Tillkännagivande • May 28
Basilea Pharmaceutica Ltd Receives Additional USD 13.3 Million From BARDA To Continue Development Of Novel Antibiotic Ceftibuten-Ledaborbactam Etzadroxil Basilea Pharmaceutica Ltd, Allschwil announced that the Biomedical Advanced Research and Development Authority (BARDA), part of the Administration for Strategic Preparedness and Response (ASPR) within the U.S. Department of Health and Human Services, awarded USD 13.3 million to Basilea to continue the development of Basilea’s novel oral antibiotic ceftibuten-ledaborbactam etzadroxil, a beta-lactam/beta-lactamase inhibitor (BL/BLI) combination, for the treatment of complicated urinary tract infections (cUTIs), including pyelonephritis. After the current tranche of USD 13.3 million, a total of USD 25 million have been committed by BARDA. The contract could provide up to USD 133 million of additional non-dilutive funding. Many Gram-negative bacteria express enzymes such as extended spectrum beta-lactamases (ESBL) that confer resistance against commonly used antibiotics. Beta-lactamase inhibitors block these enzymes and restore the activity of beta-lactam antibiotics against initially resistant Gram-negative bacteria, therefore BL/BLI combinations are an important addition to the armamentarium for the treatment of infections caused by multidrug-resistant bacterial pathogens. Ledaborbactam etzadroxil is the orally bioavailable prodrug of ledaborbactam, a novel broad-spectrum boronic acid beta-lactamase inhibitor, which is being developed in combination with ceftibuten, an oral cephalosporin antibiotic, which is approved in the US for the treatment of upper and lower respiratory tract infections and for urinary tract infections outside the US. In vitro and in vivo studies demonstrated that ledaborbactam etzadroxil restores the activity of ceftibuten against strains of Enterobacterales expressing Ambler class A extended spectrum beta-lactamases (ESBLs), class C cephalosporinases, and class A and D carbapenemases (KPC and OXA-48, respectively) as well as multidrug-resistant (MDR) Enterobacterales. Ceftibuten-ledaborbactam etzadroxil has been granted Qualified Infectious Disease Product (QIDP) and Fast Track designations by the US Food and Drug Administration (FDA) for cUTI and uncomplicated urinary tract infections. Ceftibuten-ledaborbactam etzadroxil is an investigational drug and is not yet approved in any country for commercial use. Complicated UTIs, which include pyelonephritis (kidney infections), are defined as urinary tract infections ascending from the bladder accompanied by local and systemic signs and symptoms and are one of the most common bacterial infections in hospital and community settings. Increasing resistance of bacteria causing complicated urinary tract infections has led to limited availability of effective oral antibiotic treatment options. Currently, there are no approved oral beta-lactam or beta-lactam/beta-lactamase inhibitor combinations that are effective against Enterobacterales expressing Ambler class A ESBLs, class C cephalosporinases, and class A & D serine carbapenemases (KPC and OXA-48). Tillkännagivande • Apr 27
Basilea Pharmaceutica AG to Report First Half, 2026 Results on Aug 18, 2026 Basilea Pharmaceutica AG announced that they will report first half, 2026 results on Aug 18, 2026 Tillkännagivande • Apr 17
Basilea Pharmaceutica AG Approves Board and Committee Appointments Basilea Pharmaceutica Ltd. at its annual general meeting held on April 15, 2026, approved election of Dr. Naseem Amin and Ms. Anne Whitaker as new members of the board of directors. In addition, Mr. Kruimer, Dr. Onetto and Ms. Anne Whitaker were appointed as members of the compensation committee. The term of all board members lasts until the AGM 2027. Tillkännagivande • Apr 11
Basilea Pharmaceutica Ltd Announces Additional Funding for Clinical Development of Antibiotic BAL2420 Basilea Pharmaceutica Ltd, Allschwil announced that it was awarded an additional USD 6 million from CARB-X (Combating Antibiotic-Resistant Bacteria Biopharmaceutical Accelerator), a global non-profit partnership dedicated to supporting the early development of antibacterial products. The additional non-dilutive funding will support the first-in-human phase 1 clinical study of Basilea’s novel antibiotic BAL2420 (LptA inhibitor) and related activities. The phase 1 study has already been initiated, with the first subject dosed in March 2026. BAL2420 belongs to one of the very few novel classes of antibiotics in clinical development. It is targeting LptA, which is part of the lipopolysaccharide transport bridge, an essential structure in Gram-negative bacteria. LptA inhibitors have shown potent and rapid bactericidal activity in vitro and in vivo against Gram-negative bacteria of the Enterobacteriaceae family, such as E. coli and K. pneumoniae, including strains resistant to beta-lactams and colistin, an antibiotic regarded as last-resort therapy. The Centers for Disease Control and Prevention (CDC) and the World Health Organization (WHO) have identified Enterobacteriaceae, including carbapenem-resistant strains, as high priority pathogens for which new and effective antibiotic treatments are urgently needed. CARB-X has supported the development of BAL2420 since 2020, advancing the project from the hit-to-lead stage to the first-in-human study. Research reported in this publication is supported by CARB-X. CARB-X is funded in part with federal funds from the U.S. Department of Health and Human Services (HHS); Administration for Strategic Preparedness and Response; Biomedical Advanced Research and Development Authority (BARDA) under agreement number 75A50122C00028 and by awards from Wellcome (WT224842), the UK Department of Health and Social Care’s Global Antimicrobial Resistance Innovation Fund (GAMRIF), the Gates Foundation, Germany’s Federal Ministry of Research, Technology and Space (BMFTR), the Novo Nordisk Foundation, Italy’s Ministry of Economy and Finance (MEF), Japan’s Ministry of Health, the European Commission’s DG Health Emergency Preparedness and Response Authority (DG HERA), and KfW Development Bank. The U.S. National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH) in HHS, provides support in the form of in-kind services through access to a suite of preclinical services for product development. The content of this publication is solely the responsibility of the authors and does not necessarily represent the official views of CARB-X or its funders. Tillkännagivande • Mar 26
Basilea Pharmaceutica AG, Annual General Meeting, Apr 15, 2026 Basilea Pharmaceutica AG, Annual General Meeting, Apr 15, 2026, at 14:00 W. Europe Standard Time. Tillkännagivande • Mar 23
Basilea Pharmaceutica Ltd Announces Start Of First-In-Human Study Of Novel Antibiotic BAL2420 Basilea Pharmaceutica Ltd, Allschwil (SIX: BSLN), a commercial-stage biopharmaceutical company committed to meeting the needs of patients with severe bacterial and fungal infections, announced the dosing of the first healthy volunteer in the first-in-human phase 1 study of BAL2420, evaluating the safety, tolerability and pharmacokinetics of this lipopolysaccharide transport protein A (LptA) inhibitor. BAL2420 belongs to a novel class of antibiotics. It targets LptA, which is part of the lipopolysaccharide transport bridge, an essential structure in Gram-negative bacteria. LptA inhibitors have shown potent and rapid bactericidal activity in vitro and in vivo against Gram-negative bacteria of the Enterobacteriaceae family, such as E. coli and K. pneumoniae, including strains resistant to beta-lactams and colistin, an antibiotic regarded as last-resort therapy. The Centers for Disease Control and Prevention (CDC) and the World Health Organization (WHO) have identified Enterobacteriaceae, including carbapenem-resistant strains, as high priority pathogens for which new and effective antibiotic treatments are urgently needed. This single-center, randomized, dose-escalation, double-blind and placebo-controlled phase 1 study assesses intravenous administration of BAL2420 using a single- and multiple-ascending dose study design. Data from this study will support the further clinical development of BAL2420 as a potential treatment option for serious infections caused by Gram-negative bacteria, including multidrug-resistant bacteria. CARB-X has supported the development of BAL2420 since 2020, advancing the project from the Hit-to-Lead stage to the first-in-human study. CARB-X’s funding for this project is provided by federal funds from the US Department of Health and Human Services; Administration for Strategic Preparedness and Response; Biomedical Advanced Research and Development Authority; under agreement number: 75A50122C00028, and by awards from Wellcome (WT224842) and Germany’s Federal Ministry of Research, Technology and Space (BMFTR). The content of this press release is solely the responsibility of the authors and does not necessarily represent the official views of CARB-X or any of its funders. Tillkännagivande • Aug 19
Basilea Pharmaceutica AG Updates Earnings Guidance for the Full Year 2025 Basilea Pharmaceutica AG updated earnings guidance for the full year 2025. For the period, the company expects total revenue is expected to increase by 8% to CHF 225 million against CHF 220 million previously estimated. Operating result of CHF 50 million against CHF 62 million previously estimated. Tillkännagivande • Jul 29
Basilea Pharmaceutica Ltd. Initiates Phase 3 Study with Antifungal Fosmanogepix in Invasive Mold Infections Basilea Pharmaceutica Ltd, Allschwil announced the initiation of FORWARD-IM, a phase 3 registrational study evaluating the efficacy and safety of its broad-spectrum antifungal fosmanogepix for the treatment of adult patients with invasive mold infections. Fosmanogepix is a first-in-class antifungal with a novel mechanism of action and is available in both intravenous and oral formulations. It has been evaluated for efficacy and safety in a phase 1 and phase 2 program, including three open-label phase 2 studies for the treatment of Candidemia, including Candida auris, and invasive mold infections. The FORWARD-IM study is the second phase 3 study for fosmano gepix, following the initiation of FAST-IC in September 2024, a randomized, double-blind phase 3 registrational study in adult patients with candidemia and/or invasive candidiasis. Its broad-spectrum activity against multidrug-resistant molds and yeasts highlights the unique potential of fosmanogepIX to address significant gaps in current antifungal therapies. The first cohort will enroll approximately 160 patients, randomized in a 2:1 ratio to receive either fosmanogepX or current standard-of-care therapy. The second cohort will enroll approximately 60 patients who have developed intolerance, toxicities, lack of clinical response, or whose fungal isolate is resistant to standard-of-care therapy". All patients in the second cohort will receive fosmanogepx. The completion of the study and publication of results are expected in 2028. The Swiss-based global company PSI CRO AG is managing the phase 3 program. Basilea acquired fosmanogepax from Amplyx Pharmaceuticals Inc., an affiliate of Pfizer Inc. Pfizer retains a right of first negotiation for commercializing fosmanogeppix, once phase 3 development is successfully completed. This project is funded in part with federal funds from the U.S. Department of Health and Human Services (HHS); Administration of Strategic Preparedness and Response (ASPR); Biomedical Advanced Research and Development Authority (BARDA), under OT number: 75A50124C00033. The contract and federal funding are not an endorsement of the study results, product, or company. Tillkännagivande • Jul 08
Basilea Pharmaceutica AG Receives USD 39 Million Funding Under BARDA Agreement to Continue to Advance Novel Antifungals Fosmanogepix and BAL2062 Basilea Pharmaceutica Ltd, Allschwil announced that the Biomedical Advanced Research and Development Authority (BARDA), part of the Administration for Strategic Preparedness and Response (ASPR) within the U.S. Department of Health and Human Services, committed the next USD 39 million to Basilea to continue to advance the development of Basilea’s novel antifungals fosmanogepix and BAL2062. This additional funding is based on the successful completion of a milestone within the “Other Transaction Agreement” (OTA, agreement number 75A50124C00033) that was awarded on September 30, 2024, and which allows for potential funding of up to approximately USD 268 million in total to develop antifungal and antibacterial assets. The USD 39 million is in addition to the initial USD 29 million BARDA committed at the signing of the OTA in September 2024. BARDA’s financial contribution is about 60% of the total costs of the supported projects over the term of the OTA, which could provide a total potential non-dilutive funding of up to approximately USD 268 million, over up to 12 years, if all additional options to extend the contract are exercised by BARDA, upon successful completion of pre-defined milestones, including clinical and regulatory activities. Tillkännagivande • Jun 14
Basilea Pharmaceutica AG to Report Fiscal Year 2025 Results on Feb 17, 2026 Basilea Pharmaceutica AG announced that they will report fiscal year 2025 results on Feb 17, 2026 Tillkännagivande • May 20
Basilea Pharmaceutica Ltd Announces Commercial Availability of Antibody Zevtera (Cftobiprole) in the United States Basilea Pharmaceutica Ltd, Allschwil announced that its antibiotic Zevtera (ceftobiprole medocaril for injection) is now commercially available in the United States through Basilea's partner Innoviva Specialty Therapeutics Inc., a wholly owned subsidiary of Innoviva Inc. Zevtera is used in hospitals for the treatment of bacterial infections, such as those caused by Staphylococcus aureus bacteria, including methicillin-resistant strains. It is the only advanced-generation cephalosporin approved by the United States Food and Drug Administration (FDA) for the treatment of adult patients with Staphylcus aureus bacteremia, including those with right-sided infective endocarditis. It is also indicated in the United States to treat adult patients with acute bacterial skin and skin structure infections (ABSSSI) and for the treatment of adult and pediatric patients (3 months to less than 18 years old) with community-acquired bacterial pneumonia. Administration for Strategic Preparedness and Response (ASPR); Biomedical Advanced Research and Development Authority (BARDA), under contract number HHSO100201600002C. The contract and federal funding are not an endorsement of the study results, product, or company. Basilea has been awarded approximately USD 111 million, or approximately 75% of the costs related to the Staphylococcus auresus bacteremia and acute bacterial skin and skin structure infection (ABSSSI) phase 3 studies, regulatory activities and non-clinical work. ZEVTERA®? (ceftobIProle medocaril sodium for injection), for intravenous use, is indicated for the treatment of: Adult patients with Staphylococcus auredus bloodstream infections (bacteremia), including those With right-sided infective end cardiacitis, caused by methicillin-susceptible and methicillin-resistant isolates. Adult patients with acute bacterial skin and Skin structure infections (ABSSS I) caused by susceptible isolates of the following gram-positive and gram-negative microorganisms: Staphylococcus aUREus (methicillin-susceptable and methicillin-resistant isolateates), Streptococcus pyogenes, and Klebsiella pneumoniae. Warnings and Prec precautions: Increased mortality with unapproved use in ventilator-associated bacterial pneumonia Patients: The safety and effectiveness of ZEVTERA for the treatment of VABP has not been established and the use of ZEVTERA for VABP is not approved. Serious hypersensitivity reactions, including anaphylaxis, were observed in ZEVTERA-treated patients in clinical trials. Serious and occasionally fatal hypersensitivity reactions and serious skin reactions have been reported in patients receiving beta-lactam antibacterial drugs. Pediatr ic Patients: The most common adverse reactions occurring in 2% of pediatric patients were vomiting, headache, hepatic enzyme increased, diarrhea, infusion site reaction, phlebitis, and pyrexia. Tillkännagivande • Apr 17
Basilea Pharmaceutica Ag Announces Board Changes Basilea Pharmaceutica AG at the annual general meeting held on April 16, 2025, Mr. Stephan Schindler was elected as chairman, In addition, Mr. Kruimer was elected to the compensation committee. Tillkännagivande • Apr 09
Basilea Pharmaceutica AG to Report First Half, 2025 Results on Aug 19, 2025 Basilea Pharmaceutica AG announced that they will report first half, 2025 results on Aug 19, 2025 Tillkännagivande • Mar 27
Basilea Pharmaceutica AG, Annual General Meeting, Apr 16, 2025 Basilea Pharmaceutica AG, Annual General Meeting, Apr 16, 2025, at 14:00 W. Europe Standard Time. Tillkännagivande • Dec 10
Basilea Pharmaceutica AG to Report Fiscal Year 2024 Results on Feb 18, 2025 Basilea Pharmaceutica AG announced that they will report fiscal year 2024 results on Feb 18, 2025 Tillkännagivande • Sep 19
Basilea Pharmaceutica AG Updates Financial Guidance for the Year 2024 Basilea Pharmaceutica AG updated financial guidance for the year 2024. For the year the company expects total revenue of CHF 203 million and net profit of CHF 60 million compared to previous guidance for total revenue of CHF 190 million and net profit of CHF 42 million. Tillkännagivande • Aug 27
European Commission Approves the Pediatric Use of Basilea Pharmaceutica AG's Antifungal Cresemba® (Isavuconazole) Basilea Pharmaceutica Ltd, Allschwil announced that the European Commission (EC) has extended the indications of the antifungal Cresemba® (isavuconazole) to pediatric patients and also granted an extension of market exclusivity by two additional years, which triggered a CHF 10 million milestone payment from Basilea’s license partner Pfizer Inc. The approval is based on results from two pediatric clinical studies, including a phase 2 open label, non-comparative, multicenter study, evaluating the safety, efficacy and pharmacokinetics of Cresemba for the treatment of invasive aspergillosis and invasive mucormycosis in pediatric patients aged 1 to 17 years old. In addition to the approval, the EC granted pediatric exclusivity for Cresemba, which extends the period of market exclusivity for Cresemba in the European Union by an additional two years to October 2027. Tillkännagivande • May 03
Basilea Reports Presentation of New Data for Ceftobiprole (Zevtera®) At Escmid Global 2024 Basilea Pharmaceutica AG announced that scientific presentations with new data on its antibiotic ceftobiprole (Zevtera®) have been presented at ESCMID Global 2024, the annual meeting of the European Society of Clinical Microbiology and Infectious Diseases, which took place from April 27 to 30, 2024 in Barcelona, Spain. Ceftobiprole was recently approved by the US Food and Drug Administration (FDA), supported by data from three phase 3 studies: ERADICATE, conducted in patients with Staphylococcus aureus bacteremia (SAB), TARGET, in acute bacterial skin and skin structure infections (ABSSSI), and a study in community-acquired bacterial pneumonia (CABP). Additional data from the ERADICATE phase 3 study were presented in three posters, comparing ceftobiprole to daptomycin in the treatment of complicated Staphylococcus aureus bacteremia. One poster focused on subgroup analyses in patients with renal impairment, demonstrating consistent efficacy and safety of ceftobiprole in this specific patient group, which included patients with chronic dialysis, representing 13% of patients in the ERADICATE study. Furthermore, baseline characteristics of patients in the ERADICATE study were presented, underlining the complexity of the infections in the studied patient population, with about 30% of patients presenting with more than one underlying infectious condition, foci, or complications at baseline, including soft tissue infections, dialysis, abdominal and thoracic abscesses, osteoarticular infections and right-sided endocarditis. Data presented on a third poster demonstrated that bloodstream clearance was achieved at a median of four days after the start of treatment in both the ceftobiprole and comparator groups. In the group treated with ceftobiprole, fewer patients had Staphylococcus aureus-positive blood cultures after ten days compared to the comparator treatment group. An oral presentation focused on a re-analysis of the previously conducted ceftobiprole phase 3 study in patients with community-acquired bacterial pneumonia (CABP). The study compared ceftobiprole with ceftriaxone ± linezolid and was performed prior to the availability of the current FDA guidance for the development of drugs for the treatment of CABP (FDA-CABP-2020). Using the FDA-CABP-2020 primary endpoint of early clinical success at day 3 after study start, this re-analysis supported the non-inferiority of ceftobiprole to ceftriaxone ± linezolid. Basilea’s phase 3 program for ceftobiprole is funded in part with federal funds from the US Department of Health and Human Services (HHS); Administration for Strategic Preparedness and Response (ASPR); Biomedical Advanced Research and Development Authority (BARDA), under contract number HHSO100201600002C. Through this partnership, Basilea has been awarded approximately USD 112 million, or approximately 75% of the costs related to the SAB and ABSSSI phase 3 studies, regulatory activities and non-clinical work. Tillkännagivande • Mar 15
Basilea Pharmaceutica AG to Report First Half, 2024 Results on Aug 13, 2024 Basilea Pharmaceutica AG announced that they will report first half, 2024 results on Aug 13, 2024 Tillkännagivande • Nov 21
Basilea Pharmaceutica AG to Report Fiscal Year 2023 Results on Feb 13, 2024 Basilea Pharmaceutica AG announced that they will report fiscal year 2023 results on Feb 13, 2024 Tillkännagivande • Oct 29
Basilea Pharmaceutica AG, Annual General Meeting, Apr 24, 2024 Basilea Pharmaceutica AG, Annual General Meeting, Apr 24, 2024, at 14:00 Central European Standard Time. Location: Congress Center Basel in Basel, Switzerland. Basel Swaziland Tillkännagivande • Aug 18
Basilea Pharmaceutica AG Revises Earnings Guidance for the Year 2023 Basilea Pharmaceutica AG revised earnings guidance for the year 2023. For the year, the company expects revised total revenue to be in the range of CHF 157 million to CHF 160 million, operating profit to be in the range of CHF 50 million to CHF 55 million and net profit to be in the range of CHF 41 million to CHF 46 million compared to previously expected total revenue to be in the range of CHF 155 million to CHF 158 million, operating profit to be in the range of CHF 45 million to CHF 50 million and net profit to be in the range of CHF 36 million to CHF 41 million. Tillkännagivande • Jan 24
Basilea Pharmaceutica Ltd Revises Earnings Guidance for the Year 2022 Basilea Pharmaceutica Ltd. revised earnings guidance for the year 2022. The company announced that on preliminary basis it expects to have achieved an operating profit of approximately CHF 18 million for the financial year 2022 and expects to report a net profit. The company had previously guided for an operating loss for 2022 of CHF 10 million to CHF 15 million. The company announced that the total revenue for 2022 is expected to amount to approximately CHF 148 million, exceeding the previous full-year 2022 guidance of CHF 116 million to CHF 122 million. Tillkännagivande • Dec 24
Basilea Pharmaceutica AG to Report Fiscal Year 2022 Results on Feb 14, 2023 Basilea Pharmaceutica AG announced that they will report fiscal year 2022 results on Feb 14, 2023