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Corvus Pharmaceuticals Announces Closing of Upsized Public Offering of Common Stock and Full Exercise of the Underwriters’ Option to Purchase Additional Shares, Generating Gross Proceeds of Approximately $201M

On January 23, 2026 Corvus Pharmaceuticals, Inc. (Nasdaq: CRVS), a clinical-stage biopharmaceutical company, reported the closing of an upsized underwritten public offering of 9,085,778 shares of its common stock, which includes the full exercise of the underwriters’ option to purchase 1,185,101 additional shares, at a price to the public of $22.15 per share. Gross proceeds from the underwritten public offering before deducting underwriting discounts and commissions and estimated offering expenses are expected to be approximately $201.2 million, including proceeds from the full exercise of the underwriters’ option to purchase additional shares. All of the shares of common stock were offered by Corvus.

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Corvus currently expects to use the net proceeds from this offering for working capital and general corporate purposes, which may include capital expenditures and research and development, including for its Phase 3 T cell lymphoma, and Phase 2 atopic dermatitis, hidradenitis suppurativa and asthma clinical trials, sales and marketing and administrative expenses.

Jefferies and Goldman Sachs & Co. LLC acted as lead book-running managers for the offering. Mizuho acted as bookrunner for the offering. Ladenburg Thalmann acted as co-manager for the offering.

A shelf registration statement on Form S-3 (File No. 333-281318) relating to the securities sold in this offering was declared effective by the Securities and Exchange Commission ("SEC") on August 15, 2024 and a related registration statement that was filed with the SEC on January 21, 2026 pursuant to Rule 462(b) under the Securities Act of 1933 (and became automatically effective upon filing). The offering of these securities was made only by means of a prospectus supplement and accompanying prospectus forming a part of the effective registration statements. A final prospectus supplement and accompanying prospectus relating to the offering have been filed with the SEC and is available on the SEC’s website at www.sec.gov. A copy of the final prospectus supplement and accompanying prospectus relating to the offering may be obtained from: Jefferies LLC, Attention: Equity Syndicate Prospectus Department, 520 Madison Avenue, New York, New York 10022, by telephone at 1-877-821-7388, or by email at [email protected]; and Goldman Sachs & Co. LLC, Attention: Prospectus Department, 200 West Street, New York, New York 10282, by telephone at 1-866-471-2526, or by email at [email protected].

This press release shall not constitute an offer to sell or a solicitation of an offer to buy, nor shall there be any offer or sale of, these securities in any state or jurisdiction in which such offer, solicitation, or sale would be unlawful prior to registration or qualification of these securities under the securities laws of any such state or jurisdiction.

(Press release, Corvus Pharmaceuticals, JAN 23, 2026, View Source [SID1234662188])

AIM ImmunoTech Announces Key Dates and Terms Related to Announced Rights Offering

On January 23, 2026 AIM ImmunoTech Inc. (NYSE American: AIM) – AIM ImmunoTech Inc. ("AIM" or the "Company"), an immuno-pharma company focused on the research and development of therapeutics to treat multiple types of cancers, immune disorders and viral diseases, reported an informational update to its security holders regarding its proposed rights offering (the "Rights Offering") and the expected key dates and terms relative to the Rights Offering. Assuming that the Rights Offering is fully subscribed, the Company will receive gross proceeds of $12 million, less expenses related to the Rights Offering.

The Company is distributing to all holders of record of its common stock, par value $0.001 (the "Common Stock"), and to holders of certain options and warrants that have the right to participate in the Rights Offering (the "Participating Securities"), as of 5:00 p.m., Eastern Time, on February 4, 2026 (the "Record Date"), for each share of the Common Stock and each Participating Security, one non-transferable subscription right (a "Subscription Right") to purchase one unit, at a subscription price of $1,000 per unit. Each unit consists of one share of Series G Convertible Preferred Stock (the "Preferred Stock") and warrants to purchase 1,492 shares of Common Stock (the "Warrants"). Each share of Preferred Stock will be convertible, at the option of the holder at any time, into a number of shares of Common Stock equal to the quotient of the stated value of the Preferred Stock ($1,000) divided by the conversion price (initially, $1.34 per share). Each Warrant will be exercisable for one share of Common Stock at an exercise price of $1.34 per share from the date of issuance through its expiration five years from the date of issuance. The Preferred Stock and the Warrants will separate upon the expiration of the Rights Offering and will be issued separately but may only be purchased as a subscription, and the subscriptions will not trade as a separate security. The subscriptions will not be tradable.

The Subscription Rights will be non-transferable and may only be exercised during the anticipated subscription period of Thursday, February 5, 2026 through 5:00 PM ET on Monday, February 23, 2026, unless extended by AIM.

The expected calendar for the Rights Offering is as follows:

February 3, 2026: Ownership Day – in order to be considered a stockholder of record on February 4, 2026, shares should be acquired by this date (open market purchases of Common Stock should be completed by February 3 to be considered a stockholder of record on the Record Date).
February 4, 2026: Record Date (5:00 p.m. Eastern Time)
February 5, 2026: Distribution Date; Subscription Period Begins
February 23, 2026: Subscription Period Ends 5:00 p.m. Eastern Time
The Rights Offering will include an over-subscription privilege which permits each holder of Subscription Rights that exercises such holder’s basic Subscription Right in full to purchase additional subscriptions (if any) that remain unsubscribed at the expiration of the Rights Offering. The availability of the over-subscription privilege will be subject to certain terms and restrictions set forth in the prospectus. If the aggregate subscriptions (basic subscriptions plus over-subscriptions) exceed the number of subscriptions offered in the Rights Offering, then the aggregate over-subscription amount will be pro-rated among the holders exercising their respective over-subscription privileges (in proportion to the number of subscriptions held after giving effect to all basic subscriptions).

Certain of AIM’s leadership have indicated to the Company on a non-binding basis that they intend to participate in the Rights Offering, including Board member and Chief Executive Officer Thomas K. Equels.

The Company intends to use the net proceeds from the exercise of subscriptions for general corporate purposes – including clinical trial expenses and manufacturing expenses associated with prospective Phase 2/3 pancreatic cancer trials – and allocate a portion of the net proceeds to repay, according to their terms, certain existing debt obligations.

The Rights Offering will expire at 5:00 p.m., Eastern Time, on Monday, February 23, 2026, unless it is extended or earlier terminated by the Company, If the Company elects to extend the Rights Offering, it will issue a press release announcing the extension no later than 9:00 a.m., Eastern Time, on the next business day after the most recently announced expiration date of the Rights Offering. The Company may extend the Rights Offering for additional periods in its sole discretion for any reason up to an additional 45 days. Once made, all exercises of subscriptions are irrevocable.

The Company expects that Broadridge Corporate Issuer Solutions, LLC, the information agent for the Rights Offering, will mail rights certificates and a copy of the prospectus for the Rights Offering to holders of record of Common Stock and Participating Securities as of the Record Date beginning on or about February 5, 2026. Holders of securities held in "street name" through a brokerage account, bank or other nominee will not receive physical rights certificates and must instruct their broker, bank or other nominee whether to exercise Subscription Rights on their behalf. For any questions or further information about the Rights Offering, please call Broadridge Corporate Issuer Solutions, LLC, the information agent for the Rights Offering, at (855) 793-5068 or via email at [email protected].

Neither the Company nor its Board of Directors has made or will make any recommendation to holders regarding the exercise of subscriptions. Holders should make an independent investment decision about whether or not to exercise their subscriptions based on their own assessment of the Company’s business and the Rights Offering.

A registration statement (Registration No. 333- 292085) relating to these securities has been filed with the Securities and Exchange Commission but has not yet become effective. These securities may not be sold nor may offers to buy be accepted prior to the time the registration statement becomes effective. The Rights Offering, which is expected to commence following the effectiveness of the registration statement, is being made only by means of a written prospectus. A preliminary prospectus relating to and describing the proposed terms of the Rights Offering has been filed with the SEC as a part of the registration statement and is available on the SEC’s website at View Source Copies of the preliminary and final prospectuses for the Rights Offering may be obtained, when available, from Maxim Group LLC, 300 Park Avenue, 16th Floor, New York, NY 10022, Attention Syndicate Department, email: [email protected] or telephone (212) 895-3745.

This press release does not constitute an offer to sell or the solicitation of an offer to buy these securities, nor will there be any sale of these securities in any state or other jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.

Maxim Group LLC is acting as the dealer-manager in connection with the Rights Offering.

(Press release, AIM ImmunoTech, JAN 23, 2026, View Source [SID1234662187])

Adagene Provides Business Update and 2026 Objectives

On January 23, 2026 Adagene Inc. ("Adagene") (Nasdaq: ADAG), a company transforming the discovery and development of novel antibody-based therapies, reported year-end unaudited cash and cash equivalents of $74.5 million and provided a business update.

2025 Key Accomplishments:

· Phase 1b/2 trial results with muzastotug in MSS CRC at ASCO (Free ASCO Whitepaper): Shared updated data from 10 mg/kg and 20 mg/kg cohorts at ASCO (Free ASCO Whitepaper) 2025, demonstrating a favorable safety profile at 10-20x times higher dosing than first generation CTLA-4 inhibitors. Encouraging overall response rates and durable responses suggest potential for long-term survival benefit.

· FDA Fast Track designation for muzastotug in combination with Merck’s (known as MSD outside of the United States and Canada) anti-PD-1 therapy, KEYTRUDA (pembrolizumab), for adult patients with microsatellite stable metastatic colorectal cancer (MSS CRC) without current or active liver metastases.

· Regulatory alignment with FDA End-of-Phase 1 meeting, clarifying dose selection, trial design, patient population and endpoints for Phase 2 and Phase 3 with muzastotug.

· Initiated randomized Phase 2 dose-optimization study with muzastotug; first patient dosed in October 2025.

· Strategic Partnerships and Collaborations:

o Sanofi: Secured a strategic investment of up to $25 million to support muzastotug’s randomized Phase 2 study. Separately, Adagene will supply Sanofi with muzastotug to evaluate the safety, efficacy, pharmacokinetics and biomarker data in combination with other anticancer therapies in over 100 patients in a Phase 1/2 clinical trial in advanced solid tumors. Sanofi also exercised its option for a third SAFEbody discovery program.

o Third Arc Bio: Partnered to develop two masked CD3 T cell engagers, expanding SAFEbody into next-generation T cell therapies.

o Exelixis: Advanced a third masked ADC against a solid tumor target, building on the 2021 collaboration.

o ConjugateBio: Collaborated on bispecific ADCs using Adagene-derived antibody, further demonstrating scalable platform potential.

As of December 31, 2025, the Company had unaudited cash and cash equivalents of $74.5 million, which is anticipated to provide sufficient runway until late 2027. Such amount of cash and cash equivalents is preliminary, unaudited and subject to finalization. This financial information should not be viewed as a substitute for the audited financial statements prepared in accordance with US GAAP and is not incorporated into any Adagene’s filings with the U.S. Securities and Exchange Commission.

2026 Objectives:

· Q1 2026: Data update from the ongoing Phase 1b/2 study of muzastotug + pembrolizumab in 3L+ MSS CRC, including 41 patients in the 10 mg/kg cohorts and 26 patients in the 20 mg/kg cohorts.

· Complete enrollment of the ongoing randomized Phase 2 dose-optimization study with muzastotug, which is being conducted in alignment with FDA Project Optimus, and designed to allow dose regimen selection for Phase 3.

· Provide preliminary clinical data, including pathological responses, to inform future development from investigator-initiated Phase 2 trial for neoadjuvant muzastotug + pembrolizumab in colorectal cancer.

· Provide initial clinical data from a new cohort of patients in the ongoing Phase 1b/2 study of muzastotug + pembrolizumab in combination with standard of care (fruquintinib) in MSS CRC patients.

· Share results of the clinical trial collaboration with Roche, which evaluates muzastotug in triplet combination with atezolizumab and bevacizumab in first-line treatment of locally advanced or metastatic hepatocellular carcinoma (HCC; liver cancer).

· Establish additional collaboration/licensing agreements.

Peter Luo, Ph.D., CEO and President of R&D at Adagene said, "Our strategy for muzastotug is grounded in Nobel Prize-recognized advances in regulatory T cell biology, which have fundamentally reshaped our understanding of immune suppression in cancer. We have translated these foundational insights into a clinical action plan for intratumoral T reg modulation that integrates mechanistic innovation with emerging clinical evidence and regulatory momentum. In 2026, we hope new data will demonstrate muzastotug’s broad applicability, positioning it as a potentially transformative next-generation backbone therapy that can be used in combination across multiple indications."

(Press release, Adagene, JAN 23, 2026, View Source [SID1234662186])

ENHERTU® Approved in China as the First and Only HER2 Directed ADC for the Second-Line Treatment of Patients with HER2 Positive Metastatic Gastric Cancer

On January 22, 2026 Daiichi Sankyo reported that ENHERTU (trastuzumab deruxtecan) has been approved in China for the treatment of adult patients with locally advanced or metastatic HER2 positive (IHC 3+ or IHC 2+/ISH+) gastric or gastroesophageal junction (GEJ) adenocarcinoma who have received one prior trastuzumab based regimen. ENHERTU previously received conditional approval for third-line or later treatment based on laterline phase 2 data.

ENHERTU is a specifically engineered HER2 directed DXd antibody drug conjugate (ADC) discovered by Daiichi Sankyo (TSE: 4568) and being jointly developed and commercialized by Daiichi Sankyo and AstraZeneca (LSE/STO/Nasdaq: AZN).

More than one third of the global cases of gastric cancer occur in China, with about 65% of patients presenting with advanced disease at the time of diagnosis.1,2,3 Approximately 359,000 cases of gastric cancer and 260,000 deaths were reported in China in 2022.1 About one in five gastric cancers are considered HER2 positive. 4,5 Prior to the results of DESTINY-Gastric04, no other HER2 directed medicine has demonstrated a survival benefit in the second-line metastatic setting in a randomized clinical trial.

The approval of ENHERTU by China’s National Medical Products Administration (NMPA) is based on results from the DESTINY-Gastric04 phase 3 trial presented as a late-breaking oral presentation at the 2025 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) (#ASCO25) Annual Meeting and simultaneously published in The New England Journal of Medicine. The China Center for Drug Evaluation (CDE) granted Breakthrough Therapy Designation for ENHERTU for the second-line gastric cancer indication in 2020 due to efficacy data from early trials and the unmet clinical need. ENHERTU also was granted Priority Review by the CDE in this setting, enabling approval in China in approximately six months.

In DESTINY-Gastric04, ENHERTU demonstrated a 30% reduction in risk of death compared to ramucirumab plus paclitaxel in patients with second-line HER2 positive unresectable and/or metastatic gastric or GEJ adenocarcinoma (hazard ratio [HR]: 0.70; confidence interval [CI]: 0.55-0.90; p=0.0044). Median overall survival (OS) was 14.7 months with ENHERTU (n=246; 95% CI: 12.1-16.6) compared to 11.4 months with ramucirumab plus paclitaxel (n=248; 95% CI: 9.9-15.5).

In the secondary endpoint analysis of progression-free survival (PFS), ENHERTU demonstrated a 26% reduction in the risk of disease progression or death versus ramucirumab plus paclitaxel (HR: 0.74; 95% CI: 0.59-0.92; p=0.0074) as assessed by investigator. Median PFS was 6.7 months (95% CI: 5.6-7.1) with ENHERTU versus 5.6 months (95% CI: 4.9-5.8) with ramucirumab plus paclitaxel. A confirmed objective response rate (ORR) of 44.3% (95% CI: 37.8-50.9) was seen in patients treated with ENHERTU with seven complete responses (CR) and 97 partial responses (PR) versus a confirmed ORR of 29.1% (95% CI: 23.4- 35.3) with three CRs and 66 PRs in the ramucirumab plus paclitaxel arm (p=0.0006). Median duration of response (DOR) was 7.4 months (95% CI: 5.7-10.1) in the ENHERTU arm and 5.3 months (95% CI: 4.1- 5.7) in the ramucirumab plus paclitaxel arm.

"Most patients with gastric cancer are diagnosed with advanced disease, which has a low survival rate and is particularly challenging to treat," said Lin Shen, MD, Director of the Department of Gastrointestinal Oncology, Peking University Cancer Hospital and lead investigator of the DESTINY-Gastric04 trial in China. "This approval is an important milestone for the clinical community in China, addressing a critical gap in second-line targeted therapy for HER2 positive gastric cancer. This development is driving a paradigm shift from chemotherapy towards precision therapy in the second-line setting for patients with HER2 positive gastric cancer. At the same time, it provides clinicians with a powerful new option capable of significantly extending patient survival. We will be able to bring this innovative treatment to earlier lines of therapy, benefit a broader patient population, improve long-term outcomes and achieve longer survival."

"This sixth approval for ENHERTU in China in less than three years fully demonstrates the potential of this innovative medicine to make significant contributions in clinical practice," said Michio Hayashi, China President, Daiichi Sankyo. "DESTINY-Gastric04 is the first randomized phase 3 trial ever to show a survival benefit in the second-line HER2 positive metastatic gastric cancer setting and also confirmed the results of the DESTINY-Gastric01 and DESTINY-Gastric06 trials."

"ENHERTU is already established in China in the third-line or later treatment setting for patients with HER2 positive metastatic gastric cancer and this approval brings this important medicine to an earlier line of therapy," said Dave Fredrickson, Executive Vice President, Oncology Hematology Business Unit, AstraZeneca. "This latest approval in China underscores our commitment to bringing ENHERTU to patients in earlier treatment settings to improve outcomes and expand the number of people who may benefit."

The safety profile of ENHERTU in DESTINY-Gastric04 was consistent with previous clinical trials with no new safety concerns identified. The most common grade 3 or grade 4 adverse reactions from a pooled safety population receiving at least one dose of ENHERTU 6.4 mg/kg (n=1,133) across multiple tumor types in clinical studies were nausea (64.3%), fatigue (57.3%), anemia (47.9%), decreased appetite (46.8%), neutropenia (45.9%), vomiting (34.7%), diarrhea (33.0%), thrombocytopenia (32.9%), leukopenia (31.2%), alopecia (29.0%), constipation (28.2%) and increased transaminases (26.4%). Grade 5 adverse reactions occurred in 2.2% of patients, including interstitial lung disease (ILD; 1.6%). Discontinuation of treatment due to an adverse reaction occurred in 13.2% of patients. The most frequent adverse reaction associated with permanent discontinuation was ILD (9.8%).

ENHERTU also is being evaluated as a potential first-line treatment for HER2 positive metastatic gastric cancer through two ongoing phase 3 trials – DESTINY-Gastric05 and ARTEMIDE-Gastric01.

About DESTINY-Gastric04

DESTINY-Gastric04 is a global, randomized, open-label, phase 3 trial evaluating the efficacy and safety of ENHERTU (6.4 mg/kg) versus ramucirumab and paclitaxel in patients with HER2 positive (IHC 3+ or IHC 2+/ISH+) unresectable and/or metastatic gastric or GEJ adenocarcinoma with disease progression on or after a trastuzumab-containing regimen.

The primary endpoint is OS. Secondary endpoints include investigator-assessed PFS, ORR, DOR, disease control rate and safety.

In March 2025, an Independent Data Monitoring Committee recommended unblinding DESTINY-Gastric04 based on the superior efficacy of ENHERTU seen at a planned interim analysis.

DESTINY-Gastric04 enrolled 494 patients in Asia, Europe and South America. For more information about the trial, visit ClinicalTrials.gov.

About HER2 Positive Gastric Cancer

Gastric (stomach) cancer is the fifth most common cancer worldwide and the fifth leading cause of cancerrelated death, with a five-year global survival rate of 5% to 10% for advanced or metastatic disease.2,7 Approximately one million cases of gastric cancer were diagnosed in 2022.

Incidence rates for gastric cancer are markedly higher in eastern Asia, particularly in China where more than one third of all global cases occur. 1,2 Gastric cancer is the fifth most common cancer in China with about 359,000 new cases diagnosed in 2022.1 Additionally, it is the third leading cause of cancer-related death in China, with approximately 260,000 deaths reported in 2022.1 Approximately 65% of patients in China present with advanced disease at the time of diagnosis.

HER2 is a tyrosine kinase receptor growth-promoting protein expressed on the surface of many types of tumors, including gastric cancer.8 Approximately one in five gastric cancers are considered HER2 positive. 4,5 Recommended first-line treatment in China for HER2 positive advanced or metastatic gastric cancer is combination chemotherapy and trastuzumab, an anti-HER2 medicine, with or without pembrolizumab. 9 For patients with metastatic gastric cancer that progresses following initial treatment with a trastuzumab-based regimen, subsequent anti-HER2 treatment options are limited.

Prior to the results of the DESTINY-Gastric04 trial of ENHERTU, no other HER2 directed medicine had demonstrated a survival benefit in the second-line metastatic setting in a randomized clinical trial.

About ENHERTU

ENHERTU (trastuzumab deruxtecan; fam-trastuzumab deruxtecan-nxki in the U.S. only) is a HER2 directed ADC. Designed using Daiichi Sankyo’s proprietary DXd ADC Technology, ENHERTU is the lead ADC in the oncology portfolio of Daiichi Sankyo and the most advanced program in AstraZeneca’s ADC scientific platform. ENHERTU consists of a HER2 monoclonal antibody attached to a number of topoisomerase I inhibitor payloads (an exatecan derivative, DXd) via tetrapeptide-based cleavable linkers.

ENHERTU (5.4 mg/kg) in combination with pertuzumab is approved in the U.S. as a first-line treatment for adult patients with unresectable or metastatic HER2 positive (IHC 3+ or ISH+) breast cancer, as determined by an FDA-approved test, based on the results from the DESTINY-Breast09 trial.

ENHERTU (5.4 mg/kg) is approved in more than 90 countries/regions worldwide for the treatment of adult patients with unresectable or metastatic HER2 positive (immunohistochemistry [IHC] 3+ or in-situ hybridization [ISH]+) breast cancer who have received a prior anti-HER2-based regimen, either in the metastatic setting or in the neoadjuvant or adjuvant setting, and have developed disease recurrence during or within six months of completing therapy based on the results from the DESTINY-Breast03 trial.

ENHERTU (5.4 mg/kg) is approved in more than 90 countries/regions worldwide for the treatment of adult patients with unresectable or metastatic HER2 low (IHC 1+ or IHC 2+/ISH-) breast cancer who have received a prior systemic therapy in the metastatic setting or developed disease recurrence during or within six months of completing adjuvant chemotherapy based on the results from the DESTINY-Breast04 trial.

ENHERTU (5.4 mg/kg) is approved in more than 60 countries/regions worldwide for the treatment of adult patients with unresectable or metastatic hormone receptor (HR) positive, HER2 low (IHC 1+ or IHC 2+/ISH-) or HER2 ultralow (IHC 0 with membrane staining) breast cancer, as determined by a locally or regionally approved test, that have progressed on one or more endocrine therapies in the metastatic setting based on the results from the DESTINY-Breast06 trial.

ENHERTU (5.4 mg/kg) is approved in more than 70 countries/regions worldwide for the treatment of adult patients with unresectable or metastatic NSCLC whose tumors have activating HER2 (ERBB2) mutations, as detected by a locally or regionally approved test, and who have received a prior systemic therapy based on the results from the DESTINY-Lung02 and/or DESTINY-Lung05 trials. Continued approval in China and the U.S. for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial.

ENHERTU (6.4 mg/kg) is approved in more than 80 countries/regions worldwide for the treatment of adult patients with locally advanced or metastatic HER2 positive (IHC 3+ or IHC 2+/ISH+) gastric or gastroesophageal junction (GEJ) adenocarcinoma who have received a prior trastuzumab-based regimen based on the results from the DESTINY-Gastric01, DESTINY-Gastric02 and/or DESTINY-Gastric04 trials.

ENHERTU (5.4 mg/kg) is approved in more than 10 countries/regions worldwide for the treatment of adult patients with unresectable or metastatic HER2 positive (IHC 3+) solid tumors who have received prior systemic treatment and have no satisfactory alternative treatment options based on efficacy results from the DESTINY-PanTumor02, DESTINY-Lung01 and DESTINY-CRC02 trials. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial.

About the ENHERTU Clinical Development Program

A comprehensive global clinical development program is underway evaluating the efficacy and safety of ENHERTU as a monotherapy or in combination or sequentially with other cancer medicines across multiple HER2 targetable cancers.

(Press release, Daiichi Sankyo, JAN 22, 2026, View Source [SID1234665023])

Guardant Health Receives FDA Approval for Guardant360® CDx as Companion Diagnostic for BRAFTOVI® (encorafenib) Combination in Patients with BRAF V600E-Mutant Metastatic Colorectal Cancer

On January 22, 2026 Guardant Health, Inc. (Nasdaq: GH), a leading precision oncology company, reported that the U.S. Food and Drug Administration (FDA) has approved Guardant360 CDx as a companion diagnostic to identify patients with BRAF V600E-mutant metastatic colorectal cancer (mCRC) who may benefit from treatment with BRAFTOVI (encorafenib) in combination with cetuximab and chemotherapy in accordance with the approved product labeling.

The accelerated approval was supported by data from Pfizer’s Phase 3 BREAKWATER trial, which evaluated encorafenib-based regimens in previously untreated patients with BRAF-mutated metastatic colorectal cancer mCRC. The study showed that treatment with encorafenib and cetuximab plus mFOLFOX6 chemotherapy significantly improved objective response rate, progression-free and overall survival compared with standard care, underscoring the importance of early genomic testing to guide targeted therapy.

Guardant360 CDx expands access to non-invasive genomic testing for this high-risk patient population. Using a simple blood draw to detect BRAF V600E and other clinically relevant genetic alterations, the test helps clinicians quickly identify patients eligible for FDA-approved treatments, enabling timely treatment decisions when tumor tissue is unavailable, insufficient, or when rapid initiation of therapy is clinically necessary.

"This latest approval highlights the growing impact of liquid biopsy across advanced cancer care and underscores the utility of Guardant360 CDx in enabling precision therapy selection for patients with diverse, hard-to-treat tumors including aggressive colorectal cancer," said Helmy Eltoukhy, Guardant Health chairman and co-CEO. "With multiple FDA-cleared companion diagnostic claims across lung and breast cancer, and now colorectal cancer, and the ability to comprehensively profile tumor genomics from a simple blood draw, Guardant360 CDx is helping clinicians match patients to the right targeted therapies faster and more effectively."

Key highlights of the BREAKWATER trial include:

Demonstrated significant improvement in overall response rate (ORR), progression-free survival (PFS) and overall survival (OS) for patients treated with encorafenib plus cetuximab with mFOLFOX6 chemotherapy.
Guardant360 CDx enabled rapid ctDNA analysis for treatment selection and resistance monitoring.
The study supports the importance of early, comprehensive genomic profiling to improve outcomes in mCRC.
Colorectal cancer remains the second-leading cause of cancer-related deaths in the U.S., with BRAF V600E mutations present in approximately 8 to 10 percent of mCRC cases.1 The mutation is a molecularly distinct and aggressive subtype of mCRC with poor prognosis and limited treatment options. Early identification of this mutation is critical to guiding patients to more effective, targeted therapies. Guardant360 CDx offers a convenient and accessible method for detecting this actionable biomarker, especially when tissue samples are unavailable or inadequate for testing.

This latest FDA approval for Guardant 360 CDx marks the 25th companion diagnostic indication across multiple tumor types and builds on the platform’s increasing clinical utility and broad coverage by Medicare and commercial payers, representing more than 300 million covered lives.

About Guardant360 CDx

Guardant360 CDx is the first FDA-approved liquid biopsy for comprehensive genomic profiling. It detects multiple genomic alterations across all solid tumors and is approved as a companion diagnostic for therapies in non-small cell lung cancer, breast cancer, and now colorectal cancer. For more information, visit Guardant360 CDx.

(Press release, Guardant Health, JAN 22, 2026, View Source [SID1234662178])