Kinaset Therapeutics Announces $103 Million Oversubscribed Series B Financing to Advance Novel, Inhaled Therapeutic Candidate for Respiratory Diseases




Kinaset Therapeutics Announces $103 Million Oversubscribed Series B Financing to Advance Novel, Inhaled Therapeutic Candidate for Respiratory Diseases

Financing round led by RA Capital Management and Forge Life Science Partners, with contributions from new and existing investors

Proceeds to advance frevecitinib, an inhaled pan-JAK inhibitor with the potential to treat the broad severe asthma population, through Phase 2 studies

BOSTON–(BUSINESS WIRE)–Kinaset Therapeutics, a clinical-stage biopharmaceutical company developing a novel and differentiated inhaled therapeutic candidate to treat serious respiratory diseases, today announced the closing of a $103 million Series B financing. New investors RA Capital Management and Forge Life Science Partners led the financing, with participation from new investors EQT Life Sciences, Vivo Capital, Schroders Capital, Willett Advisors, Pictet Alternative Advisors, Sixty Degree Capital and existing investors, Atlas Venture, 5AM Ventures and Gimv.

“Since day one, our goal has been to develop a best-in-class therapeutic for the treatment of severe inflammatory respiratory disease. Critically, and unlike the majority of existing therapeutics, frevecitinib has the potential to benefit all patients with severe asthma, including those with a non-eosinophilic phenotype who continue to suffer from an absence of safe and effective therapies,” said Robert Clarke, PhD, CEO of Kinaset Therapeutics. “This financing marks a significant milestone for Kinaset to execute our vision of advancing frevecitinib through a Phase 2 dose ranging clinical study in patients with severe asthma, and potentially beyond. The participation of leading life science investors underscores both the strength of our team and the critical unmet need we aim to address with frevecitinib.”

Proceeds from this financing are planned to be used to advance frevecitinib, a novel inhaled dry powder in development for patients with asthma that remains inadequately controlled by standard of care inhaled maintenance therapies. Frevecitinib is uniquely formulated to deliver therapeutic lung concentrations through a single-capsule dry powder inhaler, designed to minimize systemic exposure.

“Asthma is one of the most prevalent chronic respiratory conditions worldwide, affecting millions of individuals with a large proportion not adequately controlled on standard of care treatments. Frevecitinib has the potential to be the first novel mechanism, inhaled anti-inflammatory agent for asthma patients in decades. We are proud to support Kinaset and the continued development of its inhaled, broad acting JAK inhibitor to bring this much needed treatment to all patients with severe asthma,” said Henry Stusnick of RA Capital Management.

“With compelling early clinical data, an excellent safety profile and potential to address an important unmet need for asthma patients, Kinaset represents the type of company we seek to invest in,” said Anand Mehra, MD, Managing Partner, Forge Life Sciences. “We’re confident Kinaset is well positioned for success as it advances frevecitinib through clinical studies, and we are excited to support this next chapter in its growth.”

In conjunction with the financing, Henry Stusnick from RA Capital Management, Daniela Begolo from EQT Life Sciences, and Peter B. Silverman, from Forge Life Science Partners and former Chief Operating Officer of Merus N.V., have joined Kinaset’s Board of Directors.

About frevecitinib

Frevecitinib is a novel, best-in-class inhaled pan-JAK inhibitor (JAK1, JAK2, JAK3, TYK2) being developed as a maintenance treatment for patients whose asthma remains inadequately controlled on standard inhaled therapies. With its broad mechanism of action, frevecitinib has the potential for efficacy across both Th2- and Th1-driven disease, addressing a key limitation of existing asthma therapies. Through a unique integrated chemistry and formulation strategy, frevecitinib has overcome drug delivery challenges that have limited prior attempts to develop inhaled JAK inhibitors. The molecule is formulated as a dry powder for inhalation, and in contrast to other inhaled JAK candidates, delivers pharmacologically active doses via a single capsule resulting in therapeutic drug concentrations in lung tissue while minimizing systemic exposure.

About Kinaset Therapeutics, Inc.

Kinaset Therapeutics is a clinical-stage biopharmaceutical company developing novel, inhaled therapies for severe respiratory diseases. Its lead program, frevecitinib, is a differentiated inhaled pan-JAK inhibitor designed to deliver broad anti-inflammatory activity directly to the lungs while minimizing systemic exposure, with the potential to address asthma that remains inadequately controlled by standard inhaled maintenance therapies. For more information, visit the Company’s website.

Contacts

Company Contact
Roger Heerman – Chief Business Officer

info@kinasettx.com
+1 (508) 858-5810

Media Contact
LA Communications

Lauren Arnold

lauren@lacommunications.net
+1 (617) 694-5387

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




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

• Cohort 3 analysis from the BREAKWATER study shows objective response rate of 64% with BRAFTOVI plus cetuximab and FOLFIRI compared to 39% with standard-of-care treatment FOLFIRI with or without bevacizumab
• The BREAKWATER study demonstrates clinically meaningful and statistically significant results, which show potential flexibility in chemotherapy backbone for patients with BRAF V600E-mutant metastatic colorectal cancer

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

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

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

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

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

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

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

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

About BREAKWATER

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

About Colorectal Cancer (CRC)

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

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

About BRAFTOVI^® (encorafenib)

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

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

INDICATION AND USAGE

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

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

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

IMPORTANT SAFETY INFORMATION

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

WARNINGS AND PRECAUTIONS

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

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

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

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

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

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

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

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

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

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

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

ADVERSE REACTIONS

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

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

BEACON CRC Trial (previously treated BRAF V600E mutation-positive mCRC)

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

DRUG INTERACTIONS

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

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

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

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

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

View the full Prescribing Information.

About Pfizer Oncology

At Pfizer Oncology, we are at the forefront of a new era in cancer care. Our industry-leading portfolio and extensive pipeline includes three core mechanisms of action to attack cancer from multiple angles, including small molecules, antibody-drug conjugates (ADCs), and multispecific antibodies, including other immune-oncology biologics. We are focused on delivering transformative therapies in some of the world’s most common cancers, including breast cancer, genitourinary cancer, hematology-oncology, and thoracic cancers, which includes lung cancer. Driven by science, we are committed to accelerating breakthroughs to help people with cancer live better and longer lives.

About Pfizer: Breakthroughs That Change Patients’ Lives

At Pfizer, we apply science and our global resources to bring therapies to people that extend and significantly improve their lives. We strive to set the standard for quality, safety and value in the discovery, development and manufacture of health care products, including innovative medicines and vaccines. Every day, Pfizer colleagues work across developed and emerging markets to advance wellness, prevention, treatments and cures that challenge the most feared diseases of our time. Consistent with our responsibility as one of the world’s premier innovative biopharmaceutical companies, we collaborate with health care providers, governments and local communities to support and expand access to reliable, affordable health care around the world. For 175 years, we have worked to make a difference for all who rely on us. We routinely post information that may be important to investors on our website at www.Pfizer.com. In addition, to learn more, please visit us on www.Pfizer.com and follow us on X at @Pfizer and @Pfizer News, LinkedIn, YouTube and like us on Facebook at Facebook.com/Pfizer.

Disclosure Notice

The information contained in this release is as of January 10, 2026. Pfizer assumes no obligation to update forward-looking statements contained in this release as the result of new information or future events or developments.

This release contains forward-looking information about the BRAFTOVI^® (encorafenib) plus cetuximab and FOLFIRI combination for the potential treatment of metastatic colorectal cancer (CRC) with a BRAF V600E mutation, including their potential benefits and ongoing clinical development program, that involves substantial risks and uncertainties that could cause actual results to differ materially from those expressed or implied by such statements. Risks and uncertainties include, among other things, uncertainties regarding the commercial success of BRAFTOVI; the uncertainties inherent in research and development, including the ability to meet anticipated clinical endpoints, commencement and/or completion dates for our clinical trials, regulatory submission dates, regulatory approval dates and/or launch dates, as well as the possibility of unfavorable new clinical data and further analyses of existing clinical data; whether the BREAKWATER trial will meet the secondary endpoints of PFS and OS for Cohort 3; the risk that clinical trial data are subject to differing interpretations and assessments by regulatory authorities; whether regulatory authorities will be satisfied with the design of and results from our clinical studies; whether and when any drug applications may be filed in any jurisdictions for BRAFTOVI plus cetuximab and FOLFIRI for the treatment of patients with metastatic CRC with a BRAF V600E mutation or for any other potential indications for BRAFTOVI; whether and when any such applications may be approved by regulatory authorities, which will depend on myriad factors, including making a determination as to whether the product’s benefits outweigh its known risks and determination of the product’s efficacy and, if approved, whether BRAFTOVI plus cetuximab and FOLFIRI will be commercially successful; decisions by regulatory authorities impacting labeling, manufacturing processes, safety and/or other matters that could affect the availability or commercial potential of BRAFTOVI or BRAFTOVI plus cetuximab and FOLFIRI; uncertainties regarding the impact of COVID-19 on Pfizer’s business, operations and financial results; and competitive developments.

A further description of risks and uncertainties can be found in Pfizer’s Annual Report on Form 10-K for the fiscal year ended December 31, 2024, and in its subsequent reports on Form 10-Q, including in the sections thereof captioned “Risk Factors” and “Forward-Looking Information and Factors That May Affect Future Results”, as well as in its subsequent reports on Form 8-K, all of which are filed with the U.S. Securities and Exchange Commission and available at www.sec.gov and www.pfizer.com.

ERBITUX^® is a registered trademark of Eli Lilly and Company its subsidiaries, or affiliates.

References

1. American Cancer Society. Global Cancer Facts & Figures 5th Edition. Available at: https://www.cancer.org/content/dam/cancer-org/research/cancer-facts-and-statistics/global-cancer-facts-and-figures/global-cancer-facts-and-figures-2024.pdf. Last accessed: November 2025.
2. American Cancer Society. Key Statistics for Colorectal Cancer. Available at: https://www.cancer.org/cancer/types/colon-rectal-cancer/about/key-statistics.html. Last accessed: November 2025.
3. American Cancer Society. Cancer Facts & Figures 2025. Available at: https://www.cancer.org/content/dam/cancer-org/research/cancer-facts-and-statistics/annual-cancer-facts-and-figures/2025/2025-cancer-facts-and-figures-acs.pdf. Last accessed: November 2025.
4. Ciardiello F, Ciardiello D, Martini G, et al. Clinical management of metastatic colorectal cancer in the era of precision medicine. CA Cancer J Clin. 2022;72:372–40.

Contacts

Media: PfizerMediaRelations@Pfizer.com

Investor: IR@Pfizer.com

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Kezar Life Sciences Announces Regulatory Update on Zetomipzomib Program in Autoimmune Hepatitis




Kezar Life Sciences Announces Regulatory Update on Zetomipzomib Program in Autoimmune Hepatitis

SOUTH SAN FRANCISCO, Calif.–(BUSINESS WIRE)–Kezar Life Sciences, Inc. (Nasdaq:KZR), a clinical-stage biotechnology company developing novel small molecule therapeutics to treat unmet needs in immune-mediated diseases, today announced that the Food and Drug Administration (FDA) Division of Hepatology and Nutrition has granted Kezar a Type C meeting for the first quarter to discuss the development of zetomipzomib, a novel, selective inhibitor of the immunoproteasome, in patients with autoimmune hepatitis (AIH).

The Type C meeting will involve review of a potential global, randomized Phase 2b clinical study of zetomipzomib in patients with relapsed and refractory AIH. As part of the briefing package submitted to the FDA, Kezar submitted pharmacokinetic and hepatic safety data analyses from previously conducted clinical trials to support a proposal for parallel AIH and hepatic impairment studies. Kezar also submitted additional safety data and an updated risk-mitigation plan aimed to modify the previous requirement issued from the FDA to require 48-hour in-unit patient monitoring in future AIH studies.

“We appreciate the opportunity to collaborate with the FDA on key clinical trial parameters for a well-powered study of zetomipzomib in patients with AIH, a population with significant unmet medical need and currently without FDA-approved therapies,” said Chris Kirk, PhD, CEO of Kezar Life Sciences. “The additional safety and pharmacokinetic data analysis performed in response to prior FDA feedback further support our belief that zetomipzomib has the potential to change the treatment landscape in this serious disease. Furthermore, achieving alignment with the FDA on endpoints and trial conduct would provide a clear development pathway for this novel therapy and potentially unlock value for our shareholders as we continue to evaluate strategic alternatives.”

As previously disclosed, Kezar has retained TD Cowen to support the company with its ongoing strategic review process focusing on maximizing shareholder value, and which included a significant workforce reduction and other cost-containment and cash conservation measures.

About Kezar Life Sciences

Kezar Life Sciences is a clinical-stage biopharmaceutical company developing novel small molecule therapeutics to treat unmet needs in immune-mediated diseases. Zetomipzomib, a selective immunoproteasome inhibitor, is currently being evaluated for autoimmune hepatitis. This product candidate also has the potential to address multiple chronic immune-mediated diseases. For more information, visit www.kezarlifesciences.com, and follow us on LinkedIn, Facebook, X and Instagram.

About Zetomipzomib

Zetomipzomib is a novel, first-in-class, selective immunoproteasome inhibitor with broad therapeutic potential across multiple autoimmune diseases. Preclinical research demonstrates that selective immunoproteasome inhibition results in a broad anti-inflammatory response in animal models of several autoimmune diseases, while avoiding immunosuppression. Data generated from completed clinical trials provide evidence that zetomipzomib exhibits a favorable safety and tolerability profile for development in severe, chronic autoimmune diseases.

About Autoimmune Hepatitis

Autoimmune hepatitis (AIH) is a rare chronic disease in which the immune system attacks the liver and causes inflammation and tissue damage, severely impacting patients’ physical health and quality of life. Lifelong maintenance therapy is required to avoid relapse and burdensome adverse effects. If left untreated, AIH can lead to cirrhosis, liver failure and hepatocellular carcinoma. In the United States, AIH affects approximately 100,000 individuals, with incidence rates increasing. The cause of this condition remains unclear, with females affected four times as often as males. Currently, standard of care treatment for AIH is chronic, immunosuppressive treatment with corticosteroids that frequently cause life-altering side effects, including diabetes, osteoporotic fractures and cataracts. There is a significant need for treatment regimens that reduce or remove the need for chronic immunosuppression from using corticosteroids.

Cautionary Note on Forward-looking Statements

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Words such as “may,” “will,” “can,” “should,” “expect,” “believe,” “potential,” “anticipate” and similar expressions (as well as other words or expressions referencing future events, conditions or circumstances) are intended to identify forward-looking statements. These forward-looking statements are based on Kezar’s expectations and assumptions as of the date of this press release. Each of these forward-looking statements involves risks and uncertainties that could cause Kezar’s clinical development programs, future results or performance to differ materially from those expressed or implied by the forward-looking statements. Forward-looking statements contained in this press release include, but are not limited to, statements regarding: the timing and outcome of regulatory submissions and interactions with the FDA or any other regulatory agencies with respect to zetomipzomib or Kezar’s clinical trials; the possibility of achieving alignment with the FDA on endpoints and clinical trial conduct; the potential value of the company as part of its strategic review process; the design, initiation, progress, timing, scope and results of ongoing and potential future clinical trials; the potential of zetomipzomib to be the first approved agent in AIH; and Kezar’s evaluation of strategic alternatives available to maximize shareholder value. Many factors may cause differences between current expectations and actual results, including the significant workforce reduction and cost-containment measures implemented by Kezar, unexpected safety or efficacy data observed during clinical studies, changes in the regulatory environment, the uncertainties and timing of the regulatory approval process, and unexpected litigation or other disputes. Other factors that may cause actual results to differ from those expressed or implied in the forward-looking statements in this press release are discussed in Kezar’s filings with the U.S. Securities and Exchange Commission, including the “Risk Factors” contained therein. Except as required by law, Kezar assumes no obligation to update any forward-looking statements contained herein to reflect any change in expectations, even as new information becomes available.

Contacts

Investor and Media Contact:

Kezar Life Sciences, Inc.

IR@kezarbio.com

Aurora Therapeutics Launches to Realize Potential of Personalized Gene Editing for Millions of Patients with Rare Diseases




Aurora Therapeutics Launches to Realize Potential of Personalized Gene Editing for Millions of Patients with Rare Diseases

– Leveraging modular gene editors and new regulatory pathways, Aurora will develop and commercialize therapies that can be rapidly tailored to many rare variants –

– Founded by CRISPR pioneers Jennifer Doudna and Fyodor Urnov to scale up impact of gene editing therapies –

– Company incubated by Menlo Ventures with an experienced management team led by CEO Edward M. Kaye –

BOSTON–(BUSINESS WIRE)–Aurora Therapeutics today announced its official launch to transform personalized gene editing from a one-patient breakthrough into a scalable model capable of bringing therapies to millions of patients with rare diseases. The company launches with a $16 million seed financing from Menlo Ventures to create the first platform for treating rare genetic mutations that have historically been impossible to address at scale.

Aurora was founded by Jennifer Doudna, Ph.D., CRISPR co-inventor and Nobel Laureate, and Fyodor Urnov, Ph.D., a leader in translating genome-editing science into human therapeutics. Their vision builds on more than a decade of progress in CRISPR technology, including clinical validation and advances in rapid sequencing and mutation identification, opening the door to personalized therapies that correct rare, disease-causing mutations unique to each patient.

Aurora is now realizing this next frontier of genetic medicine through a repeatable, systematic approach. Following advances in guide design and AI-generated editors combined with innovations in regulatory and CMC strategies, the company aims to shift personalized gene editing from isolated breakthroughs to a platform capable of benefiting patients with rare mutations at the population scale.

“Aurora’s launch signals a turning point for personalized gene editing. We now have the science, tools and regulatory tailwinds needed to move from isolated success stories to a sustainable way of developing many therapies in parallel,” said Edward M. Kaye, M.D., Chief Executive Officer of Aurora Therapeutics. “Our team’s deep experience in rare disease drug development positions us to advance this vision with rigor and urgency.”

“Since its discovery, CRISPR has offered the promise of treating the root causes of genetic disease, but we lacked a scalable way to bring those therapies to patients with rare mutations,” said Aurora co-founder Jennifer Doudna, Ph.D. “By innovating in both clinical development and approval pathways, Aurora is showing the true promise of gene editing for patients who were previously out of reach.”

A key component of Aurora’s model is its use of emerging regulatory frameworks that support grouping multiple mutations within a disease into unified development paths. This umbrella approach is designed to make personalized therapies economically and operationally viable, addressing a longstanding gap in rare-disease drug development. Aurora is uniquely positioned to execute this model by pairing deep gene-editing expertise and hands-on clinical experience with purpose-built clinical, manufacturing, and quality systems designed for rapid, parallel development of mutation-specific therapies.

“Aurora is opening a new frontier in genetic medicine,” said Johnny Hu, Ph.D., Principal at Menlo Ventures. “We believe that the pairing of recent advances in gene editing and AI with a scalable development and regulatory strategy will dramatically expand the number of people who can benefit from gene editing. Menlo is excited to support the team in increasing access to these life-changing therapies.”

Aurora’s initial program focuses on phenylketonuria (PKU), a metabolic disorder caused by a wide range of mutations in the PAH gene that lead to toxic elevations of phenylalanine in the blood. Without early treatment and careful monitoring, PKU can lead to impaired brain development in children and adolescents. Even when early and strict disease control enables near-normal IQ, elevated phenylalanine levels continue to negatively affect cognitive functions — such as executive function, memory, and social skills — throughout life. For this reason, PKU requires lifelong management.

“Every week, PKU specialist physicians like me care for individuals with PKU who are unable to consistently maintain safe phenylalanine levels,” said Chet Whitley, Ph.D., M.D., Medical Director of the PKU Clinic and Professor of Pediatric Genetics & Metabolism at the University of Minnesota. “Gene editing has the potential to offer a definitive and durable treatment for PKU and other genetic diseases, and Aurora’s model provides a promising path to extend these therapies to far more patients — not just a limited subset.”

PKU’s high unmet need and well-characterized disease biology align closely with the U.S. Food and Drug Administration’s recently announced plausible mechanism pathway. Supported by published preclinical proof-of-concept data and encouraging regulatory feedback, Aurora is designing therapeutics intended to address multiple PKU-causing mutations from the outset, with plans to expand this approach to additional mutations over time.

Leadership Team and Board of Directors

Aurora has assembled a leadership team and Board of Directors comprising veteran biotechnology experts with deep experience in rare diseases and genetic medicine.

Leadership Team

• Edward M. Kaye, M.D., Chief Executive Officer
• Thomas Wechsler, Ph.D., Chief Scientific Officer
• David Litvak, MBA, Head of CMC and Technical Operations
• Morgan Maeder, Ph.D., Head of Research

Board of Directors

• Johnny Hu, Ph.D., Principal at Menlo Ventures (Chair)
• Greg Yap, Partner at Menlo Ventures
• Edward M. Kaye, M.D., Chief Executive Officer
• Fyodor Urnov, Ph.D., Professor of Molecular Therapeutics at University of California, Berkeley; Scientific Director of the Innovative Genomics Institute

Founders

• Jennifer Doudna, Ph.D., Li Ka Shing Chancellor’s Chair and a Professor in the Departments of Chemistry and of Molecular and Cell Biology at the University of California, Berkeley; Howard Hughes Medical Institute investigator; President and Chair of the Board of the Innovative Genomics Institute
• Fyodor Urnov, Ph.D., Professor of Molecular Therapeutics at University of California, Berkeley; Scientific Director of the Innovative Genomics Institute

About Aurora Therapeutics

Aurora Therapeutics is reinventing how personalized gene-editing medicines are developed and approved for patients with rare diseases. The company combines state-of-the-art CRISPR engineering with umbrella regulatory pathways and modular CMC frameworks that allow many mutation-specific therapies to move forward in parallel. Aurora’s approach addresses the fundamental economic and operational barriers that have historically prevented treatments for rare mutations, enabling CRISPR therapies to reach patients at population scale. For more information, visit http://auroratherapeutics.com.

About Menlo Ventures

Menlo Ventures is a leading early-stage venture capital firm investing in digital health and novel life science companies. Our portfolio includes more than 85 public companies and over 170 exits through mergers and acquisitions. Currently managing more than $7 billion in assets, we invest at the intersection of bio and tech, across consumer, enterprise, and healthcare, with a differentiated approach in core thesis areas including therapeutic platforms, transformative technologies, digital health, and healthcare SaaS. Our portfolio companies include Benchling, Chai Discovery, Delfi, Eleos Health, Function Health, Gilead, H1, PillPack, Recursion, and Xaira. We strive to have a positive impact on everything we do, and we believe innovations at the intersection of tech and bio will drive major improvements in the quality of our health and the cost of healthcare. When we’re in, we’re ALL IN.

Contacts

Media Contact
Lisa Raffensperger

Ten Bridge Communications

lisa@tenbridgecommunications.com

Insulet to Announce Fourth Quarter and Full Year 2025 Financial Results on February 18, 2026 




Insulet to Announce Fourth Quarter and Full Year 2025 Financial Results on February 18, 2026 

ACTON, Mass.–(BUSINESS WIRE)–Insulet Corporation (NASDAQ: PODD) (Insulet or the Company), the global leader in tubeless insulin pump technology with its Omnipod^® brand of products, today announced it will report financial results for the fourth quarter and full year of 2025 on February 18, 2026, before the opening of the financial markets. In connection with the release, management will host a conference call that day at 8:00 a.m. (Eastern Time).

The link to the live call will be available on the Investor Relations section of the Company’s website at investors.insulet.com, “Events and Presentations,” and will be archived for future replay. You may also access the live call by dialing (888) 770-7129 for domestic callers, or (929) 203-2109 for international callers; the passcode is 5904836.

About Insulet Corporation:

Insulet Corporation (NASDAQ: PODD), headquartered in Massachusetts, is an innovative medical device company dedicated to simplifying life for people with diabetes and other conditions through its Omnipod product platform. The Omnipod Insulin Management System provides a unique alternative to traditional insulin delivery methods. With its simple, wearable design, the tubeless disposable Pod provides up to three days of non-stop insulin delivery, without the need to see or handle a needle. Insulet’s flagship innovation, the Omnipod 5 Automated Insulin Delivery System, integrates with a continuous glucose monitor to manage blood sugar with no multiple daily injections, zero fingersticks, and can be controlled by a compatible personal smartphone in the U.S. or by the Omnipod 5 Controller. Insulet also leverages the unique design of its Pod by tailoring its Omnipod technology platform for the delivery of non-insulin subcutaneous drugs across other therapeutic areas. For more information, visit: insulet.com and omnipod.com.

©2026 Insulet Corporation. Omnipod is a registered trademark of Insulet Corporation. All rights reserved.

Contacts

Investor Relations: 

Clare Trachtman 

Vice President, Investor Relations 

ir@insulet.com 

Media: 

Angela Geryak Wiczek 

Senior Director, Corporate Communications 

pr@insulet.com  

MRM Health Secures FDA IND Clearance to Launch its Phase 2b Trial of MH002 in Mild-to-Moderate Ulcerative Colitis




MRM Health Secures FDA IND Clearance to Launch its Phase 2b Trial of MH002 in Mild-to-Moderate Ulcerative Colitis

• MH002 is currently the most advanced Live Biotherapeutic Product (LBP) based on a rationally-designed combination of disease specific bacteria (microbial consortia), for the treatment of inflammatory bowel diseases (IBD)
• STARFISH-UC Phase 2b trial is designed to confirm MH002’s early efficacy signals and favorable safety observed in Phase 2a studies

GHENT, Belgium–(BUSINESS WIRE)–#Parkinson–MRM Health NV, a clinical-stage biopharmaceutical company pioneering microbiome-based therapeutics for inflammatory diseases and immune-oncology, today announced that the U.S. Food and Drug Administration (FDA) has granted clearance of its Investigational New Drug (IND) application for its lead program MH002. This enables the initiation of the STARFISH-UC Phase 2b clinical trial in patients with mild-to-moderate ulcerative colitis, marking a significant step forward in the development of next-generation therapies for inflammatory bowel diseases (IBD).

About the STARFISH-UC Phase 2b Trial

The STARFISH-UC trial is a randomized, double-blind, placebo-controlled study designed to confirm the promising efficacy signals and favorable safety profile previously observed in MH002’s Phase 2a studies. MH002, a rationally designed live microbial consortium, is the most advanced Live Biotherapeutic Product (LBP) of its kind, targeting disease-specific mechanisms through a synergistic combination of six well-characterized commensal strains. The study (NCT07296315) will enroll approximately 204 patients with mild-to-moderate ulcerative colitis (UC) inadequately controlled by 5 aminosalicylic acid (5 ASA) with or without low-dose steroids, the current standard of care. The trial will run across Europe and the U.S., featuring a 12-week placebo-controlled induction phase with two dosing regimens, followed by a 40-week open-label extension. Enrollment is expected to begin mid-2026.

Promising Clinical Results to Date

A previous Phase 2a trial with MH002 in mild-to-moderate UC suggested excellent safety and encouraging efficacy upon 8 weeks of treatment, indicative of mucosal healing and anti-inflammatory effects, recovery of the gut microbiome and induction of clinical remission. No safety signals or adverse reactions were observed. Additionally, MH002 showed positive results in an open-label study for acute pouchitis, underscoring its broad therapeutic potential.

Executive Commentary

“Receiving IND clearance from the FDA is a testament to MH002’s robust clinical foundation and its potential to transform the lives of those living with UC,” stated Sam Possemiers, CEO of MRM Health. “The upcoming STARFISH-UC study is a critical next step in our mission to deliver a convenient, immune system-sparing, one-pill solution for IBD patients. We are excited to further validate MH002’s benefits and advance it as a frontrunner among innovative UC treatments.”

Innovative Technology and Manufacturing

MH002 is engineered using MRM Health’s proprietary CORAL® platform, which enables the design and scalable cGMP manufacturing of complete microbial consortia as a single drug substance. This approach offers regulatory and patient compliance advantages, supporting the development of cost-effective, high-quality therapeutics for chronic inflammatory conditions.

***

About MRM Health

MRM Health is a clinical-stage biotech developing innovative microbiome-based Live Biotherapeutic Products for chronic inflammatory diseases with high unmet need. Its CORAL® platform enables the design and manufacture of disease-focused microbial consortia with enhanced efficacy and scalability. In addition to advancing lead program MH002 into pivotal clinical development in ulcerative colitis and the orphan disease indication, pouchitis, MRM Health has ongoing preclinical programs in other inflammatory diseases and immune-oncology. In September 2025, MRM Health successfully closed a 55M€ Series B Round led by Biocodex, with strong support of ATHOS, BNP Paribas Fortis Private Equity and existing investors SFPIM, AvH, OMX Europe VF, QBic and VIB.

For more information, please follow us on LinkedIn or visit the website at www.mrmhealth.com.

MRM Health will attend the JP Morgan Week and Biotech Showcase 2026 in San Francisco (January 12-15). If you are interested in learning more about MRM Health programs, please schedule a meeting using the Biotech Showcase partneringONE portal or the Company’s direct contact info@mrmhealth.com.

Contacts

Corporate
MRM Health NV

Dr. Sam Possemiers – CEO

info@mrmhealth.com

Media relations

International & DACH
MC Services AG

Anne Hennecke

Phone: +49.151.125.557.59

anne.hennecke@mc-services.eu

Media relations

BeNeLux/France
Backstage Communication

Gunther De Backer

Phone: +32.475.903.909

gunther@backstagecom.be

Johnson & Johnson Reaches Agreement with U.S. Government to Improve Access to Medicines and Lower Costs for Millions of Americans; Delivers on U.S. Manufacturing and Innovation Investments




Johnson & Johnson Reaches Agreement with U.S. Government to Improve Access to Medicines and Lower Costs for Millions of Americans; Delivers on U.S. Manufacturing and Innovation Investments

Voluntary agreement will allow millions of Americans to purchase medicines at significantly discounted rates

Agreement provides Johnson & Johnson pharmaceutical products an exemption from U.S. tariffs

Company announces two new additional manufacturing facilities to be built in North Carolina and Pennsylvania; continues to deliver on $55 billion U.S. investment

NEW BRUNSWICK, N.J.–(BUSINESS WIRE)–Johnson & Johnson (NYSE: JNJ) (the “Company”), healthcare’s leading, most comprehensive innovation powerhouse, today announced a voluntary agreement with the Trump Administration to improve access to medicines and lower costs for millions of American patients. The joint agreement meets the requests laid out by President Trump to the industry and provides the Company’s pharmaceutical products an exemption from tariffs¹.

“Today’s agreement shows that when the public and private sectors work together towards shared goals, we can deliver real results for patients and the U.S. economy,” said Joaquin Duato, Chairman and Chief Executive Officer, Johnson & Johnson. “I’m proud that Johnson & Johnson is answering President Trump’s call to lower drug prices for everyday Americans while maintaining our role in improving and saving lives and ensuring that the United States continues to lead the world in healthcare innovation.”

Improving Access and Lowering Costs for U.S. Patients

Johnson & Johnson is working with the Trump Administration to improve access to medicines and lower costs for millions of American patients. The Company is:

• Participating in TrumpRx.gov, a direct to patient platform, which will allow millions of American patients to purchase medicines from Johnson & Johnson at significantly discounted rates.
• Enabling American patients to access medicines at comparable prices to other developed countries.
• Providing Medicaid program access at comparable prices to other developed countries.
• Continuing to support the Administration’s efforts to ensure better recognition of the value of health care across developed markets globally.

Delivering On Our $55B U.S. Investment

Johnson & Johnson also continues to deliver on our previously announced $55 billion investment to support U.S. manufacturing, research and development, and technology investments by early 2029. In just the last 10 months, the Company has initiated billions of dollars in investment in U.S. manufacturing, which will support the Company’s goal of manufacturing the vast majority of its advanced medicines in the U.S. to meet the needs of U.S. patients.

Today, as part of the $55 billion investment, the Company is announcing two new U.S. manufacturing facilities, including a next generation cell therapy manufacturing site in Pennsylvania and a state-of-the-art drug product manufacturing facility in North Carolina.

Additionally, construction is progressing on our $2 billion state-of-the-art biologics manufacturing facility in Wilson, North Carolina, which the Company broke ground on last year. That project will create approximately 5,000 skilled manufacturing and construction jobs in the state. Johnson & Johnson is already ramping up the hiring of advanced manufacturing employees to work at the facility.

In September, the Company also secured a new 160,000+ square foot dedicated biopharmaceutical manufacturing site in Holly Springs, North Carolina. The $2 billion commitment over the next 10 years will create approximately 120 new jobs in North Carolina.

Johnson & Johnson expects to announce additional U.S. investments later this year.

About Johnson & Johnson:

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow and profoundly impact health for humanity. Learn more at www.jnj.com.

Cautions Concerning Forward-Looking Statements

This press release contains “forward-looking statements” as defined in the Private Securities Litigation Reform Act of 1995. The reader is cautioned not to rely on these forward-looking statements. These statements are based on current expectations of future events. If underlying assumptions prove inaccurate or known or unknown risks or uncertainties materialize, actual results could vary materially from the expectations and projections of Johnson & Johnson. Risks and uncertainties include, but are not limited to: challenges and uncertainties inherent in product research and development, including the uncertainty of clinical success and of obtaining regulatory approvals; uncertainty of commercial success; manufacturing difficulties and delays; competition, including technological advances, new products and patents attained by competitors; challenges to patents; product efficacy or safety concerns resulting in product recalls or regulatory actions; changes in behavior and spending patterns of purchasers of health care products and services; changes to applicable laws and regulations, including global health care reforms; and trends toward health care cost containment. A further list and descriptions of these risks, uncertainties and other factors can be found in Johnson & Johnson’s most recent Annual Report on Form 10-K, including in the sections captioned “Cautionary Note Regarding Forward-Looking Statements” and “Item 1A. Risk Factors,” and in Johnson & Johnson’s subsequent Quarterly Reports on Form 10-Q and other filings with the Securities and Exchange Commission. Copies of these filings are available online at www.sec.gov, www.jnj.com, www.investor.jnj.com or on request from Johnson & Johnson. Johnson & Johnson does not undertake to update any forward-looking statement as a result of new information or future events or developments.

¹ Specific terms of the agreement remain confidential.

Contacts

Media contact:
media-relations@its.jnj.com

Investor contact:

investor-relations@its.jnj.com

FineHeart Secures €83 Million to Support Its Growth and Establish Itself as a Future European Leader in Active Implantable Medical Devices (AIMDs)




FineHeart Secures €83 Million to Support Its Growth and Establish Itself as a Future European Leader in Active Implantable Medical Devices (AIMDs)

• €35 million Series C funding to accelerate the clinical and industrial development of FlowMaker^®
• €48 million in grants from the IPCEI Tech4Cure program to structure the European Active Implantable Medical Devices (AIMD) sector

BORDEAUX, France–(BUSINESS WIRE)–FineHeart, a clinical-stage medical technology company specializing in the development of innovative solutions for cardiology, announced today the completion of a €35 million first closing of its Series C financing round. This funding is a key lever for activating European public funding, IPCEI Tech4Cure¹, and for establishing its role as a European Active Implantable Medical Devices (AIMDs) leader.

In total, FineHeart has secured €83 million in financing combining private capital and non-dilutive European public funding to accelerate the industrialization and clinical development of FlowMaker^® and establish itself as a future European AIMD leader.

Arnaud Mascarell, CEO and co-founder of FineHeart, said: “We are delighted to welcome new investors at this first closing. I would like to extend my special thanks to Groupe Pasteur Mutualité and the European Innovation Council (EIC) for their key contributions, as well as to our long-standing shareholders, led by FH Founders, for their unwavering support. Together with the IPCEI, this funding strengthens our ambition to build disruptive, IP-protected technologies that enable more predictive, personalized, preventive, and participatory medicine—while advancing Europe’s industrial competitiveness and healthcare sovereignty.”

A first €35 million closing, paving the way for the remainder of the Series C round.

This first €35 million closing brings together new investors, including Groupe Pasteur Mutualité and Groupe Etchart, alongside significant participation from the European Innovation Council (EIC)’s EIB fund. Existing investors—FH Founders (the founders’ holding company bringing together primarily international private investors from healthcare and entrepreneurship), Lurra, IRDI, Groupe Doliam and NACO—renew their confidence and support this next FlowMaker development phase.

“Groupe Pasteur Mutualité acts for health by combining prevention, solidarity, and support for innovation. By supporting FineHeart, we fund a technology that can transform the treatment of severe heart failure, driven by the same ambition: to advance health for everyone,” declared Thierry Lorente, Managing Director of Groupe Pasteur Mutualité.

€48 million in grants under the IPCEI Tech4Cure¹: FineHeart, European leader in AIMDs

In parallel, FineHeart is to benefit from €48 million in grants from the IPCEI Tech4Cure program, disbursed in several tranches, in its role as the lead partner in the project to structure the European AIMD sector. The work will focus on key technological challenges inherent to AIMDs, including:

• Miniaturization of power supply systems,
• Drastic reduction of energy requirements,
• Long-term reliability and durability of implantable systems.

These innovations form a technological pillar of FlowMaker^® developed by FineHeart

The advisors involved in this transaction:

• Legal advisors : Olivier Mourain & cabinet La Tour International – La Tour International
• Auditors : Aeccelis & Forvis Mazars Secteurs – Forvis Mazars
• Helinnov conseil

About FlowMaker^®

FlowMaker^® is the world’s first fully implantable cardiac output accelerator designed to treat advanced heart failure. Fully intraventricular, it provides physiological support synchronized with the natural heart contractions. It respects natural blood flow and does not require aortic bypass. By operating in synergy with native cardiac contractions, the FlowMaker^® consumes little energy and does not require any percutaneous connection to external batteries. It is recharged via a transcutaneous energy transfer (TET) system, thereby reducing any risk of infection and significantly improving patients’ quality of life. The device is implanted through a minimally invasive procedure on a beating heart, with an average duration of 90 minutes. This procedure is widely practiced by cardiac surgeons and limits any physiological changes.

About FineHeart – www.fineheart.com

FineHeart is a clinical-stage medical device company based in Bordeaux and Tours. Its innovative product, FlowMaker^®, could treat 200,000 patients with advanced heart failure every year. FineHeart is initially targeting the 50,000 most severe patients eligible for cardiac assistance and not treated by current LVADs. This first potential market is estimated at over 5 billion euros.

FineHeart was founded by CEO Arnaud Mascarell and a team of internationally renowned cardiac surgeons and electro-physiologists, including Dr. Stéphane Garrigue, CSO and inventor of the concept, and Dr. Philippe Ritter, co-inventor of cardiac resynchronization therapy (CRT). The company holds an international portfolio of 160 patents in 27 different families.

Financed by a consortium of public and private investors, including the founders’ holding company, FH Founders, as well as Doliam, Etchart Group, and investment funds Groupe Pasteur Mutualité, Lurra, Aquiti Gestion, Galia Gestion, Broadview Ventures, IRDI Capital Investment, M Capital, UI Investment & Verve Capital. FineHeart is supported by the European Union (EIC), Bpifrance and the Nouvelle-Aquitaine and Centre-Val de Loire regions.

¹Important Project of Common European Interest (‘IPCEI’) Tech4Cure.

Contacts

Europe
Media Relations

Annie-Florence Loyer

afloyer@newcap.fr
+33 (6) 88 20 35

FineHeart Communications
James Palmer

j.palmer@orpheonfinance.com
+33 (0) 7 60 92 77 72

Quanterix Appoints Everett Cunningham as President and CEO Effective January 19, 2026




Quanterix Appoints Everett Cunningham as President and CEO Effective January 19, 2026

Planned Leadership Transition Positions Company for Growth

Company Expects to Exceed Revenue and Cash Guidance for the Full Year 2025

BILLERICA, Mass.–(BUSINESS WIRE)–Quanterix Corporation (“Quanterix” or the “Company”) (NASDAQ: QTRX), a company transforming healthcare by accelerating biomarker breakthroughs from discovery to diagnostics, today announced that its Board of Directors (the “Board”) has appointed Everett Cunningham as the Company’s next President and Chief Executive Officer and a member of the Board, effective January 19, 2026.

Mr. Cunningham will succeed Masoud Toloue, who will continue to serve as Chief Executive Officer until Mr. Cunningham assumes the role on January 19, 2026. Following Mr. Cunningham’s start date, Dr. Toloue will remain available to the Company in an advisory capacity to support continuity and help ensure a smooth leadership transition. Contemporaneous with Mr. Cunningham’s appointment, Bill Donnelly, Executive Chair of the Board, will transition to his prior role as non-executive Chair of the Board.

Since June 2024, Mr. Cunningham has served as Chief Commercial Officer of Illumina, a global leader in DNA sequencing and array-based technologies, where he was responsible for the company’s global commercial strategy and execution. During his tenure, Mr. Cunningham helped implement a redesigned commercial operating model to improve customer engagement and accelerate the commercialization of Illumina’s sequencing- and array-based solutions for genetic and genomic analysis. Previously, Mr. Cunningham served as Chief Commercial Officer at Exact Sciences, where he led marketing, sales, and customer service across the company’s portfolio of cancer screening and precision oncology diagnostics. Earlier in his career, he held senior leadership roles at Quest Diagnostics, GE Healthcare and Pfizer.

“We are excited to welcome Everett to Quanterix,” said Bill Donnelly, Executive Chair of the Board. “Throughout his career, Everett has demonstrated his ability to accelerate growth at both research tools and diagnostics companies, build high-performing commercial organizations and lead transformational change at scale. His deep understanding of our customers and markets and his track record of operational execution makes him exceptionally well suited to lead Quanterix in its next phase of growth.”

Mr. Cunningham’s appointment follows a comprehensive search process, with the assistance of a leading executive search firm, as part of the Board’s long-term succession planning efforts.

Mr. Donnelly continued, “On behalf of the Board, I want to thank Masoud for his many contributions to Quanterix. Under his leadership, the Company significantly expanded its assay menu, entered adjacent markets, and built its Diagnostics business from the ground up, advancing the translation of its technology into clinical applications. These initiatives, together with the transformative acquisition of Akoya Biosciences, have positioned Quanterix for broader scientific impact, deeper clinical relevance and enhanced long-term value creation. To that end, we are pleased to share that we expect to exceed our guidance for revenue and cash for the full year 2025. We appreciate Masoud’s continued leadership during this transition and wish him every success in his next chapter.”

Mr. Cunningham commented, “I am thrilled to join Quanterix as Chief Executive Officer at such an exciting time for the Company. With its differentiated technology platform, expanding portfolio and talented team, Quanterix is uniquely positioned to lead the next wave of innovation in advanced disease detection and therapeutic development. I look forward to working closely with the Board and my colleagues to advance the Company’s mission to improve health outcomes worldwide and deliver meaningful value for shareholders, patients, partners and other stakeholders.”

About Everett Cunningham

Everett Cunningham, age 58, has served as Chief Commercial Officer of Illumina, Inc. (NASDAQ: ILMN), a global leader in sequencing- and array-based solutions for genetic and genomic analysis since June 2024. Prior to Illumina, he was Chief Commercial Officer of Exact Sciences Corporation (NASDAQ: EXAS), a leader in cancer screening and precision oncology diagnostics, from 2021 to 2024, overseeing global marketing, sales, and customer service functions.

Before joining Exact Sciences, Mr. Cunningham served as President & Chief Executive Officer of GE Healthcare’s U.S. & Canada region from 2019 to 2021. Earlier, he served as Senior Vice President, Commercial at Quest Diagnostics Inc. (NYSE: DGX), where he was responsible for global sales, marketing, and commercial operations from 2012 to 2019. And prior to that, from 1991 to 2012, Mr. Cunningham held a range of senior leadership positions at Pfizer Inc. (NYSE: PFE), including Regional President, Established Products for Asia Pacific, Senior Director of Worldwide Learning and Development, Senior Director of Business Operations, Vice President Sales for U.S. Pharmaceuticals, and Vice President of Global Corporate Human Resources.

Mr. Cunningham currently serves on the boards of Arvinas, Inc. (NASDAQ: ARVN) and Visby Medical. At Arvinas, he is a member of the Compensation and Audit committees.

Mr. Cunningham holds a bachelor’s degree in economics from Northwestern University.

Inducement Grants Under Nasdaq Listing Rule 5635(c)(4)

In connection with his appointment, Mr. Cunningham will receive long-term equity incentive awards consisting of (i) restricted stock units (RSUs) covering 1,070,000 shares of Company common stock, subject to time-based vesting (the “Time-Based RSUs”) and (ii) RSUs covering 813,750 shares of Company common stock, subject to performance-based vesting (the “Performance-Based RSUs”).

The Time-Based RSUs vest in four equal annual installments on each of the first four anniversaries of Mr. Cunningham’s start date. One-fifth of the Performance-Based RSUs will vest on the later of (i) the date that the volume weighted average price of the Company’s common stock on the Nasdaq Global Market (“VWAP”) equals or exceeds $10 per share for 30 consecutive days prior to the second anniversary of Mr. Cunningham’s start date and (ii) the first anniversary of his start date, two-fifths will vest on the later of (i) the date that such VWAP equals or exceeds $15 per share for 30 consecutive days prior to the third anniversary of Mr. Cunningham’s start date and (ii) the second anniversary of his start date, and the remaining two-fifths will vest on the later of (i) the date that such VWAP equals or exceeds $20 per share for 30 consecutive days prior to the fourth anniversary of Mr. Cunningham’s start date and (ii) the third anniversary of his start date.

The equity awards were granted under the Company’s 2025 Inducement Plan as an inducement material to Mr. Cunningham’s joining Quanterix in accordance with Nasdaq Listing Rule 5635(c)(4) and were approved by the Company’s Board of Directors.

About Quanterix

Quanterix is a global leader in ultra-sensitive biomarker detection, enabling breakthroughs in disease research, diagnostics, and drug development. Its proprietary Simoa® technology delivers industry-leading sensitivity, allowing researchers to detect and quantify biomarkers in blood and other fluids at concentrations far below traditional limits. With approximately 6,000 peer-reviewed publications, Quanterix has been a trusted partner to the scientific community for nearly two decades. In 2025, Quanterix acquired Akoya Biosciences, The Spatial Biology Company®, adding multiplexed tissue imaging with single-cell resolution to its portfolio and 1,396 installed instruments. Together, the combined company offers a uniquely integrated platform that connects biology across blood and tissue—advancing precision medicine from discovery to diagnostics. Learn more at www.quanterix.com.

Cautionary Statement Regarding Forward-Looking Statements

The financial results mentioned above are preliminary, unaudited results and may be subject to change as a result of the completion of Quanterix’s year-end financial reporting and auditing processes.

Statements included in this press release that are not historical in nature or do not relate to current facts are intended to be, and are hereby identified as, forward-looking statements for purposes of the safe harbor provided by Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. Forward-looking statements include, among other things, statements about Quanterix’s future business outlook, operations, strategy and financial performance, including statements related to our expectations regarding our financial results for the year ended December 31, 2025, about the development and commercialization of our products, and about the benefits we may realize from the acquisition of Akoya Biosciences Inc. Words and phrases such as “may,” “approximately,” “continue,” “should,” “expects,” “projects,” “anticipates,” “is likely,” “look ahead,” “look forward,” “believes,” “will,” “intends,” “estimates,” “strategy,” “plan,” “could,” “potential,” “possible” and variations of such words and similar expressions are intended to identify such forward-looking statements. Forward-looking statements are subject to certain risks and uncertainties that are difficult to predict with regard to, among other things, timing, extent, likelihood and degree of occurrence, which could cause actual results to differ materially from anticipated results. Such risks and uncertainties include, among others, the following possibilities with respect to Quanterix’s future business, operations, strategy and financial performance: risks related to the impact of recent U.S. government policies, including reductions in federal research funding and increased tariffs; risks that we may not realize the expected benefits of our cost reduction actions; risks associated with the anticipated timing for launch of, and features of, Quanterix’s next-generation instrument, Simoa One; risks that Quanterix may fail to realize the anticipated benefits and synergies of its recent acquisitions of Emission, Inc. and Akoya Biosciences Inc.; risk that integrating Quanterix’s business with that of Akoya could be more difficult, costly or time-consuming than expected; Quanterix risks that Quanterix’s estimates regarding expenses, future revenues, capital requirements, and needs for additional financing could be incorrect; risks related to the restatement of Quanterix’s consolidated financial statements, including risks of increased costs and the increased possibility of legal proceedings and regulatory inquiries, sanctions, or investigation; risks related to Quanterix’s ability to maintain effective internal control over financial reporting and disclosure controls and procedures, including its ability to remediate existing material weaknesses in its internal control over financial reporting and the timing of any such remediation; risks related to defects or other quality issues in Quanterix’s products that could lead to unforeseen costs, product recalls, adverse regulatory actions, negative publicity and litigation; risks related to Quanterix’s ability to retain and expand its customer base and achieve sufficient market acceptance of its products; and other factors that may affect future results of Quanterix. Additional factors that could cause results to differ materially from those described above can be found in the periodic reports filed by Quanterix with the SEC, including the “Risk Factors” sections contained therein, which are available on the SEC’s website at www.sec.gov.

All forward-looking statements, expressed or implied, included in this press release are expressly qualified in their entirety by the cautionary statements contained or referred to herein. If one or more events related to these or other risks or uncertainties materialize, or if Quanterix’s underlying assumptions prove to be incorrect, actual results may differ materially from what Quanterix anticipates. Quanterix cautions readers not to place undue reliance on any such forward-looking statements, which speak only as of the date they are made and are based on information available at that time. Quanterix does not assume any obligation to update or otherwise revise any forward-looking statements to reflect circumstances or events that occur after the date the forward-looking statements were made or to reflect the occurrence of unanticipated events except as required by federal securities laws.

Contacts

Investor Contact:
Joshua Young

(508) 846-3327

ir@quanterix.com

GenNx360 Capital Partners Portfolio Company Nutra-Med Packaging Appoints Hany Salama as Chief Executive Officer




GenNx360 Capital Partners Portfolio Company Nutra-Med Packaging Appoints Hany Salama as Chief Executive Officer

NEW YORK–(BUSINESS WIRE)–GenNx360 Capital Partners (“GenNx360”), a New York City-based private equity firm investing in middle-market industrial and business services companies, today announced the appointment of Hany Salama as Chief Executive Officer of its portfolio company, Nutra-Med Packaging (“Nutra-Med” or the “Company”), one of the leading contract development and manufacturing organizations serving the health, wellness, and pharmaceutical sectors. Mr. Salama succeeds Kunal Gupta, effective January 12, 2026.

Mr. Salama brings more than twenty years of global leadership experience across healthcare, biopharma, consumer health, and life sciences. He has held senior operational and commercial roles at some of the world’s most respected organizations, including Johnson & Johnson, Merck, Roche, and BASF. At Johnson & Johnson, he led end-to-end supply chain and manufacturing operations for major consumer brands across complex, highly regulated environments. Most recently, as Senior Vice President and General Manager at McKesson, Mr. Salama oversaw biopharma services, private-label strategy, commercialization, and specialty distribution, driving growth and operational transformation across large-scale, mission-critical platforms.

“Hany’s leadership experience at the intersection of regulated manufacturing, operational excellence, and commercial scale makes him exceptionally well suited to lead Nutra-Med into its next chapter,” said Marie Ffolkes, Managing Partner of GenNx360 Capital Partners. “As Nutra-Med continues to expand its capabilities and deepen customer partnerships, we are confident that Hany’s disciplined approach and strategic perspective will help accelerate growth and strengthen the Company’s market position.”

As Chief Executive Officer, Mr. Salama will focus on advancing Nutra-Med’s core manufacturing capabilities, expanding its service offerings, and scaling the platform to meet growing customer demand. He will work closely with the Company’s experienced leadership team to enhance quality systems, increase capacity, and further differentiate Nutra-Med as a trusted partner to customers across the health, wellness, and pharmaceutical markets.

“We are delighted to welcome Hany to Nutra-Med,” said Kunal Gupta, outgoing Chief Executive Officer. “I am incredibly proud of what our team has built over the past four years and believe Hany is the right leader to guide the Company through its next phase of growth. His experience, leadership style, and vision will be invaluable as Nutra-Med continues to evolve and pursue its significant market opportunity.” Mr. Gupta will transition into the role of President, where he will continue to support Nutra-Med’s long-term success.

“I am honored to join Nutra-Med at such a pivotal moment in the Company’s evolution,” said Mr. Salama. “I look forward to working with the talented Nutra-Med team to build on the Company’s strong foundation, continue delivering high-quality packaging solutions, and create lasting value for our customers and partners.”

About Nutra-Med

Nutra-Med is a Whippany, New Jersey-based company focused on contract packaging for the Pharmaceutical, Health & Wellness and Medical Devices industries. Nutra-Med’s primary service capabilities include bottling, blistering, kitting, and secondary packaging for domestic and global customers. For more information on Nutra-Med, please visit www.nutra-med.com.

About GenNx360 Capital Partners

GenNx360 Capital Partners is a private equity firm focused on acquiring middle market industrial and business services companies. GenNx360 invests in companies with proven and sustainable business models in expanding industries, with the objective of implementing value-enhancing operational improvements to accelerate growth, deliver efficiencies and generate strong financial returns. Target sectors include infrastructure & utility services, commercial & facility services, testing/environmental equipment/services, automation & industrial technology, industrial distribution/supply chain, packaging products/equipment services, food ingredients and equipment/services. GenNx360 was founded in 2006 and is headquartered in New York City. https://www.gennx360.com/

Contacts

Media Contact:
Edward Lopez

Profile Advisors

P: 646-818-9018

E: Elopez@profileadvisors.com