Shares of a small, Durham, North Carolina-based pharmaceutical company have climbed more than 40% in the past week after the company said it was initiating a clinical trial of its antiviral drug in Covid-19 patients.
BioCryst Pharmaceuticals’ (BCRX, Financial) study of galidesivir will be done in two phases with hospitalized adults who have moderate to severe coronavirus infections, according to an article in FierceBiotech.
The clinical trial will be done in Brazil. The Latin American country was chosen because the company was originally going to study galidesivir’s effectiveness in treating patients with yellow fever, according to an article in FierceBiotech. That viral infection, which is spread by a particular type of mosquito, is endemic in Brazil. The therapy may also work with patients with a variety of other serious diseases, including Ebola, Marburg and Zika, in addition to Covid-19 infections.
Some 2,000 new cases of Covid-19 are occurring in Brazil daily, with the total growing to 20,000. Deaths have gone from about 200 at the start of April to 2,000 today. Deaths are growing rapidly and could reach 6,000 by the end of April.
BioCryst, with a market capitalization of about $420 million, currently trades at $2.75. Its 52-week high is more than $8.50.
While galidesivir is administered intra-muscularly, BioCryst’s main focus is developing oral medications for rare diseases. The oral method is preferred by patients because of its relative simplicity, enabling patients to manage their disease with very little disruption to day-to-day activities.
The company’s lead therapy is an oral medication called berotralstat, which is aimed at preventing swelling in people with hereditary angioedema, a rare genetic disease. The company hopes to receive regulatory approval for the drug in the U.S., Europe and Japan within the next year. Those approvals would prove “transformational” for BioCryst, with peak sales potential of more than $500 million, the company told analysts during an early March earnings conference call.
BioCryst’s other priority is achieving proof of concept for its oral Factor D inhibitor, which is currently in phase 1 trials for treating complement-mediated diseases. Patients with complement-mediated diseases, many of which can cause death or severe morbidity, currently either have no treatments available or are limited to repeated intravenous infusion treatments.
For the three months ended Dec. 31, 2019, BioCryst reported revenues just under $40 million, compared to $2.7 million in the fourth quarter of 2018. The increase was primarily due to the recognition of $20.1 million of the $22.0 million upfront payment from Torii Pharmaceutical Co. (TSE:4551, Financial) of Japan for commercialization rights in that country for berotralstat and sales of nearly $14 million for peramivir injection.
Net loss for the fourth quarter of 2019 was $2.6 million, or 2 cents per share, compared to a net loss of $27.4 million, or 25 cents per share, for the fourth quarter of 2018.
Disclosure: The author holds no positions of any of the stocks mentioned in this article.
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