Lurbinectedin

Stockholm, Sweden, March 27, 2026 – Immedica today announces that Zepzelca® (lurbinectedin), in combination with atezolizumab, has received a positive opinion from the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) as first-line treatment for adult patients with extensive-stage small cell lung cancer (ES-SCLC) whose disease has not progressed following induction therapy with atezolizumab, carboplatin and etoposide. Extensive-stage small cell lung cancer is an aggressive and fast-growing disease with a poor prognosis and limited treatment options, with the majority of patients diagnosed at an advanced stage. “Small cell lung cancer remains a highly challenging disease with significant unmet medical need,” said Anders Edvell, CEO of Immedica. “The CHMP’s positive opinion represents an important step towards bringing this new treatment option to patients in Europe.” The decision is based on results from the Phase 3 IMforte trial, which showed that the lurbinectedin and atezolizumab combination reduced the risk of disease progression or death by 46% and the risk of death by 27%, compared to atezolizumab maintenance therapy alone. Following four cycles of induction therapy, from the point of randomization the median overall survival (OS) for the combination regimen was 13.2 months versus 10.6 months (stratified hazard ratio [HR]=0.73; 95% CI: 0.57–0.95; p=0.0174). From the point of randomization, median progression-free survival (PFS) by independent assessment was 5.4 months versus 2.1 months, respectively (stratified HR=0.54, 95% CI: 0.43–0.67; p<0.0001). Safety was consistent with the known safety profiles of both treatments. The results were presented at the 2025 American Society of Clinical Oncology (ASCO) annual meeting and simultaneously published in The Lancet. The CHMP positive opinion will now be reviewed by the European Commission, which is responsible for the final decision on the marketing authorization in the EU. Immedica has a strategic partnership with PharmaMar, where Immedica holds the distribution rights to Zepzelca in the Nordics, the UK & Ireland, Central Eastern Europe as well as in the Middle East and North Africa. About small cell lung cancer (SCLC) SCLC is an aggressive form of lung cancer characterized by rapid growth, early metastasis, and limited therapeutic options. It accounts for about 10–15 % of all lung cancer cases and tends to present at an advanced stage, often requiring systemic therapy. Because of its aggressive nature and propensity for relapse the prognosis remains poor. About Zepzelca® (lurbinectedin) Zepzelca® (lurbinectedin), also known as PM1183, is an analog of the marine compound ET-736 isolated from the sea squirt Ecteinascidia turbinata in which a hydrogen atom has been replaced by a methoxy group. It is a selective inhibitor of the oncogenic transcription programs on which many tumors are particularly dependent. Together with its effect on cancer cells, lurbinectedin inhibits oncogenic transcription in tumor-associated macrophages, downregulating the production of cytokines that are essential for the growth of the tumor. Transcriptional addiction is an acknowledged target in those diseases, many of them lacking other actionable targets. About PharmaMar PharmaMar is a biopharmaceutical company headquartered in Madrid, Spain, specializing in the discovery, development, and commercialization of anticancer therapies derived from marine biodiversity. The company focuses its R&D efforts on rare and difficult-to-treat cancers, leveraging a proprietary platform of marine-derived compounds and strong collaborations with academic and industry partners. For more information, visit www.pharmamar.com About Immedica Immedica is a pharmaceutical company, headquartered in Stockholm, Sweden, focused on the commercialization of medicines for rare diseases and specialty care products. Immedica’s capabilities cover marketing and sales, compliance, pharmacovigilance, quality assurance, regulatory, medical affairs and market access, as well as a global distribution network serving patients in more than 50 countries. Immedica is fully dedicated to helping those living with diseases which have a large unmet medical need. Immedica’s therapeutic areas are within RARE metabolic, RARE hematology & oncology, RARE neurology, RARE Endocrinology and specialty care. Immedica was founded in 2018 and employs today around 180 people across Europe, the Middle East and the United States. Immedica is backed by the investment firms KKR and Impilo. For more information visit www.immedica.com. Immedica contact: Linda Holmström Head of HR & Communication linda.holmstrom@immedica.com We believe we have an important role to fill in society – bringing new, innovative treatments to patients with rare diseases. Focus areas are within RARE metabolic, RARE neurology, RARE hematology & oncology and specialty care. We operate products from phase 2 and all the way to mature products. ESG is an integrated part of our business model. Stay up to date with our latest news. Telephone: +46 (0) 8 533 39 500 E-mail: info@immedica.com

PharmaMar, a Madrid-based company focused on marine-derived oncology therapeutics, and Globant, a Buenos Aires-founded digital and AI services firm listed on the NYSE, announced a collaboration to deploy a multi-agent artificial intelligence framework across PharmaMar’s research operations (announcement). The deal is structured as a technology services partnership rather than a traditional drug licensing agreement. No specific molecule is being licensed or co-developed. Globant is providing its Enterprise AI platform to help PharmaMar prioritize compound-indication combinations from its marine-derived compound portfolio in oncology. Financial terms of the collaboration were not disclosed. The announcement contains no mention of upfront payments, milestone structures, royalty rates, equity components, or total deal value. The absence of such terms is consistent with the nature of the arrangement, which resembles a technology services engagement rather than a structured biopharma transaction with defined financial triggers tied to development or commercial events. Deal context The collaboration centers on Globant Enterprise AI, configured as a multi-agent AI system in which more than 20 specialized digital agents operate across preclinical, clinical, regulatory, and commercial functions within PharmaMar’s research ecosystem. The system is designed to ingest and analyze large volumes of scientific literature, regulatory documents, and clinical data. In a pilot phase, the platform processed over 4,500 research documents to identify and rank the 10 most viable treatment-indication combinations from more than 8,000 possibilities. PharmaMar reported that the system reduced the time required for this analysis from weeks to hours and achieved over 90% accuracy in data retrieval tasks. No specific drug candidate has been named as an output of the platform. PharmaMar’s existing portfolio includes lurbinectedin, marketed as Zepzelca for small cell lung cancer, and other marine-derived compounds at various development stages. The AI system is intended to evaluate this portfolio broadly rather than advance a single asset. Future phases are expected to add autonomous hypothesis generation, real-time regulatory compliance checks, and automated scientific reporting. The collaboration fits within a broader industry pattern of pharmaceutical companies engaging AI technology providers to accelerate early research. Several dedicated AI drug discovery companies operate in this space with purpose-built platforms and validated pharma partnerships. BenevolentAI has deployed its knowledge graph platform with AstraZeneca to identify novel targets in idiopathic pulmonary fibrosis and chronic kidney disease. Insilico Medicine advanced ISM001-055, an AI-discovered molecule for idiopathic pulmonary fibrosis, into Phase II clinical testing through a partnership with Sanofi covering six targets. Recursion Pharmaceuticals, which merged with Exscientia, operates a phenomics-driven platform with partnerships at Roche and Bayer. These companies differ from Globant in that they maintain proprietary biological datasets and have generated clinical-stage assets from their platforms. For PharmaMar, the partnership addresses a specific operational need: systematically evaluating its library of marine-derived compounds against potential oncology indications using data-driven methods rather than manual literature review. The company’s pipeline is concentrated in oncology, and the AI system is designed to surface compound-indication pairs that merit further preclinical or clinical investment. No new clinical trials or regulatory submissions have been announced as a result of the collaboration. Globant’s role is that of a technology vendor applying its general-purpose AI infrastructure to pharmaceutical research workflows. The company has not previously generated drug candidates or validated targets through its platform. This positions the collaboration as an early test of whether general-purpose multi-agent AI systems can produce actionable outputs in drug discovery, a domain where specialized platforms with proprietary biomedical data have established longer track records. Your email address will not be published. Required fields are marked * Comment * Name * Email * Website