BioCryst Pharmaceuticals, Inc. BCRX announced that the Ministry of Health, Labor and Welfare (MHLW) in Japan has granted marketing and manufacturing approval to oral, once-daily Orladeyo (berotralstat) 150 mg for prophylactic treatment of hereditary angioedema (HAE) in adults and pediatric patients 12 years or older.
Shares of BioCryst have surged 186.9% in the past year compared with the industry’s growth of 0.5%.
Orladeyo is the first and only prophylactic HAE medication approved in Japan. One capsule of Orladeyo per day works to prevent HAE attacks by decreasing the activity of plasma kallikrein.The approval in Japan was based on data from APeX-J and APeX-2 studies. The APeX-J study in Japan met its primary endpoint of a reduction in HAE attacks from baseline for Orladeyo 150 mg compared to placebo, and Orladeyo was safe and generally well-tolerated in the study.
Orladeyo significantly reduced attacks at 24 weeks and this reduction was sustained through 48 weeks as observed in the phase III APeX-2 study. HAE patients who completed 48 weeks of treatment (150 mg) saw reductions in their HAE attack rates, from a mean of 2.9 attacks per month at baseline to a mean of 1.0 attacks, following 48 weeks of therapy.
Orladeyo is a plasma kallikrein inhibitor.
Orladeyo will be commercialized in Japan by BioCryst’s partner, Torii Pharmaceutical Co., Ltd. OrphanPacific, Inc. is BioCryst’s representative partner in Japan and holds the marketing authorization.
With the approval in Japan, BioCryst is eligible to receive an additional milestone payment of $15 million from Torii. Further, BioCryst will receive tiered royalties ranging from 20% to potentially 40% of Japanese net sales.
In December 2020, the FDA approved Orladeyo in the United States. In Europe, the European Medicines Agency (EMA) validated its marketing authorization application (MAA) submission for Orladeyo and a review of the MAA is ongoing. The company expects an approval decision in Europe in the second quarter of 2021.
Meanwhile, the company has a deep pipeline with several ongoing development programs that include BCX9930, an oral Factor D inhibitor for the treatment of complement-mediated diseases; galidesivir, a potential treatment for COVID-19, Marburg virus disease and Yellow Fever; and BCX9250, an ALK-2 inhibitor for the treatment of fibrodysplasia ossificans progressiva.
Zacks Rank & Stocks to Consider
BioCryst currently carries a Zacks Rank #3 (Hold).
Some better-ranked stocks in the healthcare sector include Alkermes Plc. ALKS, Acorda Therapeutics Inc. ACOR and Alexion Pharmaceuticals Inc. ALXN. All of them carry a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
Alkermes’ earnings per share estimates have increased from 48 cents to 52 cents for 2021 over the past 60 days. Shares of the company have increased 29.4% in the past year.
Acorda’s loss per share estimates have narrowed from $9.66 to $8.48 for 2020 and from $9.60 to $7.33 for 2021 over the past 60 days.
Alexion’s earnings per share estimates have increased from $12.04 to $12.06 for 2020 over the past 60 days. Shares of the company have increased 51.7% in the past year.
BioCryst Pharmaceuticals, Inc. Price
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