BioCryst Down Despite Hereditary Angioedema Study Meets Goal

BioCryst Pharmaceuticals, Inc. (NASDAQ:BCRX) 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. (NASDAQ:ASRT) , BioLineRx Ltd. (NASDAQ:BLRX) and Jazz Pharmaceuticals PLC (NASDAQ:JAZZ) , 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 >>