This section highlights FDA-related milestones and regulatory updates for drugs developed by Schrodinger (SDGR).
Over the past two years, Schrodinger has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as
SGR-1505, SGR-3515, and SGR-4174. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.
Select a button below to view the list of FDA events for that drug.
SGR-1505 FDA Regulatory Timeline and Events
SGR-1505 is a drug developed by Schrodinger for the following indication: Relapsed or refractory B-cell lymphoma.
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:
- SGR-1505
- Announced Date:
- June 27, 2025
- Indication:
- Relapsed or refractory B-cell lymphoma
Announcement
Schrödinger, Inc. announced that SGR-1505, its clinical stage MALT1 inhibitor, was designated as a Fast Track product by the U.S. Food and Drug Administration (FDA) for the treatment of adult patients with Waldenström macroglobulinemia that have failed at least two lines of therapy, including a Bruton's tyrosine kinase (BTK) inhibitor.
AI Summary
Schrödinger, Inc. announced that its clinical-stage MALT1 inhibitor SGR-1505 has received Fast Track designation from the FDA. The designation targets adult patients with Waldenström macroglobulinemia who have not responded to at least two lines of therapy, including a Bruton's tyrosine kinase (BTK) inhibitor. This Fast Track status is a clear indication of the unmet need in treating patients facing BTK resistance. The company hopes that the designation will speed up the development and review process of SGR-1505, potentially offering a new treatment option for those who have limited alternatives. Early Phase 1 data suggest promising safety and efficacy for SGR-1505 across various B-cell malignancies, reinforcing its potential impact as both a monotherapy and in combination with other treatment regimens.
Read Announcement- Drug:
- SGR-1505
- Announced Date:
- June 12, 2025
- Indication:
- Relapsed or refractory B-cell lymphoma
Announcement
Schrödinger, Inc. announced encouraging initial clinical data from its ongoing Phase 1, open-label, dose-escalation study of SGR-1505 in patients with relapsed/refractory B-cell malignancies.
AI Summary
Schrödinger, Inc. announced encouraging initial data from its ongoing Phase 1, open-label, dose-escalation study of SGR-1505 in patients with relapsed/refractory B-cell malignancies. The study has shown that SGR-1505 is safe, well tolerated, and exhibits promising clinical activity as a monotherapy. Patients with various types of B-cell cancers, including chronic lymphocytic leukemia (CLL) and Waldenström macroglobulinemia, have experienced positive responses. These early results indicate that SGR-1505, which targets the MALT1 enzyme, may offer a beneficial treatment option for patients who have exhausted other therapies.
The data, presented at the European Hematology Association Annual Congress, also support further clinical investigation. With the dose escalation phase complete, Schrödinger looks forward to discussing a recommended Phase 2 dose with the FDA later this year, highlighting the potential for SGR-1505 to become a best-in-class therapy for B-cell malignancies.
Read Announcement- Drug:
- SGR-1505
- Announced Date:
- May 14, 2025
- Indication:
- Relapsed or refractory B-cell lymphoma
Announcement
Schrödinger, Inc announced that initial Phase 1 clinical data for SGR-1505, its investigational MALT1 inhibitor, will be presented at the European Hematology Association Annual Congress, taking place June 12 - 15, 2025, in Milan, Italy.
AI Summary
Schrödinger, Inc. announced that it will present its initial Phase 1 clinical data for SGR-1505, an investigational MALT1 inhibitor, at the European Hematology Association Annual Congress in Milan, Italy, scheduled for June 12–15, 2025. The study is focused on assessing the safety, tolerability, and anti-tumor activity of SGR-1505 in patients with relapsed or refractory B-cell malignancies, including chronic lymphocytic leukemia and small lymphocytic lymphoma. Early findings include data on safety, pharmacokinetics, pharmacodynamics, and preliminary efficacy across various dosing levels. The presentation is designed to highlight the potential of SGR-1505 as a promising treatment for patients who have not responded to previous therapies, supporting its continued clinical development.
The abstract of the presentation is available online, offering valuable insights into the investigational therapy's impact on B-cell cancers. This event is a key step in understanding how SGR-1505 may help improve treatment options for these challenging conditions.
Read Announcement- Drug:
- SGR-1505
- Announced Date:
- January 13, 2025
- Indication:
- Relapsed or refractory B-cell lymphoma
Announcement
Schrödinger, Inc provided an update on its progress across the business in 2024 and announced its strategic priorities for 2025.
AI Summary
Schrödinger, Inc. provided an update on its progress throughout 2024 and outlined its key strategic priorities for 2025. In 2024, the company made significant advancements in its computational platform, strengthening its software capabilities and expanding research collaborations, including an enhanced agreement with Otsuka Pharmaceutical. These moves are part of a broader push to accelerate drug discovery while boosting their software business. Looking ahead to 2025, Schrödinger’s priorities include driving increased customer adoption of its enterprise informatics platform and advancing the science behind its predictive toxicology initiative. The company also plans to report initial Phase 1 data on three lead therapeutic programs targeting various diseases during the upcoming year. This focus on both innovative software solutions and clinical development reflects Schrödinger’s commitment to growing its collaborative pipeline and expanding drug discovery revenue.
Read Announcement
SGR-3515 FDA Regulatory Events
SGR-3515 is a drug developed by Schrodinger for the following indication: For patients with advanced 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:
- SGR-3515
- Announced Date:
- April 28, 2025
- Indication:
- For patients with advanced solid tumors
Announcement
Schrödinger, Inc presented preclinical data on SGR-3515, its investigational Wee1/Myt1 co-inhibitor today at the American Association for Cancer Research (AACR) Annual Meeting 2025.
AI Summary
At the AACR Annual Meeting 2025, Schrödinger, Inc. presented promising preclinical data on SGR-3515, its investigational Wee1/Myt1 co-inhibitor. The data showed that SGR-3515 has improved anti-tumor activity compared to other current inhibitors and can be used effectively as a single treatment or in combination with chemotherapy. Researchers demonstrated that by optimizing the dosing schedule—using three to five days of treatment in a two-week cycle—they could maintain strong anti-cancer effects while reducing side effects like myelosuppression. Additionally, a new computational tool was highlighted that predicts responses to Wee1-based drug combinations in cancers, including head and neck cancers. This approach helps in designing better treatment strategies, reinforcing Schrödinger's commitment to using advanced computational methods to enhance cancer therapies.
Read Announcement- Drug:
- SGR-3515
- Announced Date:
- October 9, 2024
- Indication:
- For patients with advanced solid tumors
Announcement
Schrödinger announced that new preclinical data on SGR-3515, its investigational Wee1/Myt1 inhibitor, and the company's PRMT5-MTA inhibitor program, will be presented during poster sessions at the 36th EORTC-NCI-AACR Symposium (ENA 2024) taking place October 23-25, 2024 in Barcelona, Spain.
AI Summary
Schrödinger announced that new preclinical data on its investigational drug SGR-3515—a Wee1/Myt1 inhibitor—and its PRMT5-MTA inhibitor program will be presented during poster sessions at the 36th EORTC-NCI-AACR Symposium (ENA 2024) in Barcelona, Spain, from October 23-25, 2024. The SGR-3515 poster will highlight findings in preclinical oncology models, showing how inhibiting Wee1 and Myt1 kinases—key players in cell cycle control and DNA repair—could create a window of synthetic lethality in cancer cells. Additionally, the company will present data on a series of selective PRMT5-MTA inhibitors, which are being optimized for potential use against peripheral and brain tumors. These sessions underscore Schrödinger’s innovative approach to drug discovery and could help shape future clinical strategies for treating advanced solid tumors.
Read Announcement
SGR-4174 FDA Regulatory Events
SGR-4174 is a drug developed by Schrodinger for the following indication: SOS1 inhibitor.
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:
- SGR-4174
- Announced Date:
- March 25, 2025
- Indication:
- SOS1 inhibitor
Announcement
Schrödinger, Inc announced that new preclinical data on SGR-3515, its investigational Wee1/Myt1 inhibitor, and SGR-4174, its SOS1 inhibitor, will be presented at the American Association for Cancer Research (AACR) Annual Meeting 2025, taking place April 25 - 30, 2025 in Chicago, IL.
AI Summary
Schrödinger, Inc. announced that new preclinical data on two promising cancer therapies will be presented at the AACR Annual Meeting 2025 in Chicago, IL, from April 25 to 30. The session will cover SGR-3515, a Wee1/Myt1 inhibitor studied for its improved therapeutic index using an optimized intermittent dosing schedule in preclinical oncology models, and SGR-4174, a SOS1 inhibitor that targets KRAS-driven cancers. Researchers will share findings that demonstrate SGR-3515’s potential as a treatment for advanced solid tumors, with additional clinical data expected later this year. The presentation on SGR-4174 is the first of its kind in preclinical studies, highlighting its role in regulating the KRAS gene and its potential in combination therapies. These insights could pave the way for new treatment options in oncology.
Read Announcement
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