Europe.

Johnson & Johnson’s (JNJ - Free Report) single-dose COVID-19 vaccine candidate, JNJ-78436735 is being evaluated in the ENSEMBLE phase III study, which is now fully enrolled with approximately 45,000 participants. Johnson & Johnson expects to report interim efficacy data from the ENSEMBLE study by the end of January 2021. If the data are positive, J&J will file an application for EUA from the FDA in February.

BioCryst currently carries a Zacks Rank #4 (Sell). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

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