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BioCryst Submits NDA for Hereditary Angioedema Candidate

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BioCryst Pharmaceuticals, Inc. (BCRX - Free Report) announced that it has submitted a new drug application (NDA) to the FDA seeking approval of berotralstat (BCX7353), an oral once-daily treatment for the prevention of hereditary angioedema (HAE) attacks.

The company plans to submit marketing authorization application (MAA) for BCX7353 to prevent HAE attacks in the EU and Japan during the first quarter of 2020.

In November 2019, BioCryst out-licensed its commercialization rights to BCX7353 in Japan to Torii Pharmaceutical. Per the company, Torii will be solely responsible for the commercialization activities of BCX7353 to prevent HAE attacks in Japan.

HAE is a rare, genetic and potentially life-threatening disorder that can cause recurrent attacks of edema (swelling) in various parts of the body.

Shares of BioCryst have plunged 65.8% so far this year against the industry’s increase of 11.1%.




We would like to remind investors that in May 2019, BioCryst announced that the phase III APeX-2 study, which evaluated both dose levels of BCX7353 (110 mg and 150 mg) for the prevention of HAE attacks, met the primary endpoint with the higher dose reducing HAE attacks in patients by 44% as compared to placebo.

Data from the study showed that patients with less than two HAE attacks per month experienced a 66% reduction in the attacks when administered with 150 mg of BCX7353. While for patients suffering more than two attacks per month experienced 40% reduction in attacks under the same dose.

BioCryst plans to begin a phase III ZENITH-2 study on oral BCX7353 (750 mg) for the treatment of acute HAE attacks in 2020.

Zacks Rank & Stocks to Consider

BioCryst currently carries a Zacks Rank #3 (Hold). Better-ranked stocks in the healthcare sector include Anika Therapeutics Inc. ANIK, Guardant Health, Inc. GH and Innoviva, Inc. INVA, all sporting a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.

Anika’s earnings estimates have moved 16% north for 2019 and 17.4% for 2020 over the past 60 days. The stock has soared 61.4% year to date.

Guardant Health’s loss per share estimates have narrowed 30.7% for 2019 and 8.5% for 2020 over the past 60 days. The stock has soared 88.3% so far this year.

Innoviva’s earnings estimates have been revised 18.7% upward for 2019 and 25.2% for 2020 over the past 60 days.

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