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. (BLRX - Free Report) 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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