Portugal approves daily oral therapy for hereditary angioedema

Published 12/02/2025, 13:06
Portugal approves daily oral therapy for hereditary angioedema

RESEARCH TRIANGLE PARK, N.C. - BioCryst Pharmaceuticals , Inc. (NASDAQ:BCRX), a biotechnology company with impressive revenue growth of nearly 30% over the last twelve months, has announced that Infarmed, the Portuguese National Authority of Medicines and Health Products, has recommended ORLADEYO® (berotralstat) for routine prevention of hereditary angioedema (HAE) attacks in patients 12 years and older. This decision, announced today, allows Portuguese HAE patients access to the first oral, once-daily treatment option for reducing recurrent HAE attacks. According to InvestingPro data, BioCryst’s stock has shown strong momentum, trading near its 52-week high of $9.00, reflecting growing investor confidence in the company’s expansion strategy.

The recommendation by Infarmed marks a significant milestone in the treatment of HAE in Portugal, providing a new prophylaxis option for patients and healthcare providers. Charlie Gayer, the chief commercial officer of BioCryst, expressed that the availability of ORLADEYO® could potentially enhance the quality of life for those affected by HAE in Portugal. The company maintains a healthy financial position with a current ratio of 2.78, indicating strong ability to meet short-term obligations, while maintaining a robust gross profit margin of 52.14%.

ORLADEYO® (berotralstat), which works by decreasing the activity of plasma kallikrein to prevent HAE attacks, was previously granted marketing authorization by the European Commission in April 2021. The drug is now licensed in 44 countries worldwide.

The medication is indicated for prophylaxis to prevent HAE attacks in adults and pediatric patients 12 years and older. It is not recommended for the treatment of acute HAE attacks or at dosages higher than 150 mg daily due to the risk of QT prolongation. Common adverse reactions reported in clinical trials include abdominal pain, vomiting, diarrhea, back pain, and gastroesophageal reflux disease.

Patients with moderate or severe hepatic impairment are advised to take a reduced dosage of 110 mg daily. Additionally, the use of P-glycoprotein inducers with ORLADEYO® is not recommended due to the potential for decreased efficacy. For medications predominantly metabolized by CYP2D6 or CYP3A4, monitoring and dose adjustments may be necessary.

The safety and efficacy of ORLADEYO® in children under 12 years of age have not been established, and there is limited data on its use during pregnancy and breastfeeding.

This news is based on a press release statement from BioCryst Pharmaceuticals, a global biotechnology company committed to developing therapies for rare diseases. With a market capitalization of $1.86 billion, the company emphasizes its expertise in drug design to offer first-in-class or best-in-class treatments for challenging medical conditions. For deeper insights into BioCryst’s financial health and growth prospects, including additional ProTips and comprehensive analysis, visit InvestingPro, where you’ll find detailed research reports and expert financial metrics.

In other recent news, BioCryst Pharmaceuticals has seen noteworthy developments related to its drug, Orladeyo. JMP Securities reiterated its Market Outperform rating with a steady price target of $18, based on the drug’s performance and potential market growth. Evercore ISI analyst Liisa Bayko raised the price target for BioCryst to $12, highlighting the company’s strong performance and future prospects.

BioCryst has also projected net revenue for Orladeyo to be between $515 million and $535 million for 2025, with total revenue including RAPIVAB expected to range from $540 million to $560 million. The company’s 2024 Orladeyo revenue reached $437 million, marking a 34% year-over-year increase.

In addition, BioCryst has adjusted the wholesale acquisition cost of Orladeyo in the U.S., as announced in a recent filing with the Securities and Exchange Commission. These are the latest developments in the progress of BioCryst Pharmaceuticals.

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