This section highlights FDA-related milestones and regulatory updates for drugs developed by BioCryst Pharmaceuticals (BCRX).
Over the past two years, BioCryst Pharmaceuticals has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as
BCX17725, ORLADEYO, and RAPIVAB. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.
BCX17725 - FDA Regulatory Timeline and Events
BCX17725 is a drug developed by BioCryst Pharmaceuticals for the following indication: For the Treatment of Netherton Syndrome.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- BCX17725
- Announced Date:
- October 2, 2024
- Indication:
- For the Treatment of Netherton Syndrome
Announcement
BioCryst Pharmaceuticals, Inc announced the enrollment of the first participant in a Phase 1 trial evaluating BCX17725, a potent and selective investigational kallikrein 5 (KLK5) inhibitor designed to provide best-in-class disease-modifying treatment for people with Netherton syndrome.
AI Summary
BioCryst Pharmaceuticals has enrolled the first participant in a Phase 1 trial for its investigational drug, BCX17725, a novel kallikrein 5 (KLK5) inhibitor. The drug is designed to treat Netherton syndrome, a rare genetic disorder that causes severe skin, hair, and immune problems. Netherton syndrome patients currently rely on topical treatments and supportive care, highlighting an unmet need for a therapy that targets the root cause of the disease. BCX17725 aims to modify the disease by inhibiting the overactive KLK5 enzyme, which is responsible for the abnormal skin symptoms. The trial will assess the safety, tolerability, pharmacokinetics, and immunogenicity of the drug. Early data from the trial is expected by the end of 2025, and BioCryst hopes that BCX17725 could emerge as a best-in-class treatment option for those struggling with this challenging condition.
Read Announcement- Drug:
- BCX17725
- Announced Date:
- October 2, 2024
- Estimated Event Date Range:
- October 1, 2025 - December 31, 2025
- Target Action Date:
- LATE 2025
- Indication:
- For the Treatment of Netherton Syndrome
Announcement
BioCryst Pharmaceuticals, Inc announced that Initial data from trial expected by end of 2025
AI Summary
BioCryst Pharmaceuticals, Inc. has started its Phase 1 trial for BCX17725, a promising protein therapeutic designed to treat Netherton syndrome. The treatment works by inhibiting the overactive enzyme kallikrein 5 (KLK5), which is believed to contribute to the skin problems seen in this rare genetic disorder. With a goal of meeting a significant unmet need, the company is focusing on a therapy that not only eases symptoms but also targets the root cause of the disease. The trial will assess the safety and proper dosing of BCX17725 in both healthy adult volunteers and participants with Netherton syndrome. BioCryst expects to report the initial trial data by the end of 2025, potentially marking a key step toward a targeted, best-in-class treatment for this challenging condition.
Read Announcement
ORLADEYO (berotralstat) - FDA Regulatory Timeline and Events
ORLADEYO (berotralstat) is a drug developed by BioCryst Pharmaceuticals for the following indication: Hereditary angioedema (HAE).
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- ORLADEYO (berotralstat)
- Announced Date:
- June 16, 2025
- Indication:
- Hereditary angioedema (HAE)
Announcement
BioCryst Pharmaceuticals, Inc. ( announced new data on the long-term efficacy and safety of ORLADEYO® (berotralstat) for the prophylactic treatment of hereditary angioedema (HAE) in patients across all age groups.
AI Summary
BioCryst Pharmaceuticals recently presented new data on the long-term efficacy and safety of ORLADEYO® (berotralstat) for preventing hereditary angioedema (HAE) attacks in patients of all ages. The findings come from both clinical trials and real-world studies, highlighting that the medication consistently reduces the number and severity of HAE attacks in pediatric, adolescent, and adult populations. Patients experienced fewer attacks and significant improvements in daily functioning and overall quality of life. The data affirm that ORLADEYO is well tolerated, with a safety profile that remains consistent across age groups. These results add to the growing evidence supporting ORLADEYO as a reliable long-term prophylactic treatment option for those living with HAE, reinforcing its role in improving both the clinical outcomes and the everyday wellbeing of patients affected by this rare condition.
Read Announcement- Drug:
- ORLADEYO (berotralstat)
- Announced Date:
- June 13, 2025
- Indication:
- Hereditary angioedema (HAE)
Announcement
BioCryst Pharmaceuticals, Inc. announced that the National Institute of Drug and Food Surveillance (INVIMA) in Colombia has granted approval for oral, once-daily ORLADEYO® (berotralstat) for the prophylaxis of hereditary angioedema (HAE) attacks in adults and pediatric patients 12 years of age or older.
AI Summary
BioCryst Pharmaceuticals announced that Colombia’s National Institute of Drug and Food Surveillance (INVIMA) has granted approval for its oral once-daily ORLADEYO® (berotralstat). The approval allows ORLADEYO to be used as a prophylactic treatment to prevent hereditary angioedema (HAE) attacks in adults and pediatric patients aged 12 years and older. This decision marks an important step in providing more treatment options for people living with HAE in Colombia and potentially across Latin America. BioCryst is collaborating with Pint Pharma to help bring the treatment to market in the region. The approval follows previous INVIMA decisions in other Latin American countries, underlining BioCryst’s commitment to expanding access to innovative therapies for HAE patients.
Read Announcement- Drug:
- ORLADEYO (berotralstat)
- Announced Date:
- June 2, 2025
- Indication:
- Hereditary angioedema (HAE)
Announcement
BioCryst Pharmaceuticals, Inc. announced that new data on oral, once-daily ORLADEYO® (berotralstat) for the prophylactic treatment of hereditary angioedema (HAE) will be presented at the European Academy of Allergy and Clinical Immunology (EAACI) meeting in Glasgow, United Kingdom, from June 13 to 16, 2025.
AI Summary
BioCryst Pharmaceuticals announced that it will present new data on ORLADEYO® (berotralstat), an oral, once-daily treatment for the prophylaxis of hereditary angioedema (HAE), at the European Academy of Allergy and Clinical Immunology (EAACI) meeting in Glasgow, United Kingdom, from June 13 to 16, 2025. The company plans to share four abstracts that cover various aspects of the therapy, including its impact on quality of life, positive patient feedback from focus groups, and long-term effectiveness and tolerability as observed in the Berolife Study. Additionally, interim results highlighting a reduction in the number of HAE attacks requiring intervention in pediatric patients will be presented. This upcoming presentation underscores ORLADEYO’s role as a pioneering oral therapy for both adult and adolescent patients with HAE and BioCryst’s ongoing commitment to improving care for those affected by this rare disease.
Read Announcement- Drug:
- ORLADEYO (berotralstat)
- Announced Date:
- May 30, 2025
- Indication:
- Hereditary angioedema (HAE)
Announcement
BioCryst Pharmaceuticals, Inc announced new data which highlights the reduction in the percentage of days with hereditary angioedema (HAE) symptoms among young children initiating berotralstat in the APeX-P trial, and the broad safety and efficacy outcomes observed across all age groups of patients taking ORLADEYO to prevent HAE attacks.
AI Summary
BioCryst Pharmaceuticals recently announced promising new data from their APeX-P trial. The study showed that young children with hereditary angioedema (HAE) who started treatment with berotralstat experienced a significant drop in the percentage of days with HAE symptoms—from an average of 11% before treatment to 4% after 12 weeks. This reduction indicates that the treatment may help children experience fewer symptoms and improved daily life.
In addition to these findings in children, the results also highlighted the broad safety and effectiveness of ORLADEYO (berotralstat) across all age groups. Patients from adolescents to adults taking this once-daily oral medication reported consistent benefits in preventing HAE attacks. The data underscores the potential of this therapy to offer meaningful, long-term relief, ensuring more attack-free days for individuals living with HAE regardless of their age.
Read Announcement- Drug:
- ORLADEYO (berotralstat)
- Announced Date:
- May 16, 2025
- Indication:
- Hereditary angioedema (HAE)
Announcement
BioCryst Pharmaceuticals, Inc. announced new real-world evidence on the use of oral, once-daily ORLADEYO® (berotralstat) in adolescents and people with severe HAE showing significant and sustained reductions in HAE attack rates through 18 months of follow-up after beginning treatment with ORLADEYO in both patient populations.
AI Summary
BioCryst Pharmaceuticals announced promising real-world evidence for its oral, once-daily therapy ORLADEYO® (berotralstat) in treating hereditary angioedema (HAE) in adolescents and patients with severe disease. The study showed significant and sustained reductions in HAE attack rates during 18 months of follow-up after starting treatment. Adolescents experienced up to 1.85 fewer attacks per month, while those with severe HAE saw reductions of up to 6.43 attacks per month compared to baseline levels.
These results, presented at the 2025 ISPOR conference, indicate that ORLADEYO can offer improved attack control over time. This new evidence provides additional reassurance for physicians and patients managing HAE, suggesting that long-term treatment with ORLADEYO is effective in reducing the frequency of painful HAE attacks in diverse patient populations.
Read Announcement- Drug:
- ORLADEYO (berotralstat)
- Announced Date:
- May 14, 2025
- Indication:
- Hereditary angioedema (HAE)
Announcement
BioCryst Pharmaceuticals, Inc announced that the U.S. Food and Drug Administration (FDA) has accepted its New Drug Application (NDA) for the use of oral, once-daily ORLADEYO® (berotralstat) in pediatric patients with hereditary angioedema (HAE) aged 2 to 11 years.
AI Summary
BioCryst Pharmaceuticals announced that the FDA has accepted its New Drug Application (NDA) for the use of ORLADEYO® (berotralstat) as a once-daily oral treatment for pediatric patients aged 2 to 11 with hereditary angioedema (HAE). The therapy, if approved, would be the first targeted oral prophylactic treatment for children under 12 with HAE.
The FDA has granted Priority Review for this application, with a Prescription Drug User Fee Act (PDUFA) target action date of September 12, 2025. This decision is based on encouraging interim data from the APeX-P clinical trial, which is the largest trial for a prophylactic therapy in this age group. The promising results indicate that ORLADEYO is well tolerated and effectively reduces the frequency of HAE attacks, offering a more convenient and safer option for young children and their families.
Read Announcement- Drug:
- ORLADEYO (berotralstat)
- Announced Date:
- May 14, 2025
- Estimated Event Date Range:
- September 12, 2025 - September 12, 2025
- Target Action Date:
- September 12, 2025
- Indication:
- Hereditary angioedema (HAE)
Announcement
BioCryst Pharmaceuticals, Inc. FDA grants Priority Review of application, with PDUFA target action date of September 12, 2025–
AI Summary
BioCryst Pharmaceuticals recently received FDA Priority Review for its New Drug Application for ORLADEYO®, an oral once-daily therapy intended to prevent hereditary angioedema attacks in pediatric patients aged 2 to 11 years. The FDA’s decision comes with a Prescription Drug User Fee Act (PDUFA) target action date set for September 12, 2025. If approved, ORLADEYO® would be the first targeted oral prophylactic treatment for children under 12, offering a more convenient option than current therapies. The application was supported by positive interim data from the APeX-P clinical trial, which showed that the treatment was well tolerated and effective in reducing monthly attack rates in this young population. BioCryst’s initiative aims to address a significant need for early intervention in hereditary angioedema, potentially improving the quality of life for affected children and their families.
Read Announcement- Drug:
- ORLADEYO (berotralstat)
- Announced Date:
- February 12, 2025
- Indication:
- Hereditary angioedema (HAE)
Announcement
BioCryst Pharmaceuticals, Inc. announced that Infarmed in Portugal has recommended ORLADEYO® (berotralstat) for the routine prevention of recurrent attacks of hereditary angioedema (HAE) in eligible patients 12 years and older.
AI Summary
BioCryst Pharmaceuticals announced that Infarmed in Portugal has recommended ORLADEYO® (berotralstat) for the routine prevention of recurrent hereditary angioedema (HAE) attacks in eligible patients aged 12 and older. This new recommendation means that Portuguese patients will now have access to the first oral, once-daily therapy designed specifically to reduce the frequency of HAE attacks. By easing the treatment process with a simple daily capsule, ORLADEYO offers a convenient, modern option that could improve the quality of life for those affected by this rare condition. The treatment works by decreasing the activity of plasma kallikrein, an enzyme that contributes to HAE attacks. This positive recommendation from Infarmed follows the earlier European Commission marketing authorization and adds to the growing availability of this innovative prophylactic treatment across multiple countries.
Read Announcement- Drug:
- ORLADEYO (berotralstat)
- Announced Date:
- February 10, 2025
- Indication:
- Hereditary angioedema (HAE)
Announcement
BioCryst Pharmaceuticals, Inc. announced that the company will present five abstracts featuring new clinical and real-world outcomes with oral, once-daily ORLADEYO® (berotralstat) for the prophylactic treatment of hereditary angioedema (HAE) at the 2025 American Academy of Allergy, Asthma & Immunology (AAAAI) / World Allergy Organization (WAO) joint congress.
AI Summary
BioCryst Pharmaceuticals, Inc. announced it will present five abstracts at the 2025 American Academy of Allergy, Asthma & Immunology (AAAAI) / World Allergy Organization (WAO) joint congress. The abstracts highlight new clinical and real-world outcomes for ORLADEYO® (berotralstat), an oral, once-daily medication designed to prevent attacks in patients with hereditary angioedema (HAE).
One key abstract is a late-breaking study presenting initial results from the APeX-P trial, which evaluates the effectiveness of ORLADEYO in pediatric patients aged 2 to less than 12 years. The other abstracts provide insights into attack rate reductions, patient reported outcomes, and treatment preferences. The presentations, scheduled for March 2 at the San Diego Convention Center, will share valuable data that could impact the management of HAE across different age groups.
Read Announcement- Drug:
- ORLADEYO (berotralstat)
- Announced Date:
- November 18, 2024
- Indication:
- Hereditary angioedema (HAE)
Announcement
BioCryst Pharmaceuticals, Inc announced that the Health Services Executive (HSE) in Ireland has recommended ORLADEYO® (berotralstat) for the routine prevention of recurrent attacks of hereditary angioedema (HAE) in eligible patients 12 years and older.
AI Summary
BioCryst Pharmaceuticals, Inc. announced that Ireland’s Health Service Executive (HSE) has recommended ORLADEYO® (berotralstat) for the routine prevention of recurrent hereditary angioedema (HAE) attacks in eligible patients aged 12 years and older. This recommendation provides HAE patients in Ireland with the first oral, once-daily treatment option aimed at reducing the frequency of their attacks.
The HSE decision supports a modern approach to HAE management by giving physicians greater flexibility in prescribing a reliable prophylactic therapy. With ORLADEYO already having received European Commission marketing authorization in 2021 and being licensed in 44 countries, the new recommendation underlines its growing acceptance as a valuable treatment option. This development is expected to improve quality of life for HAE patients by offering them an easy-to-use and effective treatment alternative.
Read Announcement- Drug:
- ORLADEYO (berotralstat)
- Announced Date:
- October 10, 2024
- Indication:
- Hereditary angioedema (HAE)
Announcement
BioCryst Pharmaceuticals, Inc announced that the company will present four abstracts on oral, once-daily ORLADEYO® (berotralstat) for the prophylactic treatment of hereditary angioedema (HAE) in patients 12 years and older at the Annual Scientific Meeting of the American College of Allergy, Asthma & Immunology (ACAAI).
AI Summary
BioCryst Pharmaceuticals, Inc. announced that it will present four abstracts at the Annual Scientific Meeting of the American College of Allergy, Asthma & Immunology (ACAAI) in Boston from October 24-28, 2024. The abstracts will focus on the use of the company’s oral, once-daily therapy, ORLADEYO® (berotralstat), for the prophylactic treatment of hereditary angioedema (HAE) in patients 12 years and older. Data to be presented is expected to show high patient adherence and persistence, sustained reductions in HAE attacks, and a patient preference for this convenient, oral treatment compared to other methods. The findings underscore key benefits of ORLADEYO® in real-world settings and highlight its potential to improve the quality of life for those managing HAE through an effective and patient-friendly treatment option.
Read Announcement- Drug:
- ORLADEYO (berotralstat)
- Announced Date:
- September 17, 2024
- Indication:
- Hereditary angioedema (HAE)
Announcement
BioCryst Pharmaceuticals, Inc. announced that it successfully completed negotiations with the pan-Canadian Pharmaceutical Alliance (pCPA) for oral, once-daily PrORLADEYO® (berotralstat), which is approved in Canada for the routine prevention of attacks of hereditary angioedema (HAE) in adults and pediatric patients 12 years of age and older.
AI Summary
BioCryst Pharmaceuticals announced it has successfully completed negotiations with the pan-Canadian Pharmaceutical Alliance (pCPA) for its oral, once-daily medicine PrORLADEYO® (berotralstat). This agreement is a key step toward making the drug accessible through Canada’s publicly funded healthcare system. PrORLADEYO® is approved by Health Canada for preventing attacks of hereditary angioedema (HAE) in adults and pediatric patients aged 12 years and older.
The deal with pCPA will help include PrORLADEYO® on public formularies, ensuring broader access for Canadian patients who live with HAE. This progress follows the drug's approval by Health Canada and positive recommendations from Canada’s Drug Agency and INESSS. The outcome of these negotiations is expected to improve the quality of life for many Canadians managing HAE by offering a convenient, once-daily treatment option.
Read Announcement- Drug:
- ORLADEYO (berotralstat)
- Announced Date:
- September 6, 2024
- Indication:
- Hereditary angioedema (HAE)
Announcement
BioCryst Pharmaceuticals, Inc. announced the presentation of six posters, including the first interim real-word evidence from the APeX-N trial, and new data highlighting the value of shared decision making (SDM) between healthcare providers (HCPs) and their hereditary angioedema (HAE) patients to provide optimal patient outcomes.
AI Summary
BioCryst Pharmaceuticals recently announced that it will present six posters at the 7th Bradykinin Symposium in Berlin. One of the key highlights is the first interim real-world evidence from the APeX-N trial. This study, which gathered data from patients across several European countries, evaluated the safety and effectiveness of oral berotralstat for hereditary angioedema (HAE) prophylaxis. The interim results support previous clinical findings and show promising outcomes in terms of quality of life and tolerability.
Another important aspect of the presentation focused on the value of shared decision making (SDM) between healthcare providers and their HAE patients. New data emphasized that when both parties engage in thorough and open communication, barriers to effective HAE treatment can be overcome, resulting in better and more personalized patient care. This approach aims to improve overall treatment success and patient outcomes.
Read Announcement- Drug:
- ORLADEYO (berotralstat)
- Announced Date:
- July 9, 2024
- Indication:
- Hereditary angioedema (HAE)
Announcement
BioCryst Pharmaceuticals, Inc announced that the General Directorate of Medicines, Supplies and Drugs (DIGEMID) in Peru has granted approval for oral, once-daily ORLADEYO® (berotralstat) for the prophylaxis of hereditary angioedema (HAE) attacks in adults and pediatric patients 12 years of age or older.
AI Summary
BioCryst Pharmaceuticals, Inc. announced that Peru’s General Directorate of Medicines, Supplies and Drugs (DIGEMID) has approved ORLADEYO® (berotralstat) for the prophylaxis of hereditary angioedema (HAE) attacks in adults and pediatric patients 12 years and older. The once-daily oral therapy is designed to reduce HAE attacks by decreasing plasma kallikrein activity, providing a new preventive option for patients with this rare condition. BioCryst, in collaboration with Pint Pharma, aims to expand access to ORLADEYO across the pan-Latin America region. This approval in Peru follows previous regulatory successes in several other Latin American countries. BioCryst is committed to innovating treatments for HAE and other complement-mediated and rare diseases, offering an additional therapy option that supports patients in managing their condition on a daily basis.
Read Announcement- Drug:
- ORLADEYO (berotralstat)
- Announced Date:
- June 2, 2024
- Indication:
- Hereditary angioedema (HAE)
Announcement
BioCryst Pharmaceuticals, Inc announced new real-world evidence showing that patients with hereditary angioedema (HAE) who have normal C1-inhibitor (HAE-nC1-INH) level and function had a reduction in monthly attack rates after starting oral, once-daily ORLADEYO® (berotralstat). The data were presented at the European Academy of Allergy and Clinical Immunology (EAACI) Congress in Valencia, Spain.
AI Summary
BioCryst Pharmaceuticals recently presented promising real-world evidence on ORLADEYO® (berotralstat) for patients with hereditary angioedema (HAE) who have normal C1-inhibitor levels (HAE-nC1-INH). Presented at the European Academy of Allergy and Clinical Immunology (EAACI) Congress in Valencia, Spain, the study followed six patients over six months. Five patients experienced a reduction in their monthly HAE attack rates by 75% to 100% after starting the once-daily oral treatment, while one patient, concurrently taking tranexamic acid, saw a 29% reduction. Only one patient reported mild gastrointestinal symptoms at the start, which eased within two weeks without causing treatment discontinuation. These early findings offer valuable insight into the potential of ORLADEYO® to effectively reduce both the frequency and duration of HAE attacks in patients with normal C1-inhibitor levels.
Read Announcement - Drug:
- ORLADEYO (berotralstat)
- Announced Date:
- May 14, 2024
- Indication:
- Hereditary angioedema (HAE)
Announcement
BioCryst Pharmaceuticals Inc. announced that new data on oral, once-daily ORLADEYO® (berotralstat) for the prophylactic treatment of hereditary angioedema (HAE) will be presented at the European Academy of Allergy and Clinical Immunology (EAACI) meeting in Valencia, Spain from May 31 to June 3, 2024.
AI Summary
BioCryst Pharmaceuticals Inc. announced that new data on their once-daily oral drug ORLADEYO® (berotralstat) for the prophylactic treatment of hereditary angioedema (HAE) will be presented soon. The upcoming findings aim to provide further insights into the safety and effectiveness of ORLADEYO in reducing the frequency and severity of HAE attacks, a condition that requires ongoing management and can seriously impact patient quality of life.
The data will be shared at the European Academy of Allergy and Clinical Immunology (EAACI) meeting in Valencia, Spain, scheduled from May 31 to June 3, 2024. This event will bring together healthcare professionals and experts who will discuss the new information, helping them better understand the role of ORLADEYO in improving treatment strategies for patients with HAE.
Read Announcement- Drug:
- ORLADEYO (berotralstat)
- Announced Date:
- May 9, 2024
- Indication:
- Hereditary angioedema (HAE)
Announcement
BioCryst Pharmaceuticals announced new real-world evidence on the use of oral, once-daily ORLADEYO® (berotralstat) demonstrating that patients with hereditary angioedema (HAE) in the United States experience significant reductions in healthcare resource utilization (HRU) after beginning treatment with ORLADEYO.
Read Announcement- Drug:
- ORLADEYO (berotralstat)
- Announced Date:
- April 17, 2024
- Indication:
- Hereditary angioedema (HAE)
Announcement
BioCryst Pharmaceuticals, Inc announced that the Brazilian Health Regulatory Agency (ANVISA) has granted approval for oral, once-daily ORLADEYO® (berotralstat) for the prophylaxis of hereditary angioedema (HAE) attacks in adults and pediatric patients 12 years of age or older.
AI Summary
BioCryst Pharmaceuticals, Inc. announced that the Brazilian Health Regulatory Agency (ANVISA) has approved the use of ORLADEYO® (berotralstat) in Brazil. This oral, once-daily treatment is designed to prevent hereditary angioedema (HAE) attacks in adults and in pediatric patients aged 12 years and older. The approval marks an important milestone, providing a new and convenient option for patients living with HAE in one of Latin America’s largest markets. BioCryst expressed excitement about making the treatment accessible and is partnering with Pint Pharma to support the commercial launch throughout Brazil and the broader Latin American region. ORLADEYO works by reducing plasma kallikrein activity, aiming to decrease the frequency of HAE attacks and improve patients’ quality of life. This approval offers renewed hope to HAE patients who need effective daily protection against their condition.
Read Announcement
RAPIVAB - FDA Regulatory Timeline and Events
RAPIVAB is a drug developed by BioCryst Pharmaceuticals for the following indication: For the treatment of influenza.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- RAPIVAB
- Announced Date:
- September 30, 2024
- Indication:
- For the treatment of influenza.
Announcement
BioCryst Pharmaceuticals, Inc. announced that the U.S. Department of Health and Human Services (HHS) has awarded BioCryst up to a $69 million contract for the procurement of up to 95,625 doses over a five-year period of RAPIVAB® (peramivir injection) for the treatment of influenza.
AI Summary
BioCryst Pharmaceuticals, Inc. announced that the U.S. Department of Health and Human Services (HHS) has awarded the company a contract worth up to $69 million. Under this agreement, BioCryst will supply up to 95,625 doses of RAPIVAB® (peramivir injection) over a five-year period to treat influenza. The contract is designed to provide RAPIVAB for the Strategic National Stockpile, ensuring the availability of this valuable treatment during public health emergencies. The structure includes a 12-month base ordering period supplemented by four additional optional 12-month periods. In its first ordering period, HHS committed $13.9 million for 19,125 doses, with future orders to be determined annually. This award underlines the importance of maintaining sufficient supplies of RAPIVAB as a critical therapeutic option in the event of significant influenza outbreaks, reinforcing the nation’s preparedness efforts against emerging influenza threats.
Read Announcement
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