BioCryst Pharmaceuticals, Inc. (BCRX - Free Report) announced that its late-stage study on BCX7353, a novel, oral, once-daily, selective inhibitor of plasma kallikrein has met the primary endpoint. The phase III APeX-2 study evaluated BCX7353 for the prevention of hereditary angioedema (HAE) attacks for both the 110mg and 150mg dose levels with the higher dose reducing HAE attacks in patients by 44% as compared to placebo.
Shares of BioCryst plunged 52.9% despite this positive news on Tuesday as the reduction rate of HAE attacks fell below investors’ expectation. As a matter of fact, BioCryst stock has plummeted 56.9% so far this year versus the industry’s increase of 4.4%.
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.
Positive results from this APeX-2 study are necessary as the same will support the new drug application (NDA) submission on BCX7353. BioCryst plans to file an NDA in the United States during fourth-quarter 2019 and a marketing authorization application (MAA) in the EU during the first quarter of 2020.
All patients who completed 24-week regime, continued into the ongoing 48-week extension phase of the study. BCX7353 was generally well tolerated and safe with respect to both the doses with no drug-related serious adverse event reported.
The company expects to position BCX7353 as a potentially life-changing oral therapy for the given patient population.
Zacks Rank & Stocks to Consider
BioCryst currently carries a Zacks Rank #3 (Hold). Better-ranked stocks in the same sector include Assertio Therapeutics, Inc. (ASRT - Free Report) , BioLineRx Ltd. and Jazz Pharmaceuticals PLC (JAZZ - Free Report) , all carrying a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
Assertio’s earnings estimates have moved 12.8% north for 2019 and 4.4% for 2020 over the past 60 days.
BioLineRx’s loss per share estimates have been narrowed 32% for 2019 and 21.7% for 2020 over the past 60 days.
Jazz Pharmaceuticals’ earnings estimates have been revised 1.8% upward for 2019 and 1.9% for 2020 over the past 60 days. The stock has risen 12.9% year to date.
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BioCryst Pharmaceuticals, Inc. (BCRX - Free Report) announced that its late-stage study on BCX7353, a novel, oral, once-daily, selective inhibitor of plasma kallikrein has met the primary endpoint. The phase III APeX-2 study evaluated BCX7353 for the prevention of hereditary angioedema (HAE) attacks for both the 110mg and 150mg dose levels with the higher dose reducing HAE attacks in patients by 44% as compared to placebo.
Shares of BioCryst plunged 52.9% despite this positive news on Tuesday as the reduction rate of HAE attacks fell below investors’ expectation. As a matter of fact, BioCryst stock has plummeted 56.9% so far this year versus the industry’s increase of 4.4%.
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.
Positive results from this APeX-2 study are necessary as the same will support the new drug application (NDA) submission on BCX7353. BioCryst plans to file an NDA in the United States during fourth-quarter 2019 and a marketing authorization application (MAA) in the EU during the first quarter of 2020.
All patients who completed 24-week regime, continued into the ongoing 48-week extension phase of the study. BCX7353 was generally well tolerated and safe with respect to both the doses with no drug-related serious adverse event reported.
The company expects to position BCX7353 as a potentially life-changing oral therapy for the given patient population.
Zacks Rank & Stocks to Consider
BioCryst currently carries a Zacks Rank #3 (Hold). Better-ranked stocks in the same sector include Assertio Therapeutics, Inc. (ASRT - Free Report) , BioLineRx Ltd. and Jazz Pharmaceuticals PLC (JAZZ - Free Report) , all carrying a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
Assertio’s earnings estimates have moved 12.8% north for 2019 and 4.4% for 2020 over the past 60 days.
BioLineRx’s loss per share estimates have been narrowed 32% for 2019 and 21.7% for 2020 over the past 60 days.
Jazz Pharmaceuticals’ earnings estimates have been revised 1.8% upward for 2019 and 1.9% for 2020 over the past 60 days. The stock has risen 12.9% year to date.
Today's Best Stocks from Zacks
Would you like to see the updated picks from our best market-beating strategies? From 2017 through 2018, while the S&P 500 gained +15.8%, five of our screens returned +38.0%, +61.3%, +61.6%, +68.1%, and +98.3%.
This outperformance has not just been a recent phenomenon. From 2000 – 2018, while the S&P averaged +4.8% per year, our top strategies averaged up to +56.2% per year.
See their latest picks free >>
Zacks Names "Single Best Pick to Double"
From thousands of stocks, 5 Zacks experts each have chosen their favorite to skyrocket +100% or more in months to come. From those 5, Director of Research Sheraz Mian hand-picks one to have the most explosive upside of all.
It’s a little-known chemical company that’s up 65% over last year, yet still dirt cheap. With unrelenting demand, soaring 2022 earnings estimates, and $1.5 billion for repurchasing shares, retail investors could jump in at any time.
This company could rival or surpass other recent Zacks’ Stocks Set to Double like Boston Beer Company which shot up +143.0% in little more than 9 months and NVIDIA which boomed +175.9% in one year.
Free: See Our Top Stock and 4 Runners Up >>
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