Latest news with #MAVYRET
Yahoo
3 days ago
- Health
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Enanta Pharmaceuticals' Partner AbbVie Receives U.S. FDA Approval of an Expanded Indication for MAVYRET® (glecaprevir/pibrentasvir) as the First and Only Treatment for People with Acute Hepatitis C Virus
MAVYRET® (glecaprevir/pibrentasvir) is Now the Only Direct Acting Antiviral Therapy Approved to Treat Patients with Acute Hepatitis C Virus (HCV) in Eight Weeks with a 96% Cure Rate1*† FDA Approval Now Allows Providers to Treat HCV Patients Immediately at Time of Diagnosis If Left Untreated, Patients with Acute HCV Could Progress to Chronic Disease, Including Cirrhosis or Liver Cancer2 Glecaprevir, One of the Two Direct-Acting Antivirals in MAVYRET®, was Discovered by Enanta and Developed and Commercialized by AbbVie WATERTOWN, Mass., June 11, 2025--(BUSINESS WIRE)--Enanta Pharmaceuticals, Inc. (NASDAQ:ENTA), a clinical-stage biotechnology company dedicated to creating small molecule drugs for viral infections and immunological diseases, today announced that the U.S. Food and Drug Administration (FDA) has approved a label expansion for MAVYRET® (glecaprevir/pibrentasvir), an oral pangenotypic direct acting antiviral (DAA) therapy. It is now approved as the only eight-week treatment for adults and pediatric patients three years and older with acute or chronic HCV infection without cirrhosis or with compensated cirrhosis.* "The FDA's expanded indication of MAVYRET for acute HCV infection marks a significant milestone for patients with HCV. We are proud that our discovery of glecaprevir contributed to a therapy that continues to make a meaningful difference for patients worldwide," said Jay R. Luly, Ph.D., President and Chief Executive Officer at Enanta Pharmaceuticals. "More than one million patients with chronic HCV have been treated with MAVYRET and today's approval could allow even more patients to benefit from access to a cure. Our hope is that by being able to treat acute HCV infection, we will significantly simplify and accelerate the treatment of this condition and, in doing so, help to eliminate the physical, emotional, and economic burden of HCV. With this approval, the global public health community now has another tool to help prevent disease transmission and ultimately help drive progress toward the global public health goal of HCV elimination by 2030." The label expansion was supported by data from the Phase 3, multicenter, single-arm prospective study evaluating the safety and efficacy of MAVYRET eight-week treatment in adults with acute HCV infection.1 The study results showed MAVYRET to be a highly efficacious treatment for people with acute HCV.1 The majority of the adverse events reported were mild or moderate in severity.1 The most common adverse events were fatigue, asthenia, headache, and diarrhea.1 The FDA granted Breakthrough Therapy Designation (BTD) for MAVYRET for the treatment of acute HCV. The BTD program is designed to expedite the development and review of medicines that are intended to treat a serious condition, and preliminary clinical evidence indicates that the drug may demonstrate substantial improvement over existing therapies on one or more clinically significant endpoints.3 HCV is a highly infectious blood-borne disease affecting the liver.2 If left untreated, HCV could lead to liver-related complications such as cirrhosis or liver cancer.2 Acute HCV refers to people recently infected with the virus and can be a short-term illness.4 However, for many people, acute infection leads to chronic infection.4 Current global clinical guidance call for the universal treatment of nearly all people with acute or chronic HCV infection.5 Widespread implementation of these guidelines has the potential to substantially reduce the global spread of the disease.5 Led by the World Health Organization, the public health community aims to eliminate HCV as a public health problem by 2030.6 This involves diagnosing and treating a large portion of those infected, as well as preventing new transmissions through measures like safe injection practices and harm reduction for people who inject drugs. However, approximately 80% of high-income countries, including the U.S., are not on track to achieve this goal until after 2050.7,8 About the Phase 3 M20-350 Study9The multicenter, single-arm prospective Phase 3 M20-350 clinical trial was designed to evaluate the safety and efficacy of MAVYRET® (glecaprevir/pibrentasvir) eight-week treatment in adults and pediatric patients with acute HCV infection. The study enrolled 286 treatment-naïve adult patients with acute HCV infection across 70 locations globally. Patients received oral tablets of MAVYRET® once daily for eight weeks and were followed for 12 weeks after the end of treatment. The primary endpoint was the percentage of patients with sustained virological response 12 weeks post-treatment (SVR12) in the Intention-to-Treat (ITT) population. Secondary endpoints included the percentage of patients achieving SVR12 in the Modified ITT-Virologic Failure (mITT-VF) population, and the percentage of patients with on-treatment virologic failure and post-treatment relapse in the ITT population. More information on the study can be found on (NCT04903626). * For treatment-naïve non-cirrhotic and compensated cirrhotic patients. Liver or kidney transplant recipients are not eligible for an 8-week regimen.†Cure rate = sustained virologic response (SVR12); HCV RNA less than the lower limit of quantification at 12 weeks after the end of treatment. About MAVYRET® (glecaprevir/pibrentasvir) USE MAVYRET is a prescription medicine used to treat adults and children 3 years of age and older with: Acute (recently infected) or chronic (lasting a long time) hepatitis C virus (hep C) genotypes 1, 2, 3, 4, 5 or 6 infection without cirrhosis or with compensated cirrhosis. Hep C genotype 1 infection who have been previously treated with a regimen that contained a hep C NS5A inhibitor or an NS3/4A protease inhibitor, but not both. IMPORTANT SAFETY INFORMATION What is the most important information I should know about MAVYRET? Hepatitis B virus (hep B) reactivation: Before starting treatment with MAVYRET, your doctor will do blood tests to check for hep B infection. If you have ever had hep B infection, hep B could become active again during or after treatment for hep C with MAVYRET. Hep B that becomes active again (called reactivation) may cause serious liver problems, including liver failure and death. Your doctor will monitor you if you are at risk for hep B reactivation during treatment and after you stop taking MAVYRET. Do not take MAVYRET if you: Have moderate or severe liver impairment (Child-Pugh B or C) or any history of prior liver decompensation Are taking the medicines atazanavir or rifampin What should I tell my doctor before taking MAVYRET? If you have had hep B infection, have liver problems other than hep C infection, have HIV-1 infection, have had a liver or a kidney transplant, and all other medical conditions. If you are pregnant or plan to become pregnant, or if you are breastfeeding or plan to breastfeed. It is not known if MAVYRET will harm your unborn baby or pass into your breast milk. Talk to your doctor about the best way to feed your baby if you take MAVYRET. About all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. MAVYRET and other medicines may affect each other. This can cause you to have too much or not enough MAVYRET or other medicines in your body. This may affect the way MAVYRET or your other medicines work or may cause side effects. Do not start taking a new medicine without telling your doctor. Your doctor can tell you if it is safe to take MAVYRET with other medicines. What are the possible side effects of MAVYRET? In people who had or have advanced liver problems before starting treatment with MAVYRET, there is a rare risk of worsening liver problems, liver failure, and death. Your doctor will check you for signs and symptoms of worsening liver problems during treatment with MAVYRET. Tell your doctor right away if you have any of the following: nausea; tiredness; yellowing of your skin or white part of your eyes; bleeding or bruising more easily than normal; confusion; dark, black, or bloody stool; loss of appetite; diarrhea; dark or brown (tea-colored) urine; swelling or pain on the upper right side of your stomach area (abdomen); sleepiness; vomiting of blood; or lightheadedness. The most common side effects of MAVYRET are headache and tiredness. These are not all the possible side effects of MAVYRET. Call your doctor for medical advice about side effects. This is the most important information to know about MAVYRET. For more information, talk to your doctor or healthcare provider. MAVYRET oral pellets are dispensed in unit-dose packets. Each packet contains 50 mg glecaprevir/20 mg pibrentasvir. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit or call 1-800-FDA-1088. Please see full Prescribing Information, including the Patient Information. If you are having difficulty paying for your medicine, AbbVie may be able to help. Visit to learn more. About Enanta Pharmaceuticals, is using its robust, chemistry-driven approach and drug discovery capabilities to become a leader in the discovery and development of small molecule drugs with an emphasis on indications in virology and immunology. Enanta's clinical programs are currently focused on respiratory syncytial virus (RSV) and its earlier-stage immunology pipeline aims to develop treatments for inflammatory diseases by targeting key drivers of the type 2 immune response, including KIT and STAT6 inhibition. Glecaprevir, a protease inhibitor discovered by Enanta, is part of one of the leading treatment regimens for curing chronic and acute hepatitis C virus (HCV) infection and is sold by AbbVie in numerous countries under the tradenames MAVYRET® (U.S.) and MAVIRET® (ex-U.S.) (glecaprevir/pibrentasvir). A portion of Enanta's royalties from HCV products developed under its collaboration with AbbVie contribute ongoing funding to Enanta's operations. Please visit for more information. Forward Looking Statements DisclaimerThis press release contains forward-looking statements, including statements with respect to the prospects for AbbVie sales of Enanta's licensed products. Statements that are not historical facts are based on management's current expectations, estimates, forecasts and projections about Enanta's business and the industry in which it operates and management's beliefs and assumptions. The statements contained in this release are not guarantees of future performance and involve certain risks, uncertainties and assumptions, which are difficult to predict. Therefore, actual outcomes and results may differ materially from what is expressed in such forward-looking statements. Important factors and risks that may affect actual results include: Enanta's royalty revenues are dependent upon the continued success of AbbVie's commercialization of its MAVYRET/MAVIRET regimen; the impact of development, regulatory and marketing efforts of others with respect to competitive treatments for HCV; reimbursement and pricing actions affecting MAVYRET/MAVIRET or any competitive treatment for HCV; Enanta's need to obtain and maintain patent protection for its product candidates and avoid potential infringement of the intellectual property rights of others; and other risk factors described or referred to in "Risk Factors" in Enanta's Form 10-K for the fiscal year ended September 30, 2024, and any other periodic reports filed more recently with the Securities and Exchange Commission. Enanta cautions investors not to place undue reliance on the forward-looking statements contained in this release. These statements speak only as of the date of this release, and Enanta undertakes no obligation to update or revise these statements, except as may be required by law. References1 MAVYRET®. Prescribing Information. AbbVie, Inc.; 2025. Available at: 2 Hepatitis C. World Health Organization. Available at: U.S. Food and Drug Administration. Breakthrough Therapy. Available at: 4 Clinical Overview of Hepatitis C. U.S. Centers for Disease Control and Prevention (CDC). Available at: 5 Debika Bhattacharya, et al. American Association for the Study of Liver Diseases – Infectious Diseases Society of America Recommendations for Testing, Managing, and Treating Hepatitis C Virus Infection, Clinical Infectious Diseases, 2023;, ciad319. Available at: 6 Hepatitis. World Health Organization. Global Elimination by 2030. Available at: 7 Gamkrelidze, I Pawlotsky JM, Lazarus JV, Feld JJ, Zeuzem S, Bao Y, Gabriela Pires Dos Santos A, Sanchez Gonzalez Y, Razavi H. Progress towards hepatitis C virus elimination in high-income countries: An updated analysis. Liver Int. 2021 Mar;41(3):456-463. doi: 10.1111/liv.14779. Epub 2021 Jan 19. PMID: 33389788.8 The CDA Foundation. Hepatitis C – [United States]. Lafayette, CO: CDA Foundation, 2025. Available at: A Study to Evaluate Adverse Events and Change in Disease Activity in Adult and Adolescent Participants With Acute Hepatitis C Virus (HCV) Infection on Treatment With Oral Tablets of Glecaprevir (GLE)/Pibrentasvir (PIB). identifier: NCT04903626. Available at: View source version on Contacts Media and Investor Contact Jennifer Viera617-744-3848jviera@
Yahoo
3 days ago
- Health
- Yahoo
Enanta Pharmaceuticals' Partner AbbVie Receives U.S. FDA Approval of an Expanded Indication for MAVYRET® (glecaprevir/pibrentasvir) as the First and Only Treatment for People with Acute Hepatitis C Virus
MAVYRET® (glecaprevir/pibrentasvir) is Now the Only Direct Acting Antiviral Therapy Approved to Treat Patients with Acute Hepatitis C Virus (HCV) in Eight Weeks with a 96% Cure Rate1*† FDA Approval Now Allows Providers to Treat HCV Patients Immediately at Time of Diagnosis If Left Untreated, Patients with Acute HCV Could Progress to Chronic Disease, Including Cirrhosis or Liver Cancer2 Glecaprevir, One of the Two Direct-Acting Antivirals in MAVYRET®, was Discovered by Enanta and Developed and Commercialized by AbbVie WATERTOWN, Mass., June 11, 2025--(BUSINESS WIRE)--Enanta Pharmaceuticals, Inc. (NASDAQ:ENTA), a clinical-stage biotechnology company dedicated to creating small molecule drugs for viral infections and immunological diseases, today announced that the U.S. Food and Drug Administration (FDA) has approved a label expansion for MAVYRET® (glecaprevir/pibrentasvir), an oral pangenotypic direct acting antiviral (DAA) therapy. It is now approved as the only eight-week treatment for adults and pediatric patients three years and older with acute or chronic HCV infection without cirrhosis or with compensated cirrhosis.* "The FDA's expanded indication of MAVYRET for acute HCV infection marks a significant milestone for patients with HCV. We are proud that our discovery of glecaprevir contributed to a therapy that continues to make a meaningful difference for patients worldwide," said Jay R. Luly, Ph.D., President and Chief Executive Officer at Enanta Pharmaceuticals. "More than one million patients with chronic HCV have been treated with MAVYRET and today's approval could allow even more patients to benefit from access to a cure. Our hope is that by being able to treat acute HCV infection, we will significantly simplify and accelerate the treatment of this condition and, in doing so, help to eliminate the physical, emotional, and economic burden of HCV. With this approval, the global public health community now has another tool to help prevent disease transmission and ultimately help drive progress toward the global public health goal of HCV elimination by 2030." The label expansion was supported by data from the Phase 3, multicenter, single-arm prospective study evaluating the safety and efficacy of MAVYRET eight-week treatment in adults with acute HCV infection.1 The study results showed MAVYRET to be a highly efficacious treatment for people with acute HCV.1 The majority of the adverse events reported were mild or moderate in severity.1 The most common adverse events were fatigue, asthenia, headache, and diarrhea.1 The FDA granted Breakthrough Therapy Designation (BTD) for MAVYRET for the treatment of acute HCV. The BTD program is designed to expedite the development and review of medicines that are intended to treat a serious condition, and preliminary clinical evidence indicates that the drug may demonstrate substantial improvement over existing therapies on one or more clinically significant endpoints.3 HCV is a highly infectious blood-borne disease affecting the liver.2 If left untreated, HCV could lead to liver-related complications such as cirrhosis or liver cancer.2 Acute HCV refers to people recently infected with the virus and can be a short-term illness.4 However, for many people, acute infection leads to chronic infection.4 Current global clinical guidance call for the universal treatment of nearly all people with acute or chronic HCV infection.5 Widespread implementation of these guidelines has the potential to substantially reduce the global spread of the disease.5 Led by the World Health Organization, the public health community aims to eliminate HCV as a public health problem by 2030.6 This involves diagnosing and treating a large portion of those infected, as well as preventing new transmissions through measures like safe injection practices and harm reduction for people who inject drugs. However, approximately 80% of high-income countries, including the U.S., are not on track to achieve this goal until after 2050.7,8 About the Phase 3 M20-350 Study9The multicenter, single-arm prospective Phase 3 M20-350 clinical trial was designed to evaluate the safety and efficacy of MAVYRET® (glecaprevir/pibrentasvir) eight-week treatment in adults and pediatric patients with acute HCV infection. The study enrolled 286 treatment-naïve adult patients with acute HCV infection across 70 locations globally. Patients received oral tablets of MAVYRET® once daily for eight weeks and were followed for 12 weeks after the end of treatment. The primary endpoint was the percentage of patients with sustained virological response 12 weeks post-treatment (SVR12) in the Intention-to-Treat (ITT) population. Secondary endpoints included the percentage of patients achieving SVR12 in the Modified ITT-Virologic Failure (mITT-VF) population, and the percentage of patients with on-treatment virologic failure and post-treatment relapse in the ITT population. More information on the study can be found on (NCT04903626). * For treatment-naïve non-cirrhotic and compensated cirrhotic patients. Liver or kidney transplant recipients are not eligible for an 8-week regimen.†Cure rate = sustained virologic response (SVR12); HCV RNA less than the lower limit of quantification at 12 weeks after the end of treatment. About MAVYRET® (glecaprevir/pibrentasvir) USE MAVYRET is a prescription medicine used to treat adults and children 3 years of age and older with: Acute (recently infected) or chronic (lasting a long time) hepatitis C virus (hep C) genotypes 1, 2, 3, 4, 5 or 6 infection without cirrhosis or with compensated cirrhosis. Hep C genotype 1 infection who have been previously treated with a regimen that contained a hep C NS5A inhibitor or an NS3/4A protease inhibitor, but not both. IMPORTANT SAFETY INFORMATION What is the most important information I should know about MAVYRET? Hepatitis B virus (hep B) reactivation: Before starting treatment with MAVYRET, your doctor will do blood tests to check for hep B infection. If you have ever had hep B infection, hep B could become active again during or after treatment for hep C with MAVYRET. Hep B that becomes active again (called reactivation) may cause serious liver problems, including liver failure and death. Your doctor will monitor you if you are at risk for hep B reactivation during treatment and after you stop taking MAVYRET. Do not take MAVYRET if you: Have moderate or severe liver impairment (Child-Pugh B or C) or any history of prior liver decompensation Are taking the medicines atazanavir or rifampin What should I tell my doctor before taking MAVYRET? If you have had hep B infection, have liver problems other than hep C infection, have HIV-1 infection, have had a liver or a kidney transplant, and all other medical conditions. If you are pregnant or plan to become pregnant, or if you are breastfeeding or plan to breastfeed. It is not known if MAVYRET will harm your unborn baby or pass into your breast milk. Talk to your doctor about the best way to feed your baby if you take MAVYRET. About all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. MAVYRET and other medicines may affect each other. This can cause you to have too much or not enough MAVYRET or other medicines in your body. This may affect the way MAVYRET or your other medicines work or may cause side effects. Do not start taking a new medicine without telling your doctor. Your doctor can tell you if it is safe to take MAVYRET with other medicines. What are the possible side effects of MAVYRET? In people who had or have advanced liver problems before starting treatment with MAVYRET, there is a rare risk of worsening liver problems, liver failure, and death. Your doctor will check you for signs and symptoms of worsening liver problems during treatment with MAVYRET. Tell your doctor right away if you have any of the following: nausea; tiredness; yellowing of your skin or white part of your eyes; bleeding or bruising more easily than normal; confusion; dark, black, or bloody stool; loss of appetite; diarrhea; dark or brown (tea-colored) urine; swelling or pain on the upper right side of your stomach area (abdomen); sleepiness; vomiting of blood; or lightheadedness. The most common side effects of MAVYRET are headache and tiredness. These are not all the possible side effects of MAVYRET. Call your doctor for medical advice about side effects. This is the most important information to know about MAVYRET. For more information, talk to your doctor or healthcare provider. MAVYRET oral pellets are dispensed in unit-dose packets. Each packet contains 50 mg glecaprevir/20 mg pibrentasvir. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit or call 1-800-FDA-1088. Please see full Prescribing Information, including the Patient Information. If you are having difficulty paying for your medicine, AbbVie may be able to help. Visit to learn more. About Enanta Pharmaceuticals, is using its robust, chemistry-driven approach and drug discovery capabilities to become a leader in the discovery and development of small molecule drugs with an emphasis on indications in virology and immunology. Enanta's clinical programs are currently focused on respiratory syncytial virus (RSV) and its earlier-stage immunology pipeline aims to develop treatments for inflammatory diseases by targeting key drivers of the type 2 immune response, including KIT and STAT6 inhibition. Glecaprevir, a protease inhibitor discovered by Enanta, is part of one of the leading treatment regimens for curing chronic and acute hepatitis C virus (HCV) infection and is sold by AbbVie in numerous countries under the tradenames MAVYRET® (U.S.) and MAVIRET® (ex-U.S.) (glecaprevir/pibrentasvir). A portion of Enanta's royalties from HCV products developed under its collaboration with AbbVie contribute ongoing funding to Enanta's operations. Please visit for more information. Forward Looking Statements DisclaimerThis press release contains forward-looking statements, including statements with respect to the prospects for AbbVie sales of Enanta's licensed products. Statements that are not historical facts are based on management's current expectations, estimates, forecasts and projections about Enanta's business and the industry in which it operates and management's beliefs and assumptions. The statements contained in this release are not guarantees of future performance and involve certain risks, uncertainties and assumptions, which are difficult to predict. Therefore, actual outcomes and results may differ materially from what is expressed in such forward-looking statements. Important factors and risks that may affect actual results include: Enanta's royalty revenues are dependent upon the continued success of AbbVie's commercialization of its MAVYRET/MAVIRET regimen; the impact of development, regulatory and marketing efforts of others with respect to competitive treatments for HCV; reimbursement and pricing actions affecting MAVYRET/MAVIRET or any competitive treatment for HCV; Enanta's need to obtain and maintain patent protection for its product candidates and avoid potential infringement of the intellectual property rights of others; and other risk factors described or referred to in "Risk Factors" in Enanta's Form 10-K for the fiscal year ended September 30, 2024, and any other periodic reports filed more recently with the Securities and Exchange Commission. Enanta cautions investors not to place undue reliance on the forward-looking statements contained in this release. These statements speak only as of the date of this release, and Enanta undertakes no obligation to update or revise these statements, except as may be required by law. References1 MAVYRET®. Prescribing Information. AbbVie, Inc.; 2025. Available at: 2 Hepatitis C. World Health Organization. Available at: U.S. Food and Drug Administration. Breakthrough Therapy. Available at: 4 Clinical Overview of Hepatitis C. U.S. Centers for Disease Control and Prevention (CDC). Available at: 5 Debika Bhattacharya, et al. American Association for the Study of Liver Diseases – Infectious Diseases Society of America Recommendations for Testing, Managing, and Treating Hepatitis C Virus Infection, Clinical Infectious Diseases, 2023;, ciad319. Available at: 6 Hepatitis. World Health Organization. Global Elimination by 2030. Available at: 7 Gamkrelidze, I Pawlotsky JM, Lazarus JV, Feld JJ, Zeuzem S, Bao Y, Gabriela Pires Dos Santos A, Sanchez Gonzalez Y, Razavi H. Progress towards hepatitis C virus elimination in high-income countries: An updated analysis. Liver Int. 2021 Mar;41(3):456-463. doi: 10.1111/liv.14779. Epub 2021 Jan 19. PMID: 33389788.8 The CDA Foundation. Hepatitis C – [United States]. Lafayette, CO: CDA Foundation, 2025. Available at: A Study to Evaluate Adverse Events and Change in Disease Activity in Adult and Adolescent Participants With Acute Hepatitis C Virus (HCV) Infection on Treatment With Oral Tablets of Glecaprevir (GLE)/Pibrentasvir (PIB). identifier: NCT04903626. Available at: View source version on Contacts Media and Investor Contact Jennifer Viera617-744-3848jviera@ Error in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
Business Wire
3 days ago
- Business
- Business Wire
Enanta Pharmaceuticals' Partner AbbVie Receives U.S. FDA Approval of an Expanded Indication for MAVYRET ® (glecaprevir/pibrentasvir) as the First and Only Treatment for People with Acute Hepatitis C Virus
WATERTOWN, Mass.--(BUSINESS WIRE)--Enanta Pharmaceuticals, Inc. (NASDAQ:ENTA), a clinical-stage biotechnology company dedicated to creating small molecule drugs for viral infections and immunological diseases, today announced that the U.S. Food and Drug Administration (FDA) has approved a label expansion for MAVYRET ® (glecaprevir/pibrentasvir), an oral pangenotypic direct acting antiviral (DAA) therapy. It is now approved as the only eight-week treatment for adults and pediatric patients three years and older with acute or chronic HCV infection without cirrhosis or with compensated cirrhosis.* The FDA's expanded indication of MAVYRET for acute HCV infection marks a significant milestone for patients with HCV. We are proud our discovery of glecaprevir contributed to a therapy that continues to make a meaningful difference for patients worldwide. Share 'The FDA's expanded indication of MAVYRET for acute HCV infection marks a significant milestone for patients with HCV. We are proud that our discovery of glecaprevir contributed to a therapy that continues to make a meaningful difference for patients worldwide,' said Jay R. Luly, Ph.D., President and Chief Executive Officer at Enanta Pharmaceuticals. 'More than one million patients with chronic HCV have been treated with MAVYRET and today's approval could allow even more patients to benefit from access to a cure. Our hope is that by being able to treat acute HCV infection, we will significantly simplify and accelerate the treatment of this condition and, in doing so, help to eliminate the physical, emotional, and economic burden of HCV. With this approval, the global public health community now has another tool to help prevent disease transmission and ultimately help drive progress toward the global public health goal of HCV elimination by 2030.' The label expansion was supported by data from the Phase 3, multicenter, single-arm prospective study evaluating the safety and efficacy of MAVYRET eight-week treatment in adults with acute HCV infection. 1 The study results showed MAVYRET to be a highly efficacious treatment for people with acute HCV. 1 The majority of the adverse events reported were mild or moderate in severity. 1 The most common adverse events were fatigue, asthenia, headache, and diarrhea. 1 The FDA granted Breakthrough Therapy Designation (BTD) for MAVYRET for the treatment of acute HCV. The BTD program is designed to expedite the development and review of medicines that are intended to treat a serious condition, and preliminary clinical evidence indicates that the drug may demonstrate substantial improvement over existing therapies on one or more clinically significant endpoints. 3 HCV is a highly infectious blood-borne disease affecting the liver. 2 If left untreated, HCV could lead to liver-related complications such as cirrhosis or liver cancer. 2 Acute HCV refers to people recently infected with the virus and can be a short-term illness. 4 However, for many people, acute infection leads to chronic infection. 4 Current global clinical guidance call for the universal treatment of nearly all people with acute or chronic HCV infection. 5 Widespread implementation of these guidelines has the potential to substantially reduce the global spread of the disease. 5 Led by the World Health Organization, the public health community aims to eliminate HCV as a public health problem by 2030. 6 This involves diagnosing and treating a large portion of those infected, as well as preventing new transmissions through measures like safe injection practices and harm reduction for people who inject drugs. However, approximately 80% of high-income countries, including the U.S., are not on track to achieve this goal until after 2050. 7,8 About the Phase 3 M20-350 Study 9 The multicenter, single-arm prospective Phase 3 M20-350 clinical trial was designed to evaluate the safety and efficacy of MAVYRET ® (glecaprevir/pibrentasvir) eight-week treatment in adults and pediatric patients with acute HCV infection. The study enrolled 286 treatment-naïve adult patients with acute HCV infection across 70 locations globally. Patients received oral tablets of MAVYRET ® once daily for eight weeks and were followed for 12 weeks after the end of treatment. The primary endpoint was the percentage of patients with sustained virological response 12 weeks post-treatment (SVR12) in the Intention-to-Treat (ITT) population. Secondary endpoints included the percentage of patients achieving SVR12 in the Modified ITT-Virologic Failure (mITT-VF) population, and the percentage of patients with on-treatment virologic failure and post-treatment relapse in the ITT population. More information on the study can be found on (NCT04903626). * For treatment-naïve non-cirrhotic and compensated cirrhotic patients. Liver or kidney transplant recipients are not eligible for an 8-week regimen. † Cure rate = sustained virologic response (SVR12); HCV RNA less than the lower limit of quantification at 12 weeks after the end of treatment. About MAVYRET ® (glecaprevir/pibrentasvir) USE MAVYRET is a prescription medicine used to treat adults and children 3 years of age and older with: Acute (recently infected) or chronic (lasting a long time) hepatitis C virus (hep C) genotypes 1, 2, 3, 4, 5 or 6 infection without cirrhosis or with compensated cirrhosis. Hep C genotype 1 infection who have been previously treated with a regimen that contained a hep C NS5A inhibitor or an NS3/4A protease inhibitor, but not both. IMPORTANT SAFETY INFORMATION What is the most important information I should know about MAVYRET? Hepatitis B virus (hep B) reactivation: Before starting treatment with MAVYRET, your doctor will do blood tests to check for hep B infection. If you have ever had hep B infection, hep B could become active again during or after treatment for hep C with MAVYRET. Hep B that becomes active again (called reactivation) may cause serious liver problems, including liver failure and death. Your doctor will monitor you if you are at risk for hep B reactivation during treatment and after you stop taking MAVYRET. Do not take MAVYRET if you: Have moderate or severe liver impairment (Child-Pugh B or C) or any history of prior liver decompensation Are taking the medicines atazanavir or rifampin What should I tell my doctor before taking MAVYRET? If you have had hep B infection, have liver problems other than hep C infection, have HIV-1 infection, have had a liver or a kidney transplant, and all other medical conditions. If you are pregnant or plan to become pregnant, or if you are breastfeeding or plan to breastfeed. It is not known if MAVYRET will harm your unborn baby or pass into your breast milk. Talk to your doctor about the best way to feed your baby if you take MAVYRET. About all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. MAVYRET and other medicines may affect each other. This can cause you to have too much or not enough MAVYRET or other medicines in your body. This may affect the way MAVYRET or your other medicines work or may cause side effects. Do not start taking a new medicine without telling your doctor. Your doctor can tell you if it is safe to take MAVYRET with other medicines. What are the possible side effects of MAVYRET? In people who had or have advanced liver problems before starting treatment with MAVYRET, there is a rare risk of worsening liver problems, liver failure, and death. Your doctor will check you for signs and symptoms of worsening liver problems during treatment with MAVYRET. Tell your doctor right away if you have any of the following: nausea; tiredness; yellowing of your skin or white part of your eyes; bleeding or bruising more easily than normal; confusion; dark, black, or bloody stool; loss of appetite; diarrhea; dark or brown (tea-colored) urine; swelling or pain on the upper right side of your stomach area (abdomen); sleepiness; vomiting of blood; or lightheadedness. The most common side effects of MAVYRET are headache and tiredness. These are not all the possible side effects of MAVYRET. Call your doctor for medical advice about side effects. This is the most important information to know about MAVYRET. For more information, talk to your doctor or healthcare provider. MAVYRET oral pellets are dispensed in unit-dose packets. Each packet contains 50 mg glecaprevir/20 mg pibrentasvir. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit or call 1-800-FDA-1088. Please see full Prescribing Information, including the Patient Information. If you are having difficulty paying for your medicine, AbbVie may be able to help. Visit to learn more. About Enanta Pharmaceuticals, Inc. Enanta is using its robust, chemistry-driven approach and drug discovery capabilities to become a leader in the discovery and development of small molecule drugs with an emphasis on indications in virology and immunology. Enanta's clinical programs are currently focused on respiratory syncytial virus (RSV) and its earlier-stage immunology pipeline aims to develop treatments for inflammatory diseases by targeting key drivers of the type 2 immune response, including KIT and STAT6 inhibition. Glecaprevir, a protease inhibitor discovered by Enanta, is part of one of the leading treatment regimens for curing chronic and acute hepatitis C virus (HCV) infection and is sold by AbbVie in numerous countries under the tradenames MAVYRET ® (U.S.) and MAVIRET ® (ex-U.S.) (glecaprevir/pibrentasvir). A portion of Enanta's royalties from HCV products developed under its collaboration with AbbVie contribute ongoing funding to Enanta's operations. Please visit for more information. Forward Looking Statements Disclaimer This press release contains forward-looking statements, including statements with respect to the prospects for AbbVie sales of Enanta's licensed products. Statements that are not historical facts are based on management's current expectations, estimates, forecasts and projections about Enanta's business and the industry in which it operates and management's beliefs and assumptions. The statements contained in this release are not guarantees of future performance and involve certain risks, uncertainties and assumptions, which are difficult to predict. Therefore, actual outcomes and results may differ materially from what is expressed in such forward-looking statements. Important factors and risks that may affect actual results include: Enanta's royalty revenues are dependent upon the continued success of AbbVie's commercialization of its MAVYRET/MAVIRET regimen; the impact of development, regulatory and marketing efforts of others with respect to competitive treatments for HCV; reimbursement and pricing actions affecting MAVYRET/MAVIRET or any competitive treatment for HCV; Enanta's need to obtain and maintain patent protection for its product candidates and avoid potential infringement of the intellectual property rights of others; and other risk factors described or referred to in 'Risk Factors' in Enanta's Form 10-K for the fiscal year ended September 30, 2024, and any other periodic reports filed more recently with the Securities and Exchange Commission. Enanta cautions investors not to place undue reliance on the forward-looking statements contained in this release. These statements speak only as of the date of this release, and Enanta undertakes no obligation to update or revise these statements, except as may be required by law.
Yahoo
3 days ago
- Health
- Yahoo
Enanta Pharmaceuticals' Partner AbbVie Receives U.S. FDA Approval of an Expanded Indication for MAVYRET® (glecaprevir/pibrentasvir) as the First and Only Treatment for People with Acute Hepatitis C Virus
MAVYRET® (glecaprevir/pibrentasvir) is Now the Only Direct Acting Antiviral Therapy Approved to Treat Patients with Acute Hepatitis C Virus (HCV) in Eight Weeks with a 96% Cure Rate1*† FDA Approval Now Allows Providers to Treat HCV Patients Immediately at Time of Diagnosis If Left Untreated, Patients with Acute HCV Could Progress to Chronic Disease, Including Cirrhosis or Liver Cancer2 Glecaprevir, One of the Two Direct-Acting Antivirals in MAVYRET®, was Discovered by Enanta and Developed and Commercialized by AbbVie WATERTOWN, Mass., June 11, 2025--(BUSINESS WIRE)--Enanta Pharmaceuticals, Inc. (NASDAQ:ENTA), a clinical-stage biotechnology company dedicated to creating small molecule drugs for viral infections and immunological diseases, today announced that the U.S. Food and Drug Administration (FDA) has approved a label expansion for MAVYRET® (glecaprevir/pibrentasvir), an oral pangenotypic direct acting antiviral (DAA) therapy. It is now approved as the only eight-week treatment for adults and pediatric patients three years and older with acute or chronic HCV infection without cirrhosis or with compensated cirrhosis.* "The FDA's expanded indication of MAVYRET for acute HCV infection marks a significant milestone for patients with HCV. We are proud that our discovery of glecaprevir contributed to a therapy that continues to make a meaningful difference for patients worldwide," said Jay R. Luly, Ph.D., President and Chief Executive Officer at Enanta Pharmaceuticals. "More than one million patients with chronic HCV have been treated with MAVYRET and today's approval could allow even more patients to benefit from access to a cure. Our hope is that by being able to treat acute HCV infection, we will significantly simplify and accelerate the treatment of this condition and, in doing so, help to eliminate the physical, emotional, and economic burden of HCV. With this approval, the global public health community now has another tool to help prevent disease transmission and ultimately help drive progress toward the global public health goal of HCV elimination by 2030." The label expansion was supported by data from the Phase 3, multicenter, single-arm prospective study evaluating the safety and efficacy of MAVYRET eight-week treatment in adults with acute HCV infection.1 The study results showed MAVYRET to be a highly efficacious treatment for people with acute HCV.1 The majority of the adverse events reported were mild or moderate in severity.1 The most common adverse events were fatigue, asthenia, headache, and diarrhea.1 The FDA granted Breakthrough Therapy Designation (BTD) for MAVYRET for the treatment of acute HCV. The BTD program is designed to expedite the development and review of medicines that are intended to treat a serious condition, and preliminary clinical evidence indicates that the drug may demonstrate substantial improvement over existing therapies on one or more clinically significant endpoints.3 HCV is a highly infectious blood-borne disease affecting the liver.2 If left untreated, HCV could lead to liver-related complications such as cirrhosis or liver cancer.2 Acute HCV refers to people recently infected with the virus and can be a short-term illness.4 However, for many people, acute infection leads to chronic infection.4 Current global clinical guidance call for the universal treatment of nearly all people with acute or chronic HCV infection.5 Widespread implementation of these guidelines has the potential to substantially reduce the global spread of the disease.5 Led by the World Health Organization, the public health community aims to eliminate HCV as a public health problem by 2030.6 This involves diagnosing and treating a large portion of those infected, as well as preventing new transmissions through measures like safe injection practices and harm reduction for people who inject drugs. However, approximately 80% of high-income countries, including the U.S., are not on track to achieve this goal until after 2050.7,8 About the Phase 3 M20-350 Study9The multicenter, single-arm prospective Phase 3 M20-350 clinical trial was designed to evaluate the safety and efficacy of MAVYRET® (glecaprevir/pibrentasvir) eight-week treatment in adults and pediatric patients with acute HCV infection. The study enrolled 286 treatment-naïve adult patients with acute HCV infection across 70 locations globally. Patients received oral tablets of MAVYRET® once daily for eight weeks and were followed for 12 weeks after the end of treatment. The primary endpoint was the percentage of patients with sustained virological response 12 weeks post-treatment (SVR12) in the Intention-to-Treat (ITT) population. Secondary endpoints included the percentage of patients achieving SVR12 in the Modified ITT-Virologic Failure (mITT-VF) population, and the percentage of patients with on-treatment virologic failure and post-treatment relapse in the ITT population. More information on the study can be found on (NCT04903626). * For treatment-naïve non-cirrhotic and compensated cirrhotic patients. Liver or kidney transplant recipients are not eligible for an 8-week regimen.†Cure rate = sustained virologic response (SVR12); HCV RNA less than the lower limit of quantification at 12 weeks after the end of treatment. About MAVYRET® (glecaprevir/pibrentasvir) USE MAVYRET is a prescription medicine used to treat adults and children 3 years of age and older with: Acute (recently infected) or chronic (lasting a long time) hepatitis C virus (hep C) genotypes 1, 2, 3, 4, 5 or 6 infection without cirrhosis or with compensated cirrhosis. Hep C genotype 1 infection who have been previously treated with a regimen that contained a hep C NS5A inhibitor or an NS3/4A protease inhibitor, but not both. IMPORTANT SAFETY INFORMATION What is the most important information I should know about MAVYRET? Hepatitis B virus (hep B) reactivation: Before starting treatment with MAVYRET, your doctor will do blood tests to check for hep B infection. If you have ever had hep B infection, hep B could become active again during or after treatment for hep C with MAVYRET. Hep B that becomes active again (called reactivation) may cause serious liver problems, including liver failure and death. Your doctor will monitor you if you are at risk for hep B reactivation during treatment and after you stop taking MAVYRET. Do not take MAVYRET if you: Have moderate or severe liver impairment (Child-Pugh B or C) or any history of prior liver decompensation Are taking the medicines atazanavir or rifampin What should I tell my doctor before taking MAVYRET? If you have had hep B infection, have liver problems other than hep C infection, have HIV-1 infection, have had a liver or a kidney transplant, and all other medical conditions. If you are pregnant or plan to become pregnant, or if you are breastfeeding or plan to breastfeed. It is not known if MAVYRET will harm your unborn baby or pass into your breast milk. Talk to your doctor about the best way to feed your baby if you take MAVYRET. About all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. MAVYRET and other medicines may affect each other. This can cause you to have too much or not enough MAVYRET or other medicines in your body. This may affect the way MAVYRET or your other medicines work or may cause side effects. Do not start taking a new medicine without telling your doctor. Your doctor can tell you if it is safe to take MAVYRET with other medicines. What are the possible side effects of MAVYRET? In people who had or have advanced liver problems before starting treatment with MAVYRET, there is a rare risk of worsening liver problems, liver failure, and death. Your doctor will check you for signs and symptoms of worsening liver problems during treatment with MAVYRET. Tell your doctor right away if you have any of the following: nausea; tiredness; yellowing of your skin or white part of your eyes; bleeding or bruising more easily than normal; confusion; dark, black, or bloody stool; loss of appetite; diarrhea; dark or brown (tea-colored) urine; swelling or pain on the upper right side of your stomach area (abdomen); sleepiness; vomiting of blood; or lightheadedness. The most common side effects of MAVYRET are headache and tiredness. These are not all the possible side effects of MAVYRET. Call your doctor for medical advice about side effects. This is the most important information to know about MAVYRET. For more information, talk to your doctor or healthcare provider. MAVYRET oral pellets are dispensed in unit-dose packets. Each packet contains 50 mg glecaprevir/20 mg pibrentasvir. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit or call 1-800-FDA-1088. Please see full Prescribing Information, including the Patient Information. If you are having difficulty paying for your medicine, AbbVie may be able to help. Visit to learn more. About Enanta Pharmaceuticals, is using its robust, chemistry-driven approach and drug discovery capabilities to become a leader in the discovery and development of small molecule drugs with an emphasis on indications in virology and immunology. Enanta's clinical programs are currently focused on respiratory syncytial virus (RSV) and its earlier-stage immunology pipeline aims to develop treatments for inflammatory diseases by targeting key drivers of the type 2 immune response, including KIT and STAT6 inhibition. Glecaprevir, a protease inhibitor discovered by Enanta, is part of one of the leading treatment regimens for curing chronic and acute hepatitis C virus (HCV) infection and is sold by AbbVie in numerous countries under the tradenames MAVYRET® (U.S.) and MAVIRET® (ex-U.S.) (glecaprevir/pibrentasvir). A portion of Enanta's royalties from HCV products developed under its collaboration with AbbVie contribute ongoing funding to Enanta's operations. Please visit for more information. Forward Looking Statements DisclaimerThis press release contains forward-looking statements, including statements with respect to the prospects for AbbVie sales of Enanta's licensed products. Statements that are not historical facts are based on management's current expectations, estimates, forecasts and projections about Enanta's business and the industry in which it operates and management's beliefs and assumptions. The statements contained in this release are not guarantees of future performance and involve certain risks, uncertainties and assumptions, which are difficult to predict. Therefore, actual outcomes and results may differ materially from what is expressed in such forward-looking statements. Important factors and risks that may affect actual results include: Enanta's royalty revenues are dependent upon the continued success of AbbVie's commercialization of its MAVYRET/MAVIRET regimen; the impact of development, regulatory and marketing efforts of others with respect to competitive treatments for HCV; reimbursement and pricing actions affecting MAVYRET/MAVIRET or any competitive treatment for HCV; Enanta's need to obtain and maintain patent protection for its product candidates and avoid potential infringement of the intellectual property rights of others; and other risk factors described or referred to in "Risk Factors" in Enanta's Form 10-K for the fiscal year ended September 30, 2024, and any other periodic reports filed more recently with the Securities and Exchange Commission. Enanta cautions investors not to place undue reliance on the forward-looking statements contained in this release. These statements speak only as of the date of this release, and Enanta undertakes no obligation to update or revise these statements, except as may be required by law. References1 MAVYRET®. Prescribing Information. AbbVie, Inc.; 2025. Available at: 2 Hepatitis C. World Health Organization. Available at: U.S. Food and Drug Administration. Breakthrough Therapy. Available at: 4 Clinical Overview of Hepatitis C. U.S. Centers for Disease Control and Prevention (CDC). Available at: 5 Debika Bhattacharya, et al. American Association for the Study of Liver Diseases – Infectious Diseases Society of America Recommendations for Testing, Managing, and Treating Hepatitis C Virus Infection, Clinical Infectious Diseases, 2023;, ciad319. Available at: 6 Hepatitis. World Health Organization. Global Elimination by 2030. Available at: 7 Gamkrelidze, I Pawlotsky JM, Lazarus JV, Feld JJ, Zeuzem S, Bao Y, Gabriela Pires Dos Santos A, Sanchez Gonzalez Y, Razavi H. Progress towards hepatitis C virus elimination in high-income countries: An updated analysis. Liver Int. 2021 Mar;41(3):456-463. doi: 10.1111/liv.14779. Epub 2021 Jan 19. PMID: 33389788.8 The CDA Foundation. Hepatitis C – [United States]. Lafayette, CO: CDA Foundation, 2025. Available at: A Study to Evaluate Adverse Events and Change in Disease Activity in Adult and Adolescent Participants With Acute Hepatitis C Virus (HCV) Infection on Treatment With Oral Tablets of Glecaprevir (GLE)/Pibrentasvir (PIB). identifier: NCT04903626. Available at: View source version on Contacts Media and Investor Contact Jennifer Viera617-744-3848jviera@ Error in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
Business Wire
12-05-2025
- Business
- Business Wire
Enanta Pharmaceuticals Reports Financial Results for its Fiscal Second Quarter Ended March 31, 2025
WATERTOWN, Mass.--(BUSINESS WIRE)-- Enanta Pharmaceuticals, Inc. (NASDAQ:ENTA), a clinical-stage biotechnology company dedicated to creating small molecule drugs for viral infections and immunological diseases, today reported financial results for its fiscal second quarter ended March 31, 2025. 'Throughout the fiscal second quarter, Enanta remained squarely focused on executing across our virology and immunology pipeline. We are thrilled to have enrolled our target of 180 patients in RSVHR, a Phase 2 study of zelicapavir in high-risk adults infected with RSV, and plan to complete enrollment in late May to capture the remainder of the current Northern Hemisphere RSV season. We remain on track to report topline data late next quarter. With two differentiated mechanisms of action, N- and L-protein inhibition, Enanta has the most comprehensive RSV antiviral portfolio in development, and we will evaluate potential partnership opportunities to bring these therapeutics to patients,' said Jay. R. Luly, Ph.D., President and Chief Executive Officer at Enanta Pharmaceuticals. Dr. Luly continued, 'We are also pleased with the progress we have made in advancing our immunology programs that target key drivers of type 2 inflammation. We expect to select a lead development candidate for our oral STAT6 inhibitor program in the second half of this year, with an initial indication in atopic dermatitis and future expansion opportunities in asthma and other diseases. Additionally, we are continuing to advance EPS-1421, the lead development candidate in our KIT inhibitor program, with the goal of developing a best-in-disease, oral treatment for chronic spontaneous urticaria and other mast cell driven diseases. We look forward to continuing to expand our immunology portfolio with the announcement of a third program this year. With a strong cash position and a disciplined approach to capital allocation, we are well-suited to execute across our pipeline of oral therapeutics in development for virology and immunology indications.' Fiscal Second Quarter Ended March 31, 2025 Financial Results Total revenue for the three months ended March 31, 2025 was $14.9 million and consisted of royalty revenue from worldwide net sales of AbbVie's hepatitis C virus (HCV) regimen MAVYRET ® /MAVIRET ® (glecaprevir/pibrentasvir), compared to $17.1 million for the three months ended March 31, 2024. A portion (54.5%) of Enanta's ongoing royalty revenue from AbbVie's net sales of MAVYRET ® /MAVIRET ® is paid to OMERS, one of Canada's largest defined benefit pension plans, pursuant to a royalty sale transaction affecting royalties earned after June 2023. For financial reporting purposes, the transaction was treated as debt, with the upfront purchase payment of $200.0 million recorded as a liability. Each quarter, Enanta records 100% of the royalty earned as revenue and then amortizes the debt liability proportionally as 54.5% of the cash royalty payments are paid to OMERS through June 30, 2032, subject to a cap of 1.42 times the purchase price, after which point 100% of the cash royalty payments will be retained by Enanta. Interest expense from the royalty sale was $1.7 million for the three months ended March 31, 2025, as compared to $2.6 million for the same period ended March 31, 2024. Research and development expenses totaled $28.1 million for the three months ended March 31, 2025, compared to $35.6 million for the three months ended March 31, 2024. The decrease was primarily due to a decrease in expenses as a result of the timing of clinical trials in the Company's RSV program. General and administrative expenses totaled $11.4 million for the three months ended March 31, 2025, compared to $14.2 million for the three months ended March 31, 2024. The decrease was primarily due to a decrease in legal expenses related to the Company's patent infringement lawsuit against Pfizer. Interest and investment income, net, totaled $2.3 million for the three months ended March 31, 2025, compared to $3.8 million for the three months ended March 31, 2024. The decrease was due to lower cash and investment balances year-over-year. Enanta recorded an income tax benefit of $1.3 million for the three months ended March 31, 2025 primarily due to an additional federal income tax refund of $0.9 million. Enanta recorded an income tax benefit of $0.4 million for the three months ended March 31, 2024 related to interest earned on the federal income tax refund. The federal income tax refund of $33.8 million, including interest, was received in April 2025. Net loss for the three months ended March 31, 2025 was $22.6 million, or a loss of $1.06 per diluted common share, compared to a net loss of $31.2 million, or a loss of $1.47 per diluted common share, for the corresponding period in 2024. Enanta's cash, cash equivalents and short-term marketable securities totaled $193.4 million at March 31, 2025. Enanta expects that its current cash, cash equivalents and marketable securities, as well as its retained portion of future royalty revenue, together with a $33.8 million federal income tax refund received in April 2025, will be sufficient to meet the anticipated cash requirements of its existing business and development programs into fiscal 2028. Virology Enanta's virology pipeline is focused on developing oral antiviral treatments for serious infections, including multiple clinical-stage programs for the treatment of RSV. Enanta has the leading RSV therapeutic portfolio, consisting of zelicapavir and EDP-323, both in Phase 2 development for RSV infection. The Company will evaluate potential partnership opportunities to further develop its RSV assets. Zelicapavir, a potent, oral N-protein inhibitor, which has Fast Track designation from the U.S. Food and Drug Administration, is currently being evaluated in RSVHR, a Phase 2b, randomized, double-blind, placebo-controlled study in adults with RSV infection who are at high-risk of complications. This includes patients over age 65 years and/or those with congestive heart failure, chronic obstructive pulmonary disease or asthma. Target enrollment of 180 patients in RSVHR has been met. Enanta is continuing enrollment through late May to capture the remainder of the Northern Hemisphere RSV season. The Company will complete enrollment this month, with topline data expected late next quarter. Zelicapavir previously demonstrated positive data in a Phase 2 human challenge study and in a Phase 2 study of pediatric patients. Enanta's second RSV asset, EDP-323, is a potent, oral L-protein inhibitor, which also has Fast Track designation. In a human challenge study, EDP-323 achieved highly statistically significant reductions in both viral load and clinical symptoms compared to placebo, as well as a favorable safety and tolerability profile. EDP-323 can be used alone or in combination with other agents, such as zelicapavir, to potentially broaden the treatment window or addressable patient populations. In March, Enanta presented data from its RSV portfolio at the 13 th International RSV Symposium (RSV2025). Results from a Phase 2 human challenge study of EDP-323 were highlighted in an oral presentation, while data from the Phase 2 study of zelicapavir in pediatric patients were presented in a late breaker poster. An additional poster highlighted distinctions among fusion, N-, and L-protein inhibitors with respect to preclinical antiviral effect and resistance profiles, while a final poster detailed PK and PK/PD results from the EDP-323 Phase 2 human challenge study. Copies of these presentations can be found on the Company's website. Immunology Enanta's immunology pipeline is focused on designing and developing highly potent and selective oral inhibitors for the treatment of inflammatory diseases, by targeting key drivers of the type 2 immune response. KIT inhibitors Enanta's lead development candidate, EPS-1421, is a novel, potent and selective oral inhibitor of KIT, a receptor tyrosine kinase and central regulator of mast cell development and activation. The Company is currently conducting scale-up activities and IND enabling studies. STAT6 Inhibitors Enanta's second immunology program is targeting STAT6, the transcription factor responsible for IL-4/IL-13 signaling, which drives a type 2 dominant phenotype and downstream inflammation. Type 2 dysregulation is responsible for multiple allergic and autoimmune diseases. Enanta's prototype oral STAT6 inhibitors exhibit nanomolar inhibition in biochemical and cellular assays, with good intrinsic permeability and oral bioavailability. In addition, inhibition of IL-4 induced phosphorylation of STAT6 in human peripheral blood mononuclear cells (hPBMC) and prevention of TARC production, a STAT6 biomarker of type 2 inflammation, have been observed. Further, the STAT6 prototypes are highly selective, with no inhibition of other STATs in hPBMCs and more than 1000-fold biochemical selectivity over other STATs, demonstrating significantly more selectivity than JAK inhibitors. In a mouse model, a prototype oral inhibitor resulted in rapid and complete inhibition of IL-4 induced phosphorylated STAT6 after a single dose, demonstrating in vivo target engagement. The Company plans to select a STAT6 development candidate in the second half of 2025. Enanta plans to expand its immunology pipeline with the introduction of a third program in 2025. Corporate In April 2025, the Company received a $33.8 million federal income tax refund. On March 21, 2025, Enanta filed an opening brief with the United States Court of Appeals for the Federal Circuit. The original case was filed in the United States District Court for the District of Massachusetts on June 21, 2022, against Pfizer, Inc. seeking damages for infringement of U.S. Patent No. 11,358,953 (the '953 Patent) in the manufacture, use and sale of Pfizer's COVID-19 antiviral, Paxlovid™ (nirmatrelvir tablets; ritonavir tablets). Enanta plans to issue its fiscal third quarter financial results press release on August 11, 2025. About Enanta Pharmaceuticals, Inc. Enanta is using its robust, chemistry-driven approach and drug discovery capabilities to become a leader in the discovery and development of small molecule drugs with an emphasis on indications in virology and immunology. Enanta's clinical programs are currently focused on respiratory syncytial virus (RSV) and its earlier-stage immunology pipeline aims to develop treatments for inflammatory diseases by targeting key drivers of the type 2 immune response, including KIT and STAT6 inhibition. Glecaprevir, a protease inhibitor discovered by Enanta, is part of one of the leading treatment regimens for curing chronic hepatitis c virus (HCV) infection and is sold by AbbVie in numerous countries under the tradenames MAVYRET ® (U.S.) and MAVIRET ® (ex-U.S.) (glecaprevir/pibrentasvir). A portion of Enanta's royalties from HCV products developed under its collaboration with AbbVie contribute ongoing funding to Enanta's operations. Please visit for more information. Forward Looking Statements This press release contains forward-looking statements, including statements with respect to the timeline and prospects for advancement of Enanta's clinical programs in RSV and its preclinical immunology programs, including its programs targeting KIT and STAT6 inhibition. Statements that are not historical facts are based on management's current expectations, estimates, forecasts and projections about Enanta's business and the industry in which it operates and management's beliefs and assumptions. The statements contained in this release are not guarantees of future performance and involve certain risks, uncertainties and assumptions, which are difficult to predict. Therefore, actual outcomes and results may differ materially from what is expressed in such forward-looking statements. Important factors and risks that may affect actual results include: the impact of development, regulatory and marketing efforts of others with respect to vaccines and competitive treatments for RSV; the discovery and development risks of Enanta's programs in virology and immunology; Enanta's lack of clinical development experience; Enanta's ability to partner its RSV or other programs; Enanta's need to attract and retain senior management and key research and development personnel; Enanta's need to obtain and maintain patent protection for its product candidates and avoid potential infringement of the intellectual property rights of others; and other risk factors described or referred to in 'Risk Factors' in Enanta's Form 10-K for the fiscal year-ended September 30, 2024, and any other periodic reports filed more recently with the Securities and Exchange Commission. Enanta cautions investors not to place undue reliance on the forward-looking statements contained in this release. These statements speak only as of the date of this release, and Enanta undertakes no obligation to update or revise these statements, except as may be required by law. Tables to Follow ENANTA PHARMACEUTICALS, INC. UNAUDITED (in thousands) September 30, 2025 2024 Assets Current assets Cash and cash equivalents $ 60,213 $ 37,233 Short-term marketable securities 133,162 210,953 Accounts receivable 6,792 6,646 Prepaid expenses and other current assets 8,857 12,413 Income tax receivable 33,836 31,999 Short-term restricted cash - 608 Total current assets 242,860 299,852 Property and equipment, net 37,572 32,688 Operating lease, right-of-use assets 39,103 40,658 Long-term restricted cash 3,360 3,360 Other long-term assets 98 94 Total assets $ 322,993 $ 376,652 Liabilities and Stockholders' Equity Current liabilities Accounts payable $ 4,756 $ 8,002 Accrued expenses and other current liabilities 8,314 13,547 Liability related to the sale of future royalties 30,681 34,462 Operating lease liabilities 2,196 1,524 Total current liabilities 45,947 57,535 Liability related to the sale of future royalties, net of current portion 125,379 134,779 Operating lease liabilities, net of current portion 56,536 53,943 Series 1 nonconvertible preferred stock 1,350 1,350 Other long-term liabilities 243 231 Total liabilities 229,455 247,838 Total stockholders' equity 93,538 128,814 Total liabilities and stockholders' equity $ 322,993 $ 376,652 Expand
