RESEARCH TRIANGLE PARK, N.C. - BioCryst (NASDAQ:BCRX) Pharmaceuticals, Inc. (NASDAQ:BCRX) has received approval from Mexico's Federal Commission for Protection against Health Risks (COFEPRIS) for ORLADEYO® (berotralstat), an oral, once-daily medication for the prophylaxis of hereditary angioedema (HAE) attacks in adults and pediatric patients 12 years of age and older.
This marks the fourth country in the pan-Latin America region to approve the drug, following Chile, Argentina, and Brazil.
ORLADEYO® (berotralstat) is the first and only oral therapy designed specifically to prevent HAE attacks. It functions by decreasing the activity of plasma kallikrein, an enzyme that can cause swelling in HAE patients. The medication is intended for daily use to help reduce the frequency of HAE attacks.
The most common adverse reactions reported in patients receiving ORLADEYO were abdominal pain, vomiting, diarrhea, back pain, and gastroesophageal reflux disease. It is recommended that patients with moderate or severe hepatic impairment take a reduced dosage. Additionally, the drug may interact with other medications by inhibiting certain enzymes and transport proteins.
The approval in Mexico expands the availability of ORLADEYO, providing a new option for HAE patients in the region. BioCryst's collaboration with Pint Pharma GmbH includes registering and promoting ORLADEYO across Latin America, with Pint responsible for obtaining and maintaining marketing authorizations and commercializing the drug.
BioCryst emphasizes its commitment to improving the lives of those with rare diseases through the development of oral small-molecule and protein therapeutics. The company has leveraged its expertise in structure-guided drug design to bring this treatment to market and continues to advance its pipeline of therapies.
The information in this article is based on a press release statement from BioCryst Pharmaceuticals , Inc.
InvestingPro Insights
As BioCryst Pharmaceuticals, Inc. (NASDAQ:BCRX) continues to expand its global footprint with the approval of ORLADEYO® in Mexico, investors and stakeholders may be interested in the company's financial health and market performance. According to InvestingPro data, BioCryst has a market capitalization of approximately $1.1 billion USD. Despite a notable revenue growth of 22.68% in the last twelve months as of Q1 2024, the company's P/E ratio stands at -6.12, indicating that it is not currently profitable.
InvestingPro Tips suggest that BioCryst's stock price movements are quite volatile, which could be a point of consideration for investors seeking stability. Moreover, analysts have revised their earnings downwards for the upcoming period and do not anticipate the company to be profitable this year. However, it's worth noting that the company's liquid assets exceed its short-term obligations, providing some financial flexibility in the near term.
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