BCRX stock is soaring today after BioCryst Pharmaceuticals (NASDAQ:BCRX) announced that it had filed for regulatory approval in Japan for Berotralstat, a prophylactic treatment of hereditary angioedema (HAE).
BioCryst has already received Orphan Drug and Sakigake designations for Berotralstat and expects potential approval in the second half of 2020 under the Sakigake timeline. Berotralstat is an oral, once-daily treatment for HAE, which is a disorder characterized by recurrent episodes of severe swelling. The application contains data from two sets of clinical trials, APeX-J and APeX-2, with both trials having met their primary endpoint showing a reduction in HAE attacks compared to a placebo. News of the approval filing has sent BCRX stock up over 10% today.
“The data from APeX-J and the Berotralstat clinical program are very exciting for HAE patients in Japan,” said Dr. Isao Ohsawa, President of Saiyu Soka hospital and principal investigator of the APeX-J trial. “Based on the clinical benefit observed in patients in APeX-J, I expect many patients in Japan will want to use this new treatment, once it becomes available,” he added. Once approved, Berotralstat would be the first chronic therapy for HAE patients in Japan. BCRX stock is currently trading for $3.11.
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In preparation for receipt of the regulatory approval, BioCryst Pharmaceuticals has already lined up Torii Pharmaceutical as a commercial partner to distribute the treatment. Under the terms of its commercial agreement with Torii, BioCryst received a US$22 million upfront payment and is eligible to receive an additional milestone payment of up to US$20 million depending on the timeline of the regulatory approval. BioCryst will also receive tiered royalties of up to 40% of Japanese net sales, potentially setting up sustainable, long-term growth in BCRX stock.
BCRX shares had traded for as high as $9.72 last year, despite some volatility following the termination of its merger with Idera Pharmaceuticals (NASDAQ:IDRA), but was brought crashing back down in May after the release of those Apex-2 clinical trial results, despite showing the efficacy of the drug.
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