Schrödinger earns FDA Fast Track for SGR-1505 in Waldenström macroglobulinemia amid rising therapeutic demand

Schrödinger, Inc. (NASDAQ: SDGR), the New York-based computational chemistry pioneer advancing data-driven molecular discovery, has announced that its investigational drug SGR-1505 has received Fast Track designation from the U.S. Food and Drug Administration (FDA). The designation specifically supports the development of SGR-1505 as a treatment for adult patients with relapsed or refractory Waldenström macroglobulinemia (WM) who have failed at least two lines of therapy, including a Bruton’s tyrosine kinase (BTK) inhibitor.

SGR-1505 is Schrödinger’s lead MALT1 inhibitor, currently in a Phase 1 trial for B-cell malignancies. The FDA Fast Track decision, disclosed on June 28, 2025, provides a path for more frequent regulatory interaction, possible accelerated approval, and Priority Review eligibility—boosting hopes for faster access to new treatment options in a niche but clinically challenging hematologic cancer.

Why is SGR-1505’s Fast Track designation important for patients with BTK-resistant Waldenström macroglobulinemia?

Waldenström macroglobulinemia is a rare, slow-growing type of non-Hodgkin lymphoma primarily affecting older adults. While treatment advances in BTK inhibitors such as ibrutinib and zanubrutinib have improved outcomes, many patients eventually relapse due to resistance or intolerance. This unmet need is particularly acute for those with prior BTK exposure who have limited therapeutic options afterward.

Schrödinger’s SGR-1505 is a selective MALT1 inhibitor that targets a critical protein in the NF-κB signaling cascade—a pathway downstream of BTK known to drive B-cell malignancies. By intervening at a different node than existing therapies, SGR-1505 may bypass resistance mechanisms associated with BTK inhibitors. The FDA’s Fast Track nod underscores both the drug’s therapeutic rationale and the pressing clinical demand for novel approaches to WM.

According to Schrödinger’s Chief Medical Officer Margaret Dugan, recent Phase 1 results demonstrated preliminary efficacy in multiple B-cell malignancies, including WM patients previously treated with BTK inhibitors. The drug was also shown to be well tolerated, with a favorable safety profile presented at recent hematology conferences.

How does SGR-1505 fit into the broader competitive landscape of B-cell malignancy treatments?

SGR-1505 represents a distinctive approach within the increasingly crowded B-cell oncology space, where competition is intensifying between next-generation BTK inhibitors, bispecific antibodies, CAR-T therapies, and targeted small molecules. Unlike therapies that target surface antigens or disrupt upstream signaling proteins, SGR-1505 intervenes downstream at MALT1, a paracaspase central to signal transduction and lymphocyte proliferation.

This mechanistic innovation could make SGR-1505 a valuable option not only in WM but also in other malignancies such as chronic lymphocytic leukemia (CLL), diffuse large B-cell lymphoma (DLBCL), marginal zone lymphoma (MZL), and mantle cell lymphoma (MCL)—where it already holds orphan drug designation.

In preclinical studies, SGR-1505 has shown anti-tumor activity both as a monotherapy and in combination with BTK and BCL-2 inhibitors, supporting its positioning within multi-agent regimens. Analysts tracking the B-cell therapy market view MALT1 inhibition as a promising strategy that complements rather than competes directly with established BTK and BCL-2 therapies.

What do institutional investors and analysts expect next in the clinical and regulatory journey of SGR-1505?

The Phase 1 study of SGR-1505 is ongoing under clinical trial NCT05544019 and continues to recruit relapsed/refractory B-cell malignancy patients. Schrödinger has indicated plans to discuss the Phase 1 results and recommended Phase 2 dosing with the FDA later this year, positioning the program for potential advancement into mid-stage trials.

Analysts note that the FDA’s Fast Track designation, combined with prior Orphan Drug status for mantle cell lymphoma, may de-risk some regulatory hurdles. Fast Track also allows for rolling submissions of the New Drug Application (NDA), potentially accelerating timelines for regulatory approval if subsequent trials yield favorable data.

While still early in its clinical lifecycle, SGR-1505’s tolerability and target specificity have attracted cautious optimism from institutional investors focused on hematologic oncology. The drug’s development has been enabled by Schrödinger’s proprietary computational platform, which compresses discovery timelines—a factor viewed favorably by capital markets.

Schrödinger’s prior success in designing SGR-1505 within just 10 months of launching its MALT1 program demonstrates the scalability of its software-guided discovery model. With an active internal and collaborative pipeline of clinical-stage oncology programs, the American drug discovery innovator is increasingly being watched as a player with differentiated R&D infrastructure.

How is Schrödinger leveraging its AI-powered discovery platform to scale innovation in oncology and beyond?

Schrödinger’s development of SGR-1505 highlights the power of its platform-first drug development model. The company integrates physics-based simulations, machine learning, and proprietary data pipelines to accelerate hit discovery, lead optimization, and compound selection. This platform not only expedites molecule creation but also reduces the cost and time required for candidate validation.

SGR-1505’s journey from concept to clinic in under a year—along with its observed potency, selectivity, and early clinical activity—reflects the growing impact of computational design in oncology drug development. Schrödinger’s approach differs from traditional big pharma models by tightly coupling discovery and development within a vertically integrated infrastructure.

The company currently has three oncology programs in clinical trials and a broader pipeline spanning inflammation, autoimmunity, and rare diseases. Institutional sentiment remains focused on near-term readouts from its lead MALT1 and CDC7 inhibitors, both being tested across B-cell malignancies and solid tumors.

With approximately 800 employees and a global presence across 15 locations, Schrödinger continues to deepen its pharma partnerships while advancing internal assets toward commercial viability.

What are the strategic next steps for SGR-1505 development following FDA Fast Track recognition?

Following the Fast Track designation, Schrödinger is expected to initiate discussions with the FDA to finalize the recommended Phase 2 dose and explore trial design options that could support future Accelerated Approval pathways. The company has not disclosed definitive timelines for Phase 2 initiation but reiterated its plan to engage regulators in 2025.

The next logical steps include a randomized Phase 2 trial in BTK-experienced Waldenström macroglobulinemia patients, potentially with a broader basket trial design to capture additional B-cell malignancies. Analysts believe this strategy could allow Schrödinger to demonstrate proof-of-concept across multiple indications using a single trial platform.

Schrödinger may also explore combination regimens with BTK or BCL-2 inhibitors based on the strong preclinical rationale and early clinical signals. Such combinations could expand addressable markets while strengthening the case for regulatory flexibility via the FDA’s expedited review programs.

Future updates from Schrödinger are likely to center on patient enrollment metrics, dose optimization, and pharmacodynamic markers that validate MALT1 inhibition. Clinical updates at hematology conferences in late 2025 could serve as key catalysts for investor sentiment and partner interest.