RESEARCH TRIANGLE PARK, N.C. - BioCryst (NASDAQ:BCRX) Pharmaceuticals, Inc. (NASDAQ:BCRX) received approval from Peru's health authorities for its hereditary angioedema (HAE) treatment, ORLADEYO (berotralstat), marking a significant step in the drug's expansion across Latin America. The General Directorate of Medicines, Supplies and Drugs (DIGEMID) in Peru has sanctioned the use of ORLADEYO for preventing HAE attacks in adults and pediatric patients aged 12 and above.
The approval in Peru follows the drug's authorization in other Latin American countries including Chile, Argentina, Brazil, and Mexico. BioCryst's partnership with Pint Pharma GmbH plays a crucial role in registering and commercializing the drug throughout the region. Pint Pharma is tasked with obtaining marketing authorizations and overseeing the commercial aspects of ORLADEYO in Latin America.
ORLADEYO is the first and only oral therapy specifically designed to prevent HAE attacks in adult and pediatric patients 12 years and older. It operates by reducing the activity of plasma kallikrein, an enzyme that can lead to swelling in HAE patients. The recommended dosage of ORLADEYO is one capsule per day.
BioCryst emphasizes its dedication to addressing complement-mediated and other rare diseases, with a portfolio that includes both small-molecule and protein therapeutics.
The information about ORLADEYO's approval in Peru is based on a press release statement from BioCryst Pharmaceuticals .
In other recent news, BioCryst Pharmaceuticals reported a strong first quarter in 2024, with revenues exceeding expectations due to the performance of its drug, ORLADEYO. The company's total quarterly revenue reached $92.8 million, leading BioCryst to increase its 2024 revenue guidance for ORLADEYO to $390 million to $400 million. BioCryst also shared its plans to achieve long-term financial goals, including a projected $1 billion in peak global revenue.
In company developments, BioCryst announced the expansion of its Stock Incentive Plan by 7 million shares, following a majority vote by shareholders at the Annual Meeting. The company also elected three directors and ratified the appointment of Ernst & Young LLP as independent auditors for 2024.
In terms of product advancements, BioCryst's hereditary angioedema (HAE) drug, ORLADEYO, received approval from Mexico's Federal Commission for Protection against Health Risks. This marks the fourth Latin American country to approve the drug, expanding its availability in the region.
The company is also advancing its pipeline with IND-enabling studies for a C5 inhibitor and a multifunctional complement inhibitor, with a pediatric approval for ORLADEYO planned for the next year.
These are the recent developments in BioCryst Pharmaceuticals.
InvestingPro Insights
In light of BioCryst Pharmaceuticals' recent approval for ORLADEYO in Peru, investors are closely monitoring the company's financial health and stock performance. According to InvestingPro data, BioCryst has a market capitalization of approximately $1.32 billion and has experienced notable revenue growth, with a 22.68% increase over the last twelve months as of Q1 2024. This growth is underscored by a quarterly revenue surge of 34.87% in Q1 2024, reflecting the company's expanding market presence.
While the company's gross profit margin stands at a robust 39.44%, indicating a strong ability to control costs relative to its revenue, it is important to note that BioCryst is currently not profitable, with a negative P/E ratio of -6.04. Further emphasizing this point, InvestingPro Tips suggest that analysts do not expect the company to be profitable this year, and there have been downward revisions in earnings estimates for the upcoming period. Nevertheless, the company's liquid assets surpass its short-term obligations, which may provide some financial stability as it continues to grow its market share.
Investors are also drawn to the stock's strong return over the last three months, with a 33.75% price total return, showcasing a potential value proposition for those willing to weather the stock's volatility. However, it's worth noting that BioCryst does not pay a dividend, which may be a consideration for income-focused investors. For those interested in a deeper dive into BioCryst's financials and stock performance, InvestingPro offers additional insights and metrics. With the use of promo code PRONEWS24, users can get up to 10% off a yearly Pro and a yearly or biyearly Pro+ subscription, providing access to an array of InvestingPro Tips—there are currently six more tips listed on InvestingPro for BioCryst, available at https://www.investing.com/pro/BCRX.
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