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[Ad hoc announcement pursuant to Art. 53 LR] Roche provides safety update on Elevidys™ gene therapy for Duchenne muscular dystrophy in non-ambulatory patients

Basel, 15 June 2025 - Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today new dosing restrictions, effective immediately, for ELEVIDYS™ (delandistrogene moxeparvovec), for non-ambulatory Duchenne muscular dystrophy (DMD) patients, irrespective of age, in both clinical and commercial settings. In the commercial setting, non-ambulatory patients should no longer receive Elevidys. In the clinical trial setting, enrolment and dosing of non-ambulatory patients will be immediately paused until additional risk mitigation measures (e.g. immune modulatory treatment) are implemented in the study protocol. Health authorities, investigators and physicians are being informed so that patient care can be quickly adjusted.

Biomea Fusion Presents Updated Preliminary Clinical Data for Covalent FLT3 Inhibitor BMF-500 in Relapsed or Refractory Acute Leukemia at EHA 2025

New clinical results show sustained CRi, deep bone marrow responses, and encouraging survival in FLT3-mutant AML patients, including those previously treated with gilteritinib 
New clinical results show sustained CRi, deep bone marrow responses, and encouraging survival in FLT3-mutant AML patients, including those previously treated with gilteritinib

Blueprint Medicines Announces Data Reinforcing Sustained Clinical Efficacy and Well-Tolerated Safety Profile of Long-Term AYVAKIT®/AYVAKYT® (avapritinib) Treatment at 2025 EHA and EAACI Congresses

-- Breadth of presentations, including one oral and two flash talks, showcase Blueprint Medicines' leadership role in advancing care for patients with systemic mastocytosis...

Dizal Showcases Two First-in-Class Therapies in Hematologic Malignancies at EHA and ICML 2025

Golidocitinib demonstrated promising efficacy in maintaining and enhancing tumor response in peripheral T-cell lymphoma (PTCL) post first-line therapy with a 24-month disease-free survival (DFS)...

Significant efficacy benefit of IMBRUVICA® (ibrutinib) plus venetoclax versus acalabrutinib plus venetoclax in frontline treatment of patients with chronic lymphocytic leukaemia suggested by indirect...

Cross-study findings indicate significant clinical benefit of frontline fixed-duration ibrutinib plus venetoclax with improved likelihood of undetectable minimal residual disease and progression-free survival versus acalabrutinib plus venetoclax1

EQT Life Sciences Co-Leads USD 135 Million Series B Financing in SpliceBio

Financing was co-led by EQT Life Sciences and Sanofi Ventures, with participation from Roche Venture Fund, as well as all existing investorsProceeds will support...

Nuevocor Announces FDA Clearance of IND for NVC-001 for LMNA-Related Dilated Cardiomyopathy

LMNA-related dilated cardiomyopathy (LMNA DCM) is one of the most aggressive forms of DCM, affecting approximately 100,000 individuals in the United States and Europe,...

Thirteen Studies of Ascentage Pharma’s Assets Including Olverembatinib and Lisaftoclax Selected for Presentations at 2025 European Hematology Association Annual Congress

ROCKVILLE, Md. and SUZHOU, China, June 09, 2025 (GLOBE NEWSWIRE) -- Ascentage Pharma (NASDAQ: AAPG; HKEX: 6855), a global biopharmaceutical company dedicated to addressing unmet medical needs in cancers, announced that 13 studies of its core assets - including the novel drug olverembatinib (HQP1351), the investigational Bcl-2 inhibitor lisaftoclax (APG-2575), and the investigational EED inhibitor APG-5918 – will be featured in an oral presentation, multiple poster presentations and multiple online publications at the 2025 European Hematology Association (EHA) Annual Congress taking place in Milan, Italy, from June 12-15, 2025.

HER2+ Gastric Cancer (including GEJ) Market to Increase at a Remarkable Growth Rate of 13% During the Study Period (2020-2034) | DelveInsight

The overall HER2+ gastric cancer market is projected to grow, driven by increasing biomarker testing, better patient selection, and continued advancements in HER2-targeted ADCs,...

The British Medical Journal Publishes Study Results on Sacituzumab Tirumotecan for Previously Treated EGFR-Mutant Advanced NSCLC

CHENGDU, China, June 6, 2025 /PRNewswire/ -- Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. ("Kelun-Biotech", 6990.HK) today announced that results from its registrational study (OptiTROP-Lung03) evaluating...

ORIC Pharmaceuticals Reports Inducement Grants under Nasdaq Listing Rule 5635(c)(4)

SOUTH SAN FRANCISCO, Calif. and SAN DIEGO, June 06, 2025 (GLOBE NEWSWIRE) -- ORIC Pharmaceuticals, Inc. (Nasdaq:ORIC), a clinical stage oncology company focused on developing treatments that address mechanisms of therapeutic resistance, today announced that on June 2, 2025 (the “Grant Date”), ORIC granted a total of 39,100 non-qualified stock options and 6,500 restricted stock units to three new non-executive employees who began their employment with ORIC in May 2025.

Arvinas Announces Submission of New Drug Application to U.S. FDA for Vepdegestrant for Patients with ESR1-Mutated ER+/HER2- Advanced or Metastatic Breast Cancer

– This submission is supported by the pivotal Phase 3 VERITAC-2 clinical trial, results of which were recently presented at the 2025 American Society for Clinical Oncology Annual Meeting and published in The New England Journal of Medicine –

GenEditBio Announces First Patient Dosed in Investigator-Initiated Trial of GEB‑101, World’s First In Vivo CRISPR-Cas Ribonucleoprotein-Based Genome Editing Investigational Therapy for TGFBI Corneal Dystrophy

HONG KONG, BEIJING and BOSTON, June 6, 2025 /PRNewswire/ -- GenEditBio Limited ("GenEditBio"), a clinical-stage biotechnology start-up company focusing on genome editing therapeutic solutions...

AKEEGA® (niraparib e abiraterone acetato): la compressa a doppia azione di Johnson & Johnson è la prima combinazione di PARP inibitori a mostrare una...

I risultati dello studio di Fase 3 AMPLITUDE mettono in luce il potenziale di niraparib e abiraterone acetato nel ritardare la progressione del cancro e il peggioramento dei sintomi1

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