What happened
Shares of BioCryst Pharmaceuticals (BCRX -3.88%) were soaring 14.5% higher as of 10:51 a.m. EDT on Thursday. The big gain came after the drugmaker provided its first-quarter update before the market opened.
So what
BioCryst had plenty of good news to share in its quarterly update. The company reported total revenue in Q1 of $19.1 million, more than doubling the consensus Wall Street revenue estimate of $8.9 million.
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The primary driver of this strong growth was Orladeyo. The hereditary angioedema (HAE) drug generated net sales of $10.9 million in Q1, its first full quarter on the U.S. market. BioCryst stated that the majority of these sales came from new patients who switched to Orladeyo from other medications or from acute-only treatment.
In addition to its better-than-expected sales, BioCryst also announced that it's reached an agreement with the U.S. Food and Drug Administration (FDA) to use change from baseline in hemoglobin as the primary endpoint for its planned pivotal clinical studies evaluating BCX9930 in treating rare disease paroxysmal nocturnal hemoglobinuria (PNH). The company reported clinical results in March that showed the experimental drug achieved significant increases of hemoglobin in PNH patients.
Now what
The biotech stock could have several potential catalysts on the way. BioCryst received European Commission approval for Orladeyo on April 30. The company plans a commercial launch of the drug in Germany this quarter and will follow up by launching Orladeyo in other European markets. It also hopes to win U.K. approval of the drug.
