Exelixis Announces Preliminary Fiscal Year 2025 Financial Results, Provides 2026 Financial Guidance and Outlines Key Priorities and Milestones for 2026

On January 11, 2026 Exelixis, Inc. (Nasdaq: EXEL) reported its preliminary unaudited financial results for the fiscal year 2025, provided financial guidance for fiscal year 2026 and delivered an update on its business. Exelixis anticipates 2026 will be a significant year of clinical, regulatory and commercial progress as the company grows its current cabozantinib business, works toward building a potential second commercial franchise with zanzalintinib and moves its earlier stage pipeline forward. As outlined at its December 2025 R&D Day, the company seeks to leverage its diverse pipeline and key clinical collaborations to build next-generation oncology franchises that can improve standards of care for patients with cancer.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Preliminary Fiscal Year 2025 Financial Results & 2026 Financial Guidance

Exelixis is providing the following preliminary unaudited 2025 financial results and financial guidance for 2026. Net product and total revenues guidance do not currently reflect any revenues resulting from a potential U.S. regulatory approval and commercial launch of zanzalintinib for the treatment of patients with previously treated metastatic colorectal cancer (CRC). The U.S. Food and Drug Administration (FDA) is currently reviewing Exelixis’ New Drug Application (NDA) for this proposed indication, when used in combination with atezolizumab (Tecentriq).

Fiscal Year 2025

Fiscal Year 2026 Guidance

Total revenues

~ $2.320 billion

$2.525 billion – $2.625 billion

Net product revenues

~ $2.123 billion

$2.325 billion – $2.425 billion(1)

Cost of goods sold, % of net product revenues

~ 3.7%

3.5% – 4.5%

Research and development expenses

~ $825 million(2)

$875 million – $925 million(3)

Selling, general and administrative expenses

~ $520 million(4)

$575 million – $625 million(5)

Effective tax rate

n/a(6)

21% – 23%

Ending cash and marketable securities(7)

~ $1.65 billion

n/p

(1)

Exelixis’ 2026 net product revenues guidance range includes the impact of a U.S. wholesale acquisition cost increase of 3.0% for both CABOMETYX and COMETRIQ effective on January 1, 2026.

(2)

Includes $40.8 million of non-cash stock-based compensation expense.

(3)

Includes $50.0 million of non-cash stock-based compensation expense.

(4)

Includes $72.2 million of non-cash stock-based compensation expense.

(5)

Includes $75.0 million of non-cash stock-based compensation expense.

(6)

Preliminary results not yet available.

(7)

Cash and marketable securities are composed of cash, cash equivalents and marketable securities. Fiscal year 2026 guidance not provided (n/p).

The preliminary 2025 financial information presented in this press release has not been audited and is subject to change. The complete Exelixis Fourth Quarter and Fiscal Year 2025 Financial Results are planned for release after market on Tuesday, February 10, 2026.

"Exelixis enters 2026 with a strong and growing commercial business, the opportunity to bring a potential second oncology franchise to market and an exciting pipeline of novel small molecules and biotherapeutics," said Michael M. Morrissey, Ph.D., President & CEO, Exelixis. "Our momentum accelerated throughout 2025, driven by the continued strong commercial performance of CABOMETYX in renal cell carcinoma and advanced neuroendocrine tumors. We also achieved major milestones with the first positive pivotal data readout and subsequent U.S. regulatory filing for zanzalintinib, our next potential franchise molecule, and drove meaningful pipeline progress."

Dr. Morrissey continued: "To achieve our goal of becoming a top-5 solid tumor oncology company, Exelixis is pursuing a multi-franchise approach that fosters innovation, manages risk and maximizes the value of our portfolio for all our stakeholders. Building on the cabozantinib experience, we aim to establish lasting franchises in renal cell carcinoma, neuroendocrine tumors and colorectal cancer where our products can be successful as monotherapies or in combination, including with other Exelixis pipeline assets. Through careful prioritization and disciplined investments in high-value opportunities, we are confident we can drive sustained near- to mid-term growth while returning capital to shareholders and improving the standards of care for patients with cancer."

Anticipated Cabozantinib Milestones

Growth and Acceleration of Cabozantinib Commercial Franchise. Exelixis expects cabozantinib franchise growth to continue in 2026, building on the product’s position as the leading tyrosine kinase inhibitor (TKI) and oral therapy in renal cell carcinoma (RCC) and neuroendocrine tumors (NET). As of the third quarter 2025, in RCC, CABOMETYX (cabozantinib) was the market leader as the number one TKI monotherapy and the most prescribed TKI in combination with immunotherapy (IO). The accelerating uptake in NET builds on the March 2025 U.S. regulatory approval of CABOMETYX for two new NET indications, advanced pancreatic and extra-pancreatic NET (pNET and epNET), based on results from the CABINET study. As of the third quarter 2025, CABOMETYX was the leading oral therapy in the second-or-later line (2L+) NET market, with broad uptake across 2L+ patient types and practice settings. Based on this success and with additional gastrointestinal (GI) cancer opportunities ahead, Exelixis is expediting the full buildout of its GI sales team to accelerate growth in NET and prepare for potential future indications for zanzalintinib in GI cancers.

Anticipated Zanzalintinib Milestones

Ongoing U.S. Regulatory Review in CRC. Exelixis is preparing for the potential first commercial launch of zanzalintinib for the treatment of patients with previously treated CRC, when used in combination with atezolizumab. The regulatory filing was based on positive results from the phase 3 STELLAR-303 pivotal trial, which met one of its dual primary endpoints, with the combination of zanzalintinib and atezolizumab demonstrating a statistically significant reduction in the risk of death versus regorafenib in the intention-to-treat population at the final analysis. An overall survival (OS) benefit with the combination was consistently observed across pre-specified subgroups, including geographic region, RAS status, liver involvement and prior anti-VEGF therapy.

STELLAR-303 CRC Study Final Analysis of Second Dual Primary Endpoint of OS in Patients without Liver Metastases Expected Mid-2026. In 2025, a prespecified interim analysis of STELLAR-303’s other dual primary endpoint, OS in patients without liver metastases (non-liver metastases or NLM), showed a trend favoring the combination; however, these data were immature at the data cutoff. The trial is proceeding to the planned final analysis for this endpoint, which is expected in mid-2026, based on current event rates.

Topline Results for STELLAR-304 Anticipated Mid-2026. STELLAR-304 is a phase 3 pivotal trial evaluating zanzalintinib in combination with nivolumab versus sunitinib in previously untreated patients with advanced non-clear cell RCC. The primary endpoints in the trial are progression-free survival (PFS) and objective response rate (ORR). STELLAR-304 completed enrollment in May 2025. Topline results expected in mid-2026, based on current event rates.

Enrollment Progress for STELLAR-311 Trial of Zanzalintinib in Advanced NET. Exelixis is actively enrolling patients in the phase 2/3 STELLAR-311 pivotal trial, which is evaluating zanzalintinib versus everolimus as a first oral therapy in patients with advanced NET, regardless of site of origin, who have received up to one prior line of therapy. Initiated in June 2025, STELLAR-311 is the first study to randomize a small molecule against an active control in this setting, with the potential to broadly redefine oral treatment options for these patients. The primary endpoint of the trial is PFS per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 as assessed by Blinded Independent Central Review.

Additional Ongoing and Planned Pivotal Trials for Zanzalintinib. In addition to the ongoing Exelixis-sponsored STELLAR-303, -304, and -311 trials, additional zanzalintinib pivotal trials include:

LITESPARK-033, which is evaluating the combination of zanzalintinib and WELIREG (belzutifan) versus cabozantinib in first-line advanced RCC following IO administered in the adjuvant setting. LITESPARK-033 was initiated in December 2025 and is the first Merck-sponsored pivotal trial of zanzalintinib and belzutifan in RCC under the companies’ clinical development collaboration. A second Merck-sponsored pivotal trial of zanzalintinib and belzutifan in RCC is anticipated to begin in early 2026. Details of this anticipated study are forthcoming.
STELLAR-316, which will evaluate the potential of zanzalintinib, with and without an immune checkpoint inhibitor, to keep patients disease-free in the adjuvant CRC setting. As currently proposed, the study will enroll patients with resected stage II/III CRC who have completed definitive therapy and tested positive for molecular residual disease (MRD), but do not have radiographic evidence of disease. The primary endpoint of STELLAR-316 is disease-free survival, with secondary endpoints including circulating tumor DNA clearance. Exelixis recently announced a collaboration with Natera, a global leader in cell-free DNA and precision medicine, in which Natera will provide its Signatera assay to identify MRD-positive patients for enrollment in the trial. Exelixis expects to initiate STELLAR-316 in mid-2026.
STELLAR-201, which will evaluate zanzalintinib in recurrent meningioma, the most common primary intracranial neoplasm for which there are currently no approved systemic therapies. The study is planned to enroll patients with Grade I/II/III meningioma with relapse/progression following radiation/surgery or who are not candidates for radiation/surgery. The proposed primary endpoint of the trial is ORR, with secondary endpoints including duration of response, PFS and OS. Pending favorable results, the trial represents an opportunity for zanzalintinib to become the first and only systemic therapy approved for this form of cancer. Exelixis expects to initiate STELLAR-201 in mid-2026, and a confirmatory phase 3 study is also being planned.
Anticipated R&D Milestones

Progress of Phase 1 Clinical Programs for XL309, XB010, XB628 and XB371. Exelixis is advancing ongoing phase 1 clinical trials for XL309 (USP1 inhibitor), XB010 (5T4-targeting ADC), XB628 (PD-L1 + NKG2A bispecific) and XB371 (TF-targeting ADC). If phase 1 data are supportive, Exelixis plans to progress these molecules into full development as part of its strategy to build next-generation oncology franchises across tumor types and novel combination regimens, including with zanzalintinib and other therapeutic modalities. Combination opportunities of particular development interest highlighted at the December 2025 R&D Day include zanzalintinib plus XB628 in both advanced RCC and CRC.

Two Potential IND Applications in 2026. Exelixis anticipates advancing two programs into clinical development this year:

XL557 is an orally bioavailable small molecule Somatostatin Receptor 2 agonist. Somatostatin analogs are widely used in the first- and second-line NET treatment settings, but currently available therapies are administered via injection and pose associated challenges. Exelixis believes XL557 has the potential to become a best-in-class molecule that could serve NET patients across all lines of treatment as a monotherapy and potentially in combination with zanzalintinib.
XB773 is an antibody-drug conjugate (ADC) consisting of an exatecan payload conjugated to a monoclonal antibody targeting DLL3, a transmembrane protein that is expressed in neuroendocrine carcinomas such as small cell lung cancer and neuroendocrine prostate cancer. Exelixis believes XB773 could be a best-in-class molecule with better payload delivery compared to competitor ADCs and potential for improved therapeutic benefit, as well as strong combination potential that would facilitate its use in earlier lines and settings.
Corporate Updates

Stock Repurchase Program (SRP) Update. Since Exelixis’ Board of Directors authorized the first SRP in March 2023, Exelixis has repurchased a total of $2.16 billion of the company’s common stock, retiring 76.7 million shares, at an average price of $28.14 per share, as of the end of fiscal year 2025. In October 2025, Exelixis’ Board of Directors authorized the repurchase of up to an additional $750 million of the company’s common stock before December 31, 2026. Exelixis has begun executing stock repurchases under the October 2025 SRP, which is the fifth such program to be undertaken by the company since March 2023. Stock repurchases under this program may be made from time to time through a variety of methods, which may include open market purchases, in block trades, Rule 10b5-1 trading plans, accelerated share repurchase transactions, exchange transactions or any combination of such methods. The timing and amount of any stock repurchases under the SRP will be based on a variety of factors, including ongoing assessments of the capital needs of the business, alternative investment opportunities, the market price of our common stock and general market conditions. The program does not obligate Exelixis to acquire any amount of its common stock, and the SRP may be modified, suspended or discontinued at any time without prior notice.

Presentation and Webcast

Exelixis President and Chief Executive Officer Michael M. Morrissey, Ph.D., will provide a corporate overview and discuss the company’s preliminary fiscal year 2025 financial results, 2026 financial guidance and key priorities and milestones for 2026 during the company’s presentation at the J.P. Morgan 2026 Healthcare Conference beginning at 5:15 p.m. PT / 8:15 p.m. ET on Monday, January 12, 2026.

To access the webcast link, log onto www.exelixis.com and proceed to the Event Calendar page under the Investors & News heading. A replay will also be available at the same location for at least 30 days.

(Press release, Exelixis, JAN 11, 2026, View Source [SID1234661921])

Molecular Partners Highlights Clinical Development Progress and Anticipated Milestones at 44th Annual J.P. Morgan Healthcare Conference

On January 11, 2026 Molecular Partners AG (SIX: MOLN; NASDAQ: MOLN), a clinical-stage biotech company developing a novel class of protein drugs known as DARPin therapeutics ("Molecular Partners" or the "Company"), reported an update on its latest progress, developments plans and expected 2026 milestones, which it will present at the 44th Annual J.P. Morgan Healthcare Conference in San Francisco, California.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"We are excited to have opened our Phase 1/2a trial in the US for MP0712, our Radio-DARPin targeting DLL3, and look forward to seeing initial clinical data in 2026. Our half-life optimized approach allows us to capitalize on the rapid target internalization to deposit more radiation compared to peptide-like approaches, affording us the ambition to become a leader in alpha-targeted radiotherapy in SCLC," said Patrick Amstutz, Ph.D., CEO of Molecular Partners. "Next to MP0726 targeting MSLN for ovarian cancer, we are working on 4 additional radiotherapy programs and will update on progress in H1 2026. In addition to our Radio-DARPin pipeline, we are progressing MP0317 and MP0533 in clinical trials, ideally led by investigators, and planning first Switch-DARPin candidates for development."

Cash and Cash Equivalents:
As of December 31, 2025, Molecular Partners reports cash and cash equivalents of CHF 93.1 million (unaudited). Based on current operating assumptions, this will be sufficient to fund operating expenses and capital expenditure requirements until 2028. The Company will provide full 2025 financial results on March 12, 2026.

Key current program status updates include:

MP0712 & Radio-DARPin pipeline

MP0712, the Company’s lead Radio-DARPin Therapy (RDT) based on 212Pb and targeting the tumor-associated protein delta-like ligand 3 (DLL3), is being developed with strategic partner Orano Med, pioneer in targeted alpha therapy, for the treatment of patients with small cell lung cancer (SCLC) and other neuroendocrine cancers. The Investigational New Drug (IND) application has been cleared and a Phase 1/2a trial has now started (ClinicalTrials.gov: NCT07278479). A first site is open and dosing of the first patient is expected in Q1 2026. The Phase 1/2a study is a multi-center study in the US, with the objectives to assess safety and determine a recommended phase 2 dose for MP0712. The study contains an imaging and dosimetry step with 203Pb-labeled MP0712. The Company expects initial clinical data from the study in 2026.

Molecular Partners presented new data on MP0712 at the Targeted Radiopharmaceuticals (TRP) Summit Europe in November 2025, highlighting first encouraging images of a patient receiving MP0712 carrying the diagnostic isotope 203Pb. The images, obtained through a Named Patient Access Program for compassionate care at NuMeRI in South Africa show targeted delivery of MP0712 into tumors and limited exposure in healthy organs such as kidney and liver, as intended. The NuMeRI team, led by Prof. Mike Sathekge, plans to report the full imaging and dosimetry data of MP0712 at the Theranostics World Congress (TWC) in January 2026.

The Company’s second RDT program MP0726, co-developed with Orano Med, targets mesothelin (MSLN), a tumor target overexpressed across several cancers with high unmet need, such as ovarian cancer. Molecular Partners has developed Radio-DARPins able to selectively bind to membrane-bound MSLN without being impacted by shed MSLN – a mechanism which has hampered the development of other MSLN-targeted therapeutics. The Company presented preclinical data on MP0726 at the 2025 Annual Meeting of the Society of Nuclear Medicine and Molecular Imaging (SNMMI) in June. The Company is planning to progress several Radio-DARPin programs towards first-in-human imaging, including MP0726.

Furthermore, Molecular Partners announced in December 2025 the formation of a scientific advisory board (SAB) to accelerate the development of its targeted radiotherapeutics. The SAB, chaired by globally recognized nuclear medicine expert Prof. Ken Herrmann, will be instrumental in guiding Molecular Partners strategic direction as it transitions and evolves from early clinical validation to full clinical development of its targeted alpha radiotherapies.

Molecular Partners has designed its Radio-DARPins as ideal vectors for precise delivery of potent alpha-emitting isotopes to tumor lesions and have the potential to unlock a broad range of solid tumor targets for radiopharmaceuticals.

MP0317 (tumor-localized CD40 agonist)

An investigator-initiated, proof-of-concept Phase 2 study of MP0317 in combination with standard-of-care for the treatment of patients with advanced cholangiocarcinoma is now open with two sites activated (NCT07036380). The first patient was treated in early 2026, additional sites are being activated and patients are in screening. The study is a randomized, multicenter study in France and aims to recruit 75 patients (50 in the experimental arm, 25 in the control arm). The objective of the study is to assess the clinical benefit of MP0317 combined with standard-of-care, which comprises the immunotherapy durvalumab (an anti-PD-L1 checkpoint inhibitor) plus gemcitabine-cisplatin-based chemotherapy.

MP0317 is designed to activate immune cells specifically within the tumor microenvironment by anchoring to fibroblast activation protein (FAP), which is expressed in high amounts in the stroma of various solid tumors. The Company completed a Phase 1 dose escalation study of MP0317 in patients with advanced solid tumors with 46 patients treated across 9 dose levels, and has presented comprehensive biomarker analyses from the trial at SITC (Free SITC Whitepaper) 2024 showing tumor-localized CD40 activation and tumor microenvironment remodeling. The Company believes this tumor-localized approach has the potential to deliver greater efficacy with fewer side effects compared to systemic CD40-targeting therapies.

MP0533 (multispecific T cell engager)

MP0533 is currently being evaluated in a Phase 1/2a clinical trial for relapsed/refractory acute myeloid leukemia (AML) and myelodysplastic syndrome/AML (NCT05673057).

Data presented at the 67th American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting in December 2025 showed that densified dosing appears tolerable, and leads to markedly improved serum exposure in cycle 1 and encouraging preliminary antitumor activity, in particular in patients with low bone marrow blast count at baseline. Cohort 10 is currently dosing patients, with an update on the program foreseen in H1 2026.

Molecular Partners plans to support the exploration of MP0533 in combination, both in patients with relapsed/refractory disease as well as in front-line, and has been approached by several consortia expressing interest in conducting such studies. The Company is actively engaging with key opinion leaders and regulators to shape the next phase of development, and anticipates updating the clinical plan for MP0533 in H1 2026.

MP0533 is a novel tetra-specific T cell-engaging DARPin designed for selective and broad killing of AML cells in a mutation-agnostic manner. MP0533’s mode of action enables T cell-mediated killing of AML cells – which commonly co-express at least two of the three targeted atigens (CD33, CD123, CD70) – while preserving a therapeutic window that minimizes damage to healthy cells, which normally express one or none of the targets.

Switch-DARPin (next-generation immune cell engagers)

Molecular Partners designed a logic-gated Switch-DARPin TCE to achieve conditional tumor-localized immune activation targeting MSLN and epithelial cell adhesion molecule (EpCAM), which are highly co-expressed in ovarian cancer and other solid tumors. The Switch-DARPin TCE is designed to unmask the CD3-engaging DARPin ("Switch" on) and to activate T cells only upon binding to both MSLN and EpCAM. This Switch-DARPin is half-life extended through a Fc domain, which broadens the Company’s capabilities in half-life engineering modalities.

Based on the encouraging pre-clinical data presented in 2025 at AACR (Free AACR Whitepaper) and SITC (Free SITC Whitepaper), the Company intends to nominate a lead Switch-DARPin candidate for development in H1 2026 and will provide an update on the program at AACR (Free AACR Whitepaper) 2026.

J.P. Morgan Presentation Details:

Presenter: Molecular Partners CEO Patrick Amstutz
Time: January 15, 2026, at 10:30-11:10AM PT (19:30-20:10 CET)
Location: The Westin St. Francis San Francisco, CA, USA.

A webcast will be accessible on the Molecular Partners website, under the Events tab.

(Press release, Molecular Partners, JAN 11, 2026, View Source [SID1234661922])

Molecular Partners Highlights Clinical Development Progress and Anticipated Milestones at 44th Annual J.P. Morgan Healthcare Conference

On January 11, 2026 Molecular Partners AG (SIX: MOLN; NASDAQ: MOLN), a clinical-stage biotech company developing a novel class of protein drugs known as DARPin therapeutics ("Molecular Partners" or the "Company"), reported an update on its latest progress, developments plans and expected 2026 milestones, which it will present at the 44th Annual J.P. Morgan Healthcare Conference in San Francisco, California.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"We are excited to have opened our Phase 1/2a trial in the US for MP0712, our Radio-DARPin targeting DLL3, and look forward to seeing initial clinical data in 2026. Our half-life optimized approach allows us to capitalize on the rapid target internalization to deposit more radiation compared to peptide-like approaches, affording us the ambition to become a leader in alpha-targeted radiotherapy in SCLC," said Patrick Amstutz, Ph.D., CEO of Molecular Partners. "Next to MP0726 targeting MSLN for ovarian cancer, we are working on 4 additional radiotherapy programs and will update on progress in H1 2026. In addition to our Radio-DARPin pipeline, we are progressing MP0317 and MP0533 in clinical trials, ideally led by investigators, and planning first Switch-DARPin candidates for development."

Cash and Cash Equivalents:
As of December 31, 2025, Molecular Partners reports cash and cash equivalents of CHF 93.1 million (unaudited). Based on current operating assumptions, this will be sufficient to fund operating expenses and capital expenditure requirements until 2028. The Company will provide full 2025 financial results on March 12, 2026.

Key current program status updates include:

MP0712 & Radio-DARPin pipeline

MP0712, the Company’s lead Radio-DARPin Therapy (RDT) based on 212Pb and targeting the tumor-associated protein delta-like ligand 3 (DLL3), is being developed with strategic partner Orano Med, pioneer in targeted alpha therapy, for the treatment of patients with small cell lung cancer (SCLC) and other neuroendocrine cancers. The Investigational New Drug (IND) application has been cleared and a Phase 1/2a trial has now started (ClinicalTrials.gov: NCT07278479). A first site is open and dosing of the first patient is expected in Q1 2026. The Phase 1/2a study is a multi-center study in the US, with the objectives to assess safety and determine a recommended phase 2 dose for MP0712. The study contains an imaging and dosimetry step with 203Pb-labeled MP0712. The Company expects initial clinical data from the study in 2026.

Molecular Partners presented new data on MP0712 at the Targeted Radiopharmaceuticals (TRP) Summit Europe in November 2025, highlighting first encouraging images of a patient receiving MP0712 carrying the diagnostic isotope 203Pb. The images, obtained through a Named Patient Access Program for compassionate care at NuMeRI in South Africa show targeted delivery of MP0712 into tumors and limited exposure in healthy organs such as kidney and liver, as intended. The NuMeRI team, led by Prof. Mike Sathekge, plans to report the full imaging and dosimetry data of MP0712 at the Theranostics World Congress (TWC) in January 2026.

The Company’s second RDT program MP0726, co-developed with Orano Med, targets mesothelin (MSLN), a tumor target overexpressed across several cancers with high unmet need, such as ovarian cancer. Molecular Partners has developed Radio-DARPins able to selectively bind to membrane-bound MSLN without being impacted by shed MSLN – a mechanism which has hampered the development of other MSLN-targeted therapeutics. The Company presented preclinical data on MP0726 at the 2025 Annual Meeting of the Society of Nuclear Medicine and Molecular Imaging (SNMMI) in June. The Company is planning to progress several Radio-DARPin programs towards first-in-human imaging, including MP0726.

Furthermore, Molecular Partners announced in December 2025 the formation of a scientific advisory board (SAB) to accelerate the development of its targeted radiotherapeutics. The SAB, chaired by globally recognized nuclear medicine expert Prof. Ken Herrmann, will be instrumental in guiding Molecular Partners strategic direction as it transitions and evolves from early clinical validation to full clinical development of its targeted alpha radiotherapies.

Molecular Partners has designed its Radio-DARPins as ideal vectors for precise delivery of potent alpha-emitting isotopes to tumor lesions and have the potential to unlock a broad range of solid tumor targets for radiopharmaceuticals.

MP0317 (tumor-localized CD40 agonist)

An investigator-initiated, proof-of-concept Phase 2 study of MP0317 in combination with standard-of-care for the treatment of patients with advanced cholangiocarcinoma is now open with two sites activated (NCT07036380). The first patient was treated in early 2026, additional sites are being activated and patients are in screening. The study is a randomized, multicenter study in France and aims to recruit 75 patients (50 in the experimental arm, 25 in the control arm). The objective of the study is to assess the clinical benefit of MP0317 combined with standard-of-care, which comprises the immunotherapy durvalumab (an anti-PD-L1 checkpoint inhibitor) plus gemcitabine-cisplatin-based chemotherapy.

MP0317 is designed to activate immune cells specifically within the tumor microenvironment by anchoring to fibroblast activation protein (FAP), which is expressed in high amounts in the stroma of various solid tumors. The Company completed a Phase 1 dose escalation study of MP0317 in patients with advanced solid tumors with 46 patients treated across 9 dose levels, and has presented comprehensive biomarker analyses from the trial at SITC (Free SITC Whitepaper) 2024 showing tumor-localized CD40 activation and tumor microenvironment remodeling. The Company believes this tumor-localized approach has the potential to deliver greater efficacy with fewer side effects compared to systemic CD40-targeting therapies.

MP0533 (multispecific T cell engager)

MP0533 is currently being evaluated in a Phase 1/2a clinical trial for relapsed/refractory acute myeloid leukemia (AML) and myelodysplastic syndrome/AML (NCT05673057).

Data presented at the 67th American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting in December 2025 showed that densified dosing appears tolerable, and leads to markedly improved serum exposure in cycle 1 and encouraging preliminary antitumor activity, in particular in patients with low bone marrow blast count at baseline. Cohort 10 is currently dosing patients, with an update on the program foreseen in H1 2026.

Molecular Partners plans to support the exploration of MP0533 in combination, both in patients with relapsed/refractory disease as well as in front-line, and has been approached by several consortia expressing interest in conducting such studies. The Company is actively engaging with key opinion leaders and regulators to shape the next phase of development, and anticipates updating the clinical plan for MP0533 in H1 2026.

MP0533 is a novel tetra-specific T cell-engaging DARPin designed for selective and broad killing of AML cells in a mutation-agnostic manner. MP0533’s mode of action enables T cell-mediated killing of AML cells – which commonly co-express at least two of the three targeted atigens (CD33, CD123, CD70) – while preserving a therapeutic window that minimizes damage to healthy cells, which normally express one or none of the targets.

Switch-DARPin (next-generation immune cell engagers)

Molecular Partners designed a logic-gated Switch-DARPin TCE to achieve conditional tumor-localized immune activation targeting MSLN and epithelial cell adhesion molecule (EpCAM), which are highly co-expressed in ovarian cancer and other solid tumors. The Switch-DARPin TCE is designed to unmask the CD3-engaging DARPin ("Switch" on) and to activate T cells only upon binding to both MSLN and EpCAM. This Switch-DARPin is half-life extended through a Fc domain, which broadens the Company’s capabilities in half-life engineering modalities.

Based on the encouraging pre-clinical data presented in 2025 at AACR (Free AACR Whitepaper) and SITC (Free SITC Whitepaper), the Company intends to nominate a lead Switch-DARPin candidate for development in H1 2026 and will provide an update on the program at AACR (Free AACR Whitepaper) 2026.

J.P. Morgan Presentation Details:

Presenter: Molecular Partners CEO Patrick Amstutz
Time: January 15, 2026, at 10:30-11:10AM PT (19:30-20:10 CET)
Location: The Westin St. Francis San Francisco, CA, USA.

A webcast will be accessible on the Molecular Partners website, under the Events tab.

(Press release, Molecular Partners, JAN 11, 2026, View Source [SID1234661959])

IDEAYA Biosciences Provides a Business Update and Outlines 2026 Corporate Objectives at the 44th Annual J.P. Morgan Healthcare Conference

On January 11, 2026 IDEAYA Biosciences, Inc. (NASDAQ: IDYA), a leading precision medicine oncology company, reported a business update including an overview of key corporate objectives for 2026. The company will review these updates during its presentation at the 44th Annual J.P. Morgan Healthcare Conference on Monday, January 12, 2026 at 3:45pm PST.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"2025 was a year of execution, marked by broad pipeline advancement, commercial readiness activities for darovasertib, and the filing of four INDs resulting in nine clinical programs. Our deep pipeline and cash runway into 2030 enable IDEAYA to advance key combinations and to address multiple indications with high unmet need, including uveal melanoma, small cell lung cancer, neuroendocrine cancer, breast cancer, and MTAP-deleted lung, pancreatic, and urothelial cancers. In 2026, we plan to advance four registrational trials, including for IDE849, our Phase 1 DLL3 TOP1 ADC, as a monotherapy agent in neuroendocrine cancer, and darovasertib in both pre-metastatic and metastatic settings of uveal melanoma. These trials for darovasertib are central to our strategy to save eyes, preserve vision, and extend lives for patients with uveal melanoma – one of the poorest prognosis indications in oncology where the majority of patients have no available FDA approved therapies," said Yujiro S. Hata, President and Chief Executive Officer of IDEAYA Biosciences.

2026 Corporate Objectives

Darovasertib in uveal melanoma (UM)

Topline results, including progression free survival (PFS) data, from ongoing registrational Phase 2/3 OptimUM-02 trial of the darovasertib and crizotinib combination in first line (1L) patients with HLA*A2-negative metastatic UM (mUM) are expected in Q1 ’26
Randomized PFS analysis is based on the first 130 PFS events from the intent-to-treat population (ITT) enrolled in the Phase 2b/3 portion of the trial, which comprises approximately 313 patients randomized 2:1 to the treatment versus control arm. The topline PFS results, if positive, are anticipated to enable a potential accelerated approval filing in the United States
Darovasertib is anticipated to be in three randomized, Phase 3 registrational trials across all stages of uveal melanoma by H1 ’26
OptimUM-02 (mUM): full enrollment of 437 patients complete; overall survival (OS) data expected to support a filing for full approval in 1L HLA*A2-negative mUM
OptimUM-10 (neoadjuvant): complete full enrollment of approximately 450 patients across enucleation and plaque brachytherapy cohorts by H1 ’27
OptimUM-11 (adjuvant): initiate trial in collaboration with Servier in Q2 ’26
Complete enrollment of approximately 80 HLA*A2-positive mUM patients in ongoing single-arm, Phase 2 OptimUM-01 trial of darovasertib in combination with crizotinib by Q2 ’26; data to support a potential real world evidence (RWE) submission to the U.S. Food and Drug Administration (FDA) and/or NCCN/compendia listing in this patient subset
Antibody-drug Conjugate (ADC) + DNA damage response (DDR) combinations

IDE849 (DLL3 TOP1 ADC): target to initiate a monotherapy registrational study in the second line/refractory setting (2L+) of small cell lung cancer (SCLC) and/or neuroendocrine carcinomas (NEC) by the end of 2026
IDE034 (B7H3/PTK7 bispecific TOP1 ADC): initiate Phase 1 dose escalation trial in Q1 ’26
IDE161 (PARG): initiate clinical combination studies with IDE849 in SCLC, NEC and other DLL3-overexpressing solid tumors in Q2 ’26
MTAP Pathway

IDE397 (MAT2A): provide updated data from Phase 1/2 combination trial with Trodelvy in MTAP-deleted urothelial cancer (UC) at a medical conference in 2026
IDE892 (PRMT5): initiate a Phase 1 monotherapy dose escalation trial in Q1 ’26 to enable a combination trial with IDE397 in MTAP-deleted non-small cell lung cancer (NSCLC) in Q2 ’26
Submit an investigational new drug (IND) application for a potential first-in-class program targeting CDKN2A, the most common co-alteration of MTAP, by the end of 2026. With the CDKN2A candidate, IDEAYA plans to enable wholly owned combinations with IDE892 and IDE397 in MTAP-deleted non-small cell lung cancer (NSCLC) and pancreatic ductal adenocarcinoma (PDAC), and with IDE574, IDEAYA’s dual KAT6/7 inhibitor
Next Generation Therapies

IDE574 (KAT6/7): obtained clearance of an IND application with the U.S. FDA in January 2026; target to initiate Phase 1 dose escalation trial in Q1 ’26
Corporate

~$1.1 billion in cash, cash equivalents and marketable securities as of 9/30/25; expected to fund current operating plan into 2030
Darovasertib commercial readiness activities advancing in the United States and globally with their partner, Servier
IDEAYA’s updated corporate presentation reflecting its 2026 corporate guidance is available on its website under the Investor Relations section: View Source

(Press release, Ideaya Biosciences, JAN 11, 2026, View Source [SID1234661924])

Pfizer’s BRAFTOVI® Regimen with Additional Chemotherapy Backbone Increased Response Rates for Certain Patients with Metastatic Colorectal Cancer

On January 10, 2026 Pfizer Inc. (NYSE: PFE) reported positive results from Cohort 3, a separate randomized cohort of the pivotal BREAKWATER trial, evaluating BRAFTOVI (encorafenib) in combination with cetuximab (marketed as ERBITUX) and FOLFIRI (fluorouracil, leucovorin, and irinotecan) in patients with previously untreated metastatic colorectal cancer (mCRC) with a BRAF V600E mutation. At the time of this analysis, the BRAFTOVI combination regimen with FOLFIRI and cetuximab demonstrated a clinically meaningful and statistically significant improvement in confirmed objective response rate (ORR) assessed by blinded independent central review (BICR) compared to patients receiving standard-of-care treatment FOLFIRI with or without bevacizumab (64.4% vs 39.2%, odds ratio =2.76, p=0.001). These data will be presented today in an oral presentation (Abstract 13) at the 2026 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Gastrointestinal (ASCO GI) Cancers Symposium and highlighted in the ASCO (Free ASCO Whitepaper) GI official press program.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"These results represent a great advance for patients with BRAF V600E-mutant metastatic colorectal cancer. We’ve seen this approach significantly increase the response compared to FOLFIRI with or without bevacizumab, and these responses were rapid and durable," said Scott Kopetz, M.D., Ph.D., FACP, Professor and Deputy Chair of Gastrointestinal Medical Oncology at The University of Texas MD Anderson Cancer Center and co-principal investigator of the BREAKWATER trial. "The trial supports the potential for another chemotherapy backbone option that may be paired with encorafenib plus cetuximab in this patient population."

The estimated median duration of response as assessed by BICR was not estimable with BRAFTOVI plus cetuximab and FOLFIRI (95% Confidence Interval [CI]: not estimable [NE]-NE) or with FOLFIRI with or without bevacizumab (95% CI: 7.0 months-NE). Of patients on BRAFTOVI plus cetuximab and FOLFIRI, 57.4% had a response lasting 6 months or longer, compared to 34.5% with FOLFIRI with or without bevacizumab.

Overall survival (OS) data were analyzed descriptively (Hazard Ratio [HR]: 0.49, 95% CI: 0.24-1.03; median follow-up of approximately 10 months for both arms). The BREAKWATER trial is ongoing with an estimated completion in 2027.

"These data further strengthen the potential utility of BRAFOTVI for patients with BRAF V600E-mutant metastatic colorectal cancer. The significant improvement in response rates reflects the meaningful clinical benefit of this targeted combination therapy regimen for patients," said Jeff Legos, Chief Oncology Officer, Pfizer. "These results underscore the potential of BRAFTOVI as a standard of care for patients with this aggressive cancer and reflect our commitment to advancing precision medicine options that help tailor treatment based on patients’ needs."

The safety profile of BRAFTOVI in combination with cetuximab and FOLFIRI was consistent with the known safety profile of each respective agent. No new safety signals were identified. The most common side effects (≥15%) were nausea, diarrhea, vomiting, alopecia, anemia, neutrophil count decreased, decreased appetite, fatigue, neutropenia, skin hyperpigmentation, dry skin, asthenia, weight decreased, arthralgia, palmar-plantar erythrodysaesthesia syndrome, rash, white blood cell count decreased, and constipation. Among patients receiving BRAFTOVI in combination with cetuximab and FOLFIRI, 8.5% experienced an adverse reaction that resulted in permanent discontinuation of BRAFTOVI.

BRAFTOVI in combination with cetuximab and FOLFIRI is an investigational regimen and is not currently approved for use. BRAFTOVI in combination with cetuximab and mFOLFOX6 received accelerated approval by the U.S. Food and Drug Administration (FDA) in December 2024 for patients with BRAF V600E -mutant mCRC based on a clinically meaningful and statistically significant improvement in confirmed ORR in treatment-naïve patients, one of the study’s primary endpoints. Continued approval for this indication is contingent upon verification of clinical benefit.

Pfizer is continuing its commitment to help non-scientists understand the latest findings with the development of abstract plain language summaries (APLS) for company-sponsored research being presented, which are written in non-technical language. Those interested in learning more can visit www.Pfizer.com/apls to access the summaries.

About BREAKWATER
BREAKWATER is a Phase 3, randomized, active-controlled, open-label, multicenter trial of BRAFTOVI with cetuximab, alone or in combination with chemotherapy (mFOLFOX6 or FOLFIRI) in participants with previously untreated BRAF V600E-mutant mCRC. Patients were randomized to receive BRAFTOVI 300 mg orally once daily in combination with cetuximab (discontinued after randomization of 158 patients), BRAFTOVI 300 mg orally once daily in combination with cetuximab and mFOLFOX6 (n=236) or mFOLFOX6, FOLFOXIRI, or CAPOX, with or without bevacizumab (control arm) (n=243). The dual primary endpoints for these study groups are ORR and PFS as assessed by BICR. OS is a key secondary endpoint. In Cohort 3, patients were randomized to receive BRAFTOVI 300 mg orally once daily in combination with cetuximab and FOLFIRI (n=73) or FOLFIRI, with or without bevacizumab (control-arm) (n=74). The primary endpoint of Cohort 3 is ORR as assessed by BICR. PFS is a key secondary endpoint; OS is a secondary endpoint.

About Colorectal Cancer (CRC)
CRC is the third most common type of cancer in the world, with approximately 1.8 million new diagnoses in 2022.1 It is the second leading cause of cancer-related deaths.2 Overall, the lifetime risk of developing CRC is about 1 in 24 for men and 1 in 26 for women.2 In the U.S. alone, an estimated 154,270 people will be diagnosed with cancer of the colon or rectum in 2025, and approximately 53,000 are estimated to die from the disease each year.3 For 20% of those diagnosed with CRC, the disease has metastasized, or spread, making it harder to treat, and up to 50% of patients with localized disease eventually develop metastases.4

BRAF mutations are estimated to occur in 8-12% of people with mCRC and are associated with a poor prognosis for these patients.5 The BRAF V600E mutation is the most common BRAF mutation and the risk of mortality in CRC patients with the BRAF V600E mutation is more than double that of patients with no known mutation present.5-7 Despite the high unmet need in BRAF V600E-mutant mCRC, prior to December 20, 2024, there were no approved biomarker-driven therapies specifically indicated for people with previously untreated BRAF V600E-mutant mCRC.8,9

About BRAFTOVI (encorafenib)
BRAFTOVI is an oral small molecule kinase inhibitor that targets BRAF V600E. Inappropriate activation of proteins in the MAPK signaling pathway (RAS-RAF-MEK-ERK) has been shown to occur in certain cancers, including CRC.

Pfizer has exclusive rights to BRAFTOVI in the U.S., Canada, Latin America, Middle East, and Africa. Ono Pharmaceutical Co., Ltd. has exclusive rights to commercialize the product in Japan and South Korea, Medison has exclusive rights to commercialize the product in Israel and Pierre Fabre Laboratories has exclusive rights to commercialize the product in all other countries, including Europe and Asia (excluding Japan and South Korea).

INDICATION AND USAGE
BRAFTOVI (encorafenib) is indicated, in combination with cetuximab and mFOLFOX6, for the treatment of patients with metastatic colorectal cancer (mCRC) with a BRAF V600E mutation, as detected by an FDA-approved test. This indication is approved under accelerated approval based on response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s).

BRAFTOVI is also indicated, in combination with cetuximab, for the treatment of adult patients with mCRC with a BRAF V600E mutation, as detected by an FDA-approved test, after prior therapy.

Limitations of Use: BRAFTOVI is not indicated for treatment of patients with wild-type BRAF CRC.

IMPORTANT SAFETY INFORMATION

Refer to the prescribing information for cetuximab and individual product components of mFOLFOX6 for recommended dosing and additional safety information.

WARNINGS AND PRECAUTIONS

New Primary Malignancies: New primary malignancies, cutaneous and non-cutaneous, can occur. In BEACON CRC (previously treated BRAF V600E mutation-positive mCRC), cutaneous squamous cell carcinoma (cuSCC), including keratoacanthoma (KA), occurred in 1.4% of patients with CRC, and a new primary melanoma occurred in 1.4% of patients who received BRAFTOVI in combination with cetuximab. In BREAKWATER (previously untreated BRAF V600E mutation-positive mCRC) skin papilloma was reported in 2.6%, basal cell carcinoma in 1.3%, squamous cell carcinoma of skin in 0.9%, keratoacanthoma in 0.4% and malignant melanoma in situ in 0.4% of patients who received BRAFTOVI in combination with cetuximab and mFOLFOX6. Perform dermatologic evaluations prior to initiating treatment, every 2 months during treatment, and for up to 6 months following discontinuation of treatment. Manage suspicious skin lesions with excision and dermatopathologic evaluation. Dose modification is not recommended for new primary cutaneous malignancies. Based on its mechanism of action, BRAFTOVI may promote malignancies associated with activation of RAS through mutation or other mechanisms. Monitor patients receiving BRAFTOVI for signs and symptoms of non-cutaneous malignancies. Discontinue BRAFTOVI for RAS mutation-positive non-cutaneous malignancies. Monitor patients for new malignancies prior to initiation of treatment, while on treatment, and after discontinuation of treatment.

Tumor Promotion in BRAF Wild-Type Tumors: In vitro experiments have demonstrated paradoxical activation of MAP-kinase signaling and increased cell proliferation in BRAF wild-type cells exposed to BRAF inhibitors. Confirm evidence of BRAF V600E or V600K mutation using an FDA-approved test prior to initiating BRAFTOVI.

Cardiomyopathy: Cardiomyopathy manifesting as left ventricular dysfunction associated with symptomatic or asymptomatic decreases in ejection fraction, has been reported in patients. Assess left ventricular ejection fraction (LVEF) by echocardiogram or multi-gated acquisition (MUGA) scan prior to initiating treatment, 1 month after initiating treatment, and then every 2 to 3 months during treatment. Safety has not been established in patients with a baseline ejection fraction that is either below 50% or below the institutional lower limit of normal (LLN). Patients with cardiovascular risk factors should be monitored closely. Withhold, reduce dose, or permanently discontinue based on severity of adverse reaction.

Hepatotoxicity: Hepatotoxicity can occur. In BREAKWATER (previously untreated BRAF V600E mutation-positive mCRC), the incidence of Grade 3 or 4 increases in liver function laboratory tests in patients receiving BRAFTOVI in combination with cetuximab and mFOLFOX6 was 2.2% for alkaline phosphatase, 1.3% for ALT, and 0.9% for AST. Monitor liver laboratory tests before initiation of BRAFTOVI, monthly during treatment, and as clinically indicated. Withhold, reduce dose, or permanently discontinue based on severity of adverse reaction.

Hemorrhage: In BEACON CRC (previously treated BRAF V600E mutation-positive mCRC), hemorrhage occurred in 19% of patients receiving BRAFTOVI in combination with cetuximab; Grade 3 or higher hemorrhage occurred in 1.9% of patients, including fatal gastrointestinal hemorrhage in 0.5% of patients. The most frequent hemorrhagic events were epistaxis (6.9%), hematochezia (2.3%), and rectal hemorrhage (2.3%). In BREAKWATER (previously untreated BRAF V600E mutation-positive mCRC), hemorrhage occurred in 30% of patients receiving BRAFTOVI in combination with cetuximab and mFOLFOX6; Grade 3 or 4 hemorrhage occurred in 3% of patients. Withhold, reduce dose, or permanently discontinue based on severity of adverse reaction.

Uveitis: Uveitis, including iritis and iridocyclitis, has been reported in patients treated with BRAFTOVI. Assess for visual symptoms at each visit. Perform an ophthalmological evaluation at regular intervals and for new or worsening visual disturbances, and to follow new or persistent ophthalmologic findings. Withhold, reduce dose, or permanently discontinue based on severity of adverse reaction.

QT Prolongation: BRAFTOVI is associated with dose-dependent QTc interval prolongation in some patients. In BREAKWATER (previously untreated BRAF V600E mutation-positive mCRC), an increase of QTcF >500 ms was measured in 3.6% (8/222) of patients receiving BRAFTOVI in combination with cetuximab and mFOLFOX6. Monitor patients who already have or who are at significant risk of developing QTc prolongation, including patients with known long QT syndromes, clinically significant bradyarrhythmias, severe or uncontrolled heart failure and those taking other medicinal products associated with QT prolongation. Correct hypokalemia and hypomagnesemia prior to and during BRAFTOVI administration. Withhold, reduce dose, or permanently discontinue for QTc >500 ms.

Embryo-Fetal Toxicity: BRAFTOVI can cause fetal harm when administered to pregnant women. BRAFTOVI can render hormonal contraceptives ineffective. Advise females of reproductive potential to use effective nonhormonal contraception during treatment with BRAFTOVI and for 2 weeks after the final dose.

Risks Associated with Combination Treatment: BRAFTOVI is indicated for use as part of a regimen in combination with cetuximab, or in combination with cetuximab and mFOLFOX6. Refer to the prescribing information for cetuximab and individual product components of mFOLFOX6 for additional risk information.

Lactation: Advise women not to breastfeed during treatment with BRAFTOVI and for 2 weeks after the final dose.

Infertility: Advise males of reproductive potential that BRAFTOVI may impair fertility.

ADVERSE REACTIONS

BREAKWATER Trial (previously untreated BRAF V600E mutation-positive mCRC)

Serious adverse reactions occurred in 38% of patients who received BRAFTOVI in combination with cetuximab and mFOLFOX6. Serious adverse reactions in >3% of patients included intestinal obstruction (3.5%) and pyrexia (3.5%).
Fatal gastrointestinal perforation occurred in 0.9% of patients who received BRAFTOVI in combination with cetuximab and mFOLFOX6.
Most common adverse reactions(≥25%, all grades) in the BRAFTOVI with cetuximab and mFOLFOX6 arm compared to the control arm (mFOLFOX6 ± bevacizumab or FOLFOXIRI ± bevacizumab or CAPOX ± bevacizumab) were peripheral neuropathy (62% vs 53%), nausea (51% vs 48%), fatigue (49% vs 38%), rash (31% vs 4%), diarrhea (34% vs 47%), decreased appetite (33% vs 25%), vomiting (33% vs 21%), hemorrhage (30% vs 18%), abdominal pain (26% vs 27%), and pyrexia (26% vs 14%).
Most common laboratory abnormalities(≥10%, grade 3 or 4) in the BRAFTOVI with cetuximab and mFOLFOX6 arm compared to the control arm (mFOLFOX6 ± bevacizumab or FOLFOXIRI ± bevacizumab or CAPOX ± bevacizumab) were: increased lipase (51% vs 25%), decreased neutrophil count (36% vs 34%), decreased hemoglobin (13% vs 5%), decreased white blood cell count (12% vs 7%), and increased glucose (11% vs 2%).
BEACON CRC Trial (previously treated BRAF V600E mutation-positive mCRC)

Most common adverse reactions(≥25%, all grades) in the BRAFTOVI with cetuximab arm compared to irinotecan with cetuximab or FOLFIRI with cetuximab (control) were: fatigue (51% vs 50%), nausea (34% vs 41%), diarrhea (33% vs 48%), dermatitis acneiform (32% vs 43%), abdominal pain (30% vs 32%), decreased appetite (27% vs 27%), arthralgia (27% vs 3%), and rash (26% vs 26%).
Other clinically important adverse reactions occurring in <10% of patients who received BRAFTOVI in combination with cetuximab was pancreatitis.
Most common laboratory abnormalities (all grades) (≥20%) in the BRAFTOVI with cetuximab arm compared to irinotecan with cetuximab or FOLFIRI with cetuximab (control) were: anemia (34% vs 48%) and lymphopenia (24% vs 35%).
DRUG INTERACTIONS

Strong or moderate CYP3A4 inhibitors: Avoid coadministration of BRAFTOVI with strong or moderate CYP3A4 inhibitors, including grapefruit juice. If coadministration is unavoidable, reduce the BRAFTOVI dose.

Strong CYP3A4 inducers: Avoid coadministration of BRAFTOVI with strong CYP3A4 inducers.

Sensitive CYP3A4 substrates: Avoid the coadministration of BRAFTOVI with CYP3A4 substrates (including hormonal contraceptives) for which a decrease in plasma concentration may lead to reduced efficacy of the substrate. If the coadministration cannot be avoided, see the CYP3A4 substrate product labeling for recommendations.

Dose reductions of drugs that are substrates of OATP1B1, OATP1B3, or BCRP may be required when used concomitantly with BRAFTOVI.

Avoid coadministration of BRAFTOVI with drugs known to prolong QT/QTc interval.

(Press release, Pfizer, JAN 10, 2026, View Source [SID1234661926])