BioCryst Pharmaceuticals (BCRX) appears an attractive pick, as it has been recently upgraded to a Zacks Rank #1 (Strong Buy). An upward trend in earnings estimates -- one of the most powerful forces impacting stock prices -- has triggered this rating change.The sole determinant of the Zacks rating is a company's changing earnings picture. The Zacks Consensus Estimate -- the consensus of EPS estimates from the sell-side analysts covering the stock -- for the current and following years is tracked by the syst ...

Company Performance - Acurx Pharmaceuticals, Inc. (ACXP) has returned 0.8% year-to-date, outperforming the Medical sector, which has returned an average of -4.7% [4] - The Zacks Consensus Estimate for ACXP's full-year earnings has increased by 60.5% over the past quarter, indicating improved analyst sentiment and a stronger earnings outlook [4] Industry Ranking - Acurx Pharmaceuticals belongs to the Medical - Biomedical and Genetics industry, which has 502 stocks and is currently ranked 88 in the Zacks Industry Rank. This industry has lost an average of 4.8% year-to-date, showing that ACXP is performing better than its peers [6] - The Medical group, which includes Acurx Pharmaceuticals, is ranked 6 within the Zacks Sector Rank, indicating a relatively strong position among 16 sector groups [2] Comparison with Peers - BioCryst Pharmaceuticals (BCRX) has also outperformed the Medical sector with a year-to-date return of 32.6% and has a Zacks Rank of 2 (Buy) [5] - The consensus EPS estimate for BioCryst Pharmaceuticals has increased by 339.6% over the past three months, highlighting significant positive analyst sentiment [5]

—Data across pediatric, adolescent, and adult populations demonstrate sustained reductions in HAE attacks and consistent safety profile— —Patients report improved quality of life and daily functioning with ORLADEYO— RESEARCH TRIANGLE PARK, N.C., June 16, 2025 (GLOBE NEWSWIRE) -- BioCryst Pharmaceuticals, Inc.(Nasdaq:BCRX) today 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. "T ...

Core Viewpoint - BioCryst Pharmaceuticals has received approval from INVIMA in Colombia for ORLADEYO (berotralstat) as a prophylactic treatment for hereditary angioedema (HAE) in patients aged 12 and older, marking a significant advancement in treatment options for HAE in the pan-Latin America region [1][2]. Group 1: Product Information - ORLADEYO is the first and only oral therapy specifically designed to prevent HAE attacks in adults and pediatric patients aged 12 years and older, administered as one capsule daily [4]. - The drug functions by inhibiting plasma kallikrein, which is involved in the pathophysiology of HAE [4]. - ORLADEYO has already received regulatory approvals in several Latin American countries, including Chile, Argentina, Brazil, Mexico, and Peru [3]. Group 2: Commercial Strategy - BioCryst has an exclusive collaboration with Pint Pharma GmbH for the registration and promotion of ORLADEYO in the pan-Latin America region, with Pint responsible for obtaining marketing authorizations and commercialization [3]. - Following the approval from INVIMA, BioCryst is working with Pint Pharma to ensure the availability of ORLADEYO to patients in Colombia [2]. Group 3: Safety and Usage Information - ORLADEYO is indicated for the prophylaxis of HAE attacks but is not approved for the treatment of acute HAE attacks [5][6]. - The recommended dosage is 150 mg once daily, with a reduced dosage of 110 mg for patients with moderate or severe hepatic impairment [7]. - Common adverse reactions include abdominal pain, vomiting, diarrhea, back pain, and gastroesophageal reflux disease, occurring in 10% or more of patients [7].

Core Insights - BioCryst Pharmaceuticals has secured reimbursement approval for ORLADEYO (berotralstat) in the Netherlands, enabling routine prevention of hereditary angioedema (HAE) attacks for patients aged 12 and older [1][2] - This approval signifies national reimbursement for ORLADEYO across all major European countries, enhancing access to the first oral, once-daily preventive therapy for HAE patients [1][3] Company Overview - BioCryst Pharmaceuticals is a global biotechnology company focused on improving the lives of individuals with hereditary angioedema and other rare diseases, utilizing expertise in structure-guided drug design [11] - The company has commercialized ORLADEYO, the first oral, once-daily plasma kallikrein inhibitor, and is advancing a pipeline of small-molecule and protein therapies [11] Product Information - ORLADEYO is indicated for the prophylaxis of hereditary angioedema attacks in adults and pediatric patients aged 12 years and older, with one capsule taken daily to reduce plasma kallikrein activity [4][5] - The safety and effectiveness of ORLADEYO for treating acute HAE attacks have not been established, and it is not recommended for such use [6][10]

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]

Core Viewpoint - Momentum investing focuses on following a stock's recent price trends, aiming to buy high and sell higher, with the expectation that established trends will continue [1] Company Overview: BioCryst Pharmaceuticals (BCRX) - BioCryst Pharmaceuticals currently holds a Momentum Style Score of B, indicating a favorable momentum characteristic [2] - The company has a Zacks Rank of 1 (Strong Buy), suggesting strong potential for outperformance in the market [3] Performance Metrics - BCRX shares have increased by 1.51% over the past week, while the Zacks Medical - Drugs industry remained flat during the same period [5] - Over the last month, BCRX's price change is 8.96%, outperforming the industry's 3.76% [5] - In the past quarter, BCRX shares have surged by 48.41%, and over the last year, they have gained 66.02%, compared to the S&P 500's increases of 2.37% and 14.4%, respectively [6] Trading Volume - The average 20-day trading volume for BCRX is 4,994,540 shares, which serves as a bullish indicator when combined with rising stock prices [7] Earnings Outlook - In the last two months, 6 earnings estimates for BCRX have been revised upwards, with no downward revisions, leading to an increase in the consensus estimate from -$0.06 to $0.16 [9] - For the next fiscal year, 6 estimates have also moved upwards without any downward revisions [9] Conclusion - Considering the positive performance metrics and earnings outlook, BCRX is positioned as a 1 (Strong Buy) stock with a Momentum Score of B, making it a potential candidate for near-term investment [11]

Core Insights - BioCryst Pharmaceuticals (BCRX) is recognized for its leadership in crystallography and structure-based drug design, focusing on novel therapeutics for cancer, cardiovascular diseases, autoimmune diseases, and viral infections [1] - The company has a Zacks Rank of 1 (Strong Buy) and has seen its earnings estimate for the next year increase by 83.3% over the past 60 days [1] - Over the last three months, BioCryst Pharmaceuticals' shares have increased by 39%, significantly outperforming the S&P 500, which gained only 2.2% [2] - The company holds a Momentum Score of B, indicating strong momentum characteristics [2]

Core Insights - BioCryst Pharmaceuticals announced new data on ORLADEYO (berotralstat) for hereditary angioedema (HAE) treatment to be presented at the EAACI meeting in Glasgow from June 13 to 16, 2025 [1][2][3] Group 1: Presentation Details - Four abstracts will be presented at the EAACI meeting, including a pooled analysis of the APeX-2 and APeX-J trials focusing on the impact of berotralstat on quality of life for HAE patients [1] - A focus group study reported positive perceptions from patients following berotralstat treatment [2] - Interim results from the APeX-P study indicated that berotralstat use reduced the number of HAE attacks requiring treatment in pediatric patients [3] Group 2: Product Information - ORLADEYO (berotralstat) is the first oral therapy specifically designed to prevent HAE attacks in patients aged 12 years and older, functioning as a plasma kallikrein inhibitor [4][5] - The recommended dosage is one capsule per day, with caution advised for dosages higher than 150 mg due to potential QT prolongation [6][7] - The safety and effectiveness of ORLADEYO in pediatric patients under 12 years have not been established, and there is limited data on its use during pregnancy [9][10] Group 3: Company Overview - BioCryst Pharmaceuticals is a global biotechnology company focused on improving the lives of individuals with hereditary angioedema and other rare diseases, utilizing structure-guided drug design for developing therapeutics [11]

Core Insights - New data presented at the 14th C1-inhibitor Deficiency & Angioedema Workshop supports the use of berotralstat (ORLADEYO) for hereditary angioedema (HAE) across all age groups, demonstrating significant efficacy and safety [1][2] Group 1: Efficacy and Safety of Berotralstat - The APeX-P trial showed a reduction in the percentage of days with angioedema symptoms among young children, with a drop from a mean of 11% to 4% over 12 weeks, sustained up to 48 weeks [4] - In the Italian Expanded Access Program, median Angioedema Control Test scores improved from 11.5 to 16.0 over six months, indicating better disease control [6] - The Berolife study reported a decrease in the median monthly attack rate from 2.25 at baseline to 0.55 after six months of treatment in adolescents [10][11] Group 2: Patient Demographics and Treatment Cohorts - The APeX-P study involved children aged 2 to 11 years, with a median age of 8 years and a mean of 18 missed school days annually due to HAE prior to treatment [4] - The Italian Expanded Access Program included 22 patients receiving berotralstat free of charge, with 15 transitioning to commercially available ORLADEYO upon program closure [5][7] Group 3: Treatment Administration and Mechanism - ORLADEYO is the first oral therapy specifically designed to prevent HAE attacks in patients aged 12 years and older, administered as one capsule daily [12] - The treatment works by decreasing the activity of plasma kallikrein, which is involved in the pathophysiology of HAE [12]