An Interventional Phase 3, Open-label, Two-cohort Study to Investigate the Efficacy and Safety of Fosmanogepix in Adult Patients With Invasive Mold Infections Caused by Aspergillus Spp., Fusarium Spp., Lomentospora Prolificans, Mucorales Fungi, or Other Multidrug Resistant Molds

The purpose of this study is to evaluate the efficacy and safety of fosmanogepix (administered IV or oral) for the treatment of adult patients with invasive mold infections. The study is looking for patients who have been diagnosed with invasive mold infections. The maximum study duration will be approximately 8 months, including a target study treatment duration of 84 days which can be extended up to 180 days and follow-up period.
The patient will be assigned to one of two treatment cohorts:
Cohort A (primary therapy): Patients will receive either the study drug or institutional standard of care antifungal treatment.
Cohort B (salvage treatment; i.e. treatment given after patients did not respond to previous treatments or did not tolerate them): Patients will receive the study drug
The primary aim is to compare the all cause mortality with a fixed threshold at Day 42.

开始日期2025-08-26

申办/合作机构

Basilea Pharmaceutica AG

[+1]

NCT06961708

/ Completed临床1期

A Phase 1, Randomized, Single-center, Double-blind, Placebo-controlled Study of Fosmanogepix Administered as Single and Multiple Doses in Healthy Adult Chinese Subjects

The purpose of this study is to investigate the pharmacokinetics and safety of the investigational drug fosmanogepix including its active moiety manogepix following a single dose and multiple doses (by intravenous infusion (IV) or orally) in healthy Chinese adults.
The study consists of 2 consecutive Parts (Part-1, single-dose part followed by Part-2, multiple-dose part) including a total of approximately 52 participants.
Part-1 duration will be up to 64 days including 4 visits at the clinical site and Part-2 duration will be up to 70 days including 5 visits at the clinical site. The study will include a total of 4 study sub-groups (Cohorts 1-4) in which fosmanogepix or placebo will be administered in different strengths orally or IV.
Participants will be enrolled and randomly assigned to study drug.
During the study, serial blood samples will be collected to understand how fosmanogepix is changed and eliminated from the body. Participants will also receive physical examination and other tests. This will help to understand if fosmanogepix is safe.
All data analyses will be descriptive (no statistical analysis will be provided).

开始日期2025-04-14

申办/合作机构

Basilea Pharmaceutica AG

[+1]

NCT05421858

/ Recruiting临床3期

An Interventional Efficacy and Safety Phase 3 Double-blind 2-arm Study to Investigate IV Followed by Oral Fosmanogepix Compared With IV Caspofungin Followed by Oral Fluconazole in Adult Participants With Candidemia and/or Invasive Candidiasis

The purpose of this clinical trial is to learn about the safety and effects of the study medicine (called Fosmanogepix) for the potential treatment of candidemia and/or invasive candidiasis, a life-threatening fungal infection caused by several species of yeast called Candida.
The study is seeking patients who have a diagnosis of candidemia and/or invasive candidiasis.
Two-thirds of all patients will receive the study medication fosmanogepix Intravenous (IV) infusion followed by optional fosmanogepix tablets. One-third of all patients will receive a standard of care regimen of caspofungin Intravenous (IV) infusion followed by optional fluconazole capsules.
Fosmanogepix or caspofungin will first be given as an Intravenous (IV) infusion directly into a vein in the arm each day at the study clinic. Fosmanogepix tablets or fluconazole capsules will be taken orally by mouth daily either at the study clinic, or at home if patients are well enough to be discharged from the hospital.
The treatment effect in patients receiving fosmanogepix to those receiving caspofungin/ fluconazole will be compared. The primary aim is to show that fosmanogepix is not inferior (not worse) to caspofungin/ fluconazole with a noninferiority margin of 15%.
The duration of study treatment and number of study visits will vary depending on how long the patient will be treated for the infection. Treatment will continue for a maximum of 6 weeks depending on when the infection is cleared and whether other symptoms related to the infection have improved. There will also be a follow-up visit 6 weeks after the study treatment was stopped.

开始日期2024-12-11

申办/合作机构

Basilea Pharmaceutica AG

[+1]

100 项与 Fosmanogepix 相关的临床结果

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100 项与 Fosmanogepix 相关的转化医学

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100 项与 Fosmanogepix 相关的专利（医药）

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项与 Fosmanogepix 相关的文献（医药）

2025-09-01·BRAZILIAN JOURNAL OF MICROBIOLOGY

In vitro effects of the new antifungal compound manogepix (APX001) against the three most clinically relevant species of Sporothrix

Article

作者: Almeida-Paes, Rodrigo ; Zancopé-Oliveira, Rosely Maria ; Poester, Vanice Rodrigues ; Tenório-Alvarenga, Pedro Henrique ; Marques, Fernanda Praça Nogueira ; Xavier, Melissa Orzechowski ; Almeida-Silva, Fernando

Sporotrichosis is an endemic mycosis that pose significant public health challenges, particularly in Brazil, where zoonotic transmission has increased the number of cases in several regions of the country. The disease is caused by Sporothrix genus, with S. brasiliensis, S. schenckii, and S. globosa as the major agents. The currently available therapies may face limitations such as varying cure rates, long and expensive treatment, and adverse effects. Fosmanogepix, a prodrug converted into manogepix within the host, has demonstrated broad-spectrum antifungal activity, including other thermodimorphic fungal species. Thus, this study aimed to evaluate the in vitro antifungal efficacy of manogepix against three clinically relevant Sporothrix species. Minimal inhibitory and fungicidal concentrations were determined against 24 Sporothrix spp. isolates, as well as potential synergism with antifungal drugs, induction of resistance and growth kinetics of the fungus in the presence of the new antifungal drug. Manogepix exhibited fungicidal activity against the three Sporothrix species tested, with minimum inhibitory concentrations (MIC) ranging from 0.06 to 1 µg/ml. Furthermore, manogepix demonstrated a lower geometric mean of MIC values compared to the antifungal drugs and indifferent interactions with itraconazole, terbinafine and amphotericin B. Prolonged exposure to subinhibitory manogepix concentrations did not induce resistance in the tested strains. These findings indicate manogepix as a promising candidate for the treatment of sporotrichosis, offering a potential alternative in cases of resistance or treatment failure with current antifungals. Further studies are needed to confirm this activity in clinical settings, particularly in diverse geographic regions and against a broader range of Sporothrix strains.

2025-08-11·Future Microbiology

Clinical impact of fluconazole-resistant Candida parapsilosis: a narrative review.

Review

作者: Bassetti, Matteo ; Vena, Antonio ; Giacobbe, Daniele Roberto ; Bartalucci, Claudia

Fluconazole resistance in Candida parapsilosis is an increasing global concern, with resistance rates varying widely and reaching up to 80% in some regions. This trend has led to hospital outbreaks, primarily driven by mutations in the ERG11 gene, especially the Y132F substitution. The clinical relevance of fluconazole resistance remains controversial, as studies have yielded conflicting results regarding its impact on mortality. While some studies described an increased mortality associated with resistant strains, others reported no significant difference. Treatment options are limited: echinocandins and liposomal amphotericin B (L-AmB) are commonly used alternatives, but their use is challenged by intrinsic and emerging echinocandin resistance and L-AmB toxicity and cost. These limitations emphasize the need for robust antifungal stewardship and the development of new therapies. Novel agents such as rezafungin, fosmanogepix, and ibrexafungerp have shown promising activity against fluconazole-resistant C. parapsilosis, though further clinical studies are needed to confirm their efficacy. This narrative review aims to summarize current evidence on the epidemiology, clinical implications, and therapeutic approaches for fluconazole-resistant C. parapsilosis infections.

2025-07-11·Cureus Journal of Medical Science

Disseminated Musculoskeletal Coccidioidomycosis in an Immunocompetent Host: A Rare Case Requiring Extensive Spinal and Pelvic Surgery

Article

作者: Raman, Elangovan ; Sharma, Sorabh

Coccidioidomycosis, also known as "Valley Fever," is an endemic fungal infection caused by Coccidioides species, typically presenting as a respiratory illness. Disseminated disease, particularly with extensive skeletal involvement, is rare and typically seen in immunocompromised individuals. We report a unique and severe case of disseminated musculoskeletal coccidioidomycosis in a previously healthy immunocompetent 33-year-old African American man, involving multiple spinal levels, pelvic bones, and the right chest wall. The patient required multiple orthopedic surgeries, including anterior and posterior spinal decompression and fusion, bilateral sacroiliac joint debridement, and pelvic fixation. The diagnosis was confirmed via bone biopsy demonstrating Coccidioides spherules. Despite antifungal therapy, his disease progressed, necessitating escalation of treatment from fluconazole to isavuconazole and liposomal amphotericin B, followed by initiation of fosmanogepix as part of the approved treatment regimen. This case highlights the importance of high clinical suspicion, aggressive surgical intervention, and multidisciplinary management in complex disseminated coccidioidomycosis, even in immunocompetent hosts.

项与 Fosmanogepix 相关的新闻（医药）

2025-09-16

·EndPoints

Ark, Atom file to go public in Hong Kong; Aptevo’s stock rallies on AML data

Plus, news about Apollo Therapeutics, Reunion Neuroscience, Basilea, Tafalgie Therapeutics, Areteia Therapeutics and Avidity Biosciences: 🇨🇳 Two more biotechs look to IPO in Hong Kong: Ark Biopharmaceutical in Shanghai and Atom Therapeutics in Hangzhou joined the queue of Chinese drug developers looking to go public on the Hong Kong Stock Exchange. Founded in 2013, ArkBio is waiting for approval in China next year for an RSV treatment and a small molecule for ADHD. It also has programs in development for IPF , COPD and influenza and has in-licensed candidates from Roche and Commave Therapeutics. Meanwhile, Atom has treatments for various forms of gout , hyperuricemia and chronic kidney disease in late- and mid-stage trials. — Kyle LaHucik 🔬 Aptevo Therapeutics’ stock jumps on early AML data: The Seattle company reported a 100% remission rate in six newly diagnosed AML patients who received mipletamig, its CD123xCD3 bispecific, on top of the standard treatments of AbbVie and Roche’s Venclexta and azacitidine. These patients were given the highest dose (27 mcg) thus far of mipletamig in the Phase 1b/2 trial. Aptevo said no cases of cytokine release syndrome have been reported in frontline patients treated with its drug. The biotech’s shares $APVO jumped about 30% Tuesday morning. — Lei Lei Wu ✅ Apollo Therapeutics shares mid-stage atopic dermatitis data: The biotech’s IL-18 targeting antibody, called camoteskimab, produced a statistically significant reduction in the eczema area and severity index versus placebo at 16 weeks. Scores for the two arms were “clearly separated” at four weeks. Apollo plans to share detailed results at an upcoming scientific conference. — Ayisha Sharma 🧠 Reunion Neuroscience gets $30M Series A extension: The additional cash brings the total amount raised to $133 million. Reunion said the money will help fund a Phase 2 study in adjustment disorder in cancer and other diseases, while also supporting the launch of a separate trial for generalized anxiety disorder. — Max Gelman 🦠 Basilea gets $25M from BARDA: The company is developing a pair of antifungal treatments: fosmanogepix and BAL2062. It’s evaluating fosmanogepix in yeast infections and both drugs for mold infections. — Jaimy Lee 💶 Non-opioid pain biotech secures €12 million in Series A: Tafalgie Therapeutics, based in Marseille, plans to use the proceeds to advance its lead pain candidate, TT5, through Phase 2a development, according to a release emailed to Endpoints News . TT5 is a peptide derivative of a naturally occurring protein called TAFA4, which modulates pain signals as they move between the peripheral and central nervous systems. — Ayisha Sharma 🫁 Areteia Therapeutics toplines Phase 3 trial in eosinophilic asthma: The company studied an oral drug called dexpramipexole, which improved patients’ lung function by a statistically significant margin compared to placebo. Researchers averaged lung function measurements after 20 and 24 weeks. No specific figures were disclosed. — Max Gelman 💰 Avidity Biosciences ended up raising $690 million in its public offering. — Jaimy Lee

临床3期临床2期临床结果IPO

2025-09-16

·GlobeNewswire-Health Care

Basilea receives USD 25 million funding under BARDA agreement to continue to advance novel antifungals fosmanogepix and BAL2062

Ad hoc announcement pursuant to Art. 53 LR Allschwil, Switzerland, September 16, 2025 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 today 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 25 million to Basilea to continue to advance the development of Basilea’s novel antifungals fosmanogepix and BAL2062. This additional funding follows the achievement of a prespecified enrollment milestone in the fosmanogepix phase 3 study in candidemia/invasive candidiasis within the “Other Transaction Agreement” (OTA, agreement number 75A50124C00033), which allows for potential total funding of up to approximately USD 268 million to develop antifungal and antibacterial assets. David Veitch, Chief Executive Officer of Basilea, said: “We are very pleased with the continued funding under the OTA with BARDA to support the development of our antifungal drug candidates fosmanogepix and BAL2062. These compounds, with novel mechanisms of action, promise new therapeutic options for patients with aspergillosis, candidiasis or other life-threatening invasive fungal infections. There continues to be a high medical need for new innovative antifungal treatments.” He added: “This third tranche of funding within the BARDA OTA will support our two ongoing phase 3 studies with fosmanogepix in yeast infections and in mold infections. It also provides further funding for the phase 2 development of BAL2062 in mold infections.” The USD 25 million is in addition to the USD 68 million already committed by BARDA since 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. About fosmanogepix Fosmanogepix is a clinical-stage broad-spectrum antifungal. It has a novel mechanism of action and its active moiety has shown activity against common species of Candida and Aspergillus, including multi-drug-resistant strains, such as Candida auris and Candida glabrata, as well as rare difficult-to-treat molds including Fusarium spp., Scedosporium spp., and some fungi from the Mucorales order.1 Fosmanogepix intravenous and oral formulations have been evaluated in clinical phase 2 studies for the treatment of patients with Candidemia, including Candida auris infections, and invasive mold infections.1 The FAST study, a phase 3 study evaluating fosmanogepix in the treatment of adult patients with candidemia and/or invasive candidiasis and the FORWARD study, a phase 3 study, in the treatment of adult patients with invasive mold infections, are ongoing.2 Fosmanogepix has received Fast Track and Orphan Drug designations from the U.S. Food and Drug Administration for a number of indications, and is designated as a Qualified Infectious Disease Product (QIDP). About BAL2062 BAL2062 is a first-in-class antifungal, derived from a natural product, and has demonstrated fungicidal activity against clinically important molds such as Aspergillus spp., including azole-resistant strains.3 Safety and tolerability have been demonstrated in a previously completed phase 1 study with single and multiple ascending intravenous (i.v.) doses.4 The drug candidate has Qualified Infectious Disease Product (QIDP), Orphan Drug and Fast Track designation from the US Food and Drug Administration (FDA) for invasive aspergillosis. About invasive mold infections Invasive aspergillosis and invasive infections with rare molds (e.g., Fusarium spp., Scedosporium spp., and Mucorales fungi) are life-threatening infections that predominantly affect immunocompromised patients, including patients with hematologic malignancies (blood cancer), transplant patients, or patients with other immunodeficiency disorders. These infections are associated with high morbidity and mortality.5, 6 About invasive candidiasis Invasive candidiasis, including deep-seated tissue candidiasis and candidemia, is an increasingly important nosocomial infection, especially in patients hospitalized in intensive care units. Candida species are ranked as the fourth main cause of bloodstream infections in hospitals in the US.7 The prognosis of invasive candidiasis remains difficult, with a reported mortality rate for invasive candidiasis as high as 40%, even when patients receive antifungal therapy.8 About Basilea Basilea is a commercial-stage biopharmaceutical company founded in 2000 and headquartered in Switzerland. We are committed to discovering, developing and commercializing innovative drugs to meet the needs of patients with severe bacterial and fungal infections. We have successfully launched two hospital brands, Cresemba for the treatment of invasive fungal infections and Zevtera for the treatment of bacterial infections. In addition, we have preclinical and clinical anti-infective assets in our portfolio. Basilea is listed on the SIX Swiss Exchange (SIX: BSLN). Please visit basilea.com. Disclaimer This communication expressly or implicitly contains certain forward-looking statements, such as "believe", "assume", "expect", "forecast", "project", "may", "could", "might", "will" or similar expressions concerning Basilea Pharmaceutica Ltd, Allschwil and its business, including with respect to the progress, timing and completion of research, development and clinical studies for product candidates. Such statements involve certain known and unknown risks, uncertainties and other factors, which could cause the actual results, financial condition, performance or achievements of Basilea Pharmaceutica Ltd, Allschwil to be materially different from any future results, performance or achievements expressed or implied by such forward-looking statements. Basilea Pharmaceutica Ltd, Allschwil is providing this communication as of this date and does not undertake to update any forward-looking statements contained herein as a result of new information, future events or otherwise. This project has been funded in part with federal funds from the U.S. Department of Health and Human Services (HHS); Administration for 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. For further information, please contact: Peer Nils Schröder, PhD Head of Corporate Communications & Investor RelationsBasilea Pharmaceutica International Ltd, Allschwil Hegenheimermattweg 167b4123 AllschwilSwitzerland Phone +41 61 606 1102 E-mail media_relations@basilea.com investor_relations@basilea.com This ad hoc announcement can be downloaded from www.basilea.com. References K. J. Shaw, A. S. Ibrahim. Fosmanogepix: A Review of the First-in-Class Broad Spectrum Agent for the Treatment of Invasive Fungal Infections. Journal of Fungi (Basel) 2020 (6), 239FAST study (candidemia/invasive candidiasis): ClinicalTrials.gov identifier NCT05421858; FORWARD study (invasive mold infections): ClinicalTrials.gov identifier NCT06925321K. J. Shaw. GR-2397: Review of the Novel Siderophore-like Antifungal Agent for the Treatment of Invasive Aspergillosis. Journal of Fungi (Basel) 2022 (8), 909ClinicalTrials.gov identifier NCT02956499: M. P. Mammen, D. Armas, F. H. Hughes et al. First-in-Human Phase 1 Study To Assess Safety, Tolerability, and Pharmacokinetics of a Novel Antifungal Drug, VL-2397, in Healthy Adults. Antimicrobial Agents and Chemotherapy 2019 (63), e00969-19J. Cadena, G. R. Thompson 3rd, T. F. Patterson. Aspergillosis: Epidemiology, Diagnosis, and Treatment. Infectious Disease Clinics of North America 2021 (35), 415-434M. Slavin, S. van Hal, T. C. Sorrell et al. Invasive infections due to filamentous fungi other than Aspergillus: epidemiology and determinants of mortality. Clinical Microbiology and Infection 2015 (21), 490.e1-490.e10Candidemia (Blood Infection) and Other Candida Infections. 2019 Factsheet by the American Thoracic Society: https://www.thoracic.org/patients/patient-resources/resources/candidemia.pdf (Accessed: September 15, 2025)B. J. Kullberg, M. C. Arendrup. Invasive Candidiasis. The New England Journal of Medicine 2015 (373), 1445-1456 Attachment Press release (PDF)

临床3期孤儿药快速通道临床1期临床2期

2025-08-19

·GlobeNewswire-Health Care

Basilea on track with strong 2025 half-year results

Cresemba® and Zevtera®-related revenues rise by 24% to CHF 90.5 millionTotal revenue grows significantly by 36% to CHF 104.0 millionOperating profit surges by 160% to CHF 24.0 millionOperating cash flow increases by 29% to CHF 23.1 millionFull-year 2025 guidance: on track and updated to reflect recent in-licensing of a novel oral phase 3-ready antibiotic Ad hoc announcement pursuant to Art. 53 LR Allschwil, Switzerland, August 19, 2025 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 today its results for the first half-year ended June 30, 2025. David Veitch, Chief Executive Officer, stated: “The first half of 2025 has marked a period of strong execution and meaningful progress across both the antibacterial and antifungal parts of our portfolio. The launch of Zevtera in the US, its most important commercial market, is a major milestone and represents a pivotal moment in the brand’s history. On the antifungal side, we have seen encouraging momentum from our global commercial partnerships, including the first milestone payments for Cresemba sales in Japan. A further highlight was the release of another USD 39 million from BARDA to support the ongoing development of fosmanogepix and BAL2062. The recent start of a phase 3 clinical study for fosmanogepix in invasive mold infections, conducted in parallel with the ongoing phase 3 study in invasive yeast infections provides strong evidence of the clinical progress we are making. Our stated goal to deliver new treatment options for patients with life-threatening fungal infections is becoming reality. Furthermore, the agreement we just announced to acquire the global rights to a novel oral phase 3-ready antibiotic for the treatment of complicated urinary tract infections, marks yet another strategic milestone to strengthen our late-stage clinical pipeline with innovative assets.” Adesh Kaul, Chief Financial Officer, said: “We are reporting another period of strong financial performance, with increasing revenues, operating profits and operating cash flows. We expect continued strong in-market sales growth, which will result in increasing royalty revenue and milestone payments in the second half of this year. We strengthened our balance sheet by reducing the outstanding value of our convertible bonds by 14% to CHF 83 million in nominal value, while at the same time increasing our cash position. Our strong financial position demonstrates the robustness of our unique business model and enables us to continue investing in the expansion of our pipeline.” Financial summary For the first half year (H1) 2025, Basilea recognized total revenue of CHF 104.0 million (H1 2024: CHF 76.3 million), an increase of 36.3% year-on-year. This included royalty income of CHF 52.1 million (H1 2024: CHF 42.8 million), which increased by 21.7% year-on-year, and product revenue of CHF 31.5 million (H1 2024: CHF 27.6 million). Milestone and upfront payments have also increased to CHF 6.9 million (H1 2024: CHF 2.9 million). Other revenue amounted to CHF 13.5 million (H1 2024: CHF 3.0 million). This included CHF 11.1 million BARDA[1] reimbursements (H1 2024: CHF 2.0 million) and CHF 1.9 million CARB-X[2] funding (H1 2024: CHF 0.6 million). BARDA reimbursements were for activities related to the fosmanogepix phase 3 program, the antifungal BAL2062, and ceftobiprole, while CARB-X funding supports preclinical activities related to the antibiotic BAL2420. In H1 2025, Basilea invested CHF 38.3 million (H1 2024: CHF 33.6 million) in research and development (R&D), mainly related to the ongoing phase 3 clinical study of fosmanogepix in invasive yeast infections, the preparations for starting a second phase 3 clinical study with fosmanogepix in invasive mold infections, the preclinical profiling of BAL2062 and BAL2420 (the LptA inhibitor program), and for research work on compounds in the Company’s early-stage portfolio. Selling, general and administrative expenses, including costs for the commercialization of Cresemba and Zevtera, amounted to CHF 17.4 million (H1 2024: CHF 15.3 million) and cost of products sold increased to CHF 24.2 million (H1 2024: CHF 18.1 million), reflecting the increase in product revenue. Basilea recorded an operating result of CHF 24.0 million (H1 2024: CHF 9.3 million). In H1 2025, Basilea reported income tax expense of CHF 3.5 million (H1 2024: CHF 13.4 million income tax benefit due to the one-time effect from releasing the deferred tax asset valuation allowance) and a net profit of CHF 15.8 million (H1 2024: CHF 20.7 million), resulting in a basic and diluted earnings per share of CHF 1.29 and CHF 1.26, respectively (H1 2024: basic and diluted earnings per share CHF 1.72 and CHF 1.61, respectively). In H1 2025, a positive net cash flow of CHF 23.1 million was provided by operating activities (H1 2024: CHF 17.9 million). The Company also repurchased senior unsecured convertible bonds due July 2027 in the amount of CHF 14.3 million nominal value out of a total CHF 97.1 million nominal value. Cash and cash equivalents and restricted cash amounted to CHF 132.7 million as of June 30, 2025 (June 30, 2024: CHF 69.5 million). Basilea has reduced its total financial debt by approximately CHF 138 million since the beginning of 2022 and increased its net cash position to CHF 50.7 million as of June 30, 2025 (June 30, 2024: net debt of CHF 26.2 million). Key financial figures (In CHF million, except per share data)H1 2025H1 2024 Product revenue31.527.6 Contract revenue59.045.7 Other revenue13.53.0Total revenue 104.076.3 Cost of products sold(24.2)(18.1) Research & development expenses, net(38.3)(33.6) Selling, general & administrative expenses(17.4)(15.3)Total cost and operating expenses (79.9)(67.0)Operating result24.09.3Profit before taxes19.37.3 Income taxes(3.5)13.4Net profit15.820.7Net cash provided by operating activities23.117.9Basic earnings per share, in CHF1.291.72Diluted earnings per share, in CHF1.261.61 (in CHF million)June 30, 2025June 30, 2024Cash and cash equivalents and restricted cash132.769.5 Note: Consolidated figures in conformity with US GAAP; rounding was applied consistently. The unaudited, condensed consolidated interim financial statements of Basilea Pharmaceutica Ltd, Allschwil for the first half year 2025 can be found on the company’s website at https://www.basilea.com/financial-reports. Updating 2025 financial guidance – expecting higher total revenue and reflecting recent in-licensing of a novel oral phase 3-ready antibiotic Basilea provides the following guidance for the full year (FY) 2025: Total revenue is expected to increase by 8% to CHF 225 million Basilea can offset the impact of the strengthening of the Swiss Franc and the previously announced decrease in product supply to Pfizer on Cresemba & Zevtera-related revenue.The expected 14% increase in royalty income to CHF 110 million reflects primarily the continued strong double-digit sales growth of Cresemba in its key markets.Following a year of exceptionally high milestone payments in 2024, milestone and upfront payments in 2025 are expected to remain at the level of prior years of around CHF 32 million, despite being impacted by the strengthening of the Swiss Franc, primarily versus the US Dollar.The increase in BARDA and CARB-X reimbursements is reflecting the significant operational progress with fosmanogepix, BAL2062 and BAL2420. The increase in cost and operating expenses reflects the expected impact of the recent strategic addition of ceftibuten-ledaborbactam to our late-stage clinical pipeline and our continued investment in progressing our exciting R&D portfolio of first-in-class antifungals and antibacterials. Nevertheless, we expect to maintain a high operating profit level of CHF 50 million in 2025.We expect no material cash outflow related to income taxes as a result of the use of tax loss carry forwards, but a 10.7% income tax expense will be reflected in the 2025 net profit, in contrast to a CHF 17.3 million one-time income tax benefit from releasing the deferred tax valuation allowance in 2024. (in CHF million)FY 2025enewFY 2025epreviousFY 2024 Cresemba and Zevtera-related revenue~190~190194.9 of which royalty income~110~11096.7Total revenue ~225~220208.5Research & development expenses, net~105~8877.1Operating result~50~6261.2 Conference call and webcast Basilea Pharmaceutica Ltd, Allschwil will host a conference call and webcast today, Tuesday, August 19, 2025, at 4 p.m. (CEST), to discuss the company’s financial and operating results and to provide an outlook. Via audio webcast with presentation The live audio webcast of the results presentation can be followed here: https://event.choruscall.com/mediaframe/webcast.html?webcastid=AAxPAsgp. Please note that there is no function to ask questions via webcast. For questions, please additionally dial-in via phone (see below). Via phone To listen by phone and ask questions, please use the dial-in details below. To ensure prompt access, please call approximately five minutes prior to the scheduled start of the call. +41 (0) 58 310 5000(Switzerland, Europe and RoW)+1 (1) 866 291 4166 (USA)+44 (0) 207 107 0613(UK) Replay The webcast, along with the presentation will be available online (same link as live audio webcast above) shortly after the event and accessible for three months. About Basilea Basilea is a commercial-stage biopharmaceutical company founded in 2000 and headquartered in Switzerland. We are committed to discovering, developing and commercializing innovative drugs to meet the needs of patients with severe bacterial and fungal infections. We have successfully launched two hospital brands, Cresemba for the treatment of invasive fungal infections and Zevtera for the treatment of bacterial infections. In addition, we have preclinical and clinical anti-infective assets in our portfolio. Basilea is listed on the SIX Swiss Exchange (SIX: BSLN). Please visit basilea.com. Disclaimer This communication expressly or implicitly contains certain forward-looking statements, such as "believe", "assume", "expect", "forecast", "project", "may", "could", "might", "will" or similar expressions concerning Basilea Pharmaceutica Ltd, Allschwil and its business, including with respect to the progress, timing and completion of research, development and clinical studies for product candidates. Such statements involve certain known and unknown risks, uncertainties and other factors, which could cause the actual results, financial condition, performance or achievements of Basilea Pharmaceutica Ltd, Allschwil to be materially different from any future results, performance or achievements expressed or implied by such forward-looking statements. Basilea Pharmaceutica Ltd, Allschwil is providing this communication as of this date and does not undertake to update any forward-looking statements contained herein as a result of new information, future events or otherwise. For further information, please contact: Peer Nils Schröder, PhDHead of Corporate Communications & Investor RelationsBasilea Pharmaceutica International Ltd, Allschwil Hegenheimermattweg 167b4123 AllschwilSwitzerland Phone+41 61 606 1102 E-mailmedia_relations@basilea.cominvestor_relations@basilea.com This ad hoc announcement can be downloaded from www.basilea.com. References The Biomedical Advanced Research and Development Authority (BARDA), part of the Administration for Strategic Preparedness and Response (ASPR) within the US Department of Health and Human Services (HHS), provided partial funding for Basilea’s ceftobiprole Phase 3 program under contract number HHSO100201600002C. This funding covered approximately USD 111 million, or about 75% of the costs for the Staphylococcus aureus bacteremia (SAB) and acute bacterial skin and skin structure infections (ABSSSI) Phase 3 studies, regulatory activities, and non-clinical work. BARDA is also supporting Basilea’s fosmanogepix and BAL2062 programs under OTA number 75A50124C00033. CARB-X (Combating Antibiotic-Resistant Bacteria Biopharmaceutical Accelerator) funding for this project is provided in part by federal funds from the US Department of Health and Human Services (HHS); Administration for Strategic Preparedness and Response; Biomedical Advanced Research and Development Authority; Antibacterials branch; under agreement number 75A50122C00028; and by awards from Wellcome (WT224842) and Germany’s Federal Ministry of Education and Research (BMBF). Attachment Press release (PDF).pdf

临床3期财报引进/卖出

100 项与 Fosmanogepix 相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
D11694	-	-	DB15183

研发状态

10 条进展最快的记录,

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适应症	最高研发状态	国家/地区	公司	日期
侵袭性曲霉菌病	临床3期	美国	Basilea Pharmaceutica AG	2025-07-01
毛霉菌病	临床3期	美国	Basilea Pharmaceutica AG	2025-07-01
侵袭性念珠菌病	临床3期	-	Basilea Pharmaceutica AG	2024-08-23
念珠菌血症	临床3期	-	Pfizer Inc.	2022-12-05
耳念珠菌感染	临床2期	南非	Basilea Pharmaceutica AG	2019-12-13
肝损伤	临床1期	美国	Pfizer Inc.	2022-10-31
肝损伤	临床1期	美国	Basilea Pharmaceutica AG	2022-10-31
急性髓性白血病	临床1期	德国	Basilea Pharmaceutica AG	2017-11-27
中性粒细胞减少	临床1期	德国	Basilea Pharmaceutica AG	2017-11-27
真菌病	临床1期	荷兰	Basilea Pharmaceutica AG	2016-05-24

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临床结果

适应症

分期

评价

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研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


NCT04240886 (AEGIS, Pubmed \| Clin Infect Dis)	临床2期	侵袭性真菌感染	21	Fosmanogepix 1000 mg IV	積顧構衊顧餘壓醖積範(廠膚廠構襯選築範築鏇) = 258 adverse events (AEs) were reported (n=21) 壓醖醖衊鹹獵構衊鑰範 (齋製築繭襯壓壓鑰遞遞 ) 更多	积极	2025-04-09
NCT04804059 (Pubmed) 人工标引	临床1期	-	10	Fosmanogepix 500 mg oral	齋遞壓壓艱鏇選壓簾觸(選築製鏇夢膚衊壓鏇鑰) = 遞窪艱願蓋憲築簾餘簾簾鹹憲夢襯窪積夢選餘 (遞窪糧衊齋襯鹽鑰蓋簾 )	积极	2024-07-16
NCT04804059 (Pubmed) 人工标引	临床1期	-	10	Fosmanogepix 600 mg IV	齋遞壓壓艱鏇選壓簾觸(選築製鏇夢膚衊壓鏇鑰) = 觸製鬱壓築觸製製範夢簾鹹憲夢襯窪積夢選餘 (遞窪糧衊齋襯鹽鑰蓋簾 )	积极	2024-07-16
NCT04148287 (Pubmed) 人工标引	临床2期	念珠菌血症	9	Fosmanogepix	蓋簾願衊衊鏇窪遞膚製(簾繭餘廠憲鑰製鏇窪窪) = 襯糧夢廠遞憲糧積膚鬱蓋遞網顧餘衊簾鏇網淵 (齋築艱鏇壓構鹹顧網簾 ) 更多	积极	2023-04-06
NCT02957929 \| NCT02956499 (Pubmed) 人工标引	临床1期	侵袭性真菌感染	154	Fosmanogepix	製鑰餘齋願選壓鏇鏇簾(選艱鑰艱選憲積夢窪製) = 築簾鹹鬱範夢膚網鬱窪醖壓繭窪鹽築構壓選淵 (鑰鑰鑰齋糧憲觸網築糧 ) 更多	积极	2023-03-29
NCT02957929 \| NCT02956499 (Pubmed) 人工标引	临床1期	侵袭性真菌感染	154	placebo	-	积极	2023-03-29
NCT03604705 (PipelineReview) 人工标引	临床2期	念珠菌血症一线	21	Fosmanogepix	糧遞網獵顧壓鹹衊窪鹹(淵遞壓鹹艱簾鏇艱齋簾) = 壓鹹觸積願顧繭鑰鹹壓鹹衊簾觸構艱壓製襯選 (膚鑰繭遞鏇壓鏇夢淵醖 ) 更多	积极	2020-07-20