Monte Rosa Therapeutics Announces Milestone Achievement Associated with Second Phase 2 Clinical Study Initiation for VAV1-directed Molecular Glue Degrader MRT-6160 (DDY391)

Novartis funds Phase 2 studies, while Monte Rosa will co-fund any Phase 3 development and share U.S. profits and losses.

Rhea-AI Summary

Monte Rosa Therapeutics (GLUE) will receive a $37.5 million milestone payment following Novartis’s initiation of a second Phase 2 study of MRT-6160. The payment is tied to the first patient visit in the trial involving participants with active moderate to severe psoriatic arthritis. The Phase 2a/b study will evaluate efficacy, safety, tolerability and dose response. It follows a Sjögren’s disease trial initiated in August.

Under their exclusive worldwide license agreement, Novartis conducts and funds Phase 2 development. Monte Rosa remains eligible for additional Phase 2 initiation milestones under an agreement providing up to $2.1 billion in development, regulatory and sales milestones. Monte Rosa will co-fund any Phase 3 development and share 30% of U.S. manufacturing and commercialization profits and losses, with eligibility for tiered royalties on ex-U.S. net sales.

8 points · 0 major

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0 major · 2 points

Hollow bars mark forward-looking points. How the balance works

Positive

• Moderate pointThe second Phase 2 study triggers a $37.5 million milestone payment tied to the first patient visit. 4.1% of market cap
• Moderate point. Forward-looking: it has not happened yet and may not happen.Additional Phase 2 initiation milestones remain available within up to $2.1 billion in development, regulatory and sales milestones. 2.3× market cap
• Minor pointPsoriatic arthritis Phase 2a/b study initiated, following the Sjögren’s disease Phase 2 trial initiated in August.
• Minor pointNovartis funds and conducts Phase 2 studies under the exclusive worldwide license agreement.
• Minor point. Forward-looking: it has not happened yet and may not happen.Monte Rosa’s commercial participation includes 30% of U.S. profits and eligibility for tiered royalties on ex-U.S. net sales.

3 minor points

• Minor pointPhase 1 showed sustained, dose-dependent greater than 90% VAV1 degradation in peripheral blood T cells after single- and multiple-dose administration.
• Minor pointPhase 1 also showed suppression of inflammatory biomarkers.
• Minor pointPhase 1 administration was generally well tolerated, with no serious adverse effects observed.

Negative

• Moderate point. Forward-looking: it has not happened yet and may not happen.Monte Rosa will co-fund any Phase 3 clinical development.
• Moderate point. Forward-looking: it has not happened yet and may not happen.Monte Rosa will share 30% of U.S. manufacturing and commercialization losses.

Key Figures

Milestone payment: $37.5 million Potential milestones: Up to $2.1 billion U.S. profit and loss share: 30% +1 more

Milestone payment

$37.5 million

Payable to Monte Rosa in connection with the first patient visit

Potential milestones

Up to $2.1 billion

Development, regulatory, and sales milestones under the Novartis agreement

U.S. profit and loss share

30%

Monte Rosa share for MRT-6160 U.S. manufacturing and commercialization

VAV1 degradation

Greater than 90%

Phase 1 study; peripheral blood T cells after single- and multiple-dose administration

Previous Clinical trial Reports

1 past event · Latest: Sep 08

Same Type 1 event

1. Sep 08

   Phase 2 milestone

   24h Move

   +3.1%

   Novartis initiated the first MRT-6160 Phase 2 study in Sjögren’s disease, triggering a $50 million milestone.

24h Move is the share-price change in the day after each event; other market factors may also have contributed.

Key Terms

molecular glue degrader, double-blind, placebo-controlled, dose-response relationship, +1 more

5 terms

molecular glue degrader technical

"a VAV1-directed MGD MRT-6160 (DDY391)"

A molecular glue degrader is a small drug-like molecule that acts like a tiny adhesive, sticking a specific disease-related protein to the cell’s natural disposal machinery so the protein is destroyed rather than merely blocked. Investors watch these compounds because they can turn previously untreatable targets into removable liabilities, potentially creating breakthrough therapies, shifting development risk, and offering strong commercial upside if clinical results and regulatory approval follow.

double-blind medical

"a Phase 2a/b, randomized, double-blind, placebo-controlled, multicenter trial"

A double-blind process means that neither the people conducting an activity nor the people involved know certain key details, such as who is receiving a treatment or a placebo. This approach helps prevent bias from influencing the results, making the outcome more trustworthy. For investors, it ensures that decisions or judgments are based on unbiased information rather than preconceived opinions or expectations.

placebo-controlled medical

"randomized, double-blind, placebo-controlled, multicenter trial"

"Placebo-controlled" describes a testing method where one group receives the actual treatment or intervention, while another group receives a harmless, inactive version called a placebo. This approach helps determine whether the real treatment has genuine effects beyond psychological expectations. For investors, understanding this ensures confidence that reported benefits are real and not influenced by bias or false perceptions.

dose-response relationship medical

"evaluate the efficacy, safety, tolerability, and dose-response relationship"

A dose-response relationship describes how the size of a drug or treatment dose affects the magnitude and type of response in patients, including both desired effects and side effects — like how turning up a faucet increases water flow but can also cause overflow. It matters to investors because the shape of that relationship influences safe and effective dosing, clinical trial success, regulatory approval, labeling, and the commercial potential and risk profile of a therapy.

tiered royalties financial

"eligible for tiered royalties on ex-U.S. net sales"

Tiered royalties are a payment structure where the percentage of earnings paid as royalties changes based on different levels of sales or production. For example, a company might pay a smaller percentage on initial sales and a higher percentage as sales increase beyond certain points. This system encourages higher sales by adjusting payments, making it important for investors to understand how revenue sharing may vary as a product or project grows.

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Phase 2 study to be conducted in participants with active moderate to severe psoriatic arthritis

Novartis conducting study under global exclusive development and commercialization license agreement with Monte Rosa

Monte Rosa to receive milestone payment based on first patient visit of Phase 2 clinical study

This is the second of multiple studies planned to evaluate MRT-6160 (DDY391) across immune-mediated diseases; Monte Rosa eligible for additional Phase 2 study initiation milestones

BOSTON, Oct. 28, 2026 (GLOBE NEWSWIRE) -- Monte Rosa Therapeutics, Inc. (Nasdaq: GLUE), a clinical-stage biotechnology company developing novel molecular glue degrader (MGD)-based medicines, today announced that its collaborator Novartis has initiated a second Phase 2 clinical study for the VAV1-directed MGD MRT-6160 (DDY391) in people living with active moderate to severe psoriatic arthritis (PsA). The study follows the Phase 2 trial in Sjögren's disease initiated in August and is part of a global exclusive development and commercialization license agreement between Monte Rosa and Novartis to advance VAV1 MGDs, including MRT-6160 (DDY391). In connection with the first patient visit of the study, Monte Rosa will receive a $37.5 million milestone payment from Novartis.

“This Phase 2 study will assess MRT-6160 in participants with active moderate to severe psoriatic arthritis, a disease with significant unmet need and where there is a strong biologic rationale for targeting with a VAV1-directed MGD,” said Markus Warmuth, M.D., Chief Executive Officer of Monte Rosa Therapeutics. “This development milestone demonstrates the strong momentum behind our collaboration with Novartis, and we are pleased to continue to work closely with them as they advance development of MRT-6160.”

This study is a Phase 2a/b, randomized, double-blind, placebo-controlled, multicenter trial designed to evaluate the efficacy, safety, tolerability, and dose-response relationship of MRT-6160 (DDY391) in participants with active moderate to severe PsA. More information about the study, "A Randomized, Double-blind, Placebo-controlled, Multicenter Phase 2a/b Study Assessing the Efficacy, Safety and Tolerability of DDY391 in Participants With Active Moderate to Severe Psoriatic Arthritis," can be found at ClinicalTrials.gov, study identifier: NCT07801495.

MRT-6160 (DDY391) is a potent, highly selective, and orally bioavailable investigational molecular glue degrader of VAV1, a key signaling protein downstream of both the T- and B-cell receptors. Available preclinical and clinical data support the potential of MRT-6160 (DDY391) to address multiple immune-mediated diseases. In a Phase 1 study, MRT-6160 (DDY391) demonstrated sustained, dose-dependent VAV1 degradation of greater than 90% in peripheral blood T cells after single- and multiple-dose administration, as well as suppression of key inflammatory biomarkers. The administration of MRT-6160 (DDY391) was generally well tolerated, with no serious adverse effects observed.

About Psoriatic Arthritis

Psoriatic arthritis is a chronic, progressive inflammatory disease that affects approximately 0.1% to 0.2% of the general population or up to 50 million people worldwide¹. It is part of a family of lifelong inflammatory diseases (spondyloarthritis) that target the joints and is closely associated with psoriasis². Up to 40% of patients with psoriasis may develop PsA². Symptoms of PsA include joint pain and stiffness, skin and nail psoriasis, swollen toes and fingers, persistent painful swelling of the tendons, and irreversible joint damage².

Novartis Agreement Details

Monte Rosa has a global exclusive development and commercialization license agreement with Novartis to advance VAV1-directed MGDs, including MRT-6160. Under the terms of the agreement, Novartis has exclusive worldwide rights to develop, manufacture and commercialize MRT-6160 and other VAV1 MGDs and is responsible for all clinical development and commercialization, starting with Phase 2 clinical studies. Monte Rosa is eligible to receive up to $2.1 billion in development, regulatory, and sales milestones, beginning upon initiation of Phase 2 studies. Novartis is responsible for conducting and funding Phase 2 studies. Monte Rosa will co-fund any Phase 3 clinical development and will share 30% of any profits and losses associated with the manufacturing and commercialization of MRT-6160 in the U.S., and is also eligible for tiered royalties on ex-U.S. net sales.

About Monte Rosa

Monte Rosa Therapeutics is a clinical-stage biotechnology company developing highly selective molecular glue degrader (MGD) medicines for patients living with serious diseases. MGDs are small molecule protein degraders that have the potential to treat many diseases that other modalities, including other degraders, cannot. Monte Rosa’s QuEEN™ (Quantitative and Engineered Elimination of Neosubstrates) discovery engine combines AI-guided chemistry, diverse chemical libraries, structural biology, and proteomics to rationally design MGDs with unprecedented selectivity. Monte Rosa has developed the industry’s leading pipeline of first-in-class and only-in-class MGDs, spanning autoimmune and inflammatory diseases, oncology, and beyond, with three programs in the clinic. Monte Rosa has ongoing collaborations with leading pharmaceutical companies in the areas of immunology, oncology, and neurology. For more information, visit www.monterosatx.com. 

References

1. National Psoriasis Foundation. Psoriasis statistics. Available from: https://www.psoriasis.org/content/statistics.
2. Mease PJ, Armstrong AW. Managing patients with psoriatic disease: the diagnosis and pharmacologic treatment of psoriatic arthritis in patients with psoriasis. Drugs. 2014;74(4):423-441

Forward-Looking Statements

This communication includes express and implied “forward-looking statements,” including forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements include all statements that are not historical facts and in some cases, can be identified by terms such as “may,” “might,” “will,” “could,” “would,” “should,” “expect,” “intend,” “plan,” “objective,” “anticipate,” “believe,” “estimate,” “predict,” “potential,” “continue,” “ongoing,” or the negative of these terms, or other comparable terminology intended to identify statements about the future. Forward-looking statements contained herein include, but are not limited to, statements about the ongoing development of our VAV1-directed MGD, referred to as DDY391 (formerly designated MRT-6160), including the Phase 2 clinical study in participants with active moderate to severe psoriatic arthritis being conducted by Novartis, our expectations regarding the potential of DDY391 to address multiple immune-mediated diseases, statements regarding additional Phase 2 studies planned or expected to evaluate DDY391 across immune-mediated diseases and associated milestone payments, statements about Monte Rosa’s eligibility to receive milestone payments from Novartis, statements regarding the global exclusive development and commercialization license agreement with Novartis, statements regarding the continued momentum and progress of our collaboration with Novartis and our continued work with Novartis to advance the development of MRT-6160, statements around the advancement and application of our pipeline, including our partnered and wholly owned programs, our ability to optimize collaborations with industry partners on our development programs, and our expectations of success for our programs and the strength of our financial position, among others. By their nature, these statements are subject to numerous risks and uncertainties, including those risks and uncertainties set forth in our most recent Annual Report on Form 10-K for the year ended December 31, 2025, filed with the U.S. Securities and Exchange Commission on March 17, 2026, and any subsequent filings, that could cause actual results, performance or achievement to differ materially and adversely from those anticipated or implied in the statements. You should not rely upon forward-looking statements as predictions of future events. Although our management believes that the expectations reflected in our statements are reasonable, we cannot guarantee that the future results, performance, or events and circumstances described in the forward-looking statements will be achieved or occur. Recipients are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date such statements are made and should not be construed as statements of fact. We undertake no obligation to publicly update any forward-looking statements, whether as a result of new information, any future presentations, or otherwise, except as required by applicable law. Certain information contained in these materials and any statements made orally during any presentation of these materials that relate to the materials or are based on studies, publications, surveys and other data obtained from third-party sources and our own internal estimates and research. While we believe these third-party studies, publications, surveys and other data to be reliable as of the date of these materials, we have not independently verified, and make no representations as to the adequacy, fairness, accuracy or completeness of, any information obtained from third-party sources. In addition, no independent source has evaluated the reasonableness or accuracy of our internal estimates or research and no reliance should be made on any information or statements made in these materials relating to or based on such internal estimates and research.

Investors
Andrew Funderburk
ir@monterosatx.com

Media
Cory Tromblee, Scient PR
media@monterosatx.com

FAQ

AI-generated questions and answers. How Rhea-AI works. Not financial advice.

How much will Monte Rosa receive for the MRT-6160 psoriatic arthritis trial milestone?

Monte Rosa will receive $37.5 million from Novartis in connection with the first patient visit in the Phase 2 psoriatic arthritis study. This is the second Phase 2 study of MRT-6160, also called DDY391.

How is Monte Rosa’s MRT-6160 psoriatic arthritis study designed?

The study is a randomized, double-blind, placebo-controlled, multicenter Phase 2a/b trial. It evaluates efficacy, safety, tolerability and dose response in participants with active moderate to severe psoriatic arthritis. Its ClinicalTrials.gov identifier is NCT07801495.

What did Monte Rosa’s MRT-6160 Phase 1 study show?

MRT-6160 demonstrated sustained, dose-dependent greater than 90% VAV1 degradation in peripheral blood T cells after single- and multiple-dose administration. The study also showed suppression of inflammatory biomarkers. Administration was generally well tolerated, with no serious adverse effects observed.