This section highlights FDA-related milestones and regulatory updates for drugs developed by Monte Rosa Therapeutics (GLUE).
Over the past two years, Monte Rosa Therapeutics has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as
MRT-2359, MRT-51443, MRT-6160, MRT-8102, and MRT-9643. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.
MRT-2359 - FDA Regulatory Timeline and Events
MRT-2359 is a drug developed by Monte Rosa Therapeutics for the following indication: MYC-driven solid tumors.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- MRT-2359
- Announced Date:
- March 20, 2025
- Indication:
- MYC-driven solid tumors
Announcement
Monte Rosa Therapeutics, Inc. Provides Corporate Update Including New Clinical Results from MRT-6160 and MRT-2359 Programs
AI Summary
Monte Rosa Therapeutics recently provided a corporate update highlighting promising new clinical results from its MRT-6160 and MRT-2359 programs. The Phase 1 study of MRT-6160 showed deep degradation of the target protein VAV1 by more than 90% and significant inhibition of T and B cell activity, including reduced inflammatory cytokine release. These findings, along with a favorable safety profile, support a clear progression into Phase 2 studies for treating immune-mediated diseases in collaboration with Novartis.
Data from the early Phase 1/2 study of MRT-2359 also showed encouraging clinical responses in castration-resistant prostate cancer patients resistant to AR therapy. A confirmed partial response and cases of stable disease have been observed, positioning CRPC as the primary focus for further development, with additional results expected later this year.
Read Announcement- Drug:
- MRT-2359
- Announced Date:
- December 5, 2024
- Indication:
- MYC-driven solid tumors
Announcement
Monte Rosa Therapeutics, Inc. today reported an update from its ongoing Phase 1/2 open-label, multicenter study of MRT-2359 in patients with MYC-driven solid tumors. MRT-2359 is an investigational, orally bioavailable, GSPT1-directed MGD discovered and developed by Monte Rosa Therapeutics.
AI Summary
Monte Rosa Therapeutics, Inc. announced new findings from its ongoing Phase 1/2 open-label, multicenter study of MRT-2359 in patients with MYC-driven solid tumors. MRT-2359 is an investigational, orally bioavailable, GSPT1-directed molecular glue degrader (MGD) discovered and developed by Monte Rosa Therapeutics.
The interim results showed that MRT-2359 has a favorable safety profile, achieving targeted levels of GSPT1 degradation without serious side effects such as hypotension or cytokine release syndrome. The study used a dosing schedule of 21 days on and 7 days off, with a recommended Phase 2 dose set at 0.5 mg daily. This dosing plan is seen as more patient-friendly and has allowed for more frequent dosing per cycle compared to earlier regimens. Additional biomarker and activity data is expected to be released in the first quarter of 2025.
Read Announcement- Drug:
- MRT-2359
- Announced Date:
- December 5, 2024
- Estimated Event Date Range:
- January 1, 2025 - March 31, 2025
- Target Action Date:
- Q1 - 2025
- Indication:
- MYC-driven solid tumors
Announcement
Monte Rosa Therapeutics, Inc. announced Additional MRT-2359 Phase 1/2 study clinical results, including biomarker and activity data, anticipated in Q1 2025
AI Summary
Monte Rosa Therapeutics announced positive interim results from its Phase 1/2 study of MRT-2359, a new oral drug for MYC-driven solid tumors. The trial used a 21 days on, 7 days off dosing schedule and showed that MRT-2359 can safely target and degrade the GSPT1 protein in heavily pretreated patients. Based on these findings, the company selected 0.5 mg daily as the recommended dose for Phase 2 studies.
The company also revealed that additional clinical results, including detailed biomarker and activity data, are expected in the first quarter of 2025. These upcoming data will help demonstrate the drug’s potential in effectively reducing tumor growth, and support further clinical development of MRT-2359 as a promising treatment option for solid tumors.
Read Announcement- Drug:
- MRT-2359
- Announced Date:
- June 27, 2024
- Indication:
- MYC-driven solid tumors
Announcement
Monte Rosa Therapeutics, Inc. announced progress updates for its two lead programs, MRT-2359, an MGD being developed for MYC-driven solid tumors
AI Summary
Monte Rosa Therapeutics, Inc. announced encouraging progress with its lead program, MRT-2359, currently in a Phase 1/2 study targeting MYC-driven solid tumors. The study has revealed that a 0.5 mg dose given on a 21-day-on/7-day-off schedule is well tolerated and shows favorable pharmacodynamic activity. Because the safety profile at 0.5 mg is promising, the company has initiated evaluation of a 0.75 mg dose using the same dosing schedule. Researchers believe that the 21/7 regimen, which permits twice as frequent dosing per cycle compared to the earlier 5 days on/9 days off regimen, may lead to a better treatment outcome. Monte Rosa expects to determine the definitive recommended Phase 2 dose and share updated clinical results in the second half of 2024.
Read Announcement
MRT-51443 - FDA Regulatory Timeline and Events
MRT-51443 is a drug developed by Monte Rosa Therapeutics for the following indication: HR-positive/HER2-negative breast cancer.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- MRT-51443
- Announced Date:
- April 28, 2025
- Indication:
- HR-positive/HER2-negative breast cancer
Announcement
Monte Rosa Therapeutics, announced the company will present preclinical data on the potential of its highly selective cyclin-dependent kinase 2 (CDK2)-directed molecular glue degrader, MRT-51443, to treat HR-positive/HER2-negative breast cancer at the American Association for Cancer Research (AACR) Annual Meeting 2025, being held April 25-30 in Chicago, IL.
AI Summary
Monte Rosa Therapeutics announced it will present exciting preclinical data at the AACR Annual Meeting 2025 in Chicago, IL (April 25-30). The company showcased the potential of its highly selective cyclin-dependent kinase 2 (CDK2) molecular glue degrader, MRT-51443, for treating HR-positive/HER2-negative breast cancer. In preclinical studies, combining MRT-51443 with CDK4/6 inhibitors and anti-estrogen therapy resulted in significantly deeper tumor regressions compared to standard treatments.
Researchers found that MRT-51443 not only enhanced tumor shrinkage but also delayed resistance to CDK4/6 inhibitors, a common challenge with current therapies. This approach may offer a safer, more effective alternative by avoiding toxicities linked with less selective CDK2 inhibitors. Monte Rosa’s findings suggest that MRT-51443 could improve outcomes for patients with this challenging form of breast cancer, setting the stage for further clinical development.
Read Announcement
MRT-6160 - FDA Regulatory Timeline and Events
MRT-6160 is a drug developed by Monte Rosa Therapeutics for the following indication: To treat multiple T-cell and/or Th17 mediated autoimmune and inflammatory diseases, including ulcerative colitis (UC).
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- MRT-6160
- Announced Date:
- March 20, 2025
- Indication:
- To treat multiple T-cell and/or Th17 mediated autoimmune and inflammatory diseases, including ulcerative colitis (UC).
Announcement
Monte Rosa Therapeutics reported a clinical update, business highlights
AI Summary
Monte Rosa Therapeutics recently provided a clinical update and business highlights for the fourth quarter of 2024. The company’s Phase 1 study of MRT-6160, a VAV1-directed molecular glue degrader, showed promising results with over 90% degradation of VAV1 in T and B cells. This significant effect led to marked inhibition of cytokine release and demonstrated a favorable safety profile, setting a clear path toward Phase 2 studies for treating immune-mediated diseases.
Additionally, early data from MRT-2359 in castration-resistant prostate cancer patients resistant to AR therapy showed encouraging signals, including one confirmed partial response. The company plans to focus on this CRPC cohort and expects more results in the second half of 2025. Monte Rosa is also preparing for an IND filing for MRT-8102 and maintains a strong cash position to fund operations into 2028.
Read Announcement- Drug:
- MRT-6160
- Announced Date:
- January 10, 2025
- Estimated Event Date Range:
- January 1, 2025 - March 31, 2025
- Target Action Date:
- Q1 - 2025
- Indication:
- To treat multiple T-cell and/or Th17 mediated autoimmune and inflammatory diseases, including ulcerative colitis (UC).
Announcement
Monte Rosa Therapeutics, Inc. announced that Initial clinical data from Phase 1 SAD/MAD study of VAV1-directed molecular glue degrader (MGD) MRT-6160 expected in Q1 2025
AI Summary
Monte Rosa Therapeutics, Inc. announced that it expects to share initial clinical data from its Phase 1 single and multiple ascending dose (SAD/MAD) study of MRT-6160 in Q1 2025. MRT-6160 is a VAV1-directed molecular glue degrader being developed for autoimmune diseases. The upcoming data readout will include important information on the drug’s safety, how the body processes it, and its ability to degrade the VAV1 protein, a key factor in immune cell function.
This milestone is part of the company's broader effort to advance new treatment options for immune-related conditions. The planned results from the study are critical for understanding the clinical potential of MRT-6160 and will help guide future development efforts. Monte Rosa’s progress in this clinical trial reflects its commitment to bringing innovative therapies to patients with hard-to-treat conditions.
Read Announcement- Drug:
- MRT-6160
- Announced Date:
- January 10, 2025
- Estimated Event Date Range:
- January 1, 2025 - March 31, 2025
- Target Action Date:
- Q1 - 2025
- Indication:
- To treat multiple T-cell and/or Th17 mediated autoimmune and inflammatory diseases, including ulcerative colitis (UC).
Announcement
Monte Rosa Therapeutics, Inc. announced that Additional clinical results from Phase 1/2 study of MRT-2359 in MYC-driven solid tumors, including biomarker and activity data, anticipated in Q1 2025
AI Summary
Monte Rosa Therapeutics, Inc. announced that additional clinical results from its Phase 1/2 study of MRT-2359 in MYC-driven solid tumors are expected in the first quarter of 2025. The upcoming data will include both biomarker information and activity data from the trial. MRT-2359, an investigational molecular glue degrader, is designed to target GSPT1, a protein linked to uncontrolled cell growth in cancers driven by MYC genes. These results will help determine the safety and effectiveness of the drug in patients with hard-to-treat solid tumors. The data readout is seen as a critical milestone for the company, providing further insights into the therapeutic potential of MRT-2359. This development is part of the company’s ongoing efforts to advance innovative treatments, with the early 2025 timeline marking an important step in understanding the drug’s performance in clinical settings.Read Announcement
- Drug:
- MRT-6160
- Announced Date:
- January 10, 2025
- Indication:
- To treat multiple T-cell and/or Th17 mediated autoimmune and inflammatory diseases, including ulcerative colitis (UC).
Announcement
Monte Rosa Therapeutics, Inc today outlined anticipated 2025 milestones ahead of its participation in the 43rd Annual J.P. Morgan Healthcare Conference.
AI Summary
Monte Rosa Therapeutics, Inc. has announced key 2025 milestones ahead of its participation in the 43rd Annual J.P. Morgan Healthcare Conference. The company plans to share initial clinical data from its Phase 1 SAD/MAD study of MRT-6160, a VAV1-directed molecular glue degrader targeting autoimmune diseases. This data, expected in Q1 2025, will include details on safety, pharmacokinetics, VAV1 protein degradation, and important pharmacodynamic markers. Additionally, Monte Rosa plans to update data from its Phase 1/2 trial of MRT-2359 in MYC-driven solid tumors and submit an IND for MRT-8102 later in the year.
These milestones demonstrate the company’s strong position and progress as it advances its novel pipeline of molecular glue degraders. They also underline Monte Rosa’s commitment to moving forward with clinical development while leveraging its industry-leading QuEEN™ discovery engine in various areas, including immunology and inflammatory diseases.
Read Announcement- Drug:
- MRT-6160
- Announced Date:
- August 19, 2024
- Indication:
- To treat multiple T-cell and/or Th17 mediated autoimmune and inflammatory diseases, including ulcerative colitis (UC).
Announcement
Monte Rosa Therapeutics, Inc announced that the first participants have been dosed in a Phase 1, single ascending dose / multiple ascending dose (SAD/MAD), healthy volunteer study evaluating MRT-6160, a VAV1-directed MGD being developed for systemic and neurological autoimmune diseases.
AI Summary
Monte Rosa Therapeutics, Inc. announced that the first participants have been dosed in a Phase 1 clinical study evaluating MRT-6160, a potent and selective VAV1-directed molecular glue degrader (MGD). This study uses a single ascending dose and multiple ascending dose design in healthy volunteers. MRT-6160 is being developed for systemic and neurological autoimmune diseases, and represents a novel approach, as it is the first rationally designed MGD in clinical development outside of oncology.
The study will examine safety, pharmacokinetics, target protein degradation, and pharmacodynamic markers such as CD69, IL-2, IL-6, and IL-17. The initial data, including biomarker results that indicate pharmacodynamic effects, are expected in the first quarter of 2025. This clinical trial aims to provide further insights into a new treatment that could offer benefits for various autoimmune and inflammatory conditions.
Read Announcement- Drug:
- MRT-6160
- Announced Date:
- August 19, 2024
- Estimated Event Date Range:
- January 1, 2025 - March 31, 2025
- Target Action Date:
- Q1 - 2025
- Indication:
- To treat multiple T-cell and/or Th17 mediated autoimmune and inflammatory diseases, including ulcerative colitis (UC).
Announcement
Monte Rosa Therapeutics, Inc The Company expects to obtain initial data from the Phase 1 study in Q1 2025..
AI Summary
Monte Rosa Therapeutics, Inc. has started dosing the first participants in its Phase 1 clinical trial for MRT‑6160, a VAV1-directed molecular glue degrader. This novel drug is being developed to treat systemic and neurological autoimmune and inflammatory diseases by targeting VAV1—a key protein involved in T- and B-cell receptor activity. The trial is structured as a single and multiple ascending dose study in healthy volunteers, focusing on safety, pharmacokinetics, pharmacodynamic effects, and protein degradation.
The company expects to obtain initial clinical data in Q1 2025. These early insights will help guide further clinical strategies and inform upcoming proof-of-concept studies in conditions such as ulcerative colitis and rheumatoid arthritis. Monte Rosa Therapeutics aims to offer a differentiated treatment approach by addressing targets that have been challenging with conventional therapies.
Read Announcement- Drug:
- MRT-6160
- Announced Date:
- June 27, 2024
- Indication:
- To treat multiple T-cell and/or Th17 mediated autoimmune and inflammatory diseases, including ulcerative colitis (UC).
Announcement
Monte Rosa Therapeutics, Inc. announced that MRT-6160, a VAV1-directed MGD in development for systemic and neurological autoimmune diseases.
AI Summary
Monte Rosa Therapeutics, Inc. announced a major milestone in its development of MRT-6160, a VAV1-directed molecular glue degrader (MGD) aimed at treating systemic and neurological autoimmune diseases. The company has submitted an Investigational New Drug (IND) application to the U.S. Food and Drug Administration (FDA) for this novel treatment. MRT-6160 is designed to selectively degrade the VAV1 protein, which is involved in key immune cell processes. Preclinical studies have shown that MRT-6160 can reduce the activity of cells that cause autoimmune reactions, with promising results seen in models of diseases like inflammatory bowel disease, rheumatoid arthritis, and multiple sclerosis. Monte Rosa expects to start a Phase 1 single ascending dose/multiple ascending dose (SAD/MAD) study this summer, with initial clinical data projected for release in the first quarter of 2025.
Read Announcement- Drug:
- MRT-6160
- Announced Date:
- June 27, 2024
- Estimated Event Date Range:
- January 1, 2025 - March 31, 2025
- Target Action Date:
- Q1 - 2025
- Indication:
- To treat multiple T-cell and/or Th17 mediated autoimmune and inflammatory diseases, including ulcerative colitis (UC).
Announcement
Monte Rosa Therapeutics, Inc announced that initiation of Phase 1 SAD/MAD study expected this summer with Phase 1 clinical data anticipated in Q1 2025
AI Summary
Monte Rosa Therapeutics, Inc. announced a significant step forward for its MRT-6160 program by submitting an Investigational New Drug (IND) application to the FDA. MRT-6160 is a VAV1-directed molecular glue degrader aimed at treating systemic and neurological autoimmune diseases. The company plans to begin a Phase 1 single ascending dose/multiple ascending dose (SAD/MAD) study later this summer. Initial clinical data from this study is expected in the first quarter of 2025. This early-stage trial will help evaluate the safety and optimal dosing of MRT-6160 in humans. The results will be critical in determining the future direction of this therapeutic candidate and its potential role in addressing disorders such as inflammatory bowel disease, rheumatoid arthritis, and possibly other autoimmune and neurological conditions.
Read Announcement- Drug:
- MRT-6160
- Announced Date:
- June 14, 2024
- Estimated Event Date Range:
- January 1, 2024 - June 30, 2024
- Target Action Date:
- 2024-H1
- Indication:
- To treat multiple T-cell and/or Th17 mediated autoimmune and inflammatory diseases, including ulcerative colitis (UC).
Announcement
Monte Rosa Therapeutics, announced that Initiation of MRT-6160 Phase 1 SAD/MAD study anticipated in mid-year 2024
AI Summary
Monte Rosa Therapeutics announced that it plans to start a Phase 1 SAD/MAD study of MRT-6160, a VAV1-directed molecular glue degrader, in mid-2024. The study aims to evaluate the safety and clinical profile of MRT-6160, following promising preclinical results from a collagen-induced arthritis mouse model. In these preclinical studies, oral dosing of MRT-6160 significantly reduced disease progression, inflammatory markers, and autoantibody production. The company expects to share initial clinical data from the trial in the first quarter of 2025, marking an important step forward in testing a potential new treatment for rheumatoid arthritis and other autoimmune conditions.
This clinical trial is an important milestone for Monte Rosa Therapeutics as it moves its candidate from preclinical success toward clinical validation, supporting the hypothesis that targeting VAV1 could provide a new therapeutic strategy for patients with autoimmune and inflammatory diseases.
Read Announcement- Drug:
- MRT-6160
- Announced Date:
- June 14, 2024
- Estimated Event Date Range:
- January 1, 2025 - March 31, 2025
- Target Action Date:
- Q1 - 2025
- Indication:
- To treat multiple T-cell and/or Th17 mediated autoimmune and inflammatory diseases, including ulcerative colitis (UC).
Announcement
Monte Rosa Therapeutics, announced that initial clinical data expected in Q1 2025
AI Summary
Monte Rosa Therapeutics is moving ahead with its clinical program for MRT-6160, a new drug that targets the VAV1 protein. The company announced that MRT-6160, a molecular glue degrader, showed promising results in preclinical studies using a rheumatoid arthritis model. In these studies, the drug reduced inflammation, lowered pro-inflammatory cytokine levels, and decreased autoantibody production.
Monte Rosa plans to begin a Phase 1 study featuring single and multiple ascending doses in mid-2024. Importantly, the company expects to share the first set of clinical data from this study by the first quarter of 2025. These early clinical results will help assess the safety and potential effectiveness of MRT-6160 in treating autoimmune conditions, including rheumatoid arthritis. Monte Rosa’s work represents a hopeful step forward in addressing diseases that currently have limited treatment options.
Read Announcement- Drug:
- MRT-6160
- Announced Date:
- June 14, 2024
- Indication:
- To treat multiple T-cell and/or Th17 mediated autoimmune and inflammatory diseases, including ulcerative colitis (UC).
Announcement
Monte Rosa Therapeutics, announced the company will present preclinical data at the European Alliance of Associations for Rheumatology (EULAR) 2024 Congress, being held June 12-15 in Vienna, Austria.
AI Summary
Monte Rosa Therapeutics will share preclinical data at the upcoming European Alliance of Associations for Rheumatology (EULAR) 2024 Congress in Vienna, Austria, from June 12-15. The company’s presentation will focus on data from their study using MRT-6160, a VAV1-directed molecular glue degrader. In a collagen-induced arthritis murine model, MRT-6160 showed promising results by inhibiting disease progression, reducing pro-inflammatory cytokine levels, and lowering autoantibody production compared to controls and standard anti-TNF treatment. The data also demonstrated a dose-dependent reduction in T-cell and B-cell activation, highlighting the compound's potential to moderate immune responses by targeting VAV1, a key regulator of immune cell activity. This evidence supports Monte Rosa's hypothesis that targeting VAV1 could offer new therapeutic opportunities for patients with rheumatoid arthritis and other inflammatory autoimmune diseases.
Read Announcement- Drug:
- MRT-6160
- Announced Date:
- May 21, 2024
- Indication:
- To treat multiple T-cell and/or Th17 mediated autoimmune and inflammatory diseases, including ulcerative colitis (UC).
Announcement
Monte Rosa Therapeutics, announced the company will present preclinical data at Digestive Disease Week (DDW) 2024, being held May 18-21 in Washington, D.C. The data showed that MRT-6160-mediated degradation of VAV1 inhibited disease progression in a T-cell transfer murine model of colitis. VAV1 is a key signaling protein downstream of both the T-and B-cell receptors and its degradation has potential to treat multiple T-cell and/or Th17 mediated autoimmune and inflammatory diseases, including ulcerative colitis (UC).
AI Summary
Monte Rosa Therapeutics announced it will present preclinical data at Digestive Disease Week (DDW) 2024 in Washington, D.C. from May 18-21. The data showed that MRT-6160, a VAV1-directed molecular glue degrader, significantly inhibited disease progression in a T-cell transfer murine model of colitis. By mediating the degradation of VAV1—a key signaling protein downstream of both T- and B-cell receptors—MRT-6160 reduced colon inflammation, lowered inflammatory cytokines, and decreased the expression of several IBD-associated genes.
This approach has the potential to treat multiple autoimmune and inflammatory diseases, including ulcerative colitis, by targeting both T-cell and Th17 mediated responses. The promising preclinical results support further clinical development, with plans for an IND submission and Phase 1 studies expected mid-year 2024, and clinical data anticipated in Q1 2025.
Read Announcement - Drug:
- MRT-6160
- Announced Date:
- May 21, 2024
- Estimated Event Date Range:
- January 1, 2025 - March 31, 2025
- Target Action Date:
- Q1 - 2025
- Indication:
- To treat multiple T-cell and/or Th17 mediated autoimmune and inflammatory diseases, including ulcerative colitis (UC).
Announcement
Monte Rosa Therapeutics announced that hase 1 clinical data expected in Q1 2025
AI Summary
Monte Rosa Therapeutics, a clinical-stage biotech company, announced promising preclinical results for MRT-6160, a novel VAV1-directed molecular glue degrader. The compound has shown effectiveness in reducing inflammatory markers and disease progression in a colitis model, highlighting its potential to treat autoimmune and inflammatory conditions like ulcerative colitis.
Looking ahead, the company plans to initiate a Phase 1 single and multiple ascending dose study in mid-2024. Importantly, Monte Rosa anticipates sharing Phase 1 clinical data in Q1 2025. These upcoming clinical results are expected to provide valuable insights into MRT-6160’s safety and initial effectiveness, marking a significant step forward in developing new treatments for autoimmune and inflammatory diseases.
Read Announcement- Drug:
- MRT-6160
- Announced Date:
- May 21, 2024
- Estimated Event Date Range:
- January 1, 2024 - June 30, 2024
- Target Action Date:
- 2024-H1
- Indication:
- To treat multiple T-cell and/or Th17 mediated autoimmune and inflammatory diseases, including ulcerative colitis (UC).
Announcement
Monte Rosa Therapeutics, Initiation of MRT-6160 Phase 1 SAD/MAD study anticipated in mid-year 2024
AI Summary
Monte Rosa Therapeutics has announced plans to initiate a Phase 1 clinical study of its experimental compound, MRT-6160, by mid-year 2024. This study will use single ascending dose (SAD) and multiple ascending dose (MAD) approaches to assess safety, tolerability, and early signs of clinical benefit. Preclinical studies have shown that MRT-6160—a VAV1-directed molecular glue degrader—significantly inhibits colitis progression in a murine model, reducing colon inflammation and lowering levels of key inflammatory cytokines. These promising results support the hypothesis that targeting the VAV1 protein may offer a new treatment strategy for inflammatory bowel disease and other autoimmune conditions. Monte Rosa Therapeutics is on track for an IND submission this quarter, with clinical data from the MRT-6160 study expected to be released in early 2025.
Read Announcement
MRT-8102 - FDA Regulatory Timeline and Events
MRT-8102 is a drug developed by Monte Rosa Therapeutics for the following indication: For the treatment of inflammatory diseases.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- MRT-8102
- Announced Date:
- June 10, 2025
- Estimated Event Date Range:
- January 1, 2026 - June 30, 2026
- Target Action Date:
- 2026-H1
- Indication:
- For the treatment of inflammatory diseases
Announcement
Monte Rosa Therapeutics, Inc. announced that MRT-8102 Phase 1 clinical results, including data on safety, pharmacokinetics, NEK7 protein degradation, and key downstream pharmacodynamic markers, expected in H1 2026
AI Summary
Monte Rosa Therapeutics, Inc. announced that it is moving forward with a Phase 1 clinical study for MRT-8102, a highly selective NEK7-directed molecular glue degrader. The company expects to share key results in the first half of 2026. This study will provide important information about the drug’s safety, how it is processed in the body (pharmacokinetics), its ability to degrade the NEK7 protein, and its effects on key downstream pharmacodynamic markers.
The upcoming study aims to show whether MRT-8102 can offer a distinct clinical profile for treating inflammatory conditions, especially those linked to NLRP3, IL-1β, and IL-6 dysregulation. By collecting this data, Monte Rosa hopes to support the development of innovative therapies for patients suffering from a range of inflammatory diseases.
Read Announcement- Drug:
- MRT-8102
- Announced Date:
- June 10, 2025
- Indication:
- For the treatment of inflammatory diseases
Announcement
Monte Rosa Therapeutics, Inc. announced U.S. Food and Drug Administration (FDA) clearance of an Investigational New Drug (IND) application for MRT-8102, a NEK7-directed MGD being developed for the treatment of inflammatory diseases driven by the NLRP3 inflammasome and IL-1β.
AI Summary
Monte Rosa Therapeutics announced that the FDA has cleared its IND application for MRT-8102, a new investigational drug. MRT-8102 is a molecular glue degrader that targets NEK7, a protein involved in triggering inflammation through the NLRP3 inflammasome and IL-1β. Preclinical studies have shown that this selective drug can potently reduce inflammatory markers and has a long-lasting effect, suggesting it may offer advantages over current treatments. The company plans to initiate a Phase 1 clinical trial in the coming weeks to evaluate the drug’s safety, pharmacokinetics, and its ability to degrade the NEK7 protein, with early clinical results expected in the first half of 2026. This development is a key milestone in Monte Rosa’s goal to expand its immunology and inflammatory disease portfolio and to provide new treatment options for numerous inflammatory conditions.
Read Announcement- Drug:
- MRT-8102
- Announced Date:
- January 10, 2025
- Estimated Event Date Range:
- January 1, 2025 - June 30, 2025
- Target Action Date:
- 2025-H1
- Indication:
- For the treatment of inflammatory diseases
Announcement
Monte Rosa Therapeutics, Inc. announced that MRT-8102, a NEK7-directed MGD targeting diseases driven by IL-1β and the NLRP3 inflammasome, on track for IND filing in H1 2025
AI Summary
Monte Rosa Therapeutics, Inc. announced that its development candidate MRT-8102 is on track for an IND filing in the first half of 2025. MRT-8102 is a NEK7-directed molecular glue degrader designed to treat inflammatory diseases driven by IL-1β and the NLRP3 inflammasome. Preclinical data have shown that this approach can powerfully and selectively degrade NEK7, which plays a key role in activating the inflammasome and releasing IL-1β, a major contributor to inflammation.
This IND filing is an important milestone for the company as it works to bring innovative therapies to patients with central and peripheral inflammatory disorders. With this step, Monte Rosa continues to expand its pipeline of novel treatments, reinforcing its commitment to developing groundbreaking medicines for conditions that currently have limited treatment options.
Read Announcement
MRT-9643 - FDA Regulatory Timeline and Events
MRT-9643 is a drug developed by Monte Rosa Therapeutics for the following indication: To Treat HR-positive/HER2-negative Breast Cancer.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- MRT-9643
- Announced Date:
- December 11, 2024
- Indication:
- To Treat HR-positive/HER2-negative Breast Cancer
Announcement
Monte Rosa Therapeutics, announced the company will present preclinical data on the potential of its highly selective cyclin-dependent kinase 2 (CDK2)-directed molecular glue degrader to treat HR-positive/HER2-negative breast cancer at the 2024 San Antonio Breast Cancer Symposium, held December 10-13 in San Antonio, Texas.
AI Summary
Monte Rosa Therapeutics will present new preclinical data at the 2024 San Antonio Breast Cancer Symposium in Texas. The data focuses on MRT-9643, its highly selective cyclin-dependent kinase 2 (CDK2)-directed molecular glue degrader. In preclinical models, MRT-9643 showed strong CDK2 degradation and robust downstream pathway suppression when used in combination with a CDK4/6 inhibitor, with or without additional endocrine therapy. These results suggest that combining MRT-9643 with standard therapies could drive deep tumor regression in HR-positive/HER2-negative breast cancer. The findings are promising because they indicate a potential to provide more sustained responses for patients while avoiding toxicities often seen with less selective CDK2 inhibitors. This innovative approach may help overcome resistance seen with current CDK4/6 inhibitor treatments in a challenging patient population.
Read Announcement
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