4:12 PM
May 21, 2019
 |  BC Extra  |  Clinical News

BioCryst makes case for oral HAE therapy even as Phase III data disappoint investors

Despite reporting Phase III efficacy data for its oral hereditary angioedema therapy that fell short of marketed injectable therapies to prevent HAE attacks, BioCryst believes the demand for an oral option will enable BCX7353 to succeed as a front-line treatment. The company reiterated its plans to submit an NDA to FDA in 4Q19 and an MAA to EMA in 1Q20 for a 150 mg dose of the second-generation kallikrein inhibitor for the prophylaxis indication.

The readout sent shares of BioCryst Pharmaceuticals Inc. (NASDAQ:BCRX) down $3.91 (53%) to $3.48 on Tuesday.

A BioCryst spokesperson told BioCentury that the company believes there is “a strong demand for a safe, effective,...

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