{"success":true,"data":{"pressRelease":{"id":"141985","rtpr_id":"nGNX8XC8JV-20260914","ticker":"BSLN","exchange":"","all_tickers":["BSLN"],"title":"Basilea announces start of clinical study by partner Asahi Kasei Therapeutics in Japan with antifungal Cresemba® (isavuconazole) in pediatric patients ","author":"Globe Newswire","published_at":"2026-09-14T05:15:00.298Z","article_body":"Allschwil, Switzerland, September 14, 2026\n\nBasilea Pharmaceutica Ltd, Allschwil (SIX: BSLN), a commercial-stage\nbiopharmaceutical company committed to meeting the needs of patients with\nsevere bacterial and fungal infections, announced today that its partner Asahi\nKasei Therapeutics Corp. started a phase 2 clinical study in Japan with the\nantifungal Cresemba(®) (isavuconazole) for pediatric patients at risk of deep\nmycoses.\n\nDr. Marc Engelhardt, Chief Medical Officer of Basilea, said: “We are very\npleased with the start of the pediatric study for Cresemba by our partner\nAsahi Kasei Therapeutics Corp. Invasive fungal infections pose a critical\nthreat for children suffering from hematologic malignancies or\nimmunodeficiency disorders. Despite this high-risk setting, treatment options\nremain limited. Making Cresemba available to pediatric patients in Japan would\nrepresent a major advance in addressing this important medical need.”\n\nThe multicenter, open-label, non-controlled study is assessing the safety and\npharmacokinetics of Cresemba in children at risk from deep mycoses.\n\nCresemba is already approved for the treatment of children in the US, Canada,\nEurope and China. In Japan, Cresemba is approved for the treatment of adults\nwith severe fungal infections, but currently not for use in pediatric\npatients.\n\nAbout Cresemba(®) (isavuconazole)\n\nCresemba, with the active ingredient isavuconazole, is an intravenous (i.v.)\nand oral azole antifungal. Cresemba is marketed in more than 70 countries. In\nJapan, orally and intravenously administered isavuconazole is approved for use\nin adults for the treatment of aspergillosis (invasive aspergillosis, chronic\nprogressive pulmonary aspergillosis, simple pulmonary aspergilloma),\nmucormycosis, and cryptococcosis (pulmonary cryptococcosis and disseminated\ncryptococcosis). Isavuconazole is also approved in the European Union(1), the\nUnited Kingdom(2), the United States (US)(3) and many additional countries,\nincluding in the Asia Pacific region.(4)\n\nAccording to the latest available market data, total global in-market sales of\nCresemba in the twelve-month period between April 2025 and March 2026 amounted\nto USD 782 million, a 27 percent growth year-on-year, making it the largest\nbranded antifungal for invasive fungal infections worldwide.(5)\n\nDeep mycoses\n\nDeep mycoses like invasive aspergillosis (IA), invasive mucormycosis (IM) and\ninvasive cryptococcosis are life-threatening fungal infections that spread\nbeyond superficial sites into deep tissues, including lung, eyes, brain,\nbones, the bloodstream, and other sites or organs. They predominantly affect\nimmunocompromised patients, including patients with hematologic malignancies\n(blood cancer), transplant patients, or patients with immunodeficiency\ndisorders. These infections are associated with high morbidity and mortality,\nalso in pediatric patients.(6, 7, 8)\n\nAbout Basilea\n\nBasilea is a commercial-stage biopharmaceutical company founded in 2000 and\nheadquartered in Switzerland. We are committed to discovering, developing and\ncommercializing innovative drugs to meet the needs of patients with severe\nbacterial and fungal infections. We have successfully launched two hospital\nbrands, Cresemba for the treatment of invasive fungal infections and Zevtera\nfor the treatment of bacterial infections. In addition, we have preclinical\nand clinical anti-infective assets in our portfolio. Basilea is listed on the\nSIX Swiss Exchange (SIX: BSLN). Please visit basilea.com.\n\nDisclaimer\n\nThis communication expressly or implicitly contains certain forward-looking\nstatements, such as \"believe\", \"assume\", \"expect\", \"forecast\", \"project\",\n\"may\", \"could\", \"might\", \"will\" or similar expressions concerning Basilea\nPharmaceutica Ltd, Allschwil and its business, including with respect to the\nprogress, timing and completion of research, development and clinical studies\nfor product candidates. Such statements involve certain known and unknown\nrisks, uncertainties and other factors, which could cause the actual results,\nfinancial condition, performance or achievements of Basilea Pharmaceutica Ltd,\nAllschwil to be materially different from any future results, performance or\nachievements expressed or implied by such forward-looking statements. Basilea\nPharmaceutica Ltd, Allschwil is providing this communication as of this date\nand does not undertake to update any forward-looking statements contained\nherein as a result of new information, future events or otherwise.\n\nFor further information, please contact:\n\n Peer Nils Schröder, PhD  Head of Corporate Communications & Investor Relations Basilea Pharmaceutica International Ltd, Allschwil Hegenheimermattweg 167b 4123 Allschwil Switzerland \n Phone   +41 61 606 1102                                             \n E-mail  media_relations@basilea.com investor_relations@basilea.com  \n\nThis press release can be downloaded from www.basilea.com.\n\nReferences\n1. European Public Assessment Report (EPAR) Cresemba:\nhttps://www.ema.europa.eu/en/medicines/human/EPAR/cresemba [Accessed:\nSeptember 13, 2026]\n2. Summary of Product Characteristics (SmPC) Cresemba:\nhttps://www.medicines.org.uk/emc/search?q=cresemba [Accessed: September 13,\n2026]\n3. Full US prescribing information: https://www.astellas.us/docs/cresemba.pdf\n[Accessed: September 13, 2026]\n4. The registration status and approved indications may vary from country to\ncountry.\n5. IQVIA Analytics Link, March 2026. In-market sales reported as moving annual\ntotal (MAT) in US dollar. \n6. J. Cadena, G. R. Thompson 3rd, T. F. Patterson. Aspergillosis:\nEpidemiology, Diagnosis, and Treatment. Infectious Disease Clinics of North\nAmerica 2021 (35), 415-434\n7. M. Slavin, S. van Hal, T. C. Sorrell et al. Invasive infections due to\nfilamentous fungi other than Aspergillus: epidemiology and determinants of\nmortality. Clinical Microbiology and Infection 2015 (21), 490.e1-490.e10\n8. Z. D. Pana E. Roilides, A. Warris et al. Epidemiology of Invasive Fungal\nDisease in Children. Journal of the Pediatric Infectious Diseases Society 2017\n(6), suppl. 1, S3-S11\nAttachment\n*     Basilea Press release\n(https://ml-eu.globenewswire.com/Resource/Download/9b38da10-ae10-4bb0-8bbd-cad7b56a6759)\n(https://www.globenewswire.com/NewsRoom/AttachmentNg/4403c5ae-6c9a-43d2-8c5f-deb2de747a47)\n\n\n\nGlobeNewswire, Inc. 2026","article_body_html":"","raw_payload":{"data":{"id":"nGNX8XC8JV-20260914","title":"Basilea announces start of clinical study by partner Asahi Kasei Therapeutics in Japan with antifungal Cresemba® (isavuconazole) in pediatric patients ","author":"Globe Newswire","ticker":"BSLN","created":"2026-09-14T05:15:00.298Z","tickers":["BSLN"],"exchange":"","article_body":"Allschwil, Switzerland, September 14, 2026\n\nBasilea Pharmaceutica Ltd, Allschwil (SIX: BSLN), a commercial-stage\nbiopharmaceutical company committed to meeting the needs of patients with\nsevere bacterial and fungal infections, announced today that its partner Asahi\nKasei Therapeutics Corp. started a phase 2 clinical study in Japan with the\nantifungal Cresemba(®) (isavuconazole) for pediatric patients at risk of deep\nmycoses.\n\nDr. Marc Engelhardt, Chief Medical Officer of Basilea, said: “We are very\npleased with the start of the pediatric study for Cresemba by our partner\nAsahi Kasei Therapeutics Corp. Invasive fungal infections pose a critical\nthreat for children suffering from hematologic malignancies or\nimmunodeficiency disorders. Despite this high-risk setting, treatment options\nremain limited. Making Cresemba available to pediatric patients in Japan would\nrepresent a major advance in addressing this important medical need.”\n\nThe multicenter, open-label, non-controlled study is assessing the safety and\npharmacokinetics of Cresemba in children at risk from deep mycoses.\n\nCresemba is already approved for the treatment of children in the US, Canada,\nEurope and China. In Japan, Cresemba is approved for the treatment of adults\nwith severe fungal infections, but currently not for use in pediatric\npatients.\n\nAbout Cresemba(®) (isavuconazole)\n\nCresemba, with the active ingredient isavuconazole, is an intravenous (i.v.)\nand oral azole antifungal. Cresemba is marketed in more than 70 countries. In\nJapan, orally and intravenously administered isavuconazole is approved for use\nin adults for the treatment of aspergillosis (invasive aspergillosis, chronic\nprogressive pulmonary aspergillosis, simple pulmonary aspergilloma),\nmucormycosis, and cryptococcosis (pulmonary cryptococcosis and disseminated\ncryptococcosis). Isavuconazole is also approved in the European Union(1), the\nUnited Kingdom(2), the United States (US)(3) and many additional countries,\nincluding in the Asia Pacific region.(4)\n\nAccording to the latest available market data, total global in-market sales of\nCresemba in the twelve-month period between April 2025 and March 2026 amounted\nto USD 782 million, a 27 percent growth year-on-year, making it the largest\nbranded antifungal for invasive fungal infections worldwide.(5)\n\nDeep mycoses\n\nDeep mycoses like invasive aspergillosis (IA), invasive mucormycosis (IM) and\ninvasive cryptococcosis are life-threatening fungal infections that spread\nbeyond superficial sites into deep tissues, including lung, eyes, brain,\nbones, the bloodstream, and other sites or organs. They predominantly affect\nimmunocompromised patients, including patients with hematologic malignancies\n(blood cancer), transplant patients, or patients with immunodeficiency\ndisorders. These infections are associated with high morbidity and mortality,\nalso in pediatric patients.(6, 7, 8)\n\nAbout Basilea\n\nBasilea is a commercial-stage biopharmaceutical company founded in 2000 and\nheadquartered in Switzerland. We are committed to discovering, developing and\ncommercializing innovative drugs to meet the needs of patients with severe\nbacterial and fungal infections. We have successfully launched two hospital\nbrands, Cresemba for the treatment of invasive fungal infections and Zevtera\nfor the treatment of bacterial infections. In addition, we have preclinical\nand clinical anti-infective assets in our portfolio. Basilea is listed on the\nSIX Swiss Exchange (SIX: BSLN). Please visit basilea.com.\n\nDisclaimer\n\nThis communication expressly or implicitly contains certain forward-looking\nstatements, such as \"believe\", \"assume\", \"expect\", \"forecast\", \"project\",\n\"may\", \"could\", \"might\", \"will\" or similar expressions concerning Basilea\nPharmaceutica Ltd, Allschwil and its business, including with respect to the\nprogress, timing and completion of research, development and clinical studies\nfor product candidates. Such statements involve certain known and unknown\nrisks, uncertainties and other factors, which could cause the actual results,\nfinancial condition, performance or achievements of Basilea Pharmaceutica Ltd,\nAllschwil to be materially different from any future results, performance or\nachievements expressed or implied by such forward-looking statements. Basilea\nPharmaceutica Ltd, Allschwil is providing this communication as of this date\nand does not undertake to update any forward-looking statements contained\nherein as a result of new information, future events or otherwise.\n\nFor further information, please contact:\n\n Peer Nils Schröder, PhD  Head of Corporate Communications & Investor Relations Basilea Pharmaceutica International Ltd, Allschwil Hegenheimermattweg 167b 4123 Allschwil Switzerland \n Phone   +41 61 606 1102                                             \n E-mail  media_relations@basilea.com investor_relations@basilea.com  \n\nThis press release can be downloaded from www.basilea.com.\n\nReferences\n1. European Public Assessment Report (EPAR) Cresemba:\nhttps://www.ema.europa.eu/en/medicines/human/EPAR/cresemba [Accessed:\nSeptember 13, 2026]\n2. Summary of Product Characteristics (SmPC) Cresemba:\nhttps://www.medicines.org.uk/emc/search?q=cresemba [Accessed: September 13,\n2026]\n3. Full US prescribing information: https://www.astellas.us/docs/cresemba.pdf\n[Accessed: September 13, 2026]\n4. The registration status and approved indications may vary from country to\ncountry.\n5. IQVIA Analytics Link, March 2026. In-market sales reported as moving annual\ntotal (MAT) in US dollar. \n6. J. Cadena, G. R. Thompson 3rd, T. F. Patterson. Aspergillosis:\nEpidemiology, Diagnosis, and Treatment. Infectious Disease Clinics of North\nAmerica 2021 (35), 415-434\n7. M. Slavin, S. van Hal, T. C. Sorrell et al. Invasive infections due to\nfilamentous fungi other than Aspergillus: epidemiology and determinants of\nmortality. Clinical Microbiology and Infection 2015 (21), 490.e1-490.e10\n8. Z. D. Pana E. Roilides, A. Warris et al. Epidemiology of Invasive Fungal\nDisease in Children. Journal of the Pediatric Infectious Diseases Society 2017\n(6), suppl. 1, S3-S11\nAttachment\n*     Basilea Press release\n(https://ml-eu.globenewswire.com/Resource/Download/9b38da10-ae10-4bb0-8bbd-cad7b56a6759)\n(https://www.globenewswire.com/NewsRoom/AttachmentNg/4403c5ae-6c9a-43d2-8c5f-deb2de747a47)\n\n\n\nGlobeNewswire, Inc. 2026"},"type":"article","timestamp":"2026-09-14T05:15:00.360738279Z","server_sent_at_ms":1789362900360},"received_at":"2026-09-14T05:15:00.415Z","source_url":null},"analysis":{"id":"130821","press_release_id":"141985","analysis_json":{"industry":{"label":"Biotechnology","sector":"Health Care"},"redFlags":["Early-stage Phase 2 study — Japanese pediatric approval and any revenue contribution remain years away","No timeline disclosed for study readout or regulatory submission in Japan"],"eventType":"clinical_trial","narrative":"Basilea's Japanese partner Asahi Kasei Therapeutics has started a Phase 2 clinical study in Japan evaluating the antifungal Cresemba (isavuconazole) in pediatric patients at risk of deep mycoses.\n\nThe multicenter, open-label study assesses safety and pharmacokinetics in children. Cresemba is already approved for pediatric use in the US, Canada, Europe and China, but in Japan it is currently approved only for adults.\n\nCresemba generated USD 782 million in global in-market sales in the twelve months to March 2026, up 27% year-on-year, making it the largest branded antifungal for invasive fungal infections worldwide. A Japanese pediatric approval would add a further growth avenue for Basilea's lead hospital brand.","sentiment":"bullish","agentHooks":{"shouldPost":false,"suggestedAngle":"Partner-driven pediatric label expansion in Japan extends the growth runway for Basilea's USD 782M antifungal franchise."},"keyFigures":{"drugName":"Cresemba (isavuconazole)","phaseOfTrial":"Phase 2","customDimensions":{"sales_period":"April 2025 - March 2026","countries_marketed":"more than 70","cresemba_sales_yoy":"27%","cresemba_global_mat_sales_usd":782000000}},"quotedText":"Making Cresemba available to pediatric patients in Japan would\nrepresent a major advance in addressing this important medical need.","namedEntities":{"people":[{"name":"Dr. Marc Engelhardt","role":"Chief Medical Officer of Basilea"},{"name":"Peer Nils Schröder","role":"Head of Corporate Communications & Investor Relations"}],"products":["Cresemba","isavuconazole","Zevtera"],"companies":[{"name":"Basilea Pharmaceutica Ltd","ticker":"BSLN","relationship":"filer"},{"name":"Asahi Kasei Therapeutics Corp.","relationship":"partner (Japanese licensee running the study)"}],"dollarAmounts":[{"amount":"USD 782 million","context":"total global in-market sales of Cresemba, twelve months April 2025 - March 2026"}]},"materialImpact":{"score":2,"reasoning":"Partner Asahi Kasei Therapeutics initiated a Phase 2 pediatric study of Cresemba in Japan — an early-stage label-expansion step for Basilea's lead brand with no near-term financial impact. Positive for the long-term Cresemba growth story, but routine as pipeline news."},"tickerRelevance":{"others":[],"primary":"BSLN"},"globalImportance":20,"audienceRelevance":15,"eventTypeSecondary":["partnership"],"importanceComponents":{"tickerTier":"small-cap, SIX Swiss Exchange-listed biotech","eventGravity":"partner-led Phase 2 study start (label expansion), no binary readout near-term","commercialContext":"Cresemba MAT sales USD 782M, +27% YoY","foreignIssuerDiscount":true,"nearTermFinancialImpact":"none — early-stage pediatric trial"}},"event_type":"clinical_trial","event_type_secondary":["partnership"],"sentiment":"bullish","material_impact_score":2,"narrative":"Basilea's Japanese partner Asahi Kasei Therapeutics has started a Phase 2 clinical study in Japan evaluating the antifungal Cresemba (isavuconazole) in pediatric patients at risk of deep mycoses.\n\nThe multicenter, open-label study assesses safety and pharmacokinetics in children. Cresemba is already approved for pediatric use in the US, Canada, Europe and China, but in Japan it is currently approved only for adults.\n\nCresemba generated USD 782 million in global in-market sales in the twelve months to March 2026, up 27% year-on-year, making it the largest branded antifungal for invasive fungal infections worldwide. A Japanese pediatric approval would add a further growth avenue for Basilea's lead hospital brand.","key_figures":{"drugName":"Cresemba (isavuconazole)","phaseOfTrial":"Phase 2","customDimensions":{"sales_period":"April 2025 - March 2026","countries_marketed":"more than 70","cresemba_sales_yoy":"27%","cresemba_global_mat_sales_usd":782000000}},"named_entities":{"people":[{"name":"Dr. Marc Engelhardt","role":"Chief Medical Officer of Basilea"},{"name":"Peer Nils Schröder","role":"Head of Corporate Communications & Investor Relations"}],"products":["Cresemba","isavuconazole","Zevtera"],"companies":[{"name":"Basilea Pharmaceutica Ltd","ticker":"BSLN","relationship":"filer"},{"name":"Asahi Kasei Therapeutics Corp.","relationship":"partner (Japanese licensee running the study)"}],"dollarAmounts":[{"amount":"USD 782 million","context":"total global in-market sales of Cresemba, twelve months April 2025 - March 2026"}]},"model_name":"glm-5.3-flash","prompt_hash":"sha256:727b4b9429a443af","schema_hash":"sha256:05005c02d9cffac9","created_at":"2026-09-14T05:15:41.297Z","global_importance":20,"audience_relevance":15,"importance_components":{"tickerTier":"small-cap, SIX Swiss Exchange-listed biotech","eventGravity":"partner-led Phase 2 study start (label expansion), no binary readout near-term","commercialContext":"Cresemba MAT sales USD 782M, +27% YoY","foreignIssuerDiscount":true,"nearTermFinancialImpact":"none — early-stage pediatric trial"}},"durationMs":40874,"modelName":"glm-5.3-flash"}}