This section highlights FDA-related milestones and regulatory updates for drugs developed by Recursion Pharmaceuticals (RXRX).
Over the past two years, Recursion Pharmaceuticals has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as
REC-1245, REC-3565, REC-4881, REC-617, and REC-994. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.
REC-1245 - FDA Regulatory Timeline and Events
REC-1245 is a drug developed by Recursion Pharmaceuticals for the following indication: For the treatment of biomarker-enriched solid tumors and 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:
- REC-1245
- Announced Date:
- December 3, 2024
- Indication:
- For the treatment of biomarker-enriched solid tumors and lymphoma.
Announcement
Recursion announced that the first patient has been dosed in its Phase 1/2 clinical trial of REC-1245, a new chemical entity for the treatment of biomarker-enriched solid tumors and lymphoma.
AI Summary
Recursion has announced a significant milestone in oncology research by dosing the first patient in its Phase 1/2 clinical trial of REC-1245. This innovative program is testing REC-1245, a new chemical entity designed to treat biomarker-enriched solid tumors and lymphoma. The drug works by selectively degrading RBM39, a protein that plays a regulatory role in cancer cell growth, and was discovered using Recursion’s advanced AI-powered platform.
The DAHLIA trial is an open-label study aimed at assessing the safety, tolerability, and early activity of REC-1245. The trial will explore various dosing levels to determine the maximum tolerated dose for future studies. This groundbreaking step reflects Recursion’s dedication to quickly turning novel scientific insights into potentially life-changing cancer treatments.
Read Announcement- Drug:
- REC-1245
- Announced Date:
- October 2, 2024
- Indication:
- For the treatment of biomarker-enriched solid tumors and lymphoma.
Announcement
Recursion announced that the U.S. Food and Drug Administration (FDA) has cleared an investigational new drug (IND) application for a Phase 1/2 clinical trial of REC-1245, a new chemical entity for the treatment of biomarker-enriched solid tumors and lymphoma.
AI Summary
Recursion announced that the FDA has cleared an investigational new drug (IND) application for a Phase 1/2 clinical trial of REC-1245, a new chemical entity aimed at treating biomarker-enriched solid tumors and lymphoma. This clearance is a significant milestone for the company and reflects confidence in its AI-powered drug discovery process. The trial will examine the safety, tolerability, pharmacokinetics, pharmacodynamics, and initial efficacy of REC-1245 in patients with limited treatment options.
REC-1245 is designed to target the protein RBM39, which plays a role in cell damage response and tumor growth. The IND clearance demonstrates the FDA’s trust in Recursion’s thorough research and innovation. Dosing for the study is expected to begin in Q4 2024, offering potential new hope for patients facing serious conditions.
Read Announcement
REC-3565 - FDA Regulatory Timeline and Events
REC-3565 is a drug developed by Recursion Pharmaceuticals for the following indication: For Small-Cell Lung 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:
- REC-3565
- Announced Date:
- April 8, 2025
- Indication:
- For Small-Cell Lung Cancer
Announcement
Recursion announced that the first patient has been dosed in the Phase 1 EXCELERIZE clinical study evaluating REC-3565 for the treatment of relapsed or refractory B-cell lymphomas.
AI Summary
Recursion announced that the first patient has been dosed in its Phase 1 EXCELERIZE clinical study to evaluate REC-3565 for relapsed or refractory B-cell lymphomas. This dose marks an important step in testing the drug’s safety, tolerability, and initial signs of effectiveness in patients with limited treatment options. REC-3565, developed with an AI-powered platform, showed promising and durable tumor regression in preclinical studies, both when used alone and in combination with other agents. The study is structured in two parts, with the initial phase focusing on monotherapy dosing to determine a recommended dose. The later phase will explore combination treatments, which could provide a more effective approach to managing B-cell cancers. This milestone reflects the company’s commitment to using innovative technology to accelerate drug development and improve outcomes for patients with challenging forms of lymphoma.
Read Announcement- Drug:
- REC-3565
- Announced Date:
- January 7, 2025
- Indication:
- For Small-Cell Lung Cancer
Announcement
Recursion announced that the UK Medicines and Healthcare Products Regulatory Agency (MHRA) has cleared a clinical trial application (CTA) for a Phase 1 clinical trial of REC-3565, a potential best-in-class MALT1 inhibitor for B-cell malignancies.
AI Summary
Recursion recently announced that the UK Medicines and Healthcare Products Regulatory Agency (MHRA) approved a clinical trial application (CTA) for a Phase 1 trial of REC-3565. This potential best-in-class MALT1 inhibitor is designed for treating B-cell malignancies, including chronic lymphocytic leukemia (CLL) and B-cell lymphomas. REC-3565 aims to provide better patient outcomes by reducing the risk of hyperbilirubinemia—a common side effect seen in other MALT1 inhibitors—since it does not significantly inhibit the enzyme UGT1A1. This characteristic may allow for safer dose escalation and encourage combination with other therapies. The clinical trial, set to begin dosing in early 2025, represents a significant advancement in targeted cancer therapy for patients who have relapsed or refractory diseases. This approval highlights Recursion’s commitment to innovating more effective and safer treatments using its advanced precision design platform.
Read Announcement
REC-4881 - FDA Regulatory Timeline and Events
REC-4881 is a drug developed by Recursion Pharmaceuticals for the following indication: Familial Adenomatous Polyposis (FAP).
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:
- REC-4881
- Announced Date:
- May 4, 2025
- Indication:
- Familial Adenomatous Polyposis (FAP)
Announcement
Recursion announced preliminary safety and efficacy results from its ongoing Phase 1b/2 TUPELO trial of REC-4881, an investigational, allosteric MEK1/2 inhibitor in development for Familial Adenomatous Polyposis (FAP).
AI Summary
Recursion recently disclosed early safety and efficacy results from its ongoing Phase 1b/2 TUPELO trial studying REC-4881, an investigational allosteric MEK1/2 inhibitor for Familial Adenomatous Polyposis (FAP). In the Phase 2 portion of the trial, six patients received REC-4881 at a dose of 4 mg once daily, leading to a median reduction of 43% in polyp burden by Week 13. Notably, five out of six patients experienced reductions in polyp burden ranging from 31% to 82%, while one patient saw an increase. Additionally, 50% of the patients achieved at least a one-point improvement in Spigelman stage—a measure of upper gastrointestinal disease severity. The early safety profile was consistent with known effects of MEK1/2 inhibitors, as most treatment-related adverse events were mild or moderate, with only 16% experiencing Grade 3 events and no events of Grade 4 or higher.
Read Announcement- Drug:
- REC-4881
- Announced Date:
- April 22, 2025
- Indication:
- Familial Adenomatous Polyposis (FAP)
Announcement
Recursion announced that it will present preliminary data during the 2025 Digestive Disease Week (DDW) meeting from its ongoing Phase 1b/2 clinical trial, TUPELO, which is evaluating the safety and preliminary activity of REC-4881 for the treatment of familial adenomatous polyposis (FAP).
AI Summary
Recursion announced it will share early data from its Phase 1b/2 TUPELO clinical trial at the 2025 Digestive Disease Week (DDW) meeting in San Diego. The trial is testing REC-4881, an allosteric MEK 1/2 inhibitor, to treat familial adenomatous polyposis (FAP), a rare hereditary condition with no FDA-approved treatments. The preliminary findings will be presented in a late-breaking oral session during the Research Forum on Hereditary GI Cancer Syndromes on May 4, 2025. Early results from the trial show that REC-4881 has a promising safety profile and may reduce the total polyp burden after 12 weeks of treatment. Recursion identified REC-4881 using its AI-powered platform, which helps find potential treatments by analyzing cellular models of APC gene loss, the root cause of FAP.
Read Announcement
REC-617 - FDA Regulatory Timeline and Events
REC-617 is a drug developed by Recursion Pharmaceuticals for the following indication: CDK7 inhibitor, in 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:
- REC-617
- Announced Date:
- December 9, 2024
- Indication:
- CDK7 inhibitor, in advanced solid tumors.
Announcement
Recursion reported initial monotherapy dose-escalation data from the Phase 1/2 study (ELUCIDATE) of REC-617, a selective CDK7 inhibitor, in advanced solid tumors.
AI Summary
Recursion recently shared early results from the ELUCIDATE Phase 1/2 study of REC-617, a selective CDK7 inhibitor, tested as monotherapy in patients with advanced solid tumors. The trial showed that REC-617 has dose-linear pharmacokinetics, meaning the drug’s concentration in the body increases consistently with higher doses. It also demonstrated rapid absorption and strong modulation of pharmacodynamic biomarkers, indicating effective target engagement. In the study, one patient with platinum-resistant ovarian cancer, who had undergone four previous lines of therapy, achieved a confirmed partial response that has lasted over six months. Additionally, four other patients maintained stable disease for up to six months. The encouraging safety profile, coupled with these early signs of clinical activity, supports further monotherapy dose escalation and plans to begin combination studies in the first half of 2025.
Read Announcement
REC-994 - FDA Regulatory Timeline and Events
REC-994 is a drug developed by Recursion Pharmaceuticals for the following indication: Cerebral Cavernous Malformation (CCM).
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:
- REC-994
- Announced Date:
- February 5, 2025
- Indication:
- Cerebral Cavernous Malformation (CCM)
Announcement
Recursion reported 12 month data from the Phase 2 study (SYCAMORE) of REC-994, the first industry sponsored Phase 2 trial completed in Cerebral Cavernous Malformations (CCM).
AI Summary
Recursion recently shared 12-month data from its Phase 2 SYCAMORE study evaluating REC-994 in Cerebral Cavernous Malformations (CCM). This study is the first industry-sponsored Phase 2 trial in CCM. The trial met its primary endpoint by demonstrating that REC-994 is safe and well tolerated, with no treatment-related discontinuations or severe adverse events observed.
At a dose of 400 mg, REC-994 showed promising signs of benefit compared to placebo. About 50% of patients experienced a reduction in total lesion volume, and improvements in functional outcomes were noted using the modified Rankin scale. Even patients with brainstem lesions, a subgroup with high unmet need, showed a decrease in lesion size and symptom stabilization. Future plans for REC-994 will be guided by regulatory discussions and results from an ongoing long-term extension study.
Read Announcement- Drug:
- REC-994
- Announced Date:
- September 3, 2024
- Indication:
- Cerebral Cavernous Malformation (CCM)
Announcement
Recursion announced top-line results of the SYCAMORE trial, a 12-month Phase 2 randomized double-blind, placebo-controlled, safety, tolerability and exploratory efficacy study for REC-994 in symptomatic CCM patients.
AI Summary
Recursion recently announced top-line results from the SYCAMORE trial—a 12‐month, Phase 2, randomized, double‐blind, placebo-controlled study testing REC-994 in symptomatic CCM patients. The study’s primary goal was to assess safety and tolerability, and REC-994 met this endpoint. The safety profile was similar across the placebo group and both the 200mg and 400mg dosage arms, with comparable rates and severity of adverse events after one year of treatment.
Secondary exploratory endpoints using MRI showed trends toward reduced lesion volume and a smaller hemosiderin ring size in patients taking the highest 400mg dose compared to placebo. Although improvements in patient and physician-reported outcomes were not observed at the 12-month mark, the data supports further investigation. Recursion plans to meet with the FDA soon to discuss the next clinical study, aiming to build on these encouraging early findings.
Read Announcement
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