BioCryst Launches ORLADEYO® (berotralstat) in Spain

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Rhea-AI Summary
BioCryst Pharmaceuticals, Inc. (BCRX) has received marketing authorization from the Spanish Ministry for Health for ORLADEYO® (berotralstat) for the prevention of recurrent hereditary angioedema attacks in HAE patients 12 years and older.
  • Marketing authorization granted by the Spanish Ministry for Health for ORLADEYO®
  • Expansion of market for BioCryst Pharmaceuticals, Inc.
  • Routine prevention of recurrent HAE attacks in HAE patients
  • None.

RESEARCH TRIANGLE PARK, N.C., Nov. 21, 2023 (GLOBE NEWSWIRE) -- BioCryst Pharmaceuticals, Inc. (Nasdaq: BCRX) today announced that the Spanish Ministry for Health (Ministerio de Sanidad) has granted marketing authorization for oral, once-daily ORLADEYO® (berotralstat) for the routine prevention of recurrent hereditary angioedema (HAE) attacks in HAE patients 12 years and older.

“We have an experienced and motivated team in Spain that is enthusiastic about the impact the availability of the first oral, once daily therapy can have for people with HAE in Spain,” said Charlie Gayer, chief commercial officer of BioCryst. “Spanish patients and physicians have shared with us the need to expand treatment options and we are excited now to be in a position to support access to those who can benefit most.”

About BioCryst Pharmaceuticals
BioCryst Pharmaceuticals is a global biotechnology company with a deep commitment to improving the lives of people living with complement-mediated and other rare diseases. BioCryst leverages its expertise in structure-guided drug design to develop first-in-class or best-in-class oral small-molecule and protein therapeutics to target difficult-to-treat rare diseases. BioCryst has commercialized ORLADEYO® (berotralstat), the first oral, once-daily plasma kallikrein inhibitor, and is advancing a pipeline of small-molecule and protein therapies. For more information, please visit or follow us on LinkedIn.

Forward-Looking Statements
This press release contains forward-looking statements, including statements regarding BioCryst’s plans and expectations for ORLADEYO. These statements involve known and unknown risks, uncertainties and other factors which may cause actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements. These statements reflect our current views with respect to future events and are based on assumptions and are subject to risks and uncertainties. Given these uncertainties, you should not place undue reliance on these forward-looking statements. Some of the factors that could affect the forward-looking statements contained herein include: the ongoing COVID-19 pandemic, which could create challenges in all aspects of BioCryst’s business, including without limitation delays, stoppages, difficulties and increased expenses with respect to BioCryst’s and its partners’ development, regulatory processes and supply chains, negatively impact BioCryst’s ability to access the capital or credit markets to finance its operations, or have the effect of heightening many of the risks described below or in the documents BioCryst files periodically with the Securities and Exchange Commission; BioCryst’s ability to successfully implement its commercialization plans for, and to commercialize, ORLADEYO, which could take longer or be more expensive than planned; the commercial viability of ORLADEYO, including its ability to achieve market acceptance; the FDA, Spanish Ministry for Health, or other applicable regulatory agency may require additional studies beyond the studies planned for products and product candidates, may not provide regulatory clearances which may result in delay of planned clinical trials, may impose certain restrictions, warnings, or other requirements on products and product candidates, may impose a clinical hold with respect to product candidates, or may withhold, delay, or withdraw market approval for products and product candidates; BioCryst’s ability to successfully manage its growth and compete effectively; risks related to the international expansion of BioCryst’s business; and actual financial results may not be consistent with expectations, including that revenue, operating expenses and cash usage may not be within management's expected ranges. Please refer to the documents BioCryst files periodically with the Securities and Exchange Commission, specifically BioCryst’s most recent Annual Report on Form 10-K, Quarterly Reports on Form 10-Q, and Current Reports on Form 8-K, which identify important factors that could cause the actual results to differ materially from those contained in BioCryst’s forward-looking statements.


Investor Contact:
John Bluth
+1 919 859 7910

Press Contact:
Niamh Lyons
+353 87 774 5000 

What is the marketing authorization granted by the Spanish Ministry for Health for BioCryst Pharmaceuticals, Inc. (BCRX)?

The Spanish Ministry for Health has granted marketing authorization for ORLADEYO® (berotralstat) for the routine prevention of recurrent hereditary angioedema attacks in HAE patients 12 years and older.

What is the target market for ORLADEYO® (berotralstat)?

ORLADEYO® is aimed at HAE patients 12 years and older for the prevention of recurrent hereditary angioedema attacks.

What is the impact of the marketing authorization on BioCryst Pharmaceuticals, Inc. (BCRX)?

The marketing authorization expands the market for BioCryst Pharmaceuticals, Inc. and its product ORLADEYO®, potentially leading to increased revenue and growth opportunities.
Biocryst Pharmaceuticals Inc.


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About BCRX

biocryst pharmaceuticals, a biotechnology company, designs, optimizes and develops novel small-molecule drugs that block key enzymes involved in infectious and rare diseases. founded in 1986, biocryst has more than 50 employees and is experiencing continued growth. the company’s headquarters are located in research triangle park, north carolina and its discovery center of excellence is in birmingham, alabama. with expertise in drug discovery, clinical development, regulatory affairs and product commercialization, we continue to advance our clinical programs and to generate new compounds from our own discovery engine. we are proud of our culture of engagement and accountability that rewards people for innovative thinking and achievement of key objectives. the commitment of biocryst remains unchanged. we continue to be passionate about developing and marketing novel therapeutics for patients with rare and serious diseases.