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REGENXBIO Highlights Key 2026 Catalysts and Announces Positive Long-Term Functional Outcomes in Lead Duchenne Gene Therapy Program

PR Newswire

  • New Phase I/II RGX-202 functional data demonstrates long-term, durable treatment effect at pivotal dose at 18 months 
  • Robust patient enrollment in confirmatory trial continues, expect majority of patients to be dosed by planned BLA filing, mid-year
  • Expecting FDA PDUFA decision and multiple pivotal top-line data readouts in 2026 to support potential commercial launches 2026-2028
  • In-house manufacturing and strategic global partnerships driving commercial readiness
  • Presentation at 44th Annual J.P. Morgan Healthcare Conference Wednesday, January 14

ROCKVILLE, Md., Jan. 11, 2026 /PRNewswire/ — REGENXBIO Inc. (Nasdaq: RGNX) highlighted progress and upcoming anticipated milestones across its pipeline of AAV gene therapies for rare and retinal diseases. 

“2026 is set to be a transformative year for REGENXBIO, as we enter commercial stage with two near-term catalysts from our three late-stage assets and a clear path to sustained growth,” said Curran Simpson, President and CEO, REGENXBIO. “We are starting the year with exciting new long-term data for our Duchenne program, demonstrating how our comprehensive strategy to maximize the potential for therapeutic benefit across all our programs is resulting in positive outcomes for patients. We are continuing to set the bar high for how potentially life-changing gene therapies are discovered, developed, and manufactured; this year we are sharply focused on advancing our commercial readiness to enable successful launches of these medicines for patients in need.

CLINICAL PROGRAM UPDATES AND 2026 ANTICIPATED MILESTONES 

RGX-202 for Duchenne Muscular Dystrophy

New Functional Data

  • REGENXBIO today announced new, positive 18-month functional data from patients treated with the pivotal dose in the Phase I/II portion of the AFFINITY DUCHENNE® trial (n=4). All patients exceeded expected disease trajectory on the North Star Ambulatory Assessment (NSAA) using the established cTAP disease progression model. RGX-202 recipients improved an average of 7.4 points compared to cTAP. These same patients improved an average of 6.6 points compared to cTAP at 12 months post-treatment. The Company plans to share additional Phase I/II safety, biomarker, and functional data at the MDA Clinical and Scientific Conference in March 2026.

Clinical Trial and Regulatory Milestones

  • REGENXBIO expects to share pivotal topline data in early Q2 2026 and submit a Biologics License Application (BLA) under the accelerated approval pathway in mid-2026. Following the completion of enrollment in the pivotal trial (n=30) in October 2025, the Company continues to enroll in the confirmatory trial and expects to have majority of this trial enrolled at the time of BLA filing.
  • Regulatory interactions with the FDA and European Medical Association (EMA) are planned for 1H 2026, supporting the global expansion of the AFFINITY DUCHENNE® trial.

Clemidsogene lanparvovec (RGX-121) for MPS II, also known as Hunter syndrome

  • FDA PDUFA target date is February 8, 2026. FDA approval would result in receipt of a Priority Review Voucher (PRV), to which REGENXBIO has full rights.
  • Partner Nippon Shinyaku, with its U.S. subsidiary NS Pharma, is prepared to commercialize clemidsogene lanparvovec following potential approval. REGENXBIO plans to lead the clinical and commercial manufacturing its in-house Manufacturing Innovation Center in Rockville, Md.

Surabgene lomparvovec (sura-vec, ABBV-RGX-314) for wet age-related macular degeneration (wet AMD) and diabetic retinopathy (DR)
Sura-vec is being developed in collaboration with AbbVie, and could be the first gene therapy for a non-rare disease, if approved.

  • Sura-vec is on track to be the first gene therapy for wet AMD. REGENXBIO expects top-line data from ATMOSPHERE® and ASCENT® pivotal trials of sura-vec using subretinal delivery in Q4 2026.
  • REGENXBIO will initiate a two-part sham injection-controlled Phase IIb/III trial of sura-vec for DR using suprachoroidal delivery. The Company will receive a $100 million milestone payment from AbbVie upon first patient dosed, expected 1H 2026.

Leading Gene Therapy Capabilities 
REGENXBIO is one of the only gene therapy companies with fully in-house, end-to-end capabilities from capsid engineering and discovery through commercial-ready manufacturing, designed to reliably scale supply and realize the blockbuster potential of its gene therapy portfolio. At the REGENXBIO Manufacturing Innovation Center, in Rockville, Md., REGENXBIO expects to continue to build supply intended for potential commercial launches. Process performance qualification lots have been completed for RGX-202.

REGENXBIO continues to expand the therapeutic potential of AAV gene delivery through capsid discovery and engineering. The Company is approaching IND readiness for the treatment of geographic atrophy using a new capsid that has demonstrated higher transgene expression via suprachoroidal delivery to the eye.

J.P. Morgan Healthcare Conference Presentation
President and CEO Curran Simpson will present at the J.P Morgan Healthcare Conference on Wednesday, January 14, 2026 at 10:30 a.m. PT. A live webcast of the presentation can be accessed in the Investors section of REGENXBIO’s website at www.regenxbio.com. An archived replay of the webcast will be available for approximately 30 days following the presentation.

ABOUT REGENXBIO Inc.
REGENXBIO is a biotechnology company on a mission to improve lives through the curative potential of gene therapy. Since its founding in 2009, REGENXBIO has pioneered the field of AAV gene therapy. REGENXBIO is advancing a late-stage pipeline of one-time treatments for rare and retinal diseases, including RGX-202 for the treatment of Duchenne; clemidsogene lanparvovec (RGX-121) for the treatment of MPS II and RGX-111 for the treatment of MPS I, both in partnership with Nippon Shinyaku; and surabgene lomparvovec (ABBV-RGX-314) for the treatment of wet AMD and diabetic retinopathy, in collaboration with AbbVie. Thousands of patients have been treated with REGENXBIO’s AAV platform, including those receiving Novartis’ ZOLGENSMA®. REGENXBIO’s investigational gene therapies have the potential to change the way healthcare is delivered for millions of people. For more information, please visit www.REGENXBIO.com.

FORWARD-LOOKING STATEMENTS
This press release includes “forward-looking statements,” within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. These statements express a belief, expectation or intention and are generally accompanied by words that convey projected future events or outcomes such as “believe,” “may,” “will,” “estimate,” “continue,” “anticipate,” “assume,” “design,” “intend,” “expect,” “could,” “plan,” “potential,” “predict,” “seek,” “should,” “would” or by variations of such words or by similar expressions. The forward-looking statements include statements relating to, among other things, REGENXBIO’s future operations, clinical trials, costs and cash flow. REGENXBIO has based these forward-looking statements on its current expectations and assumptions and analyses made by REGENXBIO in light of its experience and its perception of historical trends, current conditions and expected future developments, as well as other factors REGENXBIO believes are appropriate under the circumstances. However, whether actual results and developments will conform with REGENXBIO’s expectations and predictions is subject to a number of risks and uncertainties, including the timing of enrollment, commencement and completion and the success of clinical trials conducted by REGENXBIO, its licensees and its partners, the timing of commencement and completion and the success of preclinical studies conducted by REGENXBIO and its development partners, the timing or likelihood of payments from AbbVie or Nippon Shinyaku, the monetization of any priority review voucher, the timely development and launch of new products, the ability to obtain and maintain regulatory approval of product candidates, the ability to obtain and maintain intellectual property protection for product candidates and technology, trends and challenges in the business and markets in which REGENXBIO operates, the size and growth of potential markets for product candidates and the ability to serve those markets, the rate and degree of acceptance of product candidates, and other factors, many of which are beyond the control of REGENXBIO. Refer to the “Risk Factors” and “Management’s Discussion and Analysis of Financial Condition and Results of Operations” sections of REGENXBIO’s Annual Report on Form 10-K for the year ended December 31, 2024, and comparable “risk factors” sections of REGENXBIO’s Quarterly Reports on Form 10-Q and other filings, which have been filed with the SEC and are available on the SEC’s website at WWW.SEC.GOV. All of the forward-looking statements made in this press release are expressly qualified by the cautionary statements contained or referred to herein. The actual results or developments anticipated may not be realized or, even if substantially realized, they may not have the expected consequences to or effects on REGENXBIO or its businesses or operations. Such statements are not guarantees of future performance and actual results or developments may differ materially from those projected in the forward-looking statements. Readers are cautioned not to rely too heavily on the forward-looking statements contained in this press release. These forward-looking statements speak only as of the date of this press release. Except as required by law, REGENXBIO does not undertake any obligation, and specifically declines any obligation, to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise.

Zolgensma® is a registered trademark of Novartis Gene Therapies. All other trademarks referenced herein are registered trademarks of REGENXBIO.

CONTACTS: 
Dana Cormack
Corporate Communications
[email protected] 

George E. MacDougall
Investor Relations
[email protected] 

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SOURCE REGENXBIO Inc.

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Exagen Inc. Announces Select Preliminary 2025 Financial Results

CARLSBAD, Calif., Jan. 11, 2026 (GLOBE NEWSWIRE) — Exagen Inc. (Nasdaq: XGN), a leading provider of autoimmune testing, today announced select preliminary unaudited financial results for the fourth quarter and year ended December 31, 2025, in line with prior financial guidance.

Select Preliminary Unaudited 2025 Results

  Revenue
  Three Months Ended

December 31, 2025 		  Twelve Months Ended

December 31, 2025
Total Revenue $16M to $17M   $66M to $67M
Year-Over-Year Growth 17% to 24%   19% to 20%

  Other
  Twelve Months Ended


December 31, 2025
AVISE CTD Volume 136,000 to 137,000
AVISE CTD Trailing 12-month (TTM) average selling price $441 to $445
Year-end cash and cash equivalents $32M
   

The select preliminary unaudited financial results reported today represent:

  • Record full year 2025 revenue, an increase of at least 19% over 2024
  • AVISE CTD trailing 12-month (TTM) ASP expansion by at least $30 compared to 2024
  • AVISE CTD test volume growth of at least 13,000, an 11% increase over 2024
  • Year-end cash and cash equivalents of $32 million, a $10 million increase over 2024

“I am pleased to report the completion of another strong year for Exagen in which we’ve continued to make substantial progress in building a great company; a testament to continued execution across our commercial, scientific, and operational teams,” said John Aballi, President and CEO. “Based upon our preliminary results, we delivered significant topline growth, driven by both volume and ASP expansion, despite unexpected ASP headwinds in the second half of the year. We also strengthened our scientific and commercial teams and subsequently launched our first enhancements to the AVISE platform in several years, with more on the horizon. Our strong cash position and disciplined approach provide the flexibility to continue to invest in innovation and advance our strategy to change the standard of care in autoimmune disease while pursuing our goal of operating a profitable company.”

Cautionary Note Regarding Select Preliminary Unaudited Financial Results

Exagen is providing the above select preliminary unaudited financial information and results of operations as of and for the three months and year ended December 31, 2025, based on currently available information. The company’s financial closing procedures with respect to the estimated financial data provided above are not yet complete. These procedures often result in changes to accounts. The company’s independent registered public accounting firm has not audited, reviewed, compiled or performed any procedures with respect to the select preliminary unaudited financial information and, accordingly, our independent registered public accounting firm does not express an opinion or any other form of assurance with respect thereto. As a result, the company’s final results may vary from the preliminary results presented above. Management undertakes no obligation to update or supplement the information provided above until it releases its audited financial statements prepared in accordance with U.S. Generally Accepted Accounting Principles (GAAP) for the year ended December 31, 2025.

About Exagen

Exagen Inc. (Nasdaq: XGN) is a leading provider of autoimmune diagnostics, committed to transforming care for patients with chronic and debilitating autoimmune conditions. Based in San Diego County, California, Exagen’s mission is to provide clarity in autoimmune disease decision making and improve clinical outcomes through its innovative testing portfolio. The company’s flagship product, AVISE® CTD, enables clinicians to more effectively diagnose complex autoimmune conditions such as lupus, rheumatoid arthritis, and Sjögren’s syndrome earlier and with greater accuracy. Exagen’s laboratory specializes in the testing of rheumatic diseases, delivering precise and timely results, supported by a full suite of AVISE-branded tests for disease diagnosis, prognosis, and monitoring. With a focus on research, innovation, education, and patient-centered care, Exagen is dedicated to addressing the ongoing challenges of autoimmune disease management.

For more information, please visit Exagen.com or follow @ExagenInc on X (formerly known as Twitter).

Forward Looking Statements

Exagen cautions you that statements contained in this press release regarding matters that are not historical facts are forward-looking statements. These statements are based on Exagen’s current beliefs and expectations. Such forward-looking statements include, but are not limited to, statements regarding: Exagen’s goals, strategies and ambitions; the potential utility and effectiveness of Exagen’s services and testing solutions, additional enhancements to the AVISE platform; potential shareholder value and growth and profitability; preliminary financial information for 2025. The inclusion of forward-looking statements should not be regarded as a representation by Exagen that any of its plans will be achieved. Actual results may differ from those set forth in this press release due to the risks and uncertainties inherent in Exagen’s business, including, without limitation: delays in reimbursement and coverage decisions from Medicare and third-party payors and in interactions with regulatory authorities, and delays in ongoing and planned clinical trials involving its tests; Exagen’s commercial success depends upon attaining and maintaining significant market acceptance of its testing products among rheumatologists, patients, third-party payors and others in the medical community; Exagen’s ability to successfully execute on its business strategies; third-party payors not providing coverage and adequate reimbursement for Exagen’s testing products, including Exagen’s ability to collect on funds due; Exagen’s ability to obtain and maintain intellectual property protection for its testing products; regulatory developments affecting Exagen’s business; and other risks described in Exagen’s prior press releases and Exagen’s filings with the Securities and Exchange Commission (SEC), including under the heading “Risk Factors” in Exagen’s Annual Report on Form 10-K for the year ended December 31, 2024, filed with the SEC on March 11, 2025, Quarterly Report on Form 10-Q for the quarter ended September 30, 2025 filed with the SEC on November 4, 2025 and any subsequent filings with the SEC. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof, and Exagen undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date hereof. All forward-looking statements are qualified in their entirety by this cautionary statement, which is made under the safe harbor provisions of the Private Securities Litigation Reform Act of 1995.

Contact:

Jeff Black, Chief Financial Officer
Exagen Inc.
[email protected]



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

  • Phase 1/2a study with lead Radio-DARPin MP0712 initiated; first patient dosing expected Q1 2026, initial data anticipated in 2026
  • Full imaging and dosimetry data from MP0712 compassionate care program to be presented at TWC 2026
  • Phase 2 investigator-initiated trial of MP0317 now open with patient dosing ongoing, exploring MP0317 in combination with standard-of-care for patients with cholangiocarcinoma
  • Phase 1/2a trial of multi-specific T cell engager MP0533 ongoing, update on clinical development path planned for H1 2026

ZURICH-SCHLIEREN, Switzerland and CONCORD, Mass., Jan. 11, 2026 (GLOBE NEWSWIRE) — Ad hoc announcement pursuant to Art. 53 LRMolecular 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”), today provided 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.

“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 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) 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 and SITC, 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 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.

About DARPin Therapeutics

DARPin (Designed Ankyrin Repeat Protein) therapeutics are a novel class of protein drugs based on natural binding proteins, which have been clinically-validated across several therapeutic areas and developed through to the registrational stage. The key properties of DARPins – intrinsic potential for high affinity and specificity, small size, flexible architecture, and high stability – offer unmatched advantages to drug design, such as multispecificity, broad target range, and tunable half-life. The Company’s Radio-DARPins enable highly effective and specific delivery of potent radioactive payloads to tumor lesions while sparing healthy tissues. Molecular Partners’ Switch-DARPins allow conditional, tumor-localized immune activation, which enables increased safety and potency for next generation immune cell engagers. Powered by twenty years of DARPin leadership in the clinic, Molecular Partners has built an innovative, rapid and cost-effective DARPin drug design engine, including proprietary DARPin libraries and platforms, for candidates produced with optimized properties and tailored to therapeutic needs.

About Molecular Partners AG 
Molecular Partners AG (SIX: MOLN, NASDAQ: MOLN) is a clinical-stage biotech company pioneering a novel class of protein drugs known as DARPin therapeutics, for medical challenges other treatment modalities cannot readily address. Molecular Partners leverages the key properties of DARPins to design and develop differentiated therapeutics for cancer patients, including targeted radiopharmaceuticals and next-generation immune cell engagers. The Company has proprietary programs in various stages of pre-clinical and clinical development, as well as programs developed through partnerships with leading pharmaceutical companies and academic centers. Molecular Partners, founded in 2004, has offices in both Zurich, Switzerland and Concord, MA, USA. For more information, visit www.molecularpartners.com and find us on LinkedIn and Twitter / X @MolecularPrtnrs

For further details, please contact:

Seth Lewis, SVP Investor Relations & Strategy
Concord, Massachusetts, U.S.
[email protected]
Tel: +1 781 420 2361

Laura Jeanbart, PhD, Head of Portfolio Management & Communications
Zurich-Schlieren, Switzerland
[email protected]
Tel: +41 44 575 19 35

Cautionary Note Regarding Forward-Looking Statements

This press release contains forward looking statements. Any statements contained in this press release that do not describe historical facts may constitute forward-looking statements as that term is defined in the Private Securities Litigation Reform Act of 1995, as amended, including without limitation: implied and express statements regarding the clinical development of Molecular Partners’ current or future product candidates; expectations regarding timing for reporting data from ongoing clinical trials or the initiation of future clinical trials; the potential therapeutic and clinical benefits of Molecular Partners’ product candidates and its RDT and Switch-DARPin platforms; the selection and development of future programs; Molecular Partners’ collaboration with Orano Med including the benefits and results that may be achieved through the collaboration; and Molecular Partners’ expected business and financial outlook, including anticipated expenses and cash utilization for 2026 and its expectation of its current cash runway. These statements may be identified by words such as “aim”, “anticipate”,“expect”, “guidance”, “intend”, “outlook”, “plan”, “potential”, “will” and similar expressions, and are based on Molecular Partners’ current beliefs and expectations. These statements involve risks and uncertainties that could cause actual results to differ materially from those reflected in such statements. Some of the key factors that could cause actual results to differ from Molecular Partners’ expectations include, but are not limited to, those set forth in under the heading “Risk Factors” in Molecular Partners’ Annual Report on Form 20-F for the year ended December 31, 2024 and other filings Molecular Partners makes with the SEC from time to time. These documents are available on the Investors page of Molecular Partners’ website at www.molecularpartners.com. In addition, this press release contains information relating to interim data as of the relevant data cutoff date, results of which may differ from topline results that may be obtained in the future. ​

Molecular Partners’ audited consolidated financial statements at and for the year ended December 31, 2025 are not yet available. As a result, the financial information described in this press release is preliminary and unaudited, represents management’s estimate as of the date hereof and is subject to completion of the Company’s financial closing procedures for the fourth quarter and fiscal year ended December 31, 2025. This preliminary financial information may materially differ from the actual results that will be reflected in the Company’s audited consolidated financial statements when such financial statements are completed and publicly disclosed. The Company’s independent registered public accounting firm has not conducted an audit or review of, and does not express an opinion or any other form of assurance with respect to, the Company’s preliminary results.

Any forward-looking statements speak only as of the date of this press release and are based on information available to Molecular Partners as of the date of this release, and Molecular Partners assumes no obligation to, and does not intend to, update any forward-looking statements, whether as a result of new information, future events or otherwise.​



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Stoke Therapeutics Announces Updates to Timelines for the Completion of Enrollment and a Phase 3 Data Readout from the EMPEROR Study of Zorevunersen for the Treatment of Dravet Syndrome

Stoke Therapeutics Announces Updates to Timelines for the Completion of Enrollment and a Phase 3 Data Readout from the EMPEROR Study of Zorevunersen for the Treatment of Dravet Syndrome

— Company now expects to complete enrollment of 150 patients in Q2 2026, with a Phase 3 data readout in mid-2027; Rolling NDA submission planned to initiate in first half 2027—

— Discussions with FDA ongoing following recent multidisciplinary meeting; Company continues to explore potential for expedited development, registration and delivery of zorevunersen to patients —

—Company to present at 44th Annual J.P. Morgan Healthcare Conference on Tuesday, January 13, 2026 —

BEDFORD, Mass.–(BUSINESS WIRE)–Stoke Therapeutics, Inc. (Nasdaq: STOK) is a biotechnology company dedicated to restoring protein expression by harnessing the body’s potential with RNA medicine and has a lead investigational medicine, zorevunersen, in development with Biogen (Nasdaq: BIIB) as a first-in-class potential disease-modifying treatment for Dravet syndrome. Today, the Company announced accelerated timelines for the completion of enrollment and a Phase 3 data readout from the EMPEROR study. Completion of enrollment of 150 patients is now expected in the second quarter of 2026. This enrollment progress puts the Phase 3 EMPEROR study on track for a data readout in mid-2027 that is anticipated to support the submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA). The Company plans to initiate a rolling NDA submission in the first half of 2027.

In addition, as part of zorevunersen’s Breakthrough Therapy Designation, a multidisciplinary meeting was held with the FDA to discuss the ongoing clinical development of zorevunersen, including the exploration of potential expedited regulatory pathways. No immediate changes to the zorevunersen development program were agreed to at the meeting. The FDA has requested additional information, and discussions between the Company and the Agency are ongoing regarding potential opportunities to expeditethe development, registration and delivery of zorevunersen to patients.

“The rate of enrollment in the Phase 3 EMPEROR study is highly encouraging and supports the significant need for a disease-modifying treatment for Dravet syndrome. The accelerated timing for completion of enrollment of 150 patients, in addition to Breakthrough Therapy Designation, positions us to initiate a rolling NDA submission in the first half of 2027 resulting in the potential to deliver zorevunersen to patients sooner than originally expected,” said Ian F. Smith, Chief Executive Officer and Director of Stoke Therapeutics. “Our recent multidisciplinary meeting was productive and we appreciate the FDA’s interest in deepening their understanding of Dravet syndrome and its impacts on patients and their families while also taking time to review and discuss our four years of clinical data. Subsequently, we have responded to the Agency’s request for additional information and we look forward to continuing to engage with them as part of our commitment to explore every opportunity to deliver zorevunersen to patients as quickly as possible.”

As of January 9, 2026, nearly 330 patients globally had been identified by investigators as potential study candidates. Of these, approximately 60 patients are currently in the formal 8-week screening period that immediately precedes randomization and an additional approximately 60 patients have advanced to randomization and dosing.

Financial Guidance

The Company has approximately $391.7 million in cash, cash equivalents and marketable securities as of December 31, 2025. These funds, combined with eligible proceeds from the Biogen collaboration, are anticipated to fund operations into 2028.

J.P. Morgan Healthcare Conference Webcast Information

Chief Executive Officer Ian F. Smith will present at the 44th Annual J.P. Morgan Healthcare Conference on Tuesday, January 13, 2026, at 7:30 p.m. Eastern Time (4:30 p.m. Pacific Time) in San Francisco, CA. A live audio webcast of the presentation will be available on the Investors & News section of Stoke’s website at https://investor.stoketherapeutics.com/ and can be accessed by following this Link. A replay of the webcast will be available for 30 days following the presentation.

About Dravet Syndrome

Dravet syndrome is a severe developmental and epileptic encephalopathy (DEE) characterized by recurrent seizures as well as significant cognitive and behavioral impairments. Most cases of Dravet are caused by mutations in one copy of the SCN1A gene, leading to insufficient levels of NaV1.1 protein in neuronal cells in the brain. Even when treated with the best available anti-seizure medicines (ASMs), up to 57 percent of patients with Dravet syndrome do not achieve ≥50 percent reduction in seizure frequency. Complications of the disease often contribute to a poor quality of life for patients and their caregivers. Developmental and cognitive impairments often include intellectual disability, developmental delays, movement and balance issues, language and speech disturbances, growth defects, sleep abnormalities, disruptions of the autonomic nervous system and mood disorders. Compared with the general epilepsy population, people living with Dravet syndrome have a higher risk of sudden unexpected death in epilepsy, or SUDEP; up to 20 percent of children and adolescents with Dravet syndrome die before adulthood due to SUDEP, prolonged seizures, seizure-related accidents or infections1. Dravet syndrome occurs globally and is not concentrated in a particular geographic area or ethnic group. Currently, it is estimated that up to 38,000 people are living with Dravet syndrome in the U.S. (~16,000), UK, EU-4 and Japan.2 There are no approved disease-modifying therapies for people living with Dravet syndrome.

About Zorevunersen

Zorevunersen is an investigational antisense oligonucleotide that is designed to treat the underlying cause of Dravet syndrome by increasing functional NaV1.1 protein production in brain cells from the non-mutated (wild-type) copy of the SCN1A gene. This highly differentiated mechanism of action aims to reduce seizure frequency beyond what has been achieved with anti-seizure medicines and to improve neurodevelopment, cognition and behavior. Zorevunersen has demonstrated the potential for disease modification and has been granted orphan drug designation by the FDA and the EMA. The FDA has also granted zorevunersen rare pediatric disease designation and Breakthrough Therapy Designation for the treatment of Dravet syndrome with a confirmed mutation not associated with gain-of-function, in the SCN1A gene. Stoke has a strategic collaboration with Biogen to develop and commercialize zorevunersen for Dravet syndrome. Under the collaboration, Stoke retains exclusive rights for zorevunersen in the United States, Canada, and Mexico; Biogen receives exclusive rest of world commercialization rights.

About the EMPEROR Study

The EMPEROR Phase 3 Study (NCT06872125) is a global, double-blind, sham-controlled study evaluating the efficacy, safety and tolerability of zorevunersen in children ages 2 to <18 with Dravet syndrome with a confirmed variant in the SCN1A gene not associated with gain-of-function. The trial is currently enrolling approximately 150 patients in the United States, United Kingdom and Japan which are anticipated to support an NDA. At least 20 additional patients are expected to enroll in Germany, Spain, France and Italy starting in the second quarter of 2026. Participants are randomized 1:1 to receive either zorevunersen via intrathecal administration or a sham comparator for a 52-week treatment period following an 8-week baseline period. Following the completion of the study treatment period, eligible participants will be offered ongoing treatment with zorevunersen as part of an OLE study. The primary endpoint of the study is percent change from baseline in major motor seizure frequency at week 28 in patients receiving zorevunersen as compared to sham. The key secondary endpoints are the durability of effect on major motor seizure frequency and improvements in behavior and cognition as measured by Vineland-3 subdomains, including expressive communication, receptive communication, interpersonal relationships, coping skills and personal skills. Additional endpoints include safety, Clinician Global Impression of Change (CGI-C), Caregiver Global Impression of Change (CaGI-C) and the Bayley Scales of Infant Development (BSID-IV). For more information, visit https://www.emperorstudy.com/.

About Stoke Therapeutics

Stoke Therapeutics (Nasdaq: STOK), is a biotechnology company dedicated to restoring protein expression by harnessing the body’s potential with RNA medicine. Using Stoke’s proprietary TANGO (Targeted Augmentation of Nuclear Gene Output) approach, Stoke is developing antisense oligonucleotides (ASOs) to selectively restore naturally-occurring protein levels. Stoke’s first medicine in development, zorevunersen, has demonstrated the potential for disease modification in patients with Dravet syndrome and is currently being evaluated in a Phase 3 study. Stoke’s initial focus are diseases of the central nervous system and the eye that are caused by a loss of ~50% of normal protein levels (haploinsufficiency). Proof of concept has been demonstrated in other organs, tissues, and systems, supporting broad potential for Stoke’s proprietary approach. Stoke is headquartered in Bedford, Massachusetts. For more information, visit https://www.stoketherapeutics.com/.

Stoke Therapeutics Cautionary Note Regarding Forward-Looking Statements

This press release contains forward-looking statements within the meaning of the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995, including, but not limited to: the ability of zorevunersen to treat the underlying causes of Dravet syndrome and reduce seizures or show improvements in behavior and cognition at the indicated dosing levels or at all; the potential benefits, safety and efficacy of zorevunersen; the timing and expected progress of clinical trials, data readouts, regulatory meetings, regulatory decisions and other presentations; the characterization of the Company’s meeting and discussions with the FDA; and the ability of the Company to achieve an NDA submission or approval on the expedited timeframe disclosed or at all. Statements including words such as “plan,” “potential,” “will,” “continue,” “expect,” or similar words and statements in the future tense are forward-looking statements. These forward-looking statements involve risks and uncertainties, as well as assumptions, which, if they prove incorrect or do not fully materialize, could cause Stoke’s results to differ materially from those expressed or implied by such forward-looking statements, including, but not limited to, risks and uncertainties related to: the Company’s ability to advance, obtain regulatory approval and ultimately commercialize its product candidates; that if collaborators were to breach or terminate their agreements, the Company would not obtain the anticipated financial or other benefits; the possibility that the Company and Biogen may not be successful in their development of zorevunersen and that, even if successful, they may be unable to successfully commercialize zorevunersen; positive results in a clinical trial may not be replicated in subsequent trials or successes in early stage clinical trials may not be predictive of results in later stage trials; the Company’s ability to protect its intellectual property; the Company’s ability to fund development activities and achieve development goals into 2028; and the other risks and uncertainties described under the heading “Risk Factors” in its Annual Report on Form 10-K for the year ended December 31, 2024, its quarterly reports on Form 10-Q, and the other documents it files with the Securities and Exchange Commission. These forward-looking statements speak only as of the date of this press release, and the Company undertakes no obligation to revise or update any forward-looking statements to reflect events or circumstances after the date hereof.

References:

  1. Symonds, J. et al. Early childhood epilepsies: epidemiology, classification, aetiology, and socio-economic determinants. Brain. 2021;144(9):2879-2891.

  2. Based on Stoke Therapeutics’ preliminary estimates, which scaled annual incidence to prevalence using country-specific live birth rates over the past 85 years and adjusted for Dravet-specific mortality. The estimate is based on incidence rates published by Wu et al., Pediatrics, 2015.

 

Media & Investor Contacts:

Susan Willson

Vice President, Corporate Communications

[email protected]

415-509-8202

Doug Snow

Director, Communications & Investor Relations

[email protected]

508-642-6485

KEYWORDS: Massachusetts United States North America

INDUSTRY KEYWORDS: Health Genetics Clinical Trials Research Science Pharmaceutical Biotechnology

MEDIA:

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SKYE Deadline: SKYE Investors Have Opportunity to Lead Skye Bioscience, Inc. Securities Fraud Lawsuit

PR Newswire

NEW YORK, Jan. 11, 2026 /PRNewswire/ —

Why: Rosen Law Firm, a global investor rights law firm, reminds purchasers of securities of Skye Bioscience, Inc. (NASDAQ: SKYE) between November 4, 2024 and October 3, 2025, both dates inclusive (the “Class Period”), of the important January 16, 2026 lead plaintiff deadline.

So what: If you purchased Skye securities during the Class Period you may be entitled to compensation without payment of any out of pocket fees or costs through a contingency fee arrangement.

What to do next: To join the Skye Bioscience, Inc. class action, go to https://rosenlegal.com/submit-form/?case_id=48064  or call Phillip Kim, Esq. toll-free at 866-767-3653 or email [email protected] for information on the class action. A class action lawsuit has already been filed. If you wish to serve as lead plaintiff, you must move the Court no later than January 16, 2026. A lead plaintiff is a representative party acting on behalf of other class members in directing the litigation.

Why Rosen Law: We encourage investors to select qualified counsel with a track record of success in leadership roles. Often, firms issuing notices do not have comparable experience, resources, or any meaningful peer recognition. Many of these firms do not actually litigate securities class actions, but are merely middlemen that refer clients or partner with law firms that actually litigate the cases. Be wise in selecting counsel. The Rosen Law Firm represents investors throughout the globe, concentrating its practice in securities class actions and shareholder derivative litigation. Rosen Law Firm achieved, at that time, the largest ever securities class action settlement against a Chinese Company. Rosen Law Firm was Ranked No. 1 by ISS Securities Class Action Services for number of securities class action settlements in 2017. The firm has been ranked in the top 4 each year since 2013 and has recovered hundreds of millions of dollars for investors. In 2019 alone the firm secured over $438 million for investors. In 2020, founding partner Laurence Rosen was named by law360 as a Titan of Plaintiffs’ Bar. Many of the firm’s attorneys have been recognized by Lawdragon and Super Lawyers.

Details of the case: According to the lawsuit, throughout the Class Period, defendants made materially false and misleading statements regarding Skye’s business, operations, and prospects. Specifically, defendants made false and/or misleading statements and/or failed to disclose that: (1) nimacimab was less effective than defendants had led investors to believe; (2) accordingly, nimacimab’s clinical, regulatory, and commercial prospects were overstated; and (3) as a result, defendants’ public statements were materially false and misleading at all relevant times. When the true details entered the market, the lawsuit claims that investors suffered damages.

To join the Skye Bioscience class action, go to https://rosenlegal.com/submit-form/?case_id=48064 or call Phillip Kim, Esq. toll-free at 866-767-3653 or email [email protected] for information on the class action.

No Class Has Been Certified. Until a class is certified, you are not represented by counsel unless you retain one. You may select counsel of your choice. You may also remain an absent class member and do nothing at this point. An investor’s ability to share in any potential future recovery is not dependent upon serving as lead plaintiff.

Follow us for updates on LinkedIn: https://www.linkedin.com/company/the-rosen-law-firm, on Twitter: https://twitter.com/rosen_firm or on Facebook: https://www.facebook.com/rosenlawfirm/.

Attorney Advertising. Prior results do not guarantee a similar outcome.

Contact Information:

      Laurence Rosen, Esq.
      Phillip Kim, Esq.
      The Rosen Law Firm, P.A.
      275 Madison Avenue, 40th Floor
      New York, NY 10016
      Tel: (212) 686-1060
      Toll Free: (866) 767-3653
      Fax: (212) 202-3827
      [email protected]
      www.rosenlegal.com

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Krystal Biotech Provides Business Update at 44th Annual J.P. Morgan Healthcare Conference

Preliminary 4Q 2025 VYJUVEK net revenue of $106 million to $107 million

Robust clinical pipeline with multibillion dollar opportunities and strong balance sheet for sustained growth

PITTSBURGH, Jan. 11, 2026 (GLOBE NEWSWIRE) — Krystal Biotech, Inc. (the “Company”) (NASDAQ: KRYS) today announced selected preliminary unaudited 2025 financial results, including fourth quarter and full year 2025 VYJUVEK® net product revenue, and outlined the Company’s strategic vision to drive the next stage of growth of its rare disease business. These topics will be discussed during the Company’s presentation at the 44th Annual J.P. Morgan Healthcare Conference in San Francisco tomorrow, Monday, January 12, 2026, at 10:30 am ET / 7:30 am PT.

“2025 was a standout year for Krystal, with the successful launch of VYJUVEK in Europe and Japan setting the foundation for our broader ambitions to build a true global leader in rare disease,” said Krish S. Krishnan, Chairman and CEO of Krystal Biotech. “As we execute on the next stage of our growth story, we will be leaning into our strengths – the strengths of our HSV-1 platform and the strengths of our organization – and focusing in on rare disease indications where we can move quickly and launch truly differentiated and impactful redosable genetic medicines. With multiple potential blockbuster launches in the next four years, as well as a strong growth outlook for VYJUVEK, we are well positioned to execute on this vision and deliver transformational outcomes for patients.”

Preliminary and Unaudited Fourth Quarter and Full Year 2025 Financial Updates

Based on preliminary unaudited financial information, the Company expects net product revenue for VYJUVEK to be between $106 million and $107 million for the fourth quarter of 2025. VYJUVEK net revenue for the full year 2025 is expected to be between $388 million and $389 million.

Cash, cash equivalents, and investments were approximately $955 million as of December 31, 2025.

These preliminary unaudited results are based on management’s initial analysis of operations for the year ended December 31, 2025 and subject to adjustment. The Company will report its full financial results for the fourth quarter and full year 2025 in February 2026.

Rare Disease Strategic Vision and 2026 Corporate Objectives

Over 300 million people around the world are living with rare diseases, many of whom lack adequate therapies. With global rare disease drug development and launch infrastructure and a redosable HSV-1 platform with Platform Technology Designation that is well-suited for gene delivery to high turnover tissues in the skin, lung, and eye, the Company is uniquely positioned to help fill this treatment gap.

To that end, the Company is accelerating and expanding clinical development efforts for its rare disease pipeline of programs:

  • KB803 for ocular complications of dystrophic epidermolysis bullosa (DEB)
  • KB801 for neurotrophic keratitis (NK)
  • KB407 for cystic fibrosis (CF)
  • KB111 for Hailey-Hailey disease (HHD)

In support of potential expedited development of KB801 for the treatment of NK, the Company has increased the enrollment target of its ongoing registrational double-masked, randomized, placebo-controlled study from 27 to 60 patients. The Company will provide a detailed update on the registrational study design when it reports its 2025 financial results in February 2026. Top line data from the study is expected before the end of 2026.

The Company’s strategic vision is to have at least four marketed rare disease medicines, inclusive of VYJUVEK, by the end of 2030, treating over 10,000 patients worldwide.

The Company expects to achieve these goals while remaining profitable throughout the period and continuing to invest strategically across its broader preclinical and clinical pipeline, including programs targeting larger indications such as KB408 for alpha-1 antitrypsin deficiency and KB707 for non-small cell lung cancer.

To achieve the Company’s broader ambitions in rare disease, the Company’s corporate objectives for 2026 include:

  • Launch VYJUVEK in at least one more major European market and expand specialty distributor network to cover over 40 countries
  • Report top-line results from its registrational Phase 3 study evaluating KB803 for the treatment of ocular complications of DEB
  • Report top-line results from its registrational double-masked, randomized, placebo-controlled study evaluating KB801 for the treatment of NK
  • Initiate and complete enrollment in a registrational repeat dose study evaluating KB407 for the treatment of CF
  • Dose first patient in registrational double-blind, intra-patient randomized, placebo-controlled study evaluating KB111 in HHD patients

The Company also expects to report updates for both KB408 and KB707 before the end of the year.

Non-GAAP Research & Development (R&D) and Selling, General & Administrative (SG&A) Expense Guidance for 2026

Based on its current operating plans, the Company expects its combined non-GAAP R&D and SG&A expense in 2026 to be between $175 million and $195 million. Non-GAAP R&D and SG&A expense does not include stock-based compensation.

44

th

Annual J.P. Morgan Healthcare Conference Presentation and Webcast

Krish S. Krishnan, Chairman and Chief Executive Officer, and Suma M. Krishnan, President of Research and Development, will highlight these updates and Krystal’s strategic vision in a presentation at the 44th Annual J.P. Morgan Healthcare Conference on Monday, January 12, 2026, at 10:30 am ET / 7:30 am PT.

A webcast of the presentation will be available here beginning at 10:30 am ET / 7:30 am PT on Monday, January 12, 2026 and will be posted on the Investors section of the Company’s website.

About Krystal Biotech, Inc.

Krystal Biotech, Inc. (NASDAQ: KRYS) is a fully integrated, commercial-stage, global biotechnology company focused on the discovery, development and commercialization of genetic medicines to treat diseases with high unmet medical needs. VYJUVEK®, the Company’s first commercial product, is the first-ever redosable gene therapy and the first genetic medicine approved in the United States, Europe, and Japan for the treatment of dystrophic epidermolysis bullosa. The Company is rapidly advancing a robust preclinical and clinical pipeline of investigational genetic medicines. Krystal Biotech is headquartered in Pittsburgh, Pennsylvania. For more information, please visit http://www.krystalbio.com, and follow @KrystalBiotech on LinkedIn and X (formerly Twitter).

Forward-Looking Statements

Statements in this press release about future expectations, plans, and prospects, as well as statements that are not historical facts, including statements about, among other topics, our selected preliminary and unaudited financial results for 2025; our strategic vision and our 2026 corporate goals; our combined R&D and SG&A expense guidance; and our expectations for our product pipeline, including clinical trial plans, enrollment in clinical trials, and the timing of initiating clinical trials, dosing patients, data read-outs, and regulatory submissions may constitute forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. Undue reliance should not be placed on the forward-looking statements in this press release. These statements are not guaranties of future performance and actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including uncertainties associated with regulatory review of clinical trials and applications for marketing approvals; the availability or commercial potential of VYJUVEK or our product candidates; and such other important factors as are set forth under the caption “Risk Factors” in the Company’s annual and quarterly reports on file with the U.S. Securities and Exchange Commission. The Company is providing the information in this press release as of the date hereof and undertakes no duty to update this information unless required by law.

Non-GAAP Financial Measure

This press release includes forward-looking combined R&D and SG&A expense guidance that is not required by, or presented in accordance with, U.S. GAAP. The Company believes this non-GAAP financial measure is useful to investors as a supplemental measure to evaluate operating performance. The Company has not provided a quantitative reconciliation of forecasted non-GAAP combined R&D and SG&A expense to forecasted GAAP combined R&D and SG&A expense because the Company is unable, without making unreasonable efforts, to calculate the reconciling item, stock-based compensation expenses, with confidence. This item, which could materially affect the computation of forward-looking GAAP combined R&D and SG&A expense, is inherently uncertain and depends on various factors, some of which are outside of the Company’s control.

CONTACT

Investors and Media:

Stéphane Paquette
Krystal Biotech
[email protected]



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Commerce Supports Universal Commerce Protocol, Plans to Offer Buying Directly Across Google’s AI Surfaces

New standard creates a common language for agents and systems across the entire shopping journey from discovery and buying to post-purchase experiences

AUSTIN, Texas, Jan. 11, 2026 (GLOBE NEWSWIRE) — Commerce (Nasdaq: CMRC), an open, intelligent ecosystem of technology solutions and the parent company of leading ecommerce platform BigCommerce and data feed optimization leader Feedonomics, today announced its endorsement of Google’s new Universal Commerce Protocol (UCP).

The new, open-source standard creates a common language for agents and systems to work together across the entire shopping journey from discovery and buying to post-purchase experiences. So instead of building a new connection for every agent, they can all interact seamlessly providing merchants with a frictionless way to reach customers across the entire AI ecosystem.

“AI is rapidly reshaping commerce. Merchants need to make it easy for shoppers to go from discovery to purchase, or they risk losing sales,” said Sharon Gee, senior vice president of product for AI at Commerce. “At the same time, keeping product data structured and enriched for AI can be resource-intensive. Our ongoing work with Google ensures merchants are not only present but competitive in AI-driven environments where consumers are searching and shopping.”

To start, UCP will soon enable a new checkout feature on product listings in AI Mode in Search and the Gemini app, allowing shoppers to buy directly from eligible US retailers and Commerce merchants right as they’re researching on Google.

“For agentic commerce to scale, it’s critical for the industry to align on a common set of standards,” said Ashish Gupta, vice president and general manager of merchant shopping at Google. “We are proud to have Commerce endorse the Universal Commerce Protocol as the foundation for that future.”

Discovery is shifting from traditional search that returns results to a specific query to conversational answer engines with embedded buying opportunities. Agent-driven shopping generates more specific, higher intent queries with consumers who know what they want and are ready to purchase it. Merchants must be strategic about how they show up in answer engines and remove barriers that prevent shoppers from making a purchase.

As part of the collaboration, Commerce is building toward the protocol to allow merchants to:

  • Enable buying directly within Google’s AI experiences, helping to secure transactions at the moment of intent
  • Remain merchant of record, retaining full ownership of the customer relationship and transaction data
  • Future-proof their business with a unified open standard to power additional commerce actions

The UCP endorsement builds on the ongoing Google and Commerce partnership, utilizing Commerce’s key differentiator: its Feedonomics-powered data enrichment layer. This layer structures and optimizes product feeds to align with Google’s schema, dynamically enhancing titles, attributes, and taxonomy to ensure high-quality data that boosts product visibility, improves match rates, and conversion with the Google ecosystem.

Learn more about Google’s new UCP here: https://blog.google/products/ads-commerce/agentic-commerce-ai-tools-protocol-retailers-platforms/

Learn more about how Commerce is powering the era of agentic commerce here: https://www.commerce.com/agentic-commerce/

About Commerce


Commerce
 (Nasdaq: CMRC) empowers businesses to innovate, grow, and thrive by providing an open, AI-driven commerce ecosystem. As the parent company of BigCommerce, Feedonomics, and Makeswift, Commerce connects the tools and systems that power growth, enabling businesses to unlock the full potential of their data, deliver seamless and personalized experiences across every channel, and adapt swiftly to an ever-changing market. Trusted by leading businesses like Coldwater Creek, Cole Haan, Harvey Nichols, King Arthur Baking Co., Mizuno, Perry Ellis, SportsShoes and Uplift Desk, Commerce delivers the storefront control, optimized data, and AI-ready tools businesses need to grow, serve diverse buyers, and operate with confidence in an increasingly intelligent, multi-surface world. For more information, visit commerce.com or follow us on X and LinkedIn.

BigCommerce®, the Commerce logo, and other brands are the trademarks or registered trademarks of BigCommerce Pty. Ltd. Third-party trademarks and service marks are the property of their respective owner.

Media Contact:

Brad Hem
[email protected]



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Honeywell Unveils AI-Enabled Technology to Personalize In-store Shopping with Google Cloud

PR Newswire

New Smart Shopping Platform, developed in collaboration with 66degrees, brings digitally enhanced personalization and navigation to the brick-and-mortar retail environment with Google’s AI.

NEW YORK, Jan. 11, 2026 /PRNewswire/ — Honeywell (Nasdaq: HON) today announced the launch of an AI-enabled retail solution developed in collaboration with Google Cloud and 66degrees that leverages Google’s Gemini and Google Cloud’s Vertex AI platform to transform the in-store shopping experience for retailers worldwide. The Smart Shopping Platform helps shoppers easily locate desired products, compare similar items and quickly find relevant substitutions when products are unavailable, making in-store shopping more efficient and enjoyable.

“There is nothing more frustrating than roaming through a store unable to find the last item on your grocery list or forgetting the key part needed to complete a home repair,” said David Barker, president, Honeywell Productivity Solutions and Services. ”The Smart Shopping Platform addresses these pain points, creating a better experience for shoppers. Retailers also benefit from an ’out of the box’ AI solution they can implement without having to maintain a team of AI experts.”

The Smart Shopping Platform is a cloud-based solution that creates a seamless connection between a retailer’s digital data and the physical store environment. Built on Honeywell’s Mobility Edge™ hardware and software platform and enabled by Google Cloud’s AI technologies, it offers personalized guidance, real-time product information and dynamic recommendations that mirror the convenience of online shopping.

“The Smart Shopping Platform uses Google Cloud’s AI to turn Honeywell devices into intelligent companions for both shoppers and staff,” said Jose Gomes, vice president, Retail and Consumer Packaged Goods, Google Cloud. “This collaboration integrates AI with specialized hardware to streamline operations inside the retail store and guide consumers through an efficient and delightful shopping journey. It’s a win-win that helps retailers increase basket size while building deeper customer loyalty.”

When using the platform on a Honeywell for Android device—such as the CS32 Personal Shopper—consumers can link their loyalty accounts to immediately unlock personalized recommendations based on buying history, stated preferences, complementary products and available discounts and promotions. The Smart Shopping Platform can also provide step-by-step navigation through the store to help customers easily locate everything they wish to buy. If a specific product is out of stock, the system uses AI to suggest relevant alternatives, mirroring the convenience of e-commerce.

The solution also supports retail workers by helping them become in-house experts. Associates equipped with devices like the Honeywell CT70 can use the Smart Shopping Platform to provide quick, customized guidance and insights to shoppers, helping every employee serve as a subject matter expert. For example, an employee can quickly identify the new location of a customer’s favorite dairy-free cereal in the store. Today, devices like the Honeywell CT70 are used by thousands of retail associates at major grocery chains, big box stores, specialty retailers, department stores and more.

This launch is the result of the ongoing collaboration between Honeywell and Google Cloud to help advance computing across multiple industries. The Smart Shopping Platform will be available to customers beginning in February 2026.

To learn more about Honeywell’s innovative solutions across the retail landscape, visit: https://automation.honeywell.com/us/en/solutions/productivity.

About Honeywell 

Honeywell is an integrated operating company serving a broad range of industries and geographies around the world, with a portfolio that is underpinned by our Honeywell Accelerator operating system and Honeywell Forge platform. As a trusted partner, we help organizations solve the world’s toughest, most complex challenges, providing actionable solutions and innovations for aerospace, building automation, industrial automation, process automation, and process technology, that help make the world smarter and safer as well as more secure and sustainable. For more news and information on Honeywell, please visit www.honeywell.com/newsroom.

About Honeywell Productivity Solutions and Services

Productivity Solutions and Services creates mobile computers, scanners, software and other data capture devices to improve worker productivity across key industries like retail, transportation, logistics and healthcare. An innovator in Automatic Identification and Data Collection (AIDC) and a leader in industrial products since the 1970s, the business is shaping the future by finding novel ways to significantly improve the efficiency, speed and accuracy of our customers’ complex operations.

About Google Cloud

Google Cloud is the new way to the cloud, providing AI, infrastructure, developer, data, security, and collaboration tools built for today and tomorrow. Google Cloud offers a powerful, fully integrated, and optimized AI stack with its own planet-scale infrastructure, custom-built chips, generative AI models, and development platform, as well as AI-powered applications, to help organizations transform. Customers in more than 200 countries and territories turn to Google Cloud as their trusted technology partner.

About 66degrees

66degrees is a Google Cloud Partner Advantage Premier level partner empowering organizations to thrive in the age of AI. The company delivers expertise in platform modernization, data transformation, and AI/ML implementation with a proven enterprise track record. With a global footprint of experts, 66degrees helps clients by focusing on three key pillars: modernizing data and infrastructure for AI, building AI platforms and applications, and managing and scaling those AI platforms.

Media Contact: 
Carly Ingersoll 
+1 (704) 626-1374 
[email protected] 

 

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SOURCE Honeywell

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Kroger Scales Generative AI Strategy with Google Cloud to Drive Digital Growth and Personalization

PR Newswire

Kroger will use Google Cloud new agentic platform, Gemini Enterprise for Customer Experience, to simplify and transform how customers shop and eat

CINCINNATI and SUNNYVALE, Calif., Jan. 11, 2026 /PRNewswire/ — The Kroger Co. (NYSE: KR) today announced an expanded relationship with Google Cloud. The leading grocery chain will use the Gemini Enterprise for Customer Experience (CX) solution to support its customer experience transformation, combining cutting-edge technology with the care, food knowledge and understanding customers expect from Kroger – all into a new personal shopping assistant.

Under the expansion Kroger will roll out Gemini Enterprise for CX nationwide to help make grocery planning easier through an integrated Meal assistant and Shopping assistant –providing faster shopping, without compromising on unique customer preferences. 

In addition to deploying Gemini Enterprise for CX, Kroger will also use Customer Experience Agent Studio to analyze interactions and intent on calls made by customers to stores to proactively identify and resolve issues earlier, enhance associate productivity, and deliver a more seamless, “white-glove” experience nationwide.

“We know our customers want an experience that is seamless and adapts to the context of their day, and the Shopping assistant is one more way we will transform how our customers will engage with us,” said Yael Cosset, executive vice president and chief digital officer for Kroger. “A customer planning a week of dinners, seeking recipe inspiration, or jumping into a new food regimen, will be able to ask our integrated assistant to create a shopping list based on their immediate needs, their budget, and family’s unique preferences. We are streamlining every aspect of the shopping experience from building a basket and getting relevant offers and savings, to scheduling a delivery faster than ever before. We are making grocery shopping simpler and more personal, creating more time for real connections around foods families love.”

Building a Personal Shopping Companion

Kroger has been helping families find foods they love for nearly 150 years, by removing the need for customers to compromise on the choice of product, including innovative Our Brands products, offering more options to shop how they want in store, through pickup or delivery, and providing personalized offers and value to each customer.

Kroger’s Shopping assistant will build upon this foundation, reducing the time it takes to complete complex, multi-step tasks without requiring a lot of input from customers. The Shopping assistant incorporates AI-enabled features such as:

  • Intelligent execution: Agentic integration, allowing the assistant to complete complex tasks from a single instruction—such as explore meal ideas, build complex carts for a big occasion, reorder a past purchase, or compare product details.
  • Inspiration-to-cart flow: Converts a customer request, like “I want to prepare vegan tomato soup” into a guided recipe, with a detailed ingredient list, that can be added to their shopping carts with a single click.
  • Accurate and grounded: Makes recommendations based on Kroger’s proprietary data asset and grounded in actual assortment, pricing, and availability, meaning customers receive relevant, reliable suggestions they can act on immediately. The Shopping assistant takes advantage of Kroger’s precise understanding of customer needs, and will deliver a complete solution—from finding value, to planning, to purchasing a full meal—that every member of the family will enjoy.

“Kroger is pioneering the future of commerce by embracing true generative and agentic AI at the heart of their customer journey,” said Darshan Kantak, vice president of product for applied AI at Google Cloud. “With Gemini Enterprise for Commerce, Kroger will be setting a new standard for grocery, ensuring its agent becomes a comprehensive digital concierge across every customer touchpoint.”

About The Kroger Co.

At The Kroger Co. (NYSE: KR), we are dedicated to our Purpose: To Feed the Human Spirit™. We are, across our family of companies more than 400,000 associates who serve over 11 million customers daily through an eCommerce shopping experience and retail food stores under a variety of banner names, serving America through food inspiration and uplift, and creating #ZeroHungerZeroWaste communities. To learn more about us, visit our newsroom and investor relations site.

About Google Cloud

Google Cloud is the new way to the cloud, providing AI, infrastructure, developer, data, security, and collaboration tools built for today and tomorrow. Google Cloud offers a powerful, fully integrated and optimized AI stack with its own planet-scale infrastructure, custom-built chips, generative AI models and development platform, as well as AI-powered applications, to help organizations transform. Customers in more than 200 countries and territories turn to Google Cloud as their trusted technology partner.

 

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SOURCE The Kroger Co.

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Walmart and Google Turn AI Discovery Into Effortless Shopping Experiences

Walmart and Google Turn AI Discovery Into Effortless Shopping Experiences

Expansive assortment, fast delivery and great prices combine with the power of Gemini to unlock delightful shopping journeys

BENTONVILLE, Ark.–(BUSINESS WIRE)–
Today, Walmart Inc. and Google share plans to launch a new experience that pairs the intelligence of Google’s Gemini with Walmart and Sam’s Club’s unmatched assortment, value and convenience, to make shopping more intuitive, reliable and perfectly aligned with the rhythms of everyday life. The new experience — built by Walmart and accessible directly within Gemini using the Universal Commerce Protocol — addresses several key customer needs:

  • Great items, at great prices: Gemini will automatically include Walmart and Sam’s Club in-store and online products when it’s relevant. For example, when a customer asks for advice on camping equipment for the spring season, it will return items from the retailer’s large inventory of products. And since people talk back-and-forth with Gemini, there are more opportunities to show relevant products and services throughout the conversation.
  • Personalization and familiarity: When customers discover items in Gemini, Walmart helps them move from inspiration to purchase in a seamless, trusted experience — all within the familiar Walmart and Sam’s environments they know and love. When customers link their accounts, Walmart will recommend complementary items based on their past online and in-store purchases, combine their order with other items they’ve put in their Walmart or Sam’s Club carts, and provide all the benefits of their Walmart+ and Sam’s Club memberships.
  • Fast delivery: Customers and members can get in-store and club items delivered right where and when they want it, with hundreds of thousands of locally curated products delivered in under three hours and as fast as 30 minutes.

“The transition from traditional web or app search to agent-led commerce represents the next great evolution in retail. We aren’t just watching the shift, we are driving it,” said John Furner, President and CEO of Walmart U.S. and incoming President and CEO of Walmart Inc. “We want to help customers get what they need and want, when and where they want it. Partnering with Google to bring the Walmart experience directly into Gemini is another step toward creating seamless shopping experiences for customers and members that are more intuitive and personal than ever before.”

“AI can improve every step of the consumer journey, from discovery to delivery. Walmart is an innovator in retail and we are excited to partner with them on a new open standard to make agentic commerce a reality. Customers will soon be able to experience everything they love about Walmart directly in the Gemini app,” said Sundar Pichai, CEO of Google and Alphabet.

The new experience will first launch directly within Gemini in the U.S. and internationally thereafter.

About Walmart

Walmart Inc. (Nasdaq: WMT) is a people-led, tech-powered omnichannel retailer helping people save money and live better — anytime and anywhere — in stores, online, and through their mobile devices. Each week, approximately 270 million customers and members visit more than 10,750 stores and numerous eCommerce websites in 19 countries. With fiscal year 2025 revenue of $681 billion, Walmart employs approximately 2.1 million associates worldwide. Walmart continues to be a leader in sustainability, corporate philanthropy, and employment opportunity. Additional information about Walmart can be found by visiting corporate.walmart.com, on Facebook at facebook.com/walmart, on X (formerly known as Twitter) at twitter.com/walmart, and on LinkedIn at linkedin.com/company/walmart.

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KEYWORDS: United States North America Arkansas

INDUSTRY KEYWORDS: Online Retail Technology Supermarket Discount/Variety Department Stores Electronic Commerce Apps/Applications Retail Software Artificial Intelligence Home Goods

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