On May 6, 2026 Totus Medicines, a clinical-stage, precision medicines company leveraging AI-powered small molecule drug discovery to advance a differentiated pipeline of therapeutics against high-value, historically difficult-to-drug targets, reported the presentation of interim Phase 1b clinical data from its ongoing study of TOS-358, a next-generation pan-mutant, covalent, alpha-selective PI3Ka inhibitor, in combination with Fulvestrant, in heavily pre-treated metastatic HR+/HER2− breast cancer patients. The data were presented at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Breast Cancer Annual Congress, taking place in Berlin, Germany, May 5–8, 2026.

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Presentation Details:

Conference: ESMO (Free ESMO Whitepaper) Breast Cancer 2026

Session: Poster Presentation

Abstract Number: 492P

Date / Time: 13:15, Thursday, May 7, 2026

"These initial combination data with TOS-358 and Fulvestrant are highly encouraging and reinforce our confidence in TOS-358’s differentiated profile as a covalent, pan-mutant PI3Ka inhibitor," said Zelanna Goldberg, M.D., Chief Medical Officer of Totus Medicines. "Achieving 100% disease control and an 89% clinical benefit rate in women, including patients with prior PI3K/AKT/mTOR pathway therapy, alongside a class-leading tolerability profile, underscores the potential of TOS-358 to address a critical unmet need in HR+/HER2− metastatic breast cancer. The durability of responses, with more than 60% of patients remaining on therapy beyond 24 weeks, further validates our approach of near-total, sustained PI3Ka pathway suppression."

First Combination Data: TOS-358 + Fulvestrant Efficacy and Durability

The poster (Abstract 492P) presents the early clinical data from the doublet cohort of TOS-358-001, the ongoing open-label, global, multi-center Phase 1 study. Ten evaluable HR+/HER2− breast cancer patients were treated with TOS-358 in combination with Fulvestrant (median 3.5 prior lines of therapy; range 1–5), with a data cutoff of March 31, 2026. Key efficacy and durability findings include:

100% Disease Control Rate (DCR) in women treated with TOS-358 + Fulvestrant
89% Clinical Benefit Rate (CBR) in women, including patients who had received prior PI3K/AKT/mTOR (PAM)-directed therapy and patients in the 4th line and beyond
Responses continued to deepen over time, including conversions from stable disease (SD) to partial responses (PR), consistent with TOS-358’s near-total inhibition of PI3Ka signaling
60% of patients on TOS-358 + Fulvestrant remained on therapy beyond 24 weeks, with an additional 20% of patients ongoing at less than 24 weeks on trial; median time on therapy exceeds 24 weeks for the overall Phase 1 population
A 72-year-old heavily pre-treated patient with an H1047K/G106V dual PI3Ka mutation achieved a confirmed RECIST partial response of ~68%, with near complete PET-CT resolution of bone metastases
Class-Leading Safety and Tolerability

Across the overall TOS-358 safety population to date (N=56, including monotherapy and doublet patients), TOS-358 demonstrated a class-leading tolerability profile with an absence of toxicities that have limited other PI3Ka inhibitors:

0% bone marrow toxicity
0% hepatic toxicity
0% renal toxicity
0% ocular symptoms
0% rash
0% stomatitis/mucositis
0% grade 3 diarrhea
Hyperglycemia was manageable: only 3.6% of patients (2/56) required ongoing insulin, and all patients who received insulin were obese (BMI >30)
No treatment discontinuations due to intolerance to TOS-358
Maturing Overall Phase 1 Experience

The overall Phase 1 cohort currently demonstrates a 78% DCR and 57% CBR, with data continuing to mature. Among the overall population treated with TOS-358, median time on therapy now exceeds 24 weeks, with 50% of patients maintaining disease control beyond this landmark. The ongoing Phase 1b expansion cohort is currently enrolling across doublet (TOS-358 + Fulvestrant) and triplet (TOS-358 + Fulvestrant + CDK4/6 inhibitor) arms.

TOS-358: A Differentiated Approach to PI3Ka Inhibition

TOS-358 is the first and only clinical-stage covalent PI3Ka inhibitor. As a pan-mutant, a-selective oral small molecule, TOS-358 achieves >95% continuous target engagement at clinically relevant doses through covalent binding to a cysteine residue equally accessible in helical, kinase-domain, and other mutants of PI3Ka while avoiding high plasma concentrations that can potentially lead to off-target effects. This broad mutant coverage – extending to acquired resistance mutations – differentiates TOS-358 from non-covalent and mutation-selective PI3Ka inhibitors currently approved or in development. The near-total, sustained suppression of oncogenic signaling enabled by this mechanism is reflected in the depth and durability of responses observed clinically, as well as the absence of many of the class-effect toxicities that have limited other agents.

PI3Ka driver mutations are present in approximately 40% of ER-positive/HER2-negative breast cancer, 50% of endometrial adenocarcinoma, and a meaningful subset of head and neck squamous cell carcinoma (HNSCC) patients. Totus Medicines is advancing TOS-358 as a potential best-in-class PI3Ka inhibitor across selected solid tumor indications. TOS-358-001 (EU CT 2023-505346-26-01; NCT#05683418) is an ongoing open-label, global, multi-center Phase 1 study evaluating the safety and efficacy of TOS-358 alone and in combination.

(Press release, Totus Medicines, MAY 6, 2026, View Source [SID1234665229])

On May 6, 2026 Recursion (Nasdaq: RXRX) a leading clinical stage TechBio company decoding biology to radically improve lives, reported business updates highlighting strong continued pipeline execution, clinical progress and platform advancement, as well as financial results for its first quarter ended March 31, 2026.

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Recursion will host an earnings Call on May 6, 2026 at 8:00 am ET / 6:00 am MT / 1:00 pm BST from Recursion’s X, LinkedIn, and YouTube accounts giving analysts, investors, and the public the opportunity to ask questions of the company by submitting questions here: View Source

"We are seeing strong momentum and execution across our portfolio, with increasing evidence that our full stack platform can translate biological and chemical insights into differentiated clinical programs," said Najat Khan, Ph.D., Chief Executive Officer and President of Recursion. "Recent progress, including encouraging initial safety and PK data in REC-1245 and the first patient dosed in REC-4539, represents a growing set of proof points that demonstrate our ability to translate platform insights into clinical programs. This momentum reflects the strength of our end-to-end AI platform, with multiple differentiated internal and partnered programs advancing into and through the clinic."

Business Highlights

Favorable Safety and PK Data for REC-1245 (RBM39):

Preliminary safety and pharmacokinetic (PK) data from REC-1245, a potential first-in-class RBM39 degrader discovered and developed using Recursion’s platform, highlight early clinical progress for a novel approach to targeting cancer vulnerabilities linked to replication stress and DNA repair.

REC-1245 advanced from biological discovery to development candidate in 18 months, more than twice as fast as the industry average, demonstrating Recursion’s ability to identify novel targets and design differentiated molecules using its integrated AI-enabled platform.

Early data from the ongoing Phase 1/2 DAHLIA study show:
•REC-1245 was well-tolerated across select solid tumors (n=16)
•No dose-limiting toxicities (DLTs) have been observed to date, and the maximum tolerated dose has not yet been reached
•The majority of TRAEs were Grade 1 or 2, most common GI-related events were constipation, nausea, and vomiting
•Pharmacokinetic analysis demonstrates predictable, dose-dependent exposure across evaluated patients
•Pharmacodynamic assessments demonstrate target engagement
•Dose escalation is ongoing to determine the recommended Phase 2 dose for monotherapy expansion cohorts

Treatment-Related Adverse Event (TRAE)
Patients (n=16)
Patients with any TRAE 10 (62.5%)
Grade 1-2 9 (56.3%)
Grade 3 1 (6.2%)
Grade 4-5 0 (0.0%)

Continued Momentum for REC-4881 (MEK1/2):

REC-4881 is an allosteric MEK1/2 inhibitor being developed for familial adenomatous polyposis (FAP), a genetically defined disease driven by APC loss. Based on platform insights into MAPK pathway modulation in APC-deficient systems, REC-4881 represents a targeted approach to addressing the underlying biology of disease progression:

•Phase 2 positive proof-of-concept clinical data showed a median 43% reduction in polyp burden at Week 13, deepening to 53% at Week 25 following a treatment break, with 40% of patients demonstrating improvement in Spigelman stage, supporting a differentiated and durable profile in FAP.
•Safety was consistent with MEK1/2 inhibition, with mostly Grade 1–2 TRAEs, Grade 3 events in 15.8% of patients, no Grade ≥4 TRAEs, and commonly including dermatitis acneiform/rash and increased CPK.

Recursion has initiated FDA engagement to align on a potential registrational study design, with an update expected in the second half of 2026. Expansion of TUPELO to include patients aged 18+ to support a broader development strategy is also ongoing.

First Patient Dosed in REC-4539 (LSD1 inhibitor):

REC-4539, an AI-designed, LSD1 inhibitor, highlights early progress for a differentiated approach to targeting epigenetic drivers in cancer. In April, the first patient was dosed in the ENLYGHT Phase 1 clinical study for solid tumors, including small cell lung cancer (SCLC).

REC-4539 was precision designed to have a reversible mechanism and shorter predicted human half-life to address treatment-limiting platelet toxicity observed with other LSD1 inhibitors, enabling a potentially differentiated profile across solid tumors and hematologic malignancies.

The differentiated, CNS-penetrant development candidate was delivered in approximately 20 months through Recursion’s AI-native design platform, demonstrating the Company’s ability to rapidly translate platform insights into optimized clinical candidates.

For the rest of the portfolio, programs continue to progress as planned.

Expected upcoming milestones across Recursion’s wholly-owned pipeline:

•REC-4881 (MEK1/2):
◦Regulatory update expected in 2H26
◦Additional Phase 1b/2 clinical data expected in 1H27
•REC-1245 (RBM39): Additional Phase 1 dose escalation data expected in 2H26
•REC-7735 (PI3Kα H1047R) and REC-102 (ENPP1): IND-enabling studies ongoing; data-driven go/no-go decision on Phase 1 initiation expected in 2H26
•REC-617 (CDK7): Early Phase 1 safety and PK combination data expected in 1H27
•REC-3565 (MALT1): Early Phase 1 safety and PK monotherapy data expected in 1H27
•REC-4539 (LSD1): Early Phase 1 safety and PK monotherapy data expected in 2H27

Meaningful upcoming milestones across partnered discovery:

Recursion continues to advance partnered programs that leverage complementary strengths of the Recursion OS.

In AI-enabled chemistry, Sanofi and Recursion joint programs continue progressing toward development candidate designation and earlier-stage milestones over the next 12 months, including programs designed against challenging targets in immunology and oncology.

In AI-enabled biology, Recursion expects to continue jointly translating insights from its large-scale maps of biology delivered to Roche and Genentech into potential target validation milestones over the next 12 months. The maps, jointly built by Recursion, Roche and Genentech are disease-relevant high-content maps built at large scale, including a Neuron map generated from a subset of 1 trillion internally manufactured iPSC-derived neuronal cells and a Microglia map generated from more than 100 billion internally manufactured iPSC-derived microglial cells. Additionally, we are combining our phenomics dataset with Roche and Genentech’s proprietary transcriptomics data to build multi-modal maps designed to explore potential novel targets and pathways by systematically linking gene perturbations to cellular phenotypes

Recursion OS Advances: Driving platform innovations, grounded in impact

Full Stack AI-powered Platform: The Recursion Operating System (OS) is continuing to drive program development by integrating AI across multimodal biology, precision design, and next-generation clinical development—enabling faster, more efficient, and more innovative drug discovery and development from biology to insight, insight to molecule, and molecule to patient.

State of the Art Transcriptomics Models: Built to better connect Recursion’s proprietary perturbational biology with patient biology to find novel insights and medicines, the integration of these models help bridge the translation gap between what we see in the lab and what matters in disease:

•TxPert, recently featured in Nature Biotechnology, is a proof-of-principle model for predicting transcriptomic responses to perturbations. The model can generalize beyond its training data, including predicting responses to unseen single-gene perturbations, novel combinations, and known perturbations in new cell types—enabling more efficient hypothesis generation and experimental prioritization, and laying the foundation for Recursion’s Virtual Cell.
•TxFM, presented at the ICLR Workshop on Foundation Models for Science, is a transcriptomics foundation model designed to connect lab perturbations with patient biology within the Recursion OS. Trained on a large, curated dataset of public and proprietary data, it outperforms 16 leading foundation models and baselines, including models trained on datasets 10–100x larger. Beyond enabling target identification, mechanistic understanding, and patient stratification, TxFM’s superior batch correction and denoising drive operational efficiency—reducing experimental re-runs, enabling cross-experiment comparisons, and increasing the value of every sequencing dollar spent.

First Quarter 2026 Financial Results

•Cash Position: Cash, cash equivalents and restricted cash were $665.2 million as of March 31, 2026 compared to $753.9 million as of December 31, 2025. Based on current operating plans and with no additional financing, the Company continues to expect its cash runway to extend into early 2028.
•Revenue: Total revenue, consisting primarily of revenue from collaboration agreements, was $6.5 million for the first quarter of 2026, compared to $14.7 million for the first quarter of 2025. Roche revenue recognized was less in the current period due to the successful completion of certain project phases in the prior period.
•Research and Development Expenses: Research and development expenses decreased to $87.9 million for the first quarter of 2026, from $129.6 million for the first quarter of 2025. The decrease was primarily due to lower platform costs resulting from the timing of Tempus record purchases as well as lower costs due to improved operating efficiency. Specifically, the first quarter of 2025 included $27.1 million in non-cash expenses for the use of patient-centric multimodal oncology data within the Company’s R&D pipeline.
•General and Administrative Expenses: General and administrative expenses were $34.6 million for the first quarter of 2026 compared to $54.7 million for the first quarter of 2025. The decrease of $20.1 million relative to the three months ended March 31, 2025 was primarily driven by a decrease in salaries and one-time transaction costs incurred in the prior year.
•Net Loss: Net loss was $117.5 million for the first quarter of 2026, compared to a net loss of $202.5 million for the first quarter of 2025.
•Operational cash flows: Net cash used in operating activities was $81.1 million for the three months ended March 31, 2026, compared to net cash used in operating activities of $132.0 million for the three months ended March 31, 2025. The decrease in cash used in operating activities was primarily driven by operating efficiencies across the company and the strategic reprioritization of our clinical portfolio.
•Cash Operating Expense: Cash operating expense, excluding partnership inflows and transaction costs, for the three months ended March 31, 2026 was $85.1 million compared to $120.2 million for the three months ended March 31, 2025.

(Press release, Recursion Pharmaceuticals, MAY 6, 2026, View Source [SID1234665195])

On May 6, 2026 Actinium Pharmaceuticals, Inc. (NYSE American: ATNM) (Actinium or the Company), a pioneer in the development of targeted radiotherapies, reported the upcoming presentation of three abstracts at the Society of Nuclear Medicine and Molecular Imaging (SNMMI) 2026 Annual Meeting, taking place May 30-June 2, 2026, in Los Angeles, California.

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The presentations include two posters on ATNM-400, Actinium’s first-in-class Actinium-225 (225Ac) antibody radioconjugate, demonstrating its potential in prostate cancer and non-small cell lung cancer (NSCLC), as well as a third poster presenting preclinical radiochemistry data on chelator-to-antibody ratio (CAR) optimization that underpins ATNM-400 development. Together, the data underscore Actinium’s scientific leadership in next-generation alpha-emitting radioconjugates.

Sandesh Seth, Actinium’s Chairman and CEO, said, "Data to be presented at SNMMI 2026 further strengthen the profile of ATNM-400 as a first-in-class, radiotherapy with broad solid tumor applicability. In NSCLC, ATNM-400 demonstrates the ability to overcome key resistance mechanisms to both EGFR and KRAS mutations that limit current targeted therapies and support its development as a mutation agnostic agent. In prostate cancer, new data demonstrate its potential in the PSMA negative setting, in addition to promising data in PSMA-high and medium settings further supporting the differentiated profile of ATNM-400. Importantly, as we head toward clinical studies with ATNM-400, we showcase our efforts to maximize ATNM-400’s therapeutic index by utilizing our deep radiochemistry expertise to optimize the CAR. Together, the data to be presented support ATNM-400’s growing potential as a differentiated radiotherapy across multiple high-value solid tumor indications that represent some of oncology’s largest commercial opportunities."

ATNM-400 SNMMI 2026 Presentation Details

Abstract Title: ATNM-400: A First-in-Class Actinium-225 Antibody Radioconjugate Demonstrating Potent PSMA-Independent Efficacy in Prostate Cancer Models
Session: Oncology: Discovery & Translational Meet the Author Session
Date & Time: Tuesday, June 2, 2026 11:30am-12:15pm PT | Los Angeles, California

Abstract Title: ATNM-400: A First-in-Class Actinium-225 Antibody Radioconjugate Demonstrating Durable, Mutation-Agnostic Anti-Tumor Activity in Non-Small Cell Lung Cancer Models
Session: Oncology: Discovery & Translational Meet the Author Session
Date & Time: Tuesday, June 2, 2026, 11:30am-12:15pm PT | Los Angeles, California

Abstract Title: Optimizing Chelator-to-Antibody Ratio Improves Tumor Targeting and Pharmacokinetics of 225Ac-Labeled Antibodies
Session: MTA05 RPSC/CMIIT POPs and Science Pavilion Mixer
Date & Time: Sunday, May 31, 2026, 7:30-8:00pm PT | Los Angeles, California

(Press release, Actinium Pharmaceuticals, MAY 6, 2026, View Source [SID1234665214])

On May 6, 2026 Ernexa Therapeutics (Nasdaq: ERNA), an industry innovator developing novel cell therapies for the treatment of advanced cancer and autoimmune disease, reported new preclinical data demonstrating that its lead cell therapy candidate, ERNA-101, in combination with PD-1 blockade, drives complete tumor clearance and 100% long-term survival in syngeneic ovarian cancer models.

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"This data represents a significant step forward," said Robert H. Pierce, M.D., Chief Scientific Officer of Ernexa Therapeutics. "We are not just seeing strong response, we are seeing complete tumor eradication and durable survival, driven by a powerful immune activation mechanism within the tumor itself. These findings underscore the potential of ERNA-101 to overcome one of the biggest challenges in ovarian cancer – an immunologically ‘cold’ TME – and to unlock the full potential of checkpoint inhibition. Subsequent to a positive clinical proof-of-concept trial in collaboration with the MD Anderson Cancer Center in platinum-resistant ovarian cancer, we anticipate broadening the scope of indications to include other solid tumors, where strong immunosuppression in the tumor microenvironment limits the clinical benefit of anti-PD-1 therapy."

In the study, treatment with ERNA-101 in combination with anti-PD-1 therapy resulted in complete tumor clearance (i.e., loss of detectable tumor signal by bioluminescence imaging) and 100% survival through long-term follow-up. These outcomes significantly exceeded those observed with either therapy alone and suggest potential curative activity.

The data further demonstrate that ERNA-101 remodels the TME from immunosuppressive to immune-activated, enabling robust and sustained anti-tumor immune responses.

"What we are seeing goes beyond expectations. Achieving complete tumor elimination and 100% survival in a model where current approaches typically fall short reinforces both the strength of the data and the underlying mechanism driving this response. These results give us increased confidence in ERNA-101’s ability to meaningfully enhance the activity of checkpoint inhibitors and potentially shift treatment outcomes in ovarian cancer. This approach may also extend beyond ovarian cancer, with the potential to drive meaningful responses across other immunologically ‘cold’ solid tumors characterized by highly suppressive tumor microenvironments. We believe ERNA-101 has the potential to become a foundational therapy in combination regimens, significantly expanding treatment effectiveness," said Sanjeev Luther, President and Chief Executive Officer of Ernexa Therapeutics.

ERNA-101 is an allogeneic induced mesenchymal stem cell (iMSC) therapy derived from induced pluripotent stem cells (iPSCs) and engineered to home to tumors and secrete a potent IL-7/IL-15 fusion cytokine directly within the TME. This localized cytokine delivery approach is designed to maximize immune activation while minimizing systemic toxicity.

Key findings from the preclinical studies include:

Complete tumor clearance and survival: Combination therapy eliminated detectable tumors and achieved 100% survival in treated mice through long-term follow-up
Tumor microenvironment remodeling: ERNA-101 converted the tumor environment from immunosuppressive to immune-activated, enabling stronger immune attack on the tumor
Enhanced immune cell activity: Treatment increased the activity, survival, and persistence of key cancer-fighting T cells
Immune infiltration: Significantly more CD4⁺ and CD8⁺ T cells were able to enter tumors and engage cancer cells directly
Macrophage reprogramming: Immune cells within the tumor shifted toward a cancer-fighting state rather than a tumor-supporting state
Reduced disease burden: Treatment reduced tumor burden and decreased ascites fluid accumulation associated with advanced disease
Ovarian cancer, particularly high-grade serous ovarian carcinoma (HGSOC), remains a significant unmet medical need, with most patients diagnosed at advanced stages and high relapse rates following standard therapies. Existing treatments, including checkpoint inhibitors, have shown limited efficacy due to the highly immunosuppressive TME.

Ernexa plans to incorporate these findings into its development strategy as it advances ERNA-101 toward a first-in-human clinical trial in patients with advanced ovarian cancer. Ongoing studies are evaluating ERNA-101 in combination with checkpoint inhibitors and other immuno-oncology agents.

(Press release, Ernexa Therapeutics, MAY 6, 2026, View Source [SID1234665230])

On May 6, 2026 Revolution Medicines, Inc. (Nasdaq: RVMD), a late-stage clinical oncology company developing targeted therapies for patients with RAS-addicted cancers, reported its financial results for the quarter ended March 31, 2026, and provided an update on corporate progress.

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"Last month we reported positive results from the RASolute 302 trial of daraxonrasib, demonstrating an unprecedented improvement in overall survival in patients with previously treated metastatic pancreatic cancer," said Mark A. Goldsmith, M.D., Ph.D., chief executive officer and chairman of Revolution Medicines. "These results, which we intend to submit to global health authorities, mark a major advance for patients and strengthen our conviction in our RAS(ON) inhibition strategy across RAS-driven cancers. Reinforced by a growing body of evidence supporting our portfolio led by four innovative clinical-stage RAS(ON) inhibitors and continued expansion of our commercialization capabilities, our goal is to build Revolution Medicines into a leading targeted oncology company capable of delivering impactful therapies to patients worldwide."

Clinical Highlights

Pancreatic Ductal Adenocarcinoma (PDAC)

Daraxonrasib in PDAC

Daraxonrasib, a pioneering oral RAS(ON) multi-selective inhibitor, continues to demonstrate a differentiated clinical profile across lines of therapy and in both monotherapy and combination settings.

The company recently announced positive topline results from the pivotal, randomized Phase 3 RASolute 302 trial in second line (2L) PDAC, marking a major milestone in the development of daraxonrasib by showing its potential to improve patient outcomes. Daraxonrasib demonstrated statistically significant and clinically meaningful improvements in progression-free survival (PFS) and overall survival (OS) compared to standard of care cytotoxic chemotherapy. In the overall (intent-to-treat) study population, daraxonrasib demonstrated a median OS of 13.2 months versus 6.7 months for chemotherapy (hazard ratio 0.40; p<0.0001). Daraxonrasib was generally well tolerated, with no new safety signals.

These results are considered final for PFS and OS, and Revolution Medicines intends to submit these data to global regulatory authorities, including as part of a New Drug Application to the U.S. Food and Drug Administration (FDA) under the Commissioner’s National Priority Voucher program. The results will also be presented in a Plenary Session at the 2026 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting. Following the FDA’s "safe to proceed" determination, the company has initiated an Expanded Access Program (EAP) for daraxonrasib in patients with previously treated PDAC, as previously disclosed.

The company also presented at the 2026 American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting updated clinical data from two Phase 1/2 clinical trials for daraxonrasib as monotherapy and in combination with chemotherapy in first line (1L) PDAC. The data further support the broad clinical impact of daraxonrasib and bolster the rationale for the ongoing RASolute 303 study:

RMC-6236-001: Daraxonrasib monotherapy demonstrated a manageable safety profile and encouraging clinical activity, including early signs of durability.
RMC-GI-102: Daraxonrasib in combination with standard of care chemotherapy demonstrated a manageable safety profile and encouraging clinical activity, including early signs of durability.
The company continues to evaluate daraxonrasib in two additional global randomized registrational Phase 3 studies in adjuvant and 1L metastatic PDAC:

RASolute 303: The company recently announced that it has begun treating patients to evaluate daraxonrasib as monotherapy and in combination with chemotherapy in patients with 1L metastatic disease.
RASolute 304: Enrollment continues in the registrational trial evaluating daraxonrasib monotherapy in the adjuvant setting in patients with resectable pancreatic cancer following surgery and perioperative chemotherapy.
Daraxonrasib recently received a positive opinion from the European Medicines Agency (EMA) on Orphan Drug Designation (ODD) for the treatment of pancreatic cancer, following prior ODD granted by the FDA. Previously daraxonrasib was also awarded Breakthrough Therapy Designation and a Commissioner’s National Priority Voucher for pancreatic cancer from the FDA.

Zoldonrasib in PDAC

Zoldonrasib, an innovative oral RAS(ON) G12D-selective covalent inhibitor, has shown a highly differentiated safety and tolerability profile as monotherapy and is also being evaluated across a range of combination regimens.

The company is advancing two registrational PDAC 1L Phase 3 studies incorporating zoldonrasib in combination:

RASolute 305: A randomized, double-blind, placebo-controlled trial evaluating zoldonrasib in combination with chemotherapy has been initiated.
RASolute 309: The company remains on track to initiate, in the second half of 2026, a registrational trial evaluating the RAS(ON) inhibitor doublet combination of zoldonrasib plus daraxonrasib.
Non-Small Cell Lung Cancer (NSCLC)

Daraxonrasib in NSCLC

RASolve 301, a global, randomized Phase 3 trial evaluating daraxonrasib monotherapy in patients with previously treated NSCLC, continues enrolling patients in the U.S. and globally; the company anticipates substantially completing enrollment this year.

The company remains on track to provide an update on its plans for advancing daraxonrasib combination therapy in 1L NSCLC this year.

Zoldonrasib in NSCLC

The company presented data at the AACR (Free AACR Whitepaper) Annual Meeting evaluating zoldonrasib monotherapy in patients with previously treated RAS G12D NSCLC, which demonstrated encouraging clinical activity and a generally well tolerated safety profile consistent with previously reported findings. The Phase 2 monotherapy expansion cohort in patients with previously treated NSCLC has fully enrolled to provide a more robust assessment of clinical activity and increased optionality.

The company remains on track to initiate RASolve 308, a randomized, placebo-controlled Phase 3 trial evaluating zoldonrasib in combination with standard of care as 1L treatment for patients with metastatic RAS G12D NSCLC, in the first half of 2026.

Elironrasib in NSCLC

The company remains on track to share an update on its registrational strategy for elironrasib, an innovative oral RAS(ON) mutant-selective inhibitor that binds selectively and covalently to RAS G12C, in 2026.

Colorectal Cancer (CRC)

The company is advancing multiple combination trials in colorectal cancer, including evaluations of RAS(ON) inhibitor doublets and combinations with standard of care and other investigational approaches.

The company remains on track to share updated combination data in CRC this year as it evaluates potential paths toward pivotal development.

Clinical Collaborations

The company’s development efforts continue to involve clinical collaborations studying its RAS(ON) inhibitors with other targeted therapies, including:

The APEX-103 trial, conducted in collaboration with Summit Therapeutics, Inc. (Summit), is ongoing, evaluating Revolution Medicines’ RAS(ON) inhibitors in combination with ivonescimab, Summit’s PD-1/VEGF bispecific antibody, across multiple solid tumor settings.
A clinical collaboration with Tango Therapeutics, Inc. (Tango) is ongoing, evaluating Revolution Medicines’ RAS(ON) inhibitors in combination with vopimetostat, Tango’s MTA-cooperative PRMT5 inhibitor, in patients with tumors carrying both a RAS mutation and MTAP deletion.
A clinical collaboration with Bristol Myers Squibb (BMS) is ongoing, evaluating daraxonrasib in combination with navlimetostat, BMS’ MTA-cooperative PRMT5 inhibitor, in patients with pancreatic cancer whose tumors carry both a RAS mutation and MTAP deletion.
Early-Stage Programs

RMC-5127

RMC-5127, an oral RAS(ON) G12V-selective inhibitor, is currently being evaluated in a first-in-human clinical trial, with patients actively enrolling in the dose escalation portion of the study. The company remains on track to identify a recommended monotherapy Phase 2 dose for this compound in the second half of 2026.

Innovative New Class of RAS(ON) Inhibitors

At the AACR (Free AACR Whitepaper) Annual Meeting the company presented preclinical data showing that RM-055, a representative compound from a novel class of mutant-targeted catalytic RAS(ON) inhibitors, demonstrated deep and durable antitumor activity, including in tumors with acquired RAS-dependent resistance, across RAS G12 PDAC, NSCLC and CRC preclinical models.

The company remains on track to initiate a first-in-human clinical trial of RM-055 in the fourth quarter of 2026.

Other Corporate Updates

In April 2026, the company strengthened its balance sheet with the closing of concurrent upsized public offerings of $1,725.0 million in common stock and $500.0 million in aggregate principal amount of 0.50% convertible senior notes due 2033, raising total gross proceeds of $2,225.0 million before deducting underwriting discounts, commissions and offering expenses.

In support of the company’s growing global commercialization capabilities, the company also recently appointed several leaders across the Japan and Asia Pacific (JPAC), and European regions: Neil MacGregor as senior vice president and general manager for JPAC, Tetsuo Endo as vice president and general manager of Japan, and Martin Voelkl as vice president and general manager of Germany.

Financial Highlights

First Quarter Results

Cash Position: Cash, cash equivalents and marketable securities were $1.9 billion as of March 31, 2026. In April 2026, the company received $2.1 billion in net proceeds from the April 2026 concurrent financings.

Stock-Based Compensation Expense: Stock-based compensation expense was $87.3 million for the quarter ended March 31, 2026, compared to $25.1 million for the quarter ended March 31, 2025. In the first quarter of 2026, the company updated its equity compensation program to introduce retirement benefits for employees who meet specific minimum age and service requirements. The modification of this program resulted in increased and accelerated recognition of stock-based compensation expense for eligible awards, including an incremental $44.6 million for the quarter ended March 31, 2026. As a result of this update, the company is increasing its estimates of full year 2026 stock-based compensation expense by approximately $80 million and now expects full year 2026 stock-based compensation expense to be between $260 and $280 million.

R&D Expenses: Research and development expenses were $344.0 million for the quarter ended March 31, 2026, compared to $205.7 million for the quarter ended March 31, 2025. The increase was primarily driven by higher clinical trial and manufacturing expenses for daraxonrasib and zoldonrasib, increased personnel-related costs due to additional headcount, and higher stock-based compensation expense related to changes in retirement provisions for equity awards and increased headcount.

G&A Expenses: General and administrative expenses were $101.3 million for the quarter ended March 31, 2026, compared to $35.0 million for the quarter ended March 31, 2025. The increase was primarily driven by higher stock-based compensation expense related to changes in retirement provisions for equity awards and increased headcount, higher personnel-related costs associated with additional headcount, increased commercial preparation activities, and higher administrative costs.

Net Loss: Net loss was $453.8 million for the quarter ended March 31, 2026, compared to net loss of $213.4 million for the quarter ended March 31, 2025.

Financial Guidance
Revolution Medicines is updating its full year 2026 GAAP operating expenses guidance to a range of $1.7 to $1.8 billion. The expected increase in 2026 GAAP operating expenses is due to higher projected non-cash stock-based compensation expense for full year 2026, now estimated to be between $260 and $280 million, as described earlier.

Webcast
Revolution Medicines will host a webcast this afternoon, May 6, 2026, at 4:30 p.m. Eastern Time (1:30 p.m. Pacific Time). To listen to the live webcast, or access the archived webcast, please visit: View Source Following the live webcast, a replay will be available on the company’s website for at least 14 days.

(Press release, Revolution Medicines, MAY 6, 2026, View Source [SID1234665196])