BioVersys（BIOV）株式概要BioVersys AGは臨床段階にあるバイオ医薬品企業で、多剤耐性菌による生命を脅かす深刻な感染症に対する新規抗菌製品の同定、開発、商業化に注力している。 詳細BIOV ファンダメンタル分析スノーフレーク・スコア評価0/6将来の成長2/6過去の実績0/6財務の健全性5/6配当金0/6報酬収益は年間68.27%増加すると予測されています 過去 1 年間で収益は161.7%増加しましたリスク分析今後3年間の収益は年平均14.3%減少すると予測されている。 Swiss市場と比較して、過去 3 か月間の株価の変動が非常に大きい現在は利益が出ておらず、今後3年間で利益が出る見込みはない 意味のある収益がありません ( CHF3M )すべてのリスクチェックを見るBIOV Community Fair Values Create NarrativeSee what others think this stock is worth. Follow their fair value or set your own to get alerts.Analyst Price TargetsAN53.8% undervaluedAnalystConsensusTarget•1mo agoAntibiotic Subscription Reforms And External Funding Will Support Long Term Anti Infective Upside1301AN61.6% undervaluedAnalystHighTarget•2mo agoGlobal Antibiotic Partnerships And New Reimbursement Models Will Support Strong Future Potential200AN32.8% undervaluedAnalystLowTarget•1mo agoAntibiotic Trial And Reimbursement Setbacks Will Pressure Results Before Long Term Potential Emerges100Top Analyst NarrativesAN53.8% undervaluedAnalystConsensusTarget•1mo agoAntibiotic Subscription Reforms And External Funding Will Support Long Term Anti Infective Upside1301AN61.6% undervaluedAnalystHighTarget•2mo agoGlobal Antibiotic Partnerships And New Reimbursement Models Will Support Strong Future Potential200AN32.8% undervaluedAnalystLowTarget•1mo agoAntibiotic Trial And Reimbursement Setbacks Will Pressure Results Before Long Term Potential Emerges100View all narrativesBioVersys AG 競合他社Curatis HoldingSymbol: SWX:CURNMarket cap: CHF 125.8mNewron PharmaceuticalsSymbol: SWX:NWRNMarket cap: CHF 283.8mCosmoSymbol: SWX:COPNMarket cap: CHF 1.3bAddex TherapeuticsSymbol: SWX:ADXNMarket cap: CHF 5.5m価格と性能株価の高値、安値、推移の概要BioVersys過去の株価現在の株価CHF 26.9052週高値CHF 36.0052週安値CHF 21.20ベータ01ヶ月の変化-5.94%3ヶ月変化14.47%1年変化-21.80%3年間の変化n/a5年間の変化n/aIPOからの変化-25.28%最新ニュースお知らせ • May 03Bioversys Ag Approves Election of Simona Skerjanec as Members of the Board of DirectorsBioVersys AG announced at the AGM held on April 30, 2026, approved election of Ms. Simona Skerjanec as Members of the Board of Directors.お知らせ • Apr 17BioVersys AG Announces First Patient First Visit In HABP/VABP Pivotal Phase 3 RIV-TARGET Trial Of BV100BioVersys AG announced the first patient first visit in its global pivotal Phase 3 clinical trial for BV100. The Phase 3 trial is designed to evaluate BV100 in critically ill patients with hospital-acquired or ventilator-associated bacterial pneumonia (HABP or VABP), suspected or confirmed to be due to carbapenem-resistant Acinetobacter baumannii-calcoaceticus complex (CRABC). The RIV-TARGET Phase 3 global trial is expected to enroll approximately 300 patients across approximately 100 sites in approximately 15 countries. BV100 is a novel intravenous formulation of rifabutin based on the newly identified mode of action for the active uptake of rifabutin into the Acinetobacter baumannii-calcoaceticus complex. BV100 is being developed for MDR hospital infections caused by Acinetobacter baumannii, including carbapenem-resistant Acinetobacter baumannii (CRAB) strains. BV100 has Qualified Infectious Disease Product (QIDP) Designation by the U.S. FDA, making BV100 eligible for priority FDA review, Fast Track designation, and a five-year extension of market exclusivity in the US. The RIV-TARGET Phase 3 clinical trial (NCT07326540) aims to compare BV100 plus low-dose polymyxin B to Colistin plus high-dose ampicillin-sulbactam in patients with suspected HABP or VABP due to carbapenem-resistant Acinetobacter baumannii-calcoaceticus complex (CRABC). The start of Phase 3 follows the successful Phase 2 study that showed an overall 50% reduction in mortality compared with best available therapy. Global pivotal Phase 3 trial is on track to enroll last patient by the end of 2027 and will support first regulatory approval submissions in 2028. The global Phase 3 trial is a randomized, active-controlled two-part parallel-group trial to evaluate the efficacy and safety of BV100 plus low-dose polymyxin B in patients with HABP or VABP suspected or confirmed to be due to CRABC infection (RIV-TARGET). Part A is the pivotal, randomized, comparative portion of the trial, employing a partially blinded design aiming to enroll approximately 300 HABP/VABP patients with suspected or confirmed CRABC infections. Patients will be randomized 1:1 to receive either BV100 combined with low-dose polymyxin B or Colistin combined with high-dose ampicillin-sulbactam, with both arms allowing meropenem as background in case of polymicrobial infections. The primary efficacy endpoint is defined as 28-day all-cause mortality (ACM) in the CRABC microbiological modified intention-to-treat (CRABC m-MITT) population. Secondary efficacy endpoints will include clinical cure status at the test of cure (ToC) in CRABC m-MITT, ventilator free days, time spent in intensive care unit (ICU) and time in hospital. As part of the study protocol, data safety monitoring boards (DSMBs) will be convened at regular intervals to review trial progress. The Phase 3 trial also includes an open-label, non-randomized, additional single group (Part B) to evaluate the efficacy and safety of BV100 plus low-dose polymyxin B in patients with HABP or VABP due to CRABC known to be resistant to colistin or polymyxin B prior to study entry and patients for whom colistin or polymyxin B regimen has failed prior to study entry. Approximately 25 patients are expected to be enrolled in Part B. This pivotal Phase 3 trial follows the successful completion of a Phase 2 trial in documented Acinetobacter baumannii VABP patients. BV100 combined with polymyxin B demonstrated a clear survival benefit, resulting in a 50% relative reduction in 28-day ACM compared with best available therapy (BAT), in VABP patients suffering from confirmed CRAB infections (28-day ACM: 60% for BAT vs 25% for BV100), and was generally safe and well tolerated. The current Phase 3 trial mimics the successful study design of the positive Phase 2 trial and is expected to read-out towards the end of 2027. Subsequent regulatory submissions aimed at commercial approval are planned in 2028 initially for the US, Europe and China. In parallel to the Phase 3 pivotal trial, an open-label Phase 2b differentiation trial (RIV-CARE) will be initiated in First Half 2026 comparing BV100 with BAT in multiple geographies. The Phase 2b trial aims to provide real world evidence of clinical practices in settings with very high drug resistance levels. Interim analysis is planned for the end of 2026. BV100 is a novel formulation of rifabutin suitable for intravenous administration, with a recently discovered novel mode of action showing an active uptake of rifabutin into the Gram-negative bacterial species, Acinetobacter baumannii. For the first time, BV100 allows for the targeting of the RNA-polymerase enzyme in Gram-negative bacteria with a human-suitable dose. BV100 is being developed for the treatment of infections caused by Acinetobacter baumannii calcoaceticus complex (ABC), including carbapenem-resistant ABC (CRABC) in critically important indications of ventilator associated bacterial pneumonia (VABP), hospital-acquired bacterial pneumonia (HABP) and bloodstream infections (BSI). BV100 was granted QIDP Designation by the U.S. FDA in May 2019 for use in the treatment of VABP, HABP and BSI, making BV100 eligible for priority FDA review, Fast Track designation, and a five-year extension of market exclusivity upon approval of the first QIDP indication.お知らせ • Apr 16Bioversys AG Presents Data on Clinical and Preclinical Pipeline Programs At ESCMID Global 2026BioVersys AG announced its participation in the 36th Congress of the European Society of Clinical Microbiology & Infectious Diseases (ESCMID Global 2026), where it will present the latest preclinical data on its lead clinical asset BV100 (CRABC) and its preclinical asset BV500 (NTM). Poster presentations to feature data from clinical asset BV100 addressing carbapenem-resistant Acinetobacter baumannii-calcoaceticus complex (CRABC) hospital infections and preclinical asset BV500 addressing non-tuberculosis mycobacteria (NTM) infections. Experts from the UK, Greece and Switzerland to share preclinical insights on BV100’s activity against CRABC on Sunday, April 19, 2026. BioVersys’ CEO, Marc Gitzinger, to present at a session exploring how funding and policy priorities shape infectious disease research and antibiotics innovation on Monday, April 20, 2026. ESCMID is the premier annual congress of the European Society of Clinical Microbiology and Infectious Diseases. It takes place from April 17 - 21, 2026 in Munich, Germany. BV100 is a novel intravenous formulation of rifabutin based on the newly identified mode of action for the active uptake of rifabutin into the Acinetobacter baumannii-calcoaceticus complex (ABC). It is currently being studied in a global Phase 3 clinical trial (RIV-TARGET), with the potential to be a best-in-class anti-infective agent in treating hospital-acquired bacterial pneumonia (HABP) or ventilator-associated bacterial pneumonia (VABP), caused by carbapenem-resistant Acinetobacter baumannii-calcoaceticus complex (CRABC). BV100 has Qualified Infectious Disease Product (QIDP) Designation from the U.S. FDA, making BV100 eligible for priority FDA review, Fast Track designation, and a five-year extension of market exclusivity. BV500 is derived from the company’s proprietary Ansamycin Chemistry platform and a successful collaboration within the SmartLab public-private partnership with the University of Lille (France). BioVersys’ research teams in Lille (France) and Basel (Switzerland) have identified and developed several advanced, highly potent and orally bioavailable Lead candidates, with broad-spectrum in vitro and in vivo anti-NTM activity, which are devoid of cross-resistance with other therapeutic classes. The BV500 program has received funding support and access to key expertise from the CF AMR Syndicate and the EU IHI funded RespiriNTM program. BV500 is under a global research collaboration and exclusive license option agreement with the Japanese pharmaceutical company, Shionogi & Co. Ltd. In vitro results suggest BV100 remains active against drug-resistant A. baumannii, including isolates with common rpoB resistance mutations. In vitro infection model-based studies show BV100 combinations (with polymyxin B or cefiderocol) can increase bacterial killing and may help limit resistance in tested strains. Preclinical data show BV500 Lead compounds are active against non-tuberculous mycobacteria (including M. abscessus) both in vitro and in vivo.新しいナラティブ • Apr 16Antibiotic Subscription Reforms And External Funding Will Support Long Term Anti Infective UpsideCatalysts About BioVersys BioVersys develops antibiotics and anti infective therapies targeting high mortality, drug resistant infections and tuberculosis. What are the underlying business or industry changes driving this perspective?お知らせ • Apr 13Bioversys Ag Publishes Pre-Clinical Data of Alpe Drug Combination in Nature CommunicationsBioVersys AG announced the publication of pre-clinical data in the journal of Nature Communications, for its anti-tuberculosis combination AlpE. Alpibectir, a small molecule acting through a novel mode of action, represents a new concept of overcoming drug-resistance in M. tuberculosis, by potentiating the activity of an existing antibiotic, ethionamide, and was identified in a research collaboration with GSK and the academic groups of Dr. Alain Baulard, Prof. Benoit Deprez and Prof. Nicolas Willand. Following the recently published clinical proof-of-concept for AlpE in pulmonary TB, BioVersys and collaborators now publish pre-clinical evidence supporting the potential of AlpE to provide a new therapeutic option to treat tuberculosis. in vitro studies, AlpE showed potent activity against a diverse set of M. tuberculosis clinical strains, including those resistant to standard of care treatments. AlpE was also active against intracellular M. tuberculosis. in vivo studies, AlpE rapidly reduced bacterial load levels and improved survival, demonstrating clear translation from in vitro to in vivo proof of concept. Through the BioVersys and GSK partnership, alpibectir has completed Phase 1 and two Phase 2a pulmonary TB trials and is considered to be generally safe and well tolerated. Currently, AlpE is being studied in a pulmonary TB Phase 2b trial in combination with first-line TB drugs (NCT05807399), within IMI2 UNITE4TB project and BioVersys recently initiated a Phase 2 trial in meningeal TB (NCT07350174). Alpibectir (previously known as BVL-GSK098) is a small molecule developed from BioVersys’ Transcriptional Regulatory Inhibitory Compounds (TRIC) platform in a collaboration with GSK, the Institut Pasteur de Lille and the University of Lille. Alpibectir acts through a novel mode of action, potentiating the activity of the anti-TB drug ethionamide (Eto). Alpibectir is being studied for its potential to lower the efficacious human dose of Eto, minimizing of dose-dependent side effects, and overcome Eto resistance. The combination alpibectir/Eto (AlpE) is being developed for the treatment of pulmonary TB and TB meningitis. In 2023 AlpE was granted orphan-drug designation (ODD) for the treatment of tuberculosis, by the U.S. Food and Drug Administration (U.S. FDA) providing for certain incentives including seven years US market exclusivity. Similarly in 2025, AlpE was granted Orphan Designation from the European Medicines Agency (EMA), providing for certain incentives including 10-year EU market exclusivity. Ethionamide (Eto) and prothionamide (Pto) are recommended by the World Health Organization (WHO) for use as second-line agents in the treatment of drug-resistant pulmonary TB and TB meningitis. Despite their usefulness as TB drugs, Eto/Pto cause dose-dependent adverse events that negatively impact treatment adherence. Eto/Pto are prodrugs and their antibacterial activity can be linked to the level of bioactivation inside Mycobacterium tuberculosis (Mtb). The clinical candidate alpibectir (formerly BVL-GSK098) acts on transcriptional regulators of Mtb, stimulating novel bioactivation pathways for Eto, that has resulted in an observed increase of Eto efficacy, while simultaneously overcoming Eto resistance and keeping potent activity on MDR strains, including to a vast majority of isoniazid-resistant strains. BVL-GSK098 renders Eto rapidly bactericidal and reduces the emergence of Eto resistance development in vitro and in vivo. Based on pre-clinical data, the TRIC-TB project started to explore whether BVL-GSK098 could ultimately, lower the efficacious human oral dose of Eto by at least 3-fold, minimize dose-dependent side effects, and support patient compliance. With the completion of Phase 1 a major milestone of the TRIC-TB Project was achieved and a novel, fast acting TB agent with the potential to replace isoniazid in TB therapy has been brought into clinical development.お知らせ • Apr 08+ 1 more updateBioVersys AG, Annual General Meeting, Apr 30, 2026BioVersys AG, Annual General Meeting, Apr 30, 2026, at 12:00 W. Europe Standard Time.最新情報をもっと見るRecent updatesお知らせ • May 03Bioversys Ag Approves Election of Simona Skerjanec as Members of the Board of DirectorsBioVersys AG announced at the AGM held on April 30, 2026, approved election of Ms. Simona Skerjanec as Members of the Board of Directors.お知らせ • Apr 17BioVersys AG Announces First Patient First Visit In HABP/VABP Pivotal Phase 3 RIV-TARGET Trial Of BV100BioVersys AG announced the first patient first visit in its global pivotal Phase 3 clinical trial for BV100. The Phase 3 trial is designed to evaluate BV100 in critically ill patients with hospital-acquired or ventilator-associated bacterial pneumonia (HABP or VABP), suspected or confirmed to be due to carbapenem-resistant Acinetobacter baumannii-calcoaceticus complex (CRABC). The RIV-TARGET Phase 3 global trial is expected to enroll approximately 300 patients across approximately 100 sites in approximately 15 countries. BV100 is a novel intravenous formulation of rifabutin based on the newly identified mode of action for the active uptake of rifabutin into the Acinetobacter baumannii-calcoaceticus complex. BV100 is being developed for MDR hospital infections caused by Acinetobacter baumannii, including carbapenem-resistant Acinetobacter baumannii (CRAB) strains. BV100 has Qualified Infectious Disease Product (QIDP) Designation by the U.S. FDA, making BV100 eligible for priority FDA review, Fast Track designation, and a five-year extension of market exclusivity in the US. The RIV-TARGET Phase 3 clinical trial (NCT07326540) aims to compare BV100 plus low-dose polymyxin B to Colistin plus high-dose ampicillin-sulbactam in patients with suspected HABP or VABP due to carbapenem-resistant Acinetobacter baumannii-calcoaceticus complex (CRABC). The start of Phase 3 follows the successful Phase 2 study that showed an overall 50% reduction in mortality compared with best available therapy. Global pivotal Phase 3 trial is on track to enroll last patient by the end of 2027 and will support first regulatory approval submissions in 2028. The global Phase 3 trial is a randomized, active-controlled two-part parallel-group trial to evaluate the efficacy and safety of BV100 plus low-dose polymyxin B in patients with HABP or VABP suspected or confirmed to be due to CRABC infection (RIV-TARGET). Part A is the pivotal, randomized, comparative portion of the trial, employing a partially blinded design aiming to enroll approximately 300 HABP/VABP patients with suspected or confirmed CRABC infections. Patients will be randomized 1:1 to receive either BV100 combined with low-dose polymyxin B or Colistin combined with high-dose ampicillin-sulbactam, with both arms allowing meropenem as background in case of polymicrobial infections. The primary efficacy endpoint is defined as 28-day all-cause mortality (ACM) in the CRABC microbiological modified intention-to-treat (CRABC m-MITT) population. Secondary efficacy endpoints will include clinical cure status at the test of cure (ToC) in CRABC m-MITT, ventilator free days, time spent in intensive care unit (ICU) and time in hospital. As part of the study protocol, data safety monitoring boards (DSMBs) will be convened at regular intervals to review trial progress. The Phase 3 trial also includes an open-label, non-randomized, additional single group (Part B) to evaluate the efficacy and safety of BV100 plus low-dose polymyxin B in patients with HABP or VABP due to CRABC known to be resistant to colistin or polymyxin B prior to study entry and patients for whom colistin or polymyxin B regimen has failed prior to study entry. Approximately 25 patients are expected to be enrolled in Part B. This pivotal Phase 3 trial follows the successful completion of a Phase 2 trial in documented Acinetobacter baumannii VABP patients. BV100 combined with polymyxin B demonstrated a clear survival benefit, resulting in a 50% relative reduction in 28-day ACM compared with best available therapy (BAT), in VABP patients suffering from confirmed CRAB infections (28-day ACM: 60% for BAT vs 25% for BV100), and was generally safe and well tolerated. The current Phase 3 trial mimics the successful study design of the positive Phase 2 trial and is expected to read-out towards the end of 2027. Subsequent regulatory submissions aimed at commercial approval are planned in 2028 initially for the US, Europe and China. In parallel to the Phase 3 pivotal trial, an open-label Phase 2b differentiation trial (RIV-CARE) will be initiated in First Half 2026 comparing BV100 with BAT in multiple geographies. The Phase 2b trial aims to provide real world evidence of clinical practices in settings with very high drug resistance levels. Interim analysis is planned for the end of 2026. BV100 is a novel formulation of rifabutin suitable for intravenous administration, with a recently discovered novel mode of action showing an active uptake of rifabutin into the Gram-negative bacterial species, Acinetobacter baumannii. For the first time, BV100 allows for the targeting of the RNA-polymerase enzyme in Gram-negative bacteria with a human-suitable dose. BV100 is being developed for the treatment of infections caused by Acinetobacter baumannii calcoaceticus complex (ABC), including carbapenem-resistant ABC (CRABC) in critically important indications of ventilator associated bacterial pneumonia (VABP), hospital-acquired bacterial pneumonia (HABP) and bloodstream infections (BSI). BV100 was granted QIDP Designation by the U.S. FDA in May 2019 for use in the treatment of VABP, HABP and BSI, making BV100 eligible for priority FDA review, Fast Track designation, and a five-year extension of market exclusivity upon approval of the first QIDP indication.お知らせ • Apr 16Bioversys AG Presents Data on Clinical and Preclinical Pipeline Programs At ESCMID Global 2026BioVersys AG announced its participation in the 36th Congress of the European Society of Clinical Microbiology & Infectious Diseases (ESCMID Global 2026), where it will present the latest preclinical data on its lead clinical asset BV100 (CRABC) and its preclinical asset BV500 (NTM). Poster presentations to feature data from clinical asset BV100 addressing carbapenem-resistant Acinetobacter baumannii-calcoaceticus complex (CRABC) hospital infections and preclinical asset BV500 addressing non-tuberculosis mycobacteria (NTM) infections. Experts from the UK, Greece and Switzerland to share preclinical insights on BV100’s activity against CRABC on Sunday, April 19, 2026. BioVersys’ CEO, Marc Gitzinger, to present at a session exploring how funding and policy priorities shape infectious disease research and antibiotics innovation on Monday, April 20, 2026. ESCMID is the premier annual congress of the European Society of Clinical Microbiology and Infectious Diseases. It takes place from April 17 - 21, 2026 in Munich, Germany. BV100 is a novel intravenous formulation of rifabutin based on the newly identified mode of action for the active uptake of rifabutin into the Acinetobacter baumannii-calcoaceticus complex (ABC). It is currently being studied in a global Phase 3 clinical trial (RIV-TARGET), with the potential to be a best-in-class anti-infective agent in treating hospital-acquired bacterial pneumonia (HABP) or ventilator-associated bacterial pneumonia (VABP), caused by carbapenem-resistant Acinetobacter baumannii-calcoaceticus complex (CRABC). BV100 has Qualified Infectious Disease Product (QIDP) Designation from the U.S. FDA, making BV100 eligible for priority FDA review, Fast Track designation, and a five-year extension of market exclusivity. BV500 is derived from the company’s proprietary Ansamycin Chemistry platform and a successful collaboration within the SmartLab public-private partnership with the University of Lille (France). BioVersys’ research teams in Lille (France) and Basel (Switzerland) have identified and developed several advanced, highly potent and orally bioavailable Lead candidates, with broad-spectrum in vitro and in vivo anti-NTM activity, which are devoid of cross-resistance with other therapeutic classes. The BV500 program has received funding support and access to key expertise from the CF AMR Syndicate and the EU IHI funded RespiriNTM program. BV500 is under a global research collaboration and exclusive license option agreement with the Japanese pharmaceutical company, Shionogi & Co. Ltd. In vitro results suggest BV100 remains active against drug-resistant A. baumannii, including isolates with common rpoB resistance mutations. In vitro infection model-based studies show BV100 combinations (with polymyxin B or cefiderocol) can increase bacterial killing and may help limit resistance in tested strains. Preclinical data show BV500 Lead compounds are active against non-tuberculous mycobacteria (including M. abscessus) both in vitro and in vivo.新しいナラティブ • Apr 16Antibiotic Subscription Reforms And External Funding Will Support Long Term Anti Infective UpsideCatalysts About BioVersys BioVersys develops antibiotics and anti infective therapies targeting high mortality, drug resistant infections and tuberculosis. What are the underlying business or industry changes driving this perspective?お知らせ • Apr 13Bioversys Ag Publishes Pre-Clinical Data of Alpe Drug Combination in Nature CommunicationsBioVersys AG announced the publication of pre-clinical data in the journal of Nature Communications, for its anti-tuberculosis combination AlpE. Alpibectir, a small molecule acting through a novel mode of action, represents a new concept of overcoming drug-resistance in M. tuberculosis, by potentiating the activity of an existing antibiotic, ethionamide, and was identified in a research collaboration with GSK and the academic groups of Dr. Alain Baulard, Prof. Benoit Deprez and Prof. Nicolas Willand. Following the recently published clinical proof-of-concept for AlpE in pulmonary TB, BioVersys and collaborators now publish pre-clinical evidence supporting the potential of AlpE to provide a new therapeutic option to treat tuberculosis. in vitro studies, AlpE showed potent activity against a diverse set of M. tuberculosis clinical strains, including those resistant to standard of care treatments. AlpE was also active against intracellular M. tuberculosis. in vivo studies, AlpE rapidly reduced bacterial load levels and improved survival, demonstrating clear translation from in vitro to in vivo proof of concept. Through the BioVersys and GSK partnership, alpibectir has completed Phase 1 and two Phase 2a pulmonary TB trials and is considered to be generally safe and well tolerated. Currently, AlpE is being studied in a pulmonary TB Phase 2b trial in combination with first-line TB drugs (NCT05807399), within IMI2 UNITE4TB project and BioVersys recently initiated a Phase 2 trial in meningeal TB (NCT07350174). Alpibectir (previously known as BVL-GSK098) is a small molecule developed from BioVersys’ Transcriptional Regulatory Inhibitory Compounds (TRIC) platform in a collaboration with GSK, the Institut Pasteur de Lille and the University of Lille. Alpibectir acts through a novel mode of action, potentiating the activity of the anti-TB drug ethionamide (Eto). Alpibectir is being studied for its potential to lower the efficacious human dose of Eto, minimizing of dose-dependent side effects, and overcome Eto resistance. The combination alpibectir/Eto (AlpE) is being developed for the treatment of pulmonary TB and TB meningitis. In 2023 AlpE was granted orphan-drug designation (ODD) for the treatment of tuberculosis, by the U.S. Food and Drug Administration (U.S. FDA) providing for certain incentives including seven years US market exclusivity. Similarly in 2025, AlpE was granted Orphan Designation from the European Medicines Agency (EMA), providing for certain incentives including 10-year EU market exclusivity. Ethionamide (Eto) and prothionamide (Pto) are recommended by the World Health Organization (WHO) for use as second-line agents in the treatment of drug-resistant pulmonary TB and TB meningitis. Despite their usefulness as TB drugs, Eto/Pto cause dose-dependent adverse events that negatively impact treatment adherence. Eto/Pto are prodrugs and their antibacterial activity can be linked to the level of bioactivation inside Mycobacterium tuberculosis (Mtb). The clinical candidate alpibectir (formerly BVL-GSK098) acts on transcriptional regulators of Mtb, stimulating novel bioactivation pathways for Eto, that has resulted in an observed increase of Eto efficacy, while simultaneously overcoming Eto resistance and keeping potent activity on MDR strains, including to a vast majority of isoniazid-resistant strains. BVL-GSK098 renders Eto rapidly bactericidal and reduces the emergence of Eto resistance development in vitro and in vivo. Based on pre-clinical data, the TRIC-TB project started to explore whether BVL-GSK098 could ultimately, lower the efficacious human oral dose of Eto by at least 3-fold, minimize dose-dependent side effects, and support patient compliance. With the completion of Phase 1 a major milestone of the TRIC-TB Project was achieved and a novel, fast acting TB agent with the potential to replace isoniazid in TB therapy has been brought into clinical development.お知らせ • Apr 08+ 1 more updateBioVersys AG, Annual General Meeting, Apr 30, 2026BioVersys AG, Annual General Meeting, Apr 30, 2026, at 12:00 W. Europe Standard Time.新しいナラティブ • Apr 02Antibiotic Trial And Reimbursement Setbacks Will Pressure Results Before Long Term Potential EmergesCatalysts About BioVersys BioVersys is a biopharmaceutical company focused on developing antibiotics for severe drug resistant infections and tuberculosis. What are the underlying business or industry changes driving this perspective?新しいナラティブ • Mar 18Global Antibiotic Partnerships And New Reimbursement Models Will Support Strong Future PotentialCatalysts About BioVersys BioVersys is a clinical stage biopharmaceutical company focused on antibiotics targeting severe drug resistant infections and tuberculosis. What are the underlying business or industry changes driving this perspective?お知らせ • Mar 18+ 1 more updateBioVersys AG to Report First Half, 2026 Results on Sep 03, 2026BioVersys AG announced that they will report first half, 2026 results on Sep 03, 2026お知らせ • Mar 16BioVersys AG Receives US Food and Drug Administration Approval to Start BV100 Phase 3 HABP/VABP TrialBioVersys AG announced that the US Food and Drug Administration (US FDA) has confirmed that the global Phase 3 pivotal trial to recruit US patients into the RIV-TARGET clinical trial (NCT07326540) can proceed. The Phase 3 trial will recruit patients with hospital-acquired or ventilator-associated bacterial pneumonia (HABP or VABP), due to carbapenem-resistant Acinetobacter baumannii-calcoaceticus Complex (CRABC). BV100 is a novel intravenous formulation of rifabutin based on the newly identified mode of action for the active uptake of rifabutin into the Acinetobacter baumannii-calcoaceticus complex. BV100 is being developed for MDR hospital infections caused by Acinetobacter baumannii, including carbapenem-resistant Acinetobacter baumannii (CRAB) strains. BV100 has Qualified Infectious Disease Product (QIDP) Designation from the U.S. FDA, making BV100 eligible for priority FDA review, Fast Track designation, and a five-year extension of market exclusivity. The global Phase 3 trial, is a randomized, active-controlled two-part parallel-group trial to evaluate the efficacy and safety of BV100 plus low-dose polymyxin B in patients with HABP or VABP suspected or confirmed to be due to CRABC infection (RIV-TARGET). Part A is the pivotal, randomized, comparative portion of the trial, employing a partially blinded design aiming to enroll approximately 300 HABP/VABP patients with suspected or confirmed CRABC infections. Patients will be randomized 1:1 to receive either BV100 combined with low dose polymyxin B or colistin combined with high-dose ampicillin-sulbactam, with both arms allowing meropenem as background in case of polymicrobial infections. The primary efficacy endpoint is defined as 28-day all-cause mortality (ACM) in the CRABC microbiological modified intention-to-treat (CRABC m-MITT) population. Secondary efficacy endpoints will include clinical cure status at the test of cure (ToC) in CRABC m-MITT, ventilator free days, time spent in intensive care unit (ICU) and time in hospital. As part of the study protocol, data safety monitoring boards (DSMB) will be convened at regular intervals to review trial progress. The Phase 3 trial also includes an open-label, non-randomized, additional single group (Part B) to evaluate the efficacy and safety of BV100 plus low-dose polymyxin B in patients with HABP or VABP due to CRABC known to be resistant to colistin or polymyxin B prior to study entry and patients where colistin or polymyxin B regimen has failed prior to study entry. Approximately 25 patients are expected to be enrolled in Part B. This pivotal Phase 3 trial follows the successful completion of a Phase 2 trial in documented Acinetobacter VABP patients. BV100 combined with polymyxin B demonstrated a clear survival benefit, resulting in a 50% relative reduction in 28-day ACM compared with best available therapy (BAT), in VABP patients suffering from confirmed CRAB infections (28-day ACM: 60% for BAT vs 25% for BV100), and was generally safe and well tolerated. The current Phase 3 trial mimics the successful study design of the positive Phase 2 trial and is expected to read-out towards the end of 2027. Subsequent regulatory submissions aimed at commercial approval are planned in 2028, initially for the US, Europe and China. In parallel to the Phase 3 pivotal trial an open-label Phase 2b differentiation trial (RIV-CARE) will be initiated in First Half 2026 comparing BV100 with BAT in multiple geographies. The Phase 2b trial aims to provide real world evidence of clinical practices in settings with very high drug resistance levels. Interim analysis is planned for end of 2026. BV100 is a novel formulation of rifabutin suitable for intravenous administration, with a recently discovered novel mode of action showing an active uptake of rifabutin into the Gram-negative bacterial species, Acinetobacter baumannii. For the first time, BV100 allows for the targeting of the RNA-polymerase enzyme in Gram-negative bacteria with a human-suitable dose. BV100 is being developed for the treatment of infections caused by Acinetobacter baumannii calcoaceticus complex (ABC), including carbapenem-resistant ABC (CRABC) in critically important indications of ventilator associated bacterial pneumonia (VABP), hospital-acquired bacterial pneumonia (HABP) and bloodstream infections (BSI). BV100 was granted QIDP Designation by the U.S. FDA in May 2019 for use in the treatment of VABP, HABP and BSI, making BV100 eligible for priority FDA review, Fast Track designation, and a five-year extension of market exclusivity upon approval of the first QIDP indication.New Risk • Mar 12New major risk - Share price stabilityThe company's share price has been highly volatile over the past 3 months. It is more volatile than 90% of Swiss stocks, typically moving 9.8% a week. This is considered a major risk. Share price volatility increases the risk of potential losses in the short-term as the stock tends to have larger drops in price more frequently than other stocks. It may also indicate the stock is highly sensitive to market conditions or economic conditions rather than being sensitive to its own business performance, which may also be inconsistent. Currently, the following risks have been identified for the company: Major Risks Share price has been highly volatile over the past 3 months (9.8% average weekly change). Earnings are forecast to decline by an average of 15% per year for the foreseeable future. Minor Risks Currently unprofitable and not forecast to become profitable over next 2 years (CHF29m net loss in 2 years). Revenue is less than US$5m (CHF1.3m revenue, or US$1.7m).お知らせ • Mar 12BioVersys AG Announces First Patient Dosed In Phase 2b Clinical Trial Of Alpe In Pulmonary TuberculosisBioVersys AG announced that the first patient has been dosed in a pulmonary TB Phase 2b clinical trial, evaluating the efficacy, safety and pharmacokinetics of alpibectir-ethionamide (AlpE) in combination with first-line TB drugs (NCT05807399). In this new Phase 2b trial, a portion of the recruited adults with drug sensitive pulmonary tuberculosis (DS-TB) will be dosed for 2-months with RZE in combination with AlpE, followed by 18 weeks with RH alone, to assess efficacy, safety and pharmacokinetics of AlpE. The study is being conducted in six African countries under the European Union’s IMI2 UNITE4TB project, with the Institute of Infectious Diseases and Tropical Medicine, LMU University Hospital Munich as the trial sponsor. Through this Phase 2b TB drug combination trial, BioVersys and its partner GSK are progressing the development of this unique combination and taking the next step in terms of dose finding and potential positioning of AlpE in future TB drug regimens. This trial is expected to read-out by the end of 2027. Preceding this Phase 2b trial, AlpE underwent a second Phase 2a trial in which AlpE was assessed over 14 days in an open-label trial in combination with first line TB drugs. Top-line data is expected to be available Second Quarter 2026. AlpE was generally well tolerated in this trial, supporting the progression into Phase 2b. BioVersys also plans to initiate a Phase 2 trial in meningeal TB in First Half 2026. Alpibectir (previously known as BVL-GSK098) is a small molecule developed from BioVersys’ award winning Transcriptional Regulatory Inhibitory Compounds (TRIC) platform in a successful collaboration with GSK, the Institut Pasteur Lille and the University of Lille. AlpE’s development has been strongly supported by European Union and European Pharmaceutical Industry through Innovative Medicines Initiative (IMI2) Joint Undertaking, EDCTP and now UNITE4TB. The compound represents a novel concept to overcome resistance and potentiate the activity of an existing antibiotic, ethionamide (Eto) or prothionamide (Pto), for the treatment of TB, as demonstrated in a previous 7-day early bactericidal activity Phase 2a clinical trial, recently published in the New England Journal of Medicine, which provided a first human proof-of-concept. In 2023, the fixed-dose combination of AlpE was granted orphan-drug designation (ODD) for the treatment of tuberculosis by the U.S. Food and Drug Administration (FDA), and similarly in 2025, AlpE was granted Orphan Designation from the European Medicines Agency (EMA). Alpibectir (previously known as BVL-GSK098) is a small molecule developed from BioVersys’ award winning Transcriptional Regulatory Inhibitory Compounds (TRIC) platform in a successful collaboration with GSK, the Institut Pasteur Lille and the University of Lille. Alpibectir acts through a novel mode of action, potentiating the activity of the anti-TB drug ethionamide (Eto). Alpibectir is being studied for its potential to, lower the efficacious human dose of Eto, minimizing of dose-dependent side effects, and overcome Eto resistance. The combination alpibectir/Eto (AlpE) is being developed for the treatment of pulmonary TB and TB meningitis. In 2023 AlpE was granted orphan-drug designation (ODD) for the treatment of tuberculosis, by the U.S. Food and Drug Administration (U.S. FDA) providing for certain incentives including seven years US market exclusivity. Similarly in 2025, AlpE was granted Orphan Designation from the European Medicines Agency (EMA), providing for certain incentives including 10-year EU market exclusivity.お知らせ • Mar 05BioVersys AG to Report Fiscal Year 2025 Results on Mar 18, 2026BioVersys AG announced that they will report fiscal year 2025 results at 7:00 AM, Central European Standard Time on Mar 18, 2026お知らせ • Feb 20Bioversys Ag Announces Phase 2A Clinical Trial of Alpe in Patients with Pulmonary TbBioVersys AG announced the publication of promising clinical proof of concept results in the prestigious New England Journal of Medicine from the Phase 2a clinical trial of AlpE in patients with pulmonary TB. Tuberculosis is one of the leading causes of death by infectious diseases globally, and many existing treatments are becoming less effective due to growing drug resistance. Alpibectir, a small molecule acting through a novel mode of action, represents a totally new concept of overcoming resistance by potentiating the activity of an existing antibiotic, ethionamide (Eto), and was identified in a successful public-private collaboration with GSK, the Pasteur Institute of Lille and the University of Lille. The Phase 2a bEto-TB clinical trial was conducted in South Africa through a consortium of three partners, TASK, GSK and BioVersys, and was completed in April 2024. AlpE delivered a promising clinical proof of concept in a 7-day early bactericidal activity (EBA) study, conducted in patients with pulmonary tuberculosis. AlpE seeks to offer a replacement for isoniazid (INH) in the current first-line regimen or to be added as a novel bactericidal drug to future regimens including those of TB meningitis. The clinical development of AlpE has been strongly supported by several European Union grants and public private partnerships, including the EU Innovative Medicines Initiative 2 (IMI2), TRIC-TB project and UNITE4TB project, and the European & Developing Countries Clinical Trials Partnership (EDCTP2 programme), bEto-TB project. This project brings a new anti-TB molecule, BVL-GSK098, to the current drug armamentarium. BL-GSK098 greatlyaugments the activity of, and overcomes resistance to, the well-established second line drug Eto at a lower and well-tolerated dose. The programme has previously received funding from the EU IMI 2 JU (TRIC-TB) and the Wellcome Trust.お知らせ • Nov 07BioVersys AG Announces First Subjects Dosed in Phase 1 Clinical Trial of BV100 in ChinaBioVersys AG, a multi-asset, clinical stage biopharmaceutical company focusing on research and development of novel antibacterial products for serious life-threatening infections caused by multi-drug resistant ("MDR") bacteria, announced the dosing of the first subject in a Phase 1 clinical trial with BV100 in China. The mandatory Phase 1 clinical trial in healthy volunteers in China precedes the inclusion of Chinese clinical sites by late 2026 into the single Global Phase 3 registration trial of BV100 in Ventilator Associated Bacterial Pneumonia (VABP). Recruitment in other geographies will start earlier. BV100 is a novel intravenous formulation of rifabutin based on the newly identified mode of action for the active uptake of rifabutin into the Acinetobacter baumannii-calcoaceticus complex. Combined with very high resistance rates of 60-80% to carbapenems, Acinetobacter baum Annii is the leading cause of death attributable to antimicrobial resistance in China1. Based on recent epidemiology data, BioVersys estimates that over 1 million patients annually are at risk of severe CRAB pneumonia and blood stream infections in China alone. In April 2025, BioVersys presented outstanding Phase 2 clinical data for BV100 in Ventilators Associated Bacterial Pneumonia ("VABP") at the 2025 Congress of the European Society of Clinical Microbiology and Infectious diseases (ESCMID Global) in Vienna, Austria. In that Phase 2, BV100 demonstrated strong signs of efficacy by reducing the mortality rate in critically ill patients suffering from CRAB infections compared with best available therapy. As such, the company are working with regulatory agencies from US, Europe and China to include patients from the three regions into a single global Phase 3 registration trial. The timely initiation of the Phase 1 safety and pharmacokinetic study in China demonstrates that the process to eventually include Chinese clinical sites into global Phase 3 clinical program is progressing well. BioVersys is committed to bringing BV100 to patients in need in as many regions of the world as possible. BV100 is a new formulation of rifabut in intravenous administration, with a recently discovered novel mode of action showing an active uptake of rifabUTin into the Gram-negative bacterial species, Acinetobacter bumannii. BV100 is being developed for the treatment of infections caused by Acinetobacter baumANii calcoaceticus complex (ABC) are Gram-negative bacteria found in the environment (e.g., in soil and water) and an opportunistic pathogen in humans, typically infecting critically ill and immunocompromised patients, that can result in severe pneumonia and bloodstream infections in addition to affecting other parts of the body. BioVersys forecasts the annual number of carbapenem-resistant A. baumannii infections in hospitals to have surpassed one million globally and due to the limited treatment options, such infections come with high (up to 50%) mortality rates.分析記事 • Sep 27Is BioVersys (VTX:BIOV) A Risky Investment?Some say volatility, rather than debt, is the best way to think about risk as an investor, but Warren Buffett famously...お知らせ • Sep 12Bioversys Ag Improves Earnings Guidance for the Fiscal Year 2025BioVersys AG improved earnings guidance for the fiscal year 2025. For the period, the company expect the operating loss at year end to be of CHF 29 million, which is an improvement of CHF 3-6 million compared to the CHF 32 million to CHF 35 million range provided during the Fiscal Year 2024 earnings call.お知らせ • Aug 30BioVersys AG to Report First Half, 2025 Results on Sep 10, 2025BioVersys AG announced that they will report first half, 2025 results on Sep 10, 2025New Risk • Jul 04New minor risk - Share price stabilityThe company's share price has been volatile over the past 3 months. It is more volatile than 75% of Swiss stocks, typically moving 5.8% a week. This is considered a minor risk. Share price volatility indicates the stock is highly sensitive to market conditions or economic conditions rather than being sensitive to its own business performance, which may also be inconsistent. It also increases the risk of potential losses in the short term as the stock tends to have larger drops in price more frequently than other stocks. Currently, the following risks have been identified for the company: Major Risk Earnings are forecast to decline by an average of 15% per year for the foreseeable future. Minor Risks Currently unprofitable and not forecast to become profitable over next 3 years (CHF32m net loss in 3 years). Share price has been volatile over the past 3 months (5.8% average weekly change). Revenue is less than US$5m (CHF1.2m revenue, or US$1.5m).お知らせ • Jul 01Bioversys Ag Appoints Ulrik Schulze as A Member of the Board of DirectorsBioVersys AG at its AGM held on June 27, 2025 appointed Ulrik Schulze as a Member of the Board of Directors.お知らせ • Jun 05BioVersys AG Announces Henni-Karoliina Ropponen Will Not Stand for Re-ElectionBioVersys AG announced that Dr. Henni-Karoliina Ropponen will not stand for re-election at the AGM to be held on June 27, 2025.お知らせ • Jun 04BioVersys AG, Annual General Meeting, Jun 27, 2025BioVersys AG, Annual General Meeting, Jun 27, 2025, at 12:00 W. Europe Standard Time. Location: zip auditorium stuckipark, hochbergerstrasse 60f, 4057 basel, basel SwitzerlandNew Risk • May 08New major risk - Financial data availabilityThe company has not reported any financial data. This is considered a major risk. With no or incomplete audited reported financial data, it is virtually impossible to assess the company's investment potential. This is currently the only risk that has been identified for the company.お知らせ • Mar 31BioVersys AG Announces Important BV100 Patent Granted by Chinese Patent OfficeBioVersys AG announced that the company was granted important patent claims in China for its BV100 technology. BV100 is a novel formulation of rifabutin which is suitable for intravenous administration. BV100 is based on the newly identified mode of action for the active uptake of rifabutin into the Acinetobacter baumannii-calcoaceticus complex and is being developed for resistant hospital infections caused by Acinetobacter baumannii, including carbapenem resistant strains. There is a serious lack of effective and safe treatment options for CRAB infections and mortality rates in hospitals can be as high as 50%. CRAB has been designated a priority pathogen by the World Health Organization and the Centers for Disease Control and Prevention. While CRAB infections are a serious health threat throughout the world, incidence rates for Acinetobacter infections are particularly high in China and Asia, combined with very high resistance rates of 60-80%. Based on recent epidemiology data, BioVersys expects > 1 million patients annually in China alone suffering from severe CRAB pneumonia and blood stream infections.お知らせ • Mar 26+ 1 more updateBioversys Ag Provides Earnings Guidance for the Full Year 2025BioVersys AG provided earnings guidance for the full year 2025. For the full year 2025, the company expects total operating loss to be in the range of CHF 32.0 to CHF 35.0 million.お知らせ • Mar 14BioVersys AG to Report Fiscal Year 2024 Results on Mar 26, 2025BioVersys AG announced that they will report fiscal year 2024 results at 7:00 AM, Central European Standard Time on Mar 26, 2025Board Change • Feb 07No independent directorsFollowing the recent departure of a director, there are no independent directors on the board. The company's board is composed of: No independent directors. 6 non-independent directors. was the last director to join the board, commencing their role in . The company's lack of independent directors is a risk according to the Simply Wall St Risk Model.株主還元BIOVCH PharmaceuticalsCH 市場7D2.3%0.2%1.2%1Y-21.8%29.7%8.1%株主還元を見る業界別リターン: BIOV過去 1 年間で29.7 % の収益を上げたSwiss Pharmaceuticals業界を下回りました。リターン対市場: BIOVは、過去 1 年間で8.1 % のリターンを上げたSwiss市場を下回りました。価格変動Is BIOV's price volatile compared to industry and market?BIOV volatilityBIOV Average Weekly Movement10.0%Pharmaceuticals Industry Average Movement4.5%Market Average Movement4.5%10% most volatile stocks in CH Market8.2%10% least volatile stocks in CH Market2.4%安定した株価: BIOVの株価は、 Swiss市場と比較して過去 3 か月間で変動しています。時間の経過による変動: BIOVの weekly volatility ( 10% ) は過去 1 年間安定していますが、依然としてSwissの株式の 75% よりも高くなっています。会社概要設立従業員CEO（最高経営責任者ウェブサイト200833Marc Gitzingerwww.bioversys.comBioVersys AGは臨床段階にあるバイオ医薬品企業で、多剤耐性菌による生命を脅かす重篤な感染症に対する新規抗菌製品の同定、開発、商業化に注力している。同社はBV100を開発しており、カルバペネム耐性アシネトバクター・バウマンニ肺感染症および血流感染症を対象とした臨床第3相試験中であり、肝障害および気管支肺胞洗浄（BAL）を有する患者を対象とした臨床第1相試験中である。また、肺結核治療薬として臨床第2a相試験中のAlpibectir、アトピー性皮膚炎黄色ブドウ球菌患者治療薬BV200、非結核性抗酸菌感染症治療薬BV500も開発中である。同社は2008年に設立され、スイスのバーゼルに本社を置いている。もっと見るBioVersys AG 基礎のまとめBioVersys の収益と売上を時価総額と比較するとどうか。BIOV 基礎統計学時価総額CHF 157.31m収益（TTM）-CHF 21.83m売上高(TTM)CHF 3.18m49.5xP/Sレシオ-7.2xPER（株価収益率BIOV は割高か？公正価値と評価分析を参照収益と収入最新の決算報告書（TTM）に基づく主な収益性統計BIOV 損益計算書（TTM）収益CHF 3.18m売上原価CHF 0売上総利益CHF 3.18mその他の費用CHF 25.01m収益-CHF 21.83m直近の収益報告Dec 31, 2025次回決算日Sep 03, 2026一株当たり利益（EPS）-3.73グロス・マージン100.00%純利益率-687.56%有利子負債／自己資本比率35.6%BIOV の長期的なパフォーマンスは？過去の実績と比較を見るView Valuation企業分析と財務データの現状データ最終更新日（UTC時間）企業分析2026/05/26 19:04終値2026/05/26 00:00収益2025/12/31年間収益2025/12/31データソース企業分析に使用したデータはS&P Global Market Intelligence LLC のものです。本レポートを作成するための分析モデルでは、以下のデータを使用しています。データは正規化されているため、ソースが利用可能になるまでに時間がかかる場合があります。パッケージデータタイムフレーム米国ソース例会社財務10年損益計算書キャッシュ・フロー計算書貸借対照表SECフォーム10-KSECフォーム10-Qアナリストのコンセンサス予想+プラス3年予想財務アナリストの目標株価アナリストリサーチレポートBlue Matrix市場価格30年株価配当、分割、措置ICEマーケットデータSECフォームS-1所有権10年トップ株主インサイダー取引SECフォーム4SECフォーム13Dマネジメント10年リーダーシップ・チーム取締役会SECフォーム10-KSECフォームDEF 14A主な進展10年会社からのお知らせSECフォーム8-K* 米国証券を対象とした例であり、非米国証券については、同等の規制書式および情報源を使用。特に断りのない限り、すべての財務データは1年ごとの期間に基づいていますが、四半期ごとに更新されます。これは、TTM（Trailing Twelve Month）またはLTM（Last Twelve Month）データとして知られています。詳細はこちら。分析モデルとスノーフレーク本レポートを生成するために使用した分析モデルの詳細は当社のGithubページでご覧いただけます。また、レポートの使用方法に関するガイドやYoutubeのチュートリアルも掲載しています。シンプリー・ウォールストリート分析モデルを設計・構築した世界トップクラスのチームについてご紹介します。業界およびセクターの指標私たちの業界とセクションの指標は、Simply Wall Stによって6時間ごとに計算されます。アナリスト筋BioVersys AG 5 これらのアナリストのうち、弊社レポートのインプットとして使用した売上高または利益の予想を提出したのは、 。アナリストの投稿は一日中更新されます。6 アナリスト機関Jelena MilovicCitigroup IncJyoti PrakashEdison Investment ResearchRaghuram SelvarajuH.C. Wainwright & Co.3 その他のアナリストを表示
お知らせ • May 03Bioversys Ag Approves Election of Simona Skerjanec as Members of the Board of DirectorsBioVersys AG announced at the AGM held on April 30, 2026, approved election of Ms. Simona Skerjanec as Members of the Board of Directors.
お知らせ • Apr 17BioVersys AG Announces First Patient First Visit In HABP/VABP Pivotal Phase 3 RIV-TARGET Trial Of BV100BioVersys AG announced the first patient first visit in its global pivotal Phase 3 clinical trial for BV100. The Phase 3 trial is designed to evaluate BV100 in critically ill patients with hospital-acquired or ventilator-associated bacterial pneumonia (HABP or VABP), suspected or confirmed to be due to carbapenem-resistant Acinetobacter baumannii-calcoaceticus complex (CRABC). The RIV-TARGET Phase 3 global trial is expected to enroll approximately 300 patients across approximately 100 sites in approximately 15 countries. BV100 is a novel intravenous formulation of rifabutin based on the newly identified mode of action for the active uptake of rifabutin into the Acinetobacter baumannii-calcoaceticus complex. BV100 is being developed for MDR hospital infections caused by Acinetobacter baumannii, including carbapenem-resistant Acinetobacter baumannii (CRAB) strains. BV100 has Qualified Infectious Disease Product (QIDP) Designation by the U.S. FDA, making BV100 eligible for priority FDA review, Fast Track designation, and a five-year extension of market exclusivity in the US. The RIV-TARGET Phase 3 clinical trial (NCT07326540) aims to compare BV100 plus low-dose polymyxin B to Colistin plus high-dose ampicillin-sulbactam in patients with suspected HABP or VABP due to carbapenem-resistant Acinetobacter baumannii-calcoaceticus complex (CRABC). The start of Phase 3 follows the successful Phase 2 study that showed an overall 50% reduction in mortality compared with best available therapy. Global pivotal Phase 3 trial is on track to enroll last patient by the end of 2027 and will support first regulatory approval submissions in 2028. The global Phase 3 trial is a randomized, active-controlled two-part parallel-group trial to evaluate the efficacy and safety of BV100 plus low-dose polymyxin B in patients with HABP or VABP suspected or confirmed to be due to CRABC infection (RIV-TARGET). Part A is the pivotal, randomized, comparative portion of the trial, employing a partially blinded design aiming to enroll approximately 300 HABP/VABP patients with suspected or confirmed CRABC infections. Patients will be randomized 1:1 to receive either BV100 combined with low-dose polymyxin B or Colistin combined with high-dose ampicillin-sulbactam, with both arms allowing meropenem as background in case of polymicrobial infections. The primary efficacy endpoint is defined as 28-day all-cause mortality (ACM) in the CRABC microbiological modified intention-to-treat (CRABC m-MITT) population. Secondary efficacy endpoints will include clinical cure status at the test of cure (ToC) in CRABC m-MITT, ventilator free days, time spent in intensive care unit (ICU) and time in hospital. As part of the study protocol, data safety monitoring boards (DSMBs) will be convened at regular intervals to review trial progress. The Phase 3 trial also includes an open-label, non-randomized, additional single group (Part B) to evaluate the efficacy and safety of BV100 plus low-dose polymyxin B in patients with HABP or VABP due to CRABC known to be resistant to colistin or polymyxin B prior to study entry and patients for whom colistin or polymyxin B regimen has failed prior to study entry. Approximately 25 patients are expected to be enrolled in Part B. This pivotal Phase 3 trial follows the successful completion of a Phase 2 trial in documented Acinetobacter baumannii VABP patients. BV100 combined with polymyxin B demonstrated a clear survival benefit, resulting in a 50% relative reduction in 28-day ACM compared with best available therapy (BAT), in VABP patients suffering from confirmed CRAB infections (28-day ACM: 60% for BAT vs 25% for BV100), and was generally safe and well tolerated. The current Phase 3 trial mimics the successful study design of the positive Phase 2 trial and is expected to read-out towards the end of 2027. Subsequent regulatory submissions aimed at commercial approval are planned in 2028 initially for the US, Europe and China. In parallel to the Phase 3 pivotal trial, an open-label Phase 2b differentiation trial (RIV-CARE) will be initiated in First Half 2026 comparing BV100 with BAT in multiple geographies. The Phase 2b trial aims to provide real world evidence of clinical practices in settings with very high drug resistance levels. Interim analysis is planned for the end of 2026. BV100 is a novel formulation of rifabutin suitable for intravenous administration, with a recently discovered novel mode of action showing an active uptake of rifabutin into the Gram-negative bacterial species, Acinetobacter baumannii. For the first time, BV100 allows for the targeting of the RNA-polymerase enzyme in Gram-negative bacteria with a human-suitable dose. BV100 is being developed for the treatment of infections caused by Acinetobacter baumannii calcoaceticus complex (ABC), including carbapenem-resistant ABC (CRABC) in critically important indications of ventilator associated bacterial pneumonia (VABP), hospital-acquired bacterial pneumonia (HABP) and bloodstream infections (BSI). BV100 was granted QIDP Designation by the U.S. FDA in May 2019 for use in the treatment of VABP, HABP and BSI, making BV100 eligible for priority FDA review, Fast Track designation, and a five-year extension of market exclusivity upon approval of the first QIDP indication.
お知らせ • Apr 16Bioversys AG Presents Data on Clinical and Preclinical Pipeline Programs At ESCMID Global 2026BioVersys AG announced its participation in the 36th Congress of the European Society of Clinical Microbiology & Infectious Diseases (ESCMID Global 2026), where it will present the latest preclinical data on its lead clinical asset BV100 (CRABC) and its preclinical asset BV500 (NTM). Poster presentations to feature data from clinical asset BV100 addressing carbapenem-resistant Acinetobacter baumannii-calcoaceticus complex (CRABC) hospital infections and preclinical asset BV500 addressing non-tuberculosis mycobacteria (NTM) infections. Experts from the UK, Greece and Switzerland to share preclinical insights on BV100’s activity against CRABC on Sunday, April 19, 2026. BioVersys’ CEO, Marc Gitzinger, to present at a session exploring how funding and policy priorities shape infectious disease research and antibiotics innovation on Monday, April 20, 2026. ESCMID is the premier annual congress of the European Society of Clinical Microbiology and Infectious Diseases. It takes place from April 17 - 21, 2026 in Munich, Germany. BV100 is a novel intravenous formulation of rifabutin based on the newly identified mode of action for the active uptake of rifabutin into the Acinetobacter baumannii-calcoaceticus complex (ABC). It is currently being studied in a global Phase 3 clinical trial (RIV-TARGET), with the potential to be a best-in-class anti-infective agent in treating hospital-acquired bacterial pneumonia (HABP) or ventilator-associated bacterial pneumonia (VABP), caused by carbapenem-resistant Acinetobacter baumannii-calcoaceticus complex (CRABC). BV100 has Qualified Infectious Disease Product (QIDP) Designation from the U.S. FDA, making BV100 eligible for priority FDA review, Fast Track designation, and a five-year extension of market exclusivity. BV500 is derived from the company’s proprietary Ansamycin Chemistry platform and a successful collaboration within the SmartLab public-private partnership with the University of Lille (France). BioVersys’ research teams in Lille (France) and Basel (Switzerland) have identified and developed several advanced, highly potent and orally bioavailable Lead candidates, with broad-spectrum in vitro and in vivo anti-NTM activity, which are devoid of cross-resistance with other therapeutic classes. The BV500 program has received funding support and access to key expertise from the CF AMR Syndicate and the EU IHI funded RespiriNTM program. BV500 is under a global research collaboration and exclusive license option agreement with the Japanese pharmaceutical company, Shionogi & Co. Ltd. In vitro results suggest BV100 remains active against drug-resistant A. baumannii, including isolates with common rpoB resistance mutations. In vitro infection model-based studies show BV100 combinations (with polymyxin B or cefiderocol) can increase bacterial killing and may help limit resistance in tested strains. Preclinical data show BV500 Lead compounds are active against non-tuberculous mycobacteria (including M. abscessus) both in vitro and in vivo.
新しいナラティブ • Apr 16Antibiotic Subscription Reforms And External Funding Will Support Long Term Anti Infective UpsideCatalysts About BioVersys BioVersys develops antibiotics and anti infective therapies targeting high mortality, drug resistant infections and tuberculosis. What are the underlying business or industry changes driving this perspective?
お知らせ • Apr 13Bioversys Ag Publishes Pre-Clinical Data of Alpe Drug Combination in Nature CommunicationsBioVersys AG announced the publication of pre-clinical data in the journal of Nature Communications, for its anti-tuberculosis combination AlpE. Alpibectir, a small molecule acting through a novel mode of action, represents a new concept of overcoming drug-resistance in M. tuberculosis, by potentiating the activity of an existing antibiotic, ethionamide, and was identified in a research collaboration with GSK and the academic groups of Dr. Alain Baulard, Prof. Benoit Deprez and Prof. Nicolas Willand. Following the recently published clinical proof-of-concept for AlpE in pulmonary TB, BioVersys and collaborators now publish pre-clinical evidence supporting the potential of AlpE to provide a new therapeutic option to treat tuberculosis. in vitro studies, AlpE showed potent activity against a diverse set of M. tuberculosis clinical strains, including those resistant to standard of care treatments. AlpE was also active against intracellular M. tuberculosis. in vivo studies, AlpE rapidly reduced bacterial load levels and improved survival, demonstrating clear translation from in vitro to in vivo proof of concept. Through the BioVersys and GSK partnership, alpibectir has completed Phase 1 and two Phase 2a pulmonary TB trials and is considered to be generally safe and well tolerated. Currently, AlpE is being studied in a pulmonary TB Phase 2b trial in combination with first-line TB drugs (NCT05807399), within IMI2 UNITE4TB project and BioVersys recently initiated a Phase 2 trial in meningeal TB (NCT07350174). Alpibectir (previously known as BVL-GSK098) is a small molecule developed from BioVersys’ Transcriptional Regulatory Inhibitory Compounds (TRIC) platform in a collaboration with GSK, the Institut Pasteur de Lille and the University of Lille. Alpibectir acts through a novel mode of action, potentiating the activity of the anti-TB drug ethionamide (Eto). Alpibectir is being studied for its potential to lower the efficacious human dose of Eto, minimizing of dose-dependent side effects, and overcome Eto resistance. The combination alpibectir/Eto (AlpE) is being developed for the treatment of pulmonary TB and TB meningitis. In 2023 AlpE was granted orphan-drug designation (ODD) for the treatment of tuberculosis, by the U.S. Food and Drug Administration (U.S. FDA) providing for certain incentives including seven years US market exclusivity. Similarly in 2025, AlpE was granted Orphan Designation from the European Medicines Agency (EMA), providing for certain incentives including 10-year EU market exclusivity. Ethionamide (Eto) and prothionamide (Pto) are recommended by the World Health Organization (WHO) for use as second-line agents in the treatment of drug-resistant pulmonary TB and TB meningitis. Despite their usefulness as TB drugs, Eto/Pto cause dose-dependent adverse events that negatively impact treatment adherence. Eto/Pto are prodrugs and their antibacterial activity can be linked to the level of bioactivation inside Mycobacterium tuberculosis (Mtb). The clinical candidate alpibectir (formerly BVL-GSK098) acts on transcriptional regulators of Mtb, stimulating novel bioactivation pathways for Eto, that has resulted in an observed increase of Eto efficacy, while simultaneously overcoming Eto resistance and keeping potent activity on MDR strains, including to a vast majority of isoniazid-resistant strains. BVL-GSK098 renders Eto rapidly bactericidal and reduces the emergence of Eto resistance development in vitro and in vivo. Based on pre-clinical data, the TRIC-TB project started to explore whether BVL-GSK098 could ultimately, lower the efficacious human oral dose of Eto by at least 3-fold, minimize dose-dependent side effects, and support patient compliance. With the completion of Phase 1 a major milestone of the TRIC-TB Project was achieved and a novel, fast acting TB agent with the potential to replace isoniazid in TB therapy has been brought into clinical development.
お知らせ • Apr 08+ 1 more updateBioVersys AG, Annual General Meeting, Apr 30, 2026BioVersys AG, Annual General Meeting, Apr 30, 2026, at 12:00 W. Europe Standard Time.
お知らせ • May 03Bioversys Ag Approves Election of Simona Skerjanec as Members of the Board of DirectorsBioVersys AG announced at the AGM held on April 30, 2026, approved election of Ms. Simona Skerjanec as Members of the Board of Directors.
お知らせ • Apr 17BioVersys AG Announces First Patient First Visit In HABP/VABP Pivotal Phase 3 RIV-TARGET Trial Of BV100BioVersys AG announced the first patient first visit in its global pivotal Phase 3 clinical trial for BV100. The Phase 3 trial is designed to evaluate BV100 in critically ill patients with hospital-acquired or ventilator-associated bacterial pneumonia (HABP or VABP), suspected or confirmed to be due to carbapenem-resistant Acinetobacter baumannii-calcoaceticus complex (CRABC). The RIV-TARGET Phase 3 global trial is expected to enroll approximately 300 patients across approximately 100 sites in approximately 15 countries. BV100 is a novel intravenous formulation of rifabutin based on the newly identified mode of action for the active uptake of rifabutin into the Acinetobacter baumannii-calcoaceticus complex. BV100 is being developed for MDR hospital infections caused by Acinetobacter baumannii, including carbapenem-resistant Acinetobacter baumannii (CRAB) strains. BV100 has Qualified Infectious Disease Product (QIDP) Designation by the U.S. FDA, making BV100 eligible for priority FDA review, Fast Track designation, and a five-year extension of market exclusivity in the US. The RIV-TARGET Phase 3 clinical trial (NCT07326540) aims to compare BV100 plus low-dose polymyxin B to Colistin plus high-dose ampicillin-sulbactam in patients with suspected HABP or VABP due to carbapenem-resistant Acinetobacter baumannii-calcoaceticus complex (CRABC). The start of Phase 3 follows the successful Phase 2 study that showed an overall 50% reduction in mortality compared with best available therapy. Global pivotal Phase 3 trial is on track to enroll last patient by the end of 2027 and will support first regulatory approval submissions in 2028. The global Phase 3 trial is a randomized, active-controlled two-part parallel-group trial to evaluate the efficacy and safety of BV100 plus low-dose polymyxin B in patients with HABP or VABP suspected or confirmed to be due to CRABC infection (RIV-TARGET). Part A is the pivotal, randomized, comparative portion of the trial, employing a partially blinded design aiming to enroll approximately 300 HABP/VABP patients with suspected or confirmed CRABC infections. Patients will be randomized 1:1 to receive either BV100 combined with low-dose polymyxin B or Colistin combined with high-dose ampicillin-sulbactam, with both arms allowing meropenem as background in case of polymicrobial infections. The primary efficacy endpoint is defined as 28-day all-cause mortality (ACM) in the CRABC microbiological modified intention-to-treat (CRABC m-MITT) population. Secondary efficacy endpoints will include clinical cure status at the test of cure (ToC) in CRABC m-MITT, ventilator free days, time spent in intensive care unit (ICU) and time in hospital. As part of the study protocol, data safety monitoring boards (DSMBs) will be convened at regular intervals to review trial progress. The Phase 3 trial also includes an open-label, non-randomized, additional single group (Part B) to evaluate the efficacy and safety of BV100 plus low-dose polymyxin B in patients with HABP or VABP due to CRABC known to be resistant to colistin or polymyxin B prior to study entry and patients for whom colistin or polymyxin B regimen has failed prior to study entry. Approximately 25 patients are expected to be enrolled in Part B. This pivotal Phase 3 trial follows the successful completion of a Phase 2 trial in documented Acinetobacter baumannii VABP patients. BV100 combined with polymyxin B demonstrated a clear survival benefit, resulting in a 50% relative reduction in 28-day ACM compared with best available therapy (BAT), in VABP patients suffering from confirmed CRAB infections (28-day ACM: 60% for BAT vs 25% for BV100), and was generally safe and well tolerated. The current Phase 3 trial mimics the successful study design of the positive Phase 2 trial and is expected to read-out towards the end of 2027. Subsequent regulatory submissions aimed at commercial approval are planned in 2028 initially for the US, Europe and China. In parallel to the Phase 3 pivotal trial, an open-label Phase 2b differentiation trial (RIV-CARE) will be initiated in First Half 2026 comparing BV100 with BAT in multiple geographies. The Phase 2b trial aims to provide real world evidence of clinical practices in settings with very high drug resistance levels. Interim analysis is planned for the end of 2026. BV100 is a novel formulation of rifabutin suitable for intravenous administration, with a recently discovered novel mode of action showing an active uptake of rifabutin into the Gram-negative bacterial species, Acinetobacter baumannii. For the first time, BV100 allows for the targeting of the RNA-polymerase enzyme in Gram-negative bacteria with a human-suitable dose. BV100 is being developed for the treatment of infections caused by Acinetobacter baumannii calcoaceticus complex (ABC), including carbapenem-resistant ABC (CRABC) in critically important indications of ventilator associated bacterial pneumonia (VABP), hospital-acquired bacterial pneumonia (HABP) and bloodstream infections (BSI). BV100 was granted QIDP Designation by the U.S. FDA in May 2019 for use in the treatment of VABP, HABP and BSI, making BV100 eligible for priority FDA review, Fast Track designation, and a five-year extension of market exclusivity upon approval of the first QIDP indication.
お知らせ • Apr 16Bioversys AG Presents Data on Clinical and Preclinical Pipeline Programs At ESCMID Global 2026BioVersys AG announced its participation in the 36th Congress of the European Society of Clinical Microbiology & Infectious Diseases (ESCMID Global 2026), where it will present the latest preclinical data on its lead clinical asset BV100 (CRABC) and its preclinical asset BV500 (NTM). Poster presentations to feature data from clinical asset BV100 addressing carbapenem-resistant Acinetobacter baumannii-calcoaceticus complex (CRABC) hospital infections and preclinical asset BV500 addressing non-tuberculosis mycobacteria (NTM) infections. Experts from the UK, Greece and Switzerland to share preclinical insights on BV100’s activity against CRABC on Sunday, April 19, 2026. BioVersys’ CEO, Marc Gitzinger, to present at a session exploring how funding and policy priorities shape infectious disease research and antibiotics innovation on Monday, April 20, 2026. ESCMID is the premier annual congress of the European Society of Clinical Microbiology and Infectious Diseases. It takes place from April 17 - 21, 2026 in Munich, Germany. BV100 is a novel intravenous formulation of rifabutin based on the newly identified mode of action for the active uptake of rifabutin into the Acinetobacter baumannii-calcoaceticus complex (ABC). It is currently being studied in a global Phase 3 clinical trial (RIV-TARGET), with the potential to be a best-in-class anti-infective agent in treating hospital-acquired bacterial pneumonia (HABP) or ventilator-associated bacterial pneumonia (VABP), caused by carbapenem-resistant Acinetobacter baumannii-calcoaceticus complex (CRABC). BV100 has Qualified Infectious Disease Product (QIDP) Designation from the U.S. FDA, making BV100 eligible for priority FDA review, Fast Track designation, and a five-year extension of market exclusivity. BV500 is derived from the company’s proprietary Ansamycin Chemistry platform and a successful collaboration within the SmartLab public-private partnership with the University of Lille (France). BioVersys’ research teams in Lille (France) and Basel (Switzerland) have identified and developed several advanced, highly potent and orally bioavailable Lead candidates, with broad-spectrum in vitro and in vivo anti-NTM activity, which are devoid of cross-resistance with other therapeutic classes. The BV500 program has received funding support and access to key expertise from the CF AMR Syndicate and the EU IHI funded RespiriNTM program. BV500 is under a global research collaboration and exclusive license option agreement with the Japanese pharmaceutical company, Shionogi & Co. Ltd. In vitro results suggest BV100 remains active against drug-resistant A. baumannii, including isolates with common rpoB resistance mutations. In vitro infection model-based studies show BV100 combinations (with polymyxin B or cefiderocol) can increase bacterial killing and may help limit resistance in tested strains. Preclinical data show BV500 Lead compounds are active against non-tuberculous mycobacteria (including M. abscessus) both in vitro and in vivo.
新しいナラティブ • Apr 16Antibiotic Subscription Reforms And External Funding Will Support Long Term Anti Infective UpsideCatalysts About BioVersys BioVersys develops antibiotics and anti infective therapies targeting high mortality, drug resistant infections and tuberculosis. What are the underlying business or industry changes driving this perspective?
お知らせ • Apr 13Bioversys Ag Publishes Pre-Clinical Data of Alpe Drug Combination in Nature CommunicationsBioVersys AG announced the publication of pre-clinical data in the journal of Nature Communications, for its anti-tuberculosis combination AlpE. Alpibectir, a small molecule acting through a novel mode of action, represents a new concept of overcoming drug-resistance in M. tuberculosis, by potentiating the activity of an existing antibiotic, ethionamide, and was identified in a research collaboration with GSK and the academic groups of Dr. Alain Baulard, Prof. Benoit Deprez and Prof. Nicolas Willand. Following the recently published clinical proof-of-concept for AlpE in pulmonary TB, BioVersys and collaborators now publish pre-clinical evidence supporting the potential of AlpE to provide a new therapeutic option to treat tuberculosis. in vitro studies, AlpE showed potent activity against a diverse set of M. tuberculosis clinical strains, including those resistant to standard of care treatments. AlpE was also active against intracellular M. tuberculosis. in vivo studies, AlpE rapidly reduced bacterial load levels and improved survival, demonstrating clear translation from in vitro to in vivo proof of concept. Through the BioVersys and GSK partnership, alpibectir has completed Phase 1 and two Phase 2a pulmonary TB trials and is considered to be generally safe and well tolerated. Currently, AlpE is being studied in a pulmonary TB Phase 2b trial in combination with first-line TB drugs (NCT05807399), within IMI2 UNITE4TB project and BioVersys recently initiated a Phase 2 trial in meningeal TB (NCT07350174). Alpibectir (previously known as BVL-GSK098) is a small molecule developed from BioVersys’ Transcriptional Regulatory Inhibitory Compounds (TRIC) platform in a collaboration with GSK, the Institut Pasteur de Lille and the University of Lille. Alpibectir acts through a novel mode of action, potentiating the activity of the anti-TB drug ethionamide (Eto). Alpibectir is being studied for its potential to lower the efficacious human dose of Eto, minimizing of dose-dependent side effects, and overcome Eto resistance. The combination alpibectir/Eto (AlpE) is being developed for the treatment of pulmonary TB and TB meningitis. In 2023 AlpE was granted orphan-drug designation (ODD) for the treatment of tuberculosis, by the U.S. Food and Drug Administration (U.S. FDA) providing for certain incentives including seven years US market exclusivity. Similarly in 2025, AlpE was granted Orphan Designation from the European Medicines Agency (EMA), providing for certain incentives including 10-year EU market exclusivity. Ethionamide (Eto) and prothionamide (Pto) are recommended by the World Health Organization (WHO) for use as second-line agents in the treatment of drug-resistant pulmonary TB and TB meningitis. Despite their usefulness as TB drugs, Eto/Pto cause dose-dependent adverse events that negatively impact treatment adherence. Eto/Pto are prodrugs and their antibacterial activity can be linked to the level of bioactivation inside Mycobacterium tuberculosis (Mtb). The clinical candidate alpibectir (formerly BVL-GSK098) acts on transcriptional regulators of Mtb, stimulating novel bioactivation pathways for Eto, that has resulted in an observed increase of Eto efficacy, while simultaneously overcoming Eto resistance and keeping potent activity on MDR strains, including to a vast majority of isoniazid-resistant strains. BVL-GSK098 renders Eto rapidly bactericidal and reduces the emergence of Eto resistance development in vitro and in vivo. Based on pre-clinical data, the TRIC-TB project started to explore whether BVL-GSK098 could ultimately, lower the efficacious human oral dose of Eto by at least 3-fold, minimize dose-dependent side effects, and support patient compliance. With the completion of Phase 1 a major milestone of the TRIC-TB Project was achieved and a novel, fast acting TB agent with the potential to replace isoniazid in TB therapy has been brought into clinical development.
お知らせ • Apr 08+ 1 more updateBioVersys AG, Annual General Meeting, Apr 30, 2026BioVersys AG, Annual General Meeting, Apr 30, 2026, at 12:00 W. Europe Standard Time.
新しいナラティブ • Apr 02Antibiotic Trial And Reimbursement Setbacks Will Pressure Results Before Long Term Potential EmergesCatalysts About BioVersys BioVersys is a biopharmaceutical company focused on developing antibiotics for severe drug resistant infections and tuberculosis. What are the underlying business or industry changes driving this perspective?
新しいナラティブ • Mar 18Global Antibiotic Partnerships And New Reimbursement Models Will Support Strong Future PotentialCatalysts About BioVersys BioVersys is a clinical stage biopharmaceutical company focused on antibiotics targeting severe drug resistant infections and tuberculosis. What are the underlying business or industry changes driving this perspective?
お知らせ • Mar 18+ 1 more updateBioVersys AG to Report First Half, 2026 Results on Sep 03, 2026BioVersys AG announced that they will report first half, 2026 results on Sep 03, 2026
お知らせ • Mar 16BioVersys AG Receives US Food and Drug Administration Approval to Start BV100 Phase 3 HABP/VABP TrialBioVersys AG announced that the US Food and Drug Administration (US FDA) has confirmed that the global Phase 3 pivotal trial to recruit US patients into the RIV-TARGET clinical trial (NCT07326540) can proceed. The Phase 3 trial will recruit patients with hospital-acquired or ventilator-associated bacterial pneumonia (HABP or VABP), due to carbapenem-resistant Acinetobacter baumannii-calcoaceticus Complex (CRABC). BV100 is a novel intravenous formulation of rifabutin based on the newly identified mode of action for the active uptake of rifabutin into the Acinetobacter baumannii-calcoaceticus complex. BV100 is being developed for MDR hospital infections caused by Acinetobacter baumannii, including carbapenem-resistant Acinetobacter baumannii (CRAB) strains. BV100 has Qualified Infectious Disease Product (QIDP) Designation from the U.S. FDA, making BV100 eligible for priority FDA review, Fast Track designation, and a five-year extension of market exclusivity. The global Phase 3 trial, is a randomized, active-controlled two-part parallel-group trial to evaluate the efficacy and safety of BV100 plus low-dose polymyxin B in patients with HABP or VABP suspected or confirmed to be due to CRABC infection (RIV-TARGET). Part A is the pivotal, randomized, comparative portion of the trial, employing a partially blinded design aiming to enroll approximately 300 HABP/VABP patients with suspected or confirmed CRABC infections. Patients will be randomized 1:1 to receive either BV100 combined with low dose polymyxin B or colistin combined with high-dose ampicillin-sulbactam, with both arms allowing meropenem as background in case of polymicrobial infections. The primary efficacy endpoint is defined as 28-day all-cause mortality (ACM) in the CRABC microbiological modified intention-to-treat (CRABC m-MITT) population. Secondary efficacy endpoints will include clinical cure status at the test of cure (ToC) in CRABC m-MITT, ventilator free days, time spent in intensive care unit (ICU) and time in hospital. As part of the study protocol, data safety monitoring boards (DSMB) will be convened at regular intervals to review trial progress. The Phase 3 trial also includes an open-label, non-randomized, additional single group (Part B) to evaluate the efficacy and safety of BV100 plus low-dose polymyxin B in patients with HABP or VABP due to CRABC known to be resistant to colistin or polymyxin B prior to study entry and patients where colistin or polymyxin B regimen has failed prior to study entry. Approximately 25 patients are expected to be enrolled in Part B. This pivotal Phase 3 trial follows the successful completion of a Phase 2 trial in documented Acinetobacter VABP patients. BV100 combined with polymyxin B demonstrated a clear survival benefit, resulting in a 50% relative reduction in 28-day ACM compared with best available therapy (BAT), in VABP patients suffering from confirmed CRAB infections (28-day ACM: 60% for BAT vs 25% for BV100), and was generally safe and well tolerated. The current Phase 3 trial mimics the successful study design of the positive Phase 2 trial and is expected to read-out towards the end of 2027. Subsequent regulatory submissions aimed at commercial approval are planned in 2028, initially for the US, Europe and China. In parallel to the Phase 3 pivotal trial an open-label Phase 2b differentiation trial (RIV-CARE) will be initiated in First Half 2026 comparing BV100 with BAT in multiple geographies. The Phase 2b trial aims to provide real world evidence of clinical practices in settings with very high drug resistance levels. Interim analysis is planned for end of 2026. BV100 is a novel formulation of rifabutin suitable for intravenous administration, with a recently discovered novel mode of action showing an active uptake of rifabutin into the Gram-negative bacterial species, Acinetobacter baumannii. For the first time, BV100 allows for the targeting of the RNA-polymerase enzyme in Gram-negative bacteria with a human-suitable dose. BV100 is being developed for the treatment of infections caused by Acinetobacter baumannii calcoaceticus complex (ABC), including carbapenem-resistant ABC (CRABC) in critically important indications of ventilator associated bacterial pneumonia (VABP), hospital-acquired bacterial pneumonia (HABP) and bloodstream infections (BSI). BV100 was granted QIDP Designation by the U.S. FDA in May 2019 for use in the treatment of VABP, HABP and BSI, making BV100 eligible for priority FDA review, Fast Track designation, and a five-year extension of market exclusivity upon approval of the first QIDP indication.
New Risk • Mar 12New major risk - Share price stabilityThe company's share price has been highly volatile over the past 3 months. It is more volatile than 90% of Swiss stocks, typically moving 9.8% a week. This is considered a major risk. Share price volatility increases the risk of potential losses in the short-term as the stock tends to have larger drops in price more frequently than other stocks. It may also indicate the stock is highly sensitive to market conditions or economic conditions rather than being sensitive to its own business performance, which may also be inconsistent. Currently, the following risks have been identified for the company: Major Risks Share price has been highly volatile over the past 3 months (9.8% average weekly change). Earnings are forecast to decline by an average of 15% per year for the foreseeable future. Minor Risks Currently unprofitable and not forecast to become profitable over next 2 years (CHF29m net loss in 2 years). Revenue is less than US$5m (CHF1.3m revenue, or US$1.7m).
お知らせ • Mar 12BioVersys AG Announces First Patient Dosed In Phase 2b Clinical Trial Of Alpe In Pulmonary TuberculosisBioVersys AG announced that the first patient has been dosed in a pulmonary TB Phase 2b clinical trial, evaluating the efficacy, safety and pharmacokinetics of alpibectir-ethionamide (AlpE) in combination with first-line TB drugs (NCT05807399). In this new Phase 2b trial, a portion of the recruited adults with drug sensitive pulmonary tuberculosis (DS-TB) will be dosed for 2-months with RZE in combination with AlpE, followed by 18 weeks with RH alone, to assess efficacy, safety and pharmacokinetics of AlpE. The study is being conducted in six African countries under the European Union’s IMI2 UNITE4TB project, with the Institute of Infectious Diseases and Tropical Medicine, LMU University Hospital Munich as the trial sponsor. Through this Phase 2b TB drug combination trial, BioVersys and its partner GSK are progressing the development of this unique combination and taking the next step in terms of dose finding and potential positioning of AlpE in future TB drug regimens. This trial is expected to read-out by the end of 2027. Preceding this Phase 2b trial, AlpE underwent a second Phase 2a trial in which AlpE was assessed over 14 days in an open-label trial in combination with first line TB drugs. Top-line data is expected to be available Second Quarter 2026. AlpE was generally well tolerated in this trial, supporting the progression into Phase 2b. BioVersys also plans to initiate a Phase 2 trial in meningeal TB in First Half 2026. Alpibectir (previously known as BVL-GSK098) is a small molecule developed from BioVersys’ award winning Transcriptional Regulatory Inhibitory Compounds (TRIC) platform in a successful collaboration with GSK, the Institut Pasteur Lille and the University of Lille. AlpE’s development has been strongly supported by European Union and European Pharmaceutical Industry through Innovative Medicines Initiative (IMI2) Joint Undertaking, EDCTP and now UNITE4TB. The compound represents a novel concept to overcome resistance and potentiate the activity of an existing antibiotic, ethionamide (Eto) or prothionamide (Pto), for the treatment of TB, as demonstrated in a previous 7-day early bactericidal activity Phase 2a clinical trial, recently published in the New England Journal of Medicine, which provided a first human proof-of-concept. In 2023, the fixed-dose combination of AlpE was granted orphan-drug designation (ODD) for the treatment of tuberculosis by the U.S. Food and Drug Administration (FDA), and similarly in 2025, AlpE was granted Orphan Designation from the European Medicines Agency (EMA). Alpibectir (previously known as BVL-GSK098) is a small molecule developed from BioVersys’ award winning Transcriptional Regulatory Inhibitory Compounds (TRIC) platform in a successful collaboration with GSK, the Institut Pasteur Lille and the University of Lille. Alpibectir acts through a novel mode of action, potentiating the activity of the anti-TB drug ethionamide (Eto). Alpibectir is being studied for its potential to, lower the efficacious human dose of Eto, minimizing of dose-dependent side effects, and overcome Eto resistance. The combination alpibectir/Eto (AlpE) is being developed for the treatment of pulmonary TB and TB meningitis. In 2023 AlpE was granted orphan-drug designation (ODD) for the treatment of tuberculosis, by the U.S. Food and Drug Administration (U.S. FDA) providing for certain incentives including seven years US market exclusivity. Similarly in 2025, AlpE was granted Orphan Designation from the European Medicines Agency (EMA), providing for certain incentives including 10-year EU market exclusivity.
お知らせ • Mar 05BioVersys AG to Report Fiscal Year 2025 Results on Mar 18, 2026BioVersys AG announced that they will report fiscal year 2025 results at 7:00 AM, Central European Standard Time on Mar 18, 2026
お知らせ • Feb 20Bioversys Ag Announces Phase 2A Clinical Trial of Alpe in Patients with Pulmonary TbBioVersys AG announced the publication of promising clinical proof of concept results in the prestigious New England Journal of Medicine from the Phase 2a clinical trial of AlpE in patients with pulmonary TB. Tuberculosis is one of the leading causes of death by infectious diseases globally, and many existing treatments are becoming less effective due to growing drug resistance. Alpibectir, a small molecule acting through a novel mode of action, represents a totally new concept of overcoming resistance by potentiating the activity of an existing antibiotic, ethionamide (Eto), and was identified in a successful public-private collaboration with GSK, the Pasteur Institute of Lille and the University of Lille. The Phase 2a bEto-TB clinical trial was conducted in South Africa through a consortium of three partners, TASK, GSK and BioVersys, and was completed in April 2024. AlpE delivered a promising clinical proof of concept in a 7-day early bactericidal activity (EBA) study, conducted in patients with pulmonary tuberculosis. AlpE seeks to offer a replacement for isoniazid (INH) in the current first-line regimen or to be added as a novel bactericidal drug to future regimens including those of TB meningitis. The clinical development of AlpE has been strongly supported by several European Union grants and public private partnerships, including the EU Innovative Medicines Initiative 2 (IMI2), TRIC-TB project and UNITE4TB project, and the European & Developing Countries Clinical Trials Partnership (EDCTP2 programme), bEto-TB project. This project brings a new anti-TB molecule, BVL-GSK098, to the current drug armamentarium. BL-GSK098 greatlyaugments the activity of, and overcomes resistance to, the well-established second line drug Eto at a lower and well-tolerated dose. The programme has previously received funding from the EU IMI 2 JU (TRIC-TB) and the Wellcome Trust.
お知らせ • Nov 07BioVersys AG Announces First Subjects Dosed in Phase 1 Clinical Trial of BV100 in ChinaBioVersys AG, a multi-asset, clinical stage biopharmaceutical company focusing on research and development of novel antibacterial products for serious life-threatening infections caused by multi-drug resistant ("MDR") bacteria, announced the dosing of the first subject in a Phase 1 clinical trial with BV100 in China. The mandatory Phase 1 clinical trial in healthy volunteers in China precedes the inclusion of Chinese clinical sites by late 2026 into the single Global Phase 3 registration trial of BV100 in Ventilator Associated Bacterial Pneumonia (VABP). Recruitment in other geographies will start earlier. BV100 is a novel intravenous formulation of rifabutin based on the newly identified mode of action for the active uptake of rifabutin into the Acinetobacter baumannii-calcoaceticus complex. Combined with very high resistance rates of 60-80% to carbapenems, Acinetobacter baum Annii is the leading cause of death attributable to antimicrobial resistance in China1. Based on recent epidemiology data, BioVersys estimates that over 1 million patients annually are at risk of severe CRAB pneumonia and blood stream infections in China alone. In April 2025, BioVersys presented outstanding Phase 2 clinical data for BV100 in Ventilators Associated Bacterial Pneumonia ("VABP") at the 2025 Congress of the European Society of Clinical Microbiology and Infectious diseases (ESCMID Global) in Vienna, Austria. In that Phase 2, BV100 demonstrated strong signs of efficacy by reducing the mortality rate in critically ill patients suffering from CRAB infections compared with best available therapy. As such, the company are working with regulatory agencies from US, Europe and China to include patients from the three regions into a single global Phase 3 registration trial. The timely initiation of the Phase 1 safety and pharmacokinetic study in China demonstrates that the process to eventually include Chinese clinical sites into global Phase 3 clinical program is progressing well. BioVersys is committed to bringing BV100 to patients in need in as many regions of the world as possible. BV100 is a new formulation of rifabut in intravenous administration, with a recently discovered novel mode of action showing an active uptake of rifabUTin into the Gram-negative bacterial species, Acinetobacter bumannii. BV100 is being developed for the treatment of infections caused by Acinetobacter baumANii calcoaceticus complex (ABC) are Gram-negative bacteria found in the environment (e.g., in soil and water) and an opportunistic pathogen in humans, typically infecting critically ill and immunocompromised patients, that can result in severe pneumonia and bloodstream infections in addition to affecting other parts of the body. BioVersys forecasts the annual number of carbapenem-resistant A. baumannii infections in hospitals to have surpassed one million globally and due to the limited treatment options, such infections come with high (up to 50%) mortality rates.
分析記事 • Sep 27Is BioVersys (VTX:BIOV) A Risky Investment?Some say volatility, rather than debt, is the best way to think about risk as an investor, but Warren Buffett famously...
お知らせ • Sep 12Bioversys Ag Improves Earnings Guidance for the Fiscal Year 2025BioVersys AG improved earnings guidance for the fiscal year 2025. For the period, the company expect the operating loss at year end to be of CHF 29 million, which is an improvement of CHF 3-6 million compared to the CHF 32 million to CHF 35 million range provided during the Fiscal Year 2024 earnings call.
お知らせ • Aug 30BioVersys AG to Report First Half, 2025 Results on Sep 10, 2025BioVersys AG announced that they will report first half, 2025 results on Sep 10, 2025
New Risk • Jul 04New minor risk - Share price stabilityThe company's share price has been volatile over the past 3 months. It is more volatile than 75% of Swiss stocks, typically moving 5.8% a week. This is considered a minor risk. Share price volatility indicates the stock is highly sensitive to market conditions or economic conditions rather than being sensitive to its own business performance, which may also be inconsistent. It also increases the risk of potential losses in the short term as the stock tends to have larger drops in price more frequently than other stocks. Currently, the following risks have been identified for the company: Major Risk Earnings are forecast to decline by an average of 15% per year for the foreseeable future. Minor Risks Currently unprofitable and not forecast to become profitable over next 3 years (CHF32m net loss in 3 years). Share price has been volatile over the past 3 months (5.8% average weekly change). Revenue is less than US$5m (CHF1.2m revenue, or US$1.5m).
お知らせ • Jul 01Bioversys Ag Appoints Ulrik Schulze as A Member of the Board of DirectorsBioVersys AG at its AGM held on June 27, 2025 appointed Ulrik Schulze as a Member of the Board of Directors.
お知らせ • Jun 05BioVersys AG Announces Henni-Karoliina Ropponen Will Not Stand for Re-ElectionBioVersys AG announced that Dr. Henni-Karoliina Ropponen will not stand for re-election at the AGM to be held on June 27, 2025.
お知らせ • Jun 04BioVersys AG, Annual General Meeting, Jun 27, 2025BioVersys AG, Annual General Meeting, Jun 27, 2025, at 12:00 W. Europe Standard Time. Location: zip auditorium stuckipark, hochbergerstrasse 60f, 4057 basel, basel Switzerland
New Risk • May 08New major risk - Financial data availabilityThe company has not reported any financial data. This is considered a major risk. With no or incomplete audited reported financial data, it is virtually impossible to assess the company's investment potential. This is currently the only risk that has been identified for the company.
お知らせ • Mar 31BioVersys AG Announces Important BV100 Patent Granted by Chinese Patent OfficeBioVersys AG announced that the company was granted important patent claims in China for its BV100 technology. BV100 is a novel formulation of rifabutin which is suitable for intravenous administration. BV100 is based on the newly identified mode of action for the active uptake of rifabutin into the Acinetobacter baumannii-calcoaceticus complex and is being developed for resistant hospital infections caused by Acinetobacter baumannii, including carbapenem resistant strains. There is a serious lack of effective and safe treatment options for CRAB infections and mortality rates in hospitals can be as high as 50%. CRAB has been designated a priority pathogen by the World Health Organization and the Centers for Disease Control and Prevention. While CRAB infections are a serious health threat throughout the world, incidence rates for Acinetobacter infections are particularly high in China and Asia, combined with very high resistance rates of 60-80%. Based on recent epidemiology data, BioVersys expects > 1 million patients annually in China alone suffering from severe CRAB pneumonia and blood stream infections.
お知らせ • Mar 26+ 1 more updateBioversys Ag Provides Earnings Guidance for the Full Year 2025BioVersys AG provided earnings guidance for the full year 2025. For the full year 2025, the company expects total operating loss to be in the range of CHF 32.0 to CHF 35.0 million.
お知らせ • Mar 14BioVersys AG to Report Fiscal Year 2024 Results on Mar 26, 2025BioVersys AG announced that they will report fiscal year 2024 results at 7:00 AM, Central European Standard Time on Mar 26, 2025
Board Change • Feb 07No independent directorsFollowing the recent departure of a director, there are no independent directors on the board. The company's board is composed of: No independent directors. 6 non-independent directors. was the last director to join the board, commencing their role in . The company's lack of independent directors is a risk according to the Simply Wall St Risk Model.
