Monte Rosa to receive $50 million as Novartis starts Sjögren’s Phase 2 study

Monte Rosa Therapeutics, Inc. (Nasdaq: GLUE) announced on September 8, 2026, that collaborator Novartis initiated a Phase 2 study of VAV1-directed molecular glue degrader MRT-6160 (DDY391) in participants with Sjögren’s disease. Its Form 8-K, accession 0001193125-26-384360, covers Items 7.01, 8.01 and 9.01; Item 8.01 confirms that Monte Rosa will receive a $50 million milestone payment in connection with the study’s first patient visit.

A clinical step with a payment attached

Novartis is conducting the study under its global exclusive development and commercialization license with Monte Rosa. The first patient visit carries a concrete financial consequence: Monte Rosa will receive $50 million from its partner. The disclosure describes a payment to come, without establishing that the cash has already been received.

Novartis holds exclusive worldwide rights to develop, manufacture and commercialize MRT-6160 and other VAV1 molecular glue degraders. It is responsible for all clinical development and commercialization starting with Phase 2, placing execution of this study with the license holder.

What the trial is designed to test

The Phase 2a/b study is randomized, double-blind, placebo-controlled and multi-center. It will evaluate efficacy, safety and tolerability over up to fifty-two weeks of treatment in participants with Sjögren’s disease and is intended to support dose selection for Phase 3. The company identifies the study as ClinicalTrials.gov NCT07737743.

Monte Rosa describes MRT-6160, also called DDY391, as a potent, highly selective, orally bioavailable investigational degrader of VAV1, a signaling protein downstream of T- and B-cell receptors. Starting this trial establishes neither efficacy in Sjögren’s disease nor regulatory approval.

The broader milestone pool remains conditional

Under the Novartis agreement, Monte Rosa is eligible for up to $2.1 billion in development, regulatory and sales milestones beginning upon initiation of Phase 2 studies. That figure represents potential payments under the agreement; it is not money already earned or received beyond the disclosed $50 million trigger.

The company describes the Sjögren’s study as the first of several expected studies of MRT-6160, with additional studies expected across immune-mediated diseases. Additional Phase 2 study initiation milestones are possible, but the disclosure does not establish those future payments as earned.

Earlier findings do not answer the Phase 2 question

According to Monte Rosa’s Phase 1 disclosure, single- and multiple-dose administration produced sustained, dose-dependent VAV1 degradation greater than ninety percent in peripheral blood T cells and suppressed key inflammatory biomarkers. The company reported that treatment was generally well tolerated and that no serious adverse effects were observed.

Those are company-reported Phase 1 findings. They do not establish Phase 2 efficacy or the safety and tolerability outcomes of the longer Sjögren’s study. The next clinical question is what the randomized trial shows about treatment benefit and risk.