From GlobeNewswire

AUCATZYL® (obecabtagene autoleucel) U.S. commercial launch is on track with 33 authorized treatment centers as of March 19, 2025, post US FDA approval on November 8, 2024. Obe-cel MHRA and EMA marketing authorizations expected in H2 2025. Initial six patients dosed in Phase 1 trial for Systemic Lupus Erythematosus (SLE). Company to provide updates at R&D investor event on April 23rd.: 2025-03-20 07:00:00

AUCATZYL® (obecabtagene autoleucel) U.S. launch on track with 33 treatment centers since FDA approval. Obe-cel expected to get MHRA and EMA authorizations in H2 2025. Phase 1 trial for SLE with six patients dosed. Conference on April 23 for updates, including autoimmune expansion. Call today at 08:30 am EDT.

MRT-6160 Phase 1 study results show over 90% VAV1 degradation, significant T and B cell inhibition, and cytokine release inhibition. Phase 2 studies ahead for immune-mediated diseases. MRT-2359 Phase 1/2 study signals response in CRPC patients resistant to AR therapy, focusing on CRPC cohort. MRT-8102 on track for IND filing in H1 2025.

Monte Rosa Therapeutics reports strong financials through 2028. Focus on MGD-based medicines for immune-mediated diseases. Updates on MRT-6160 and MRT-2359 clinical programs. IND filing for MRT-8102 in H1 2025. Company hosting conference call today at 8:00 a.m. ET. AI/ML-powered QuEEN™ discovery engine shows progress in expanding drug portfolio. AUCATZYL® (obecabtagene autoleucel) U.S. commercial launch on track with 33 treatment centers. Phase 1 trial for Systemic Lupus Erythematosus ongoing. R&D investor event on April 23 to discuss expansion plans. Monte Rosa enters $2.1 billion agreement with Novartis. Clinical results for MRT-2359 show signals of activity in various tumor types.

Monte Rosa updates clinical results for MRT-2359 in cancer patients. Study identifies recommended phase 2 dose. Lower-than-expected biomarker positivity rates halt further lung cancer and neuroendocrine tumor studies. Encouraging signals of clinical response in castration-resistant prostate cancer patients resistant to therapy. Safety profile remains favorable.

Monte Rosa completes GLP tox studies for MRT-8102 for inflammatory diseases. Study supports considerable safety margin. IND application for MRT-8102 planned for H1 2025. Phase 1 healthy volunteer study and proof-of-concept studies to follow. Preclinical data generated for second-generation NEK7-directed MGD for CNS diseases. AUCATZYL® (obecabtagene autoleucel) U.S. commercial launch is on track with 33 authorized treatment centers as of March 19, 2025, following FDA approval. Phase 1 trial dosed six patients in Systemic Lupus Erythematosus. IND submission expected in 2026. Monte Rosa advances cyclin E1 and CDK2-directed MGD programs for solid tumors, with plans to submit IND in 2026.

Monte Rosa is using its QuEEN™ discovery engine to develop oral MGDs targeting immunology and inflammation. Anticipated milestones include Phase 2 initiation for MRT-6160 and sharing Phase 1/2 data for MRT-2359 in H2 2025. IND applications planned for MRT-8102, NEK7-directed MGD, and CDK2/cyclin E1-directed MGD in 2026.

Fourth quarter 2024 financial results show collaboration revenue of $60.6 million. R&D expenses were $38.9 million, G&A expenses were $8.8 million. Net income for Q4 2024 was $13.4 million. Cash position as of December 31, 2024, was $377 million, expected to fund operations into 2028. Investor conference call scheduled for March 20, 2025, at 8:00 a.m. ET. AUCATZYL® (obecabtagene autoleucel) U.S. commercial launch progressing with 33 treatment centers as of March 19, 2025, after FDA approval on November 8, 2024. Obe-cel MHRA and EMA authorizations expected in H2 2025. Phase 1 trial dosed six patients for Systemic Lupus Erythematosus. Company to provide updates at R&D event on April 23rd.

MRT-2359 is an investigational molecular glue degrader targeting MYC-driven tumors by inducing GSPT1 protein degradation. MRT-6160 targets VAV1 for immune cell modulation in autoimmune diseases. Novartis has exclusive rights to develop MRT-6160. MRT-8102 targets NEK7 for inflammatory diseases like gout and cardiovascular disease. Monte Rosa Therapeutics focuses on MGD medicines for oncology and autoimmune diseases.

Monte Rosa Therapeutics develops MGD medicines using AI-guided chemistry to target protein degradation for serious diseases. The QuEEN discovery engine enables access to a wide range of degradable protein targets. Monte Rosa has a global license agreement with Novartis and a collaboration with Roche for MGDs against cancer and neurological diseases. Visit www.monterosatx.com for more information on their innovative approach. AUCATZYL® (obecabtagene autoleucel) U.S. commercial launch is on track with 33 authorized treatment centers as of March 19, 2025, after FDA approval on November 8, 2024. Obe-cel MHRA and EMA marketing authorizations expected in H2 2025. Phase 1 trial has dosed six patients for Systemic Lupus Erythematosus (SLE). Updates on clinical development program to be shared on April 23rd.

Conference call at 08:30 am EDT/12:30 pm GMT today for investors. Forward-looking statements include pipeline growth, completion of research, and development of drug candidates for various indications. Encouraging results from Phase 1 study of MRT-6160 for immune-mediated diseases. Updates on MRT-2359 development plans in CRPC. Advancement of CCNE1-directed MGD program and QuEENTM discovery engine. Expectations for data readouts in the second half of 2025 and beyond.IND submission to FDA for NEK7-directed MGD (MRT-8102) in H1 2025. Second-generation NEK7-directed MGD optimized for CNS penetration expected to submit IND in 2026. Development of CDK2 and cyclin E1-directed MGD programs ongoing. Financial position, collaboration relationships, and future development outlined. Risk factors highlighted in Annual Report on Form 10-K filed with the U.S. Securities and Exchange Commission. No guarantee of achieving anticipated results. Updates to be provided as required by applicable law. Data sourced from third-party studies, publications, and internal estimates.



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AUCATZYL® (obecabtagene autoleucel) U.S. commercial launch is on track with 33 authorized treatment centers as of March 19, 2025, post US FDA approval on November 8, 2024. Obe-cel MHRA and EMA marketing authorizations expected in H2 2025. Initial six patients dosed in Phase 1 trial for Systemic Lupus Erythematosus (SLE). Company to provide updates at R&D investor event on April 23rd.:: Monte Rosa Therapeutics Announces Fourth Quarter 2024