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BioCryst (BCRX) Wins FDA Approval for HAE Drug Orladeyo

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BioCryst Pharmaceuticals, Inc. (BCRX - Free Report) announced that the FDA approved oral, once-daily Orladeyo (berotralstat) for prophylaxis to prevent attacks of hereditary angioedema (HAE) in adult and pediatric patients 12 years and older.

Orladeyo is a plasma kallikrein inhibitor.  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. Additionally, patients completing 48 weeks of therapy (150 mg) had a mean attack rate of 0.8 attacks per month as observed in the long-term, open-label APeX-S study.

The approval bodes well for BioCryst as an oral, once-daily prophylactic option, which enables HAE patients to reduce their burden of therapy.

It is also under regulatory review for approval in Japan and the European Union.

A few drugs approved for the prevention of attacks due to HAE include Takhzyro and Haegarda.

BioCryst’s first approved product is Rapivab, a viral neuraminidase inhibitor for the treatment of influenza. It has received regulatory approval in the United States, Canada, Australia, Japan, Taiwan, Korea and the European Union.

Shares of BioCryst have surged  48.9% so far this year against the industry’s decline of 2.2%.

Meanwhile, the company has a deep pipeline with several ongoing development programs that includes 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 biotech space include Halozyme Therapeutics, Inc. (HALO - Free Report) , Repligen (RGEN - Free Report) and Vanda Pharmaceuticals (VNDA - Free Report) . All three carry a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

Halozyme’s earnings estimates are up 18 cents for 2020 in the past 30 days.

Repligen’s earnings estimates are up 16 cents for 2020 in the past 30 days.

Vanda’s earnings estimates are up 12 cents for 2020 in the past 60 days.

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