ORLADEYO® (berotralstat) now reimbursed in the NetherlandsRESEARCH TRIANGLE PARK, N.C., June 06, 2025 (GLOBE NEWSWIRE) -- BioCryst Pharmaceuticals, Inc. (Nasdaq: BCRX) today announced that, following a positive recommendation from the Zorginstituut Nederland, ORLADEYO® (berotralstat) has been approved for the routine prevention of hereditary angioedema (HAE) attacks in patients aged 12 years and older. This reimbursement approval in the Netherlands marks national reimbursement for ORLADEYO across all major ...

Summary of BioCryst Pharmaceuticals (BCRX) Conference Call Company Overview - **Company**: BioCryst Pharmaceuticals (BCRX) - **Focus**: Rare diseases, specifically targeting hereditary angioedema (HAE) with its lead drug Orlodayo, which is in its fifth year of launch [4][6] Financial Performance - **Profitability**: Expected to be profitable in 2025, with a strong financial position and debt reduction already achieved this year [5][68] - **Revenue Guidance**: Increased revenue guidance for 2025 to $580 million - $600 million from a previous estimate of $535 million - $550 million, driven by strong demand and patient access to paid therapy [6][7] Product Pipeline Orlodayo - **Market Performance**: Strong demand from both patients and physicians, particularly in the Medicare and commercial populations [7] - **Pediatric Opportunity**: FDA accepted the supplemental NDA for pediatric use with a PDUFA date set for September 12, 2025 [8][9] Netherton Syndrome (Drug: 17725) - **Mechanism of Action**: KLK5 inhibitor targeting a genetic disorder with a clear mechanism involving faulty gene function leading to uncontrolled KLK5 activity [12][13] - **Clinical Trials**: Initial evaluations in healthy volunteers have been positive, allowing progression to patient trials [20][21] - **Study Design**: Phase one study designed to assess drug penetration and skin healing, with a focus on skin outcomes and patient-reported outcomes [31][36] - **Market Opportunity**: Estimated 1,600 Netherton patients in the U.S., with potential growth as targeted therapy becomes available [49][50] Diabetic Macular Edema (DME) - **Drug: Vorlestat**: Lower solubility drug being developed for a suprachoroidal delivery approach, aiming for sustained exposure at the retina [58][60] - **Preclinical Data**: Positive results in animal models showing significant reduction in retinal vascular leakage, supporting the mechanism for DME treatment [63][64] - **Phase One Study**: Small study focusing on safety and retinal thickness changes over time, with a bar for success being measurable changes in retinal thickness [65][66] Financial Strategy - **Debt Management**: Paid down $75 million in Pharmakon debt, with a remaining debt of $249 million and a cash position of approximately $240 million [68] - **Future Investments**: Plans to continue paying down debt while investing in the pipeline and potential business development opportunities [68] Key Takeaways - BioCryst is positioned for growth with a strong financial outlook and promising drug pipeline focused on rare diseases - The company is actively pursuing regulatory approvals for pediatric indications and expanding its clinical trials for Netherton Syndrome and DME - Financial health is robust, allowing for continued investment in research and development while managing debt effectively [5][68]

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Here is the stock with buy rank and strong momentum characteristics for investors to consider today, June 4th:BioCryst Pharmaceuticals (BCRX) : This company which is a leader in the use of crystallography and structure-based drug design for the development of novel therapeutics to treat cancer, cardiovascular diseases, autoimmune diseases, and viral infections, has a Zacks Rank #1(Strong Buy), and witnessed the Zacks Consensus Estimate for its next year earnings increasing 83.3% over the last 60 days.BioCry ...

RESEARCH TRIANGLE PARK, N.C., June 02, 2025 (GLOBE NEWSWIRE) -- BioCryst Pharmaceuticals, Inc. (Nasdaq: BCRX) today 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. BioCryst will present four abstracts at the meeting: Impact of Berotralstat on Quality of Life among Patients with H ...

New data shared at the 14th C1-inhibitor Deficiency & Angioedema Workshop supports berotralstat use at all stages of lifeRESEARCH TRIANGLE PARK, N.C., May 30, 2025 (GLOBE NEWSWIRE) -- BioCryst Pharmaceuticals, Inc. (Nasdaq: BCRX) today 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 ...

Group 1 - BioCryst Pharmaceuticals (BCRX) closed at $10.59, with a 26.2% gain over the past four weeks, and a mean price target of $16.50 indicating a 55.8% upside potential [1] - The average of 12 short-term price targets ranges from a low of $11 to a high of $30, with a standard deviation of $5.32, suggesting variability in analyst estimates [2] - Analysts show strong agreement on BCRX's ability to report better earnings than previously predicted, which supports the potential for stock upside [4][11] Group 2 - The Zacks Consensus Estimate for the current year has increased by 366.9% over the past month, with six estimates revised higher and no negative revisions [12] - BCRX holds a Zacks Rank 2 (Buy), placing it in the top 20% of over 4,000 ranked stocks based on earnings estimates [13] - While consensus price targets may not be reliable for predicting stock gains, they can indicate potential price movement direction [13]

Core Insights - BioCryst Pharmaceuticals announced significant real-world evidence demonstrating the effectiveness of ORLADEYO (berotralstat) in reducing hereditary angioedema (HAE) attack rates in adolescents and individuals with severe HAE over an 18-month follow-up period [1][3][7] Group 1: Study Findings - The study presented at the ISPOR 2025 conference showed that patients experienced significantly lower HAE attack rates while on ORLADEYO, with a reduction from a baseline of 7.78-8.23 attacks/month to 1.24-1.90 attacks/month [10] - Specifically, patients had 6.25 fewer attacks/month at 12 months and 6.43 fewer attacks/month at 18 months after starting ORLADEYO [10] - Adolescents aged 12-17 years also showed significant reductions, with 1.56 fewer attacks/month at 12 months and 1.85 fewer attacks/month at 18 months [10] Group 2: Patient Population - The findings were based on a retrospective pre-post study involving 56 U.S. patients with C1-inhibitor deficiency and 99 U.S. adolescents with HAE [5][6] - The results indicate that ORLADEYO is effective across different age groups and severity levels of HAE, providing confidence to both physicians and patients [3][7] Group 3: Product Information - ORLADEYO is the first and only oral therapy specifically designed for the prophylaxis of HAE attacks in patients aged 12 years and older, functioning as a plasma kallikrein inhibitor [8][9] - The therapy is administered as a once-daily capsule, which works by decreasing the activity of plasma kallikrein to prevent HAE attacks [8]

Summary of BioCryst Pharmaceuticals (BCRX) Conference Call Company Overview - **Company**: BioCryst Pharmaceuticals (BCRX) - **Event**: 2025 Conference on May 14, 2025 - **Speakers**: John Stonehouse (CEO), Charlie Geier (Chief Commercial Officer) Key Industry Insights - **Impact of Executive Orders**: The recent executive order regarding most favored nation status may affect BioCryst, but details are still unclear. The company is monitoring the situation closely [3][4][5] - **Tariff Position**: BioCryst feels well-positioned regarding tariffs due to low cost of goods for Orlodea and a redundant supply chain in both Europe and the US [8] Financial Performance - **Q1 Results**: BioCryst reported a 51% year-over-year growth in Q1, driven by strong demand and an increase in the paid rate for Orlodea [13][14] - **Paid Rate Increase**: The paid rate for patients has jumped to 84%, with Medicare segment reaching 89%, attributed to the IRA making drugs more affordable [15] - **Sales Guidance**: The company is confident in achieving at least $800 million in US sales, with a global sales target of $1 billion by 2029 [27][29] Product Insights - **Orlodea**: The product has shown strong market demand and patient retention due to its efficacy and convenience. Patients prefer Orlodea for its oral administration and low attack rates [18][19][20][22] - **Market Stickiness**: The stickiness of the market is attributed to patient satisfaction with Orlodea, making it difficult for new competitors to gain traction [20] Pipeline Developments - **BCX1775**: The company is advancing its first biologic for Netherton Syndrome, aiming to control KLK activity and improve skin turnover [36][38] - **Avorostat**: This drug is being explored for diabetic macular edema (DME), with a focus on its potential to address unmet needs in patients who do not respond to VEGF therapies [68][70] Clinical Trials and Future Outlook - **Clinical Trials**: BioCryst is conducting studies for both BCX1775 and Avorostat, with expectations for data by the end of the year. The company is optimistic about the potential for accelerated pathways to market if results are favorable [61][66][78] - **Market Potential**: The company believes that the market for Netherton Syndrome could grow significantly if a targeted therapy is introduced, similar to the growth seen in other rare diseases [56] Conclusion - BioCryst Pharmaceuticals is positioned for strong growth with its current product offerings and pipeline developments. The company is actively monitoring regulatory changes and market dynamics while focusing on delivering effective therapies for rare diseases.

Group 1: BioCryst Pharmaceuticals, Inc. (BCRX) - BioCryst has a Zacks Rank 1 and the Zacks Consensus Estimate for its current year earnings increased by 285.7% over the last 60 days [1] - The company's shares gained 15% over the last three months, while the S&P 500 declined by 7.2% [1] - BioCryst possesses a Momentum Score of A [1] Group 2: WidePoint Corporation (WYY) - WidePoint has a Zacks Rank 1 and the Zacks Consensus Estimate for its current year earnings increased by 108.3% over the last 60 days [2] - The company's shares gained 35.7% over the last three months, compared to the S&P 500's decline of 7.2% [2] - WidePoint possesses a Momentum Score of B [2] Group 3: Rambus Inc. (RMBS) - Rambus has a Zacks Rank 1 and the Zacks Consensus Estimate for its current year earnings increased by 3.9% over the last 60 days [3] - The company's shares gained 11.6% over the past month, while the S&P 500 advanced by 6.9% [3] - Rambus possesses a Momentum Score of B [3]