Category: 3. Business

Fiserv Small Business Index rises to 144 as year-over-year sales increase +1.6%

MILWAUKEE–(BUSINESS WIRE)–
Fiserv, Inc. (NASDAQ:FISV), a leading global provider of payments and financial services technology, has published the Fiserv Small Business Index for December 2025, indicating small businesses closed out the holiday season with modest gains. The seasonally adjusted Index climbed to 144, while year-over-year sales grew (+1.6%), due to higher average ticket sizes and steady demand for essentials.

December sales rose month-over-month (+0.8%), while transaction volume remained flat. Compared to 2024, average ticket sizes were up (+2.0%), signaling that consumers spent more per purchase during the holiday period.

“December’s sales gains show the resilience of small businesses during a competitive holiday season,” said Prasanna Dhore, Chief Data Officer at Fiserv. “Consumers focused on essentials and made selective discretionary purchases, driven by ongoing cost pressures. These patterns, resulting in modest monthly sales growth, highlight how small businesses continue to adjust in a challenging economic climate.”

Key Takeaways

Holiday Demand Boosts Retail Sales

Retail sales among small businesses rose (+0.9%) month-over-month and (+0.3%) year-over-year, with Core Retail (excluding volatile categories) posting stronger (+1.1%) year-over-year growth. Sporting Goods (+5.2%) led annual gains, supported by increased foot traffic (+5.8%).

Spending on Essentials Outpaces Discretionary Spending

Essential categories continued to outperform discretionary purchases, growing (+2.8%) year-over-year compared to (+0.7%) for discretionary items. Grocery sales dipped slightly (-0.3%) despite a small uptick in foot traffic (+0.2%).

Restaurant Sales Remain Flat in December

Small business restaurants saw minimal change, with sales up (+0.1%) year-over-year and flat month-over-month. Falling year-over-year foot traffic (-1.5%) was the key driver of the low annual growth. Limited-Service Restaurants (+0.5%) outperformed Full-Service Restaurants (-0.6%) year-over-year, while bars saw +1.0% growth, driven entirely by increased foot traffic.

States Experience Broad Sales Growth

Compared to November, sales grew in 43 of 50 states during the month of December, a significant increase from the month prior, when only 11 states saw sales increases. Month-over-month increases from high-volume states, including California (+1.6%) and Texas (+1.1%), contributed significantly to this growth. New York (-0.5%), Colorado (-1.5%) and Pennsylvania (-0.2%) were among the few states to experience month-over-month declines.

To access the full Fiserv Small Business Index, visit fiserv.com/FiservSmallBusinessIndex.

About the Fiserv Small Business Index^®

The Fiserv Small Business Index is published during the first week of every month and differentiated by its direct aggregation of consumer spending activity within the U.S. small business ecosystem. Rather than relying on survey or sentiment data, the Fiserv Small Business Index is derived from point-of-sale transaction data, including card, cash, and check transactions in-store and online across approximately 2 million U.S. small businesses, including hundreds of thousands leveraging the Clover point-of-sale and business management platform.

Benchmarked to 2019, the Fiserv Small Business Index provides a numeric value measuring consumer spending, with an accompanying transaction index measuring customer traffic. Through a simple interface, users can access data by region, state, and/or across business types categorized by the North American Industry Classification System (NAICS). Featuring the most detailed classification available, the Fiserv Small Business Index provides visibility into 56 standardized level-6 national industries across 26 subsectors and 13 sectors, allowing users to track sales trends with precision and understand the diverse dynamics shaping the U.S. small business economy.

About Fiserv

Fiserv, Inc. (NASDAQ: FISV), a Fortune 500 company, moves more than money. As a global leader in payments and financial technology, the company helps clients achieve best-in-class results through a commitment to innovation and excellence in areas including account processing and digital banking solutions; card issuer processing and network services; payments; e-commerce; merchant acquiring and processing; and Clover^®, the world’s smartest point-of-sale system and business management platform. Fiserv is a member of the S&P 500^® Index, one of TIME Magazine’s Most Influential Companies™ and one of Fortune^® World’s Most Admired Companies™. Visit fiserv.com and follow on social media for more information and the latest company news.

FISV-G

View source version on businesswire.com: https://www.businesswire.com/news/home/20260105567516/en/

For more information contact:

Media Relations:

Melissa Moritz

Vice President, External Communications

Fiserv, Inc.

+1 516-410-1188

melissa.moritz@fiserv.com

Source: Fiserv, Inc.

Released January 5, 2026

Statistically Significant (p=0.006) Waist Circumference Reduction of 9.8 cm at Day 54

Significant Direct Hepatic Activity with a 23.7% Reduction in Liver Stiffness (VCTE) by Day 54

Strong Glycemic Response with a 12.3 mg/dL Fasted Glucose Reduction by Day 54

Robust Weight Loss with 9.1% Reduction (21.2 lbs) by Day 54

CAMBRIDGE, Mass., Jan. 5, 2026 /PRNewswire/ — MetaVia Inc. (Nasdaq: MTVA), a clinical-stage biotechnology company focused on transforming cardiometabolic diseases, today announced positive statistically significant results from the 8-week (extended from four weeks) non-titrated 48 mg, multiple ascending dose (MAD) cohort of its Phase 1 clinical trial of DA-1726, a novel, dual oxyntomodulin (OXM) analog agonist that functions as a glucagon-like peptide-1 receptor (GLP1R) and glucagon receptor (GCGR), for the treatment of obesity. The results show robust early weight loss, statistically significant reductions in waist circumference, strong improvements in glucose control, and meaningful reductions in liver stiffness, alongside a favorable safety and tolerability profile.

In the non-titrated 48 mg cohort, patients experienced no treatment-related discontinuations, and gastrointestinal events were mild to moderate in severity. By Day 26, patients receiving DA-1726 achieved a statistically significant average weight reduction of 6.1% (14.6 lbs.) (p=0.003) and a statistically significant decrease in waist circumference of 5.8 cm (2.3 inches) (p=0.006). These improvements deepened through Day 54, with an average weight loss of 9.1% (21.2 lbs.) and a statistically significant 9.8 cm (3.8 inch) (p=0.022) reduction in waist circumference. Patients also demonstrated a 12.3 mg/dL improvement in fasted glucose from a baseline of 105.3 mg/dL by Day 54. In addition, vibration-controlled transient elastography (VCTE) indicated a 23.7% reduction in liver stiffness from a baseline of 5.9 kPa, suggesting a significant direct hepatic effect from DA-1726.

“Extending DA-1726 administration to a full eight weeks at the non-titrated 48 mg dose has provided us with extremely encouraging insights,” said Hyung Heon Kim, president and chief executive officer of MetaVia. “Patients in this cohort achieved a statistically significant 6.1% weight loss by Day 26 and 9.1% by Day 54, along with reductions in waist circumference of 5.8 cm and 9.8 cm at those same time points. We believe the statistically significant waist reductions reflect the glucagon component of DA-1726, which may contribute to deeper visceral fat loss than GLP-1 agonists alone. Combined with a favorable tolerability profile with no treatment-related discontinuations, these results highlight DA-1726’s differentiated potential to be a best-in-class treatment option.”

“We also observed meaningful metabolic improvements, including a 12.3 mg/dL reduction in fasted glucose and early HbA1c benefits, such as a drop from 6.0% to 5.5% by day 54, in a prediabetic subject. These findings are especially important because the vast majority of people with obesity—ranging from 70% to 80%—have diabetes or prediabetes, and diabetic patients typically receive broader insurance coverage for anti-obesity therapies. DA-1726 has the potential to be the most effective GLP-1/glucagon dual agonist in development that has demonstrated glucose lowering without elevations, which may offer both clinical and reimbursement advantages. Because VCTE is the leading noninvasive tool for liver stiffness assessment and is recognized by the FDA as a biomarker in MASH development, seeing a 23.7% reduction in only eight weeks underscores the hepatic potential of DA-1726. Taken together, the data reinforce our view that DA-1726 has best-in-class potential, delivering a compelling balance of weight loss, metabolic improvement, direct hepatic benefit, and tolerability as we advance toward later-stage development.”

Mr. Kim added, “Looking ahead, our planned 16-week titration studies—to 48 mg in a single step and to 64 mg using a two-step regimen—reflect our confidence in DA-1726’s tolerability and our expectation that it will compare favorably to the slower, more restrictive titration schedules required by today’s GLP-1 drugs. We believe this represents a key competitive advantage. With results expected in the fourth quarter of 2026, we are well positioned to unlock further value creation as we continue advancing DA-1726 toward later-stage development.”

The Phase 1 trial was a randomized, double-blind, placebo-controlled study designed to evaluate the safety, tolerability, PK, and pharmacodynamics (PD) of single and multiple ascending doses of DA-1726 in obese but otherwise healthy adults with a body mass index (BMI) of 30–45 kg/m². Nine subjects in each cohort were randomized in a 6:3 ratio, with each subject receiving either 4 weekly administrations of DA-1726 or placebo. The extended dosing cohort added 4 weekly administrations of DA-1726 or placebo for a total of 8 weeks of exposure. The primary objective was to assess safety and tolerability based on adverse events (AEs), serious adverse events (SAEs), treatment-emergent events (TAEs), and discontinuations. Secondary endpoints included the PK of DA-1726, assessed via serum concentrations over time and metabolite profiling at the highest doses of DA-1726. Exploratory endpoints included the effect of DA-1726 on metabolic parameters, cardiac parameters, fasting lipid levels, body weight, waist circumference and body mass index (BMI), among others.

For more information on this clinical trial, please visit: www.clinicaltrials.gov NCT06252220.

About DA-1726
DA-1726 is a novel oxyntomodulin (OXM) analogue functioning as a GLP1R/GCGR dual agonist for the treatment of obesity and Metabolic Dysfunction-Associated Steatohepatitis (MASH) that is to be administered once weekly subcutaneously. DA-1726 acts as a dual agonist of GLP-1 receptors (GLP1R) and glucagon receptors (GCGR), leading to weight loss through reduced appetite and increased energy expenditure. DA-1726 has a well understood mechanism and, in pre-clinical mice models, resulted in improved weight loss compared to semaglutide (Wegovy®). Additionally, in pre-clinical mouse models, DA-1726 elicited similar weight reduction, while consuming more food, compared to tirzepatide (Zepbound®) and survodutide (a drug with the same MOA), while also preserving lean body mass and demonstrating improved lipid-lowering effects compared to survodutide. In the Phase 1 multiple ascending dose (MAD) trial in obesity, the 32 mg dose of DA-1726 demonstrated best-in-class potential for weight loss, glucose control, and waist circumference reduction.

About MetaVia
MetaVia Inc. is a clinical-stage biotechnology company focused on transforming cardiometabolic diseases. The company is currently developing DA-1726 for the treatment of obesity, and is developing vanoglipel (DA-1241) for the treatment of Metabolic Dysfunction-Associated Steatohepatitis (MASH). DA-1726 is a novel oxyntomodulin (OXM) analogue that functions as a glucagon-like peptide-1 receptor (GLP1R) and glucagon receptor (GCGR) dual agonist. OXM is a naturally-occurring gut hormone that activates GLP1R and GCGR, thereby decreasing food intake while increasing energy expenditure, thus potentially resulting in superior body weight loss compared to selective GLP1R agonists. In a Phase 1 multiple ascending dose (MAD) trial in obesity, DA-1726 demonstrated best-in-class potential for weight loss, glucose control, and waist reduction. Vanoglipel is a novel G-protein-coupled receptor 119 (GPR119) agonist that promotes the release of key gut peptides GLP-1, GIP, and PYY. In pre-clinical studies, vanoglipel demonstrated a positive effect on liver inflammation, lipid metabolism, weight loss, and glucose metabolism, reducing hepatic steatosis, hepatic inflammation, and liver fibrosis, while also improving glucose control. In a Phase 2a clinical study, vanoglipel demonstrated direct hepatic action in addition to its glucose lowering effects.

For more information, please visit www.metaviatx.com.

Forward Looking Statements

Certain statements in this press release may be considered forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Words such as “believes”, “expects”, “anticipates”, “may”, “will”, “should”, “seeks”, “approximately”, “potential”, “intends”, “projects”, “plans”, “estimates” or the negative of these words or other comparable terminology (as well as other words or expressions referencing future events, conditions or circumstances) are intended to identify forward-looking statements, which include, among other statements, statements regarding the timing and release of data related to the company’s planned 16-week titration studies. Forward-looking statements are predictions, projections and other statements about future events that are based on current expectations and assumptions and, as a result, are subject to risks and uncertainties. Many factors could cause actual future events to differ materially from the forward-looking statements in this press release, including, without limitation, those risks associated with MetaVia’s ability to execute on its commercial strategy; MetaVia’s expectations regarding the sufficiency of its existing cash on hand to fund MetaVia’s operations; the timeline for regulatory submissions; the ability to obtain regulatory approval through the development steps of MetaVia’s current and future product candidates; the ability to realize the benefits of the license agreement with Dong-A ST Co. Ltd., including the impact on future financial and operating results of MetaVia; the cooperation of MetaVia’s contract manufacturers, clinical study partners and others involved in the development of MetaVia’s current and future product candidates; potential negative interactions between MetaVia’s product candidates and any other products with which they are combined for treatment; MetaVia’s ability to initiate and complete clinical trials on a timely basis; MetaVia’s ability to recruit subjects for its clinical trials; whether MetaVia receives results from MetaVia’s clinical trials that are consistent with the results of pre-clinical and previous clinical trials; impact of costs related to the license agreement, known and unknown, including costs of any litigation or regulatory actions relating to the license agreement; the effects of changes in applicable laws or regulations; the effects of changes to MetaVia’s stock price on the terms of the license agreement and any future fundraising; and other risks and uncertainties described in MetaVia’s filings with the Securities and Exchange Commission, including MetaVia’s most recent Annual Report on Form 10-K and subsequent Quarterly Reports on Form 10-Q. Forward-looking statements speak only as of the date when made. MetaVia does not assume any obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by law.

Contacts:

MetaVia
Marshall H. Woodworth
Chief Financial Officer
+1-857-299-1033
[email protected]

Rx Communications Group
Michael Miller
+1-917-633-6086
[email protected]

SOURCE MetaVia Inc.

CAMBRIDGE, Mass.–(BUSINESS WIRE)–Jan. 5, 2026–
Sarepta Therapeutics, Inc. (NASDAQ:SRPT), the leader in precision genetic medicine for rare diseases, today announced that senior management will present at the 44th Annual J.P. Morgan Healthcare Conference in San Francisco, Calif. on Monday, Jan. 12, 2026 at 12:00 p.m. E.T. / 9:00 a.m. P.T. Following the presentation there will be a Q&A session starting at 12:20 p.m. E.T. / 9:20 a.m. P.T.

The presentation will be webcast live under the Events & Presentations section of the investor relations section of Sarepta’s website at https://investorrelations.sarepta.com/events-presentations and will be archived there following the presentation for 90 days. Please connect to Sarepta’s website several minutes prior to the start of the broadcast to ensure adequate time for any software download that may be necessary.

About Sarepta Therapeutics

Sarepta is on an urgent mission: engineer precision genetic medicine for rare diseases that devastate lives and cut futures short. We hold leadership positions in Duchenne muscular dystrophy (Duchenne) and are building a robust portfolio of programs across muscle, central nervous system, and cardiac diseases.

Internet Posting of Information

We routinely post information that may be important to investors in the ‘For Investors’ section of our website at www.sarepta.com. We encourage investors and potential investors to consult our website regularly for important information about us.

View source version on businesswire.com: https://www.businesswire.com/news/home/20260105003354/en/

Investor:
Ian Estepan, 617-274-4052

iestepan@sarepta.com Ryan Wong, 617-800-4112

rwong@sarepta.com

Media:
Tracy Sorrentino, 617-301-8566

tsorrentino@sarepta.com

Source: Sarepta Therapeutics, Inc.

Sustainability is increasingly proving to be a driver of corporate financial performance. Recent analysis from WBCSD shows positive financial returns, with reported ROI ranging from 2x to 14x, especially in sectors like food and beverage. Companies with strong sustainability practices often benefit from a lower cost of capital, while those that fail to act face tangible financial penalties, including EBITDA reductions of 5% to 25%. In agrifood value chains, there is growing evidence of the linkage between climate, nature, and equity outcomes and management of material risks and opportunities that shape long-term value and resilience. In October 2025, WBCSD and Principles for Responsible Investment brought together a group of agrifood companies and investors to discuss how shared metrics can better support decision-making for both corporates and investors and drive more coordinated action across the sector. The article highlights the main insights fromthe dialogue.

WBCSD Drives Convergence on Environmental and Socioeconomic Metrics for Decision-Making 

Through WBCSD and OP2B, 52 companies and 33 partner organizations representing over 1,100 businesses have converged on core outcomes and indicators for regenerative agriculture and sustainable land use. This is a holistic set of environmental, social, and economic outcomes and indicators, in alignment with leading standards and areas of convergence. This links corporate, policy and investor decision-making with actions at the farm and landscape levels, for instance through the SAI Platform.   

WBCSD supports the recognition of sustainable corporate performance by financial markets to ensure that companies demonstrating strong sustainability outcomes are financially rewarded. An effective corporate performance and accountability system is key to this; harmonized standards, metrics and measurement approaches that companies and investors can use for decision-making. By translating these outcomes into comparable data, metrics empower financial market actors to make informed decisions that align financial performance with sustainability goals. The growing momentum behind mandatory reporting further accelerates the adoption of standardized disclosures, ensuring transparency and consistency across markets.

Investors are Increasingly Using and Interpreting Sustainability Metrics Through a Financial and Strategic Lens

Regenerative agriculture is emerging as a key focus area for investors as a means to enhance supply chain resilience, protect land value, and monetize ecosystem services. Investors are therefore seeking metrics that are consistent, comparable, and outcome-focused and that help them translate sustainability performance into measurable financial terms, such as improved returns, lower risk, and more stable long-term supply chains. Beyond indicators like soil health and carbon sequestration, investors are also looking for metrics that capture broader biodiversity and social benefits to better understand the full scope of value creation.  

Currently, there’s a lack of recognized sector pathways or benchmarks, making it premature for investors to set performance thresholds. Instead, they’re assessing whether companies use comprehensive metrics aligned with recognized initiatives like those from WBCSD.

– Bethany Davies, Principles for Responsible Investment 

Tikehau Capital shared a practical example of an impact measurement framework to evaluate corporate performance on regenerative agriculture. In partnership with AXA and Unilever, the fund integrates cross-sector expertise to identify investable opportunities. Its framework measures both environmental and social outcomes, including biodiversity, water, carbon, nutrition, and health, using outcome-based indicators such as the number of hectares managed under regenerative practices. 

Overcoming Key Bottlenecks to Investor Action 

Although investors recognized the value of the WBCSD outcomes in driving consistent, scalable, and outcome-based assessment, several barriers continue to limit their broader integration into investment practice. 

Low corporate reporting rates and fragmented disclosure frameworks limit investor benchmarking. 

Inconsistent reporting frameworks and limited disclosure from companies limit investors’ ability to assess performance and allocate capital effectively. Greater harmonization and broader participation in reporting are needed to ensure interoperability, reduce duplication, and enhance comparability. Continued corporate engagement in metric development should be leveraged to accelerate adoption and build more robust datasets for benchmarking. 

From an investor standpoint, disclosures are important because they show how a company is adopting its strategy on regenerative agriculture, or any other solution for that matter.

– Sajeev Mohankumar, FAIRR Initiative 

Lack of recognized sectoral pathways or benchmarks. 

Without agreed definitions of what good looks like in regenerative agriculture, investors rely heavily on qualitative indicators, such as alignment with outcomes through WBCSD. There is a need to establish clear, sector-specific benchmarks and combine metric evaluation with company engagement to validate results, strengthen data reliability, and encourage consistent disclosure. 

Disconnect between sustainability goals and executive incentives. 

Senior leaders are often rewarded based on short-term financial performance rather than long-term sustainability outcomes. To shift this dynamic, stronger evidence linking regenerative outcomes to tangible business outcomes such as resilience, risk mitigation, supply chain security, and long-term productivity is needed. Embedding these outcomes into incentive structures can help align corporate priorities with sustainability objectives. 

Limited guidance on applying and interpreting metrics. 

Clear, science-based guidance is needed to support consistent use of metrics and interpretation of results. This includes defining robust baselines and sector-specific thresholds to improve the credibility and usability of reported data for both companies and investors. 

Call to Action 

Overcoming these barriers will be key to scaling investment in regenerative agriculture and turning ambition into a measurable impact. WBCSD continues to work with investors, companies, and standard-setting bodies to build alignment across frameworks, and support the adoption and implementation of consistent, comparable, and decision-useful metrics.  

For more information about the agriculture and food metrics we will take into 2025, please reach out to Kate Newbury-Hyde (newbury@wbcsd.org) or Ludmila Cmarkova (cmarkova@wbcsd.org). To engage in the work, ensure you are part of WBCSD’s Agriculture and Food Pathway.

COCONUT CREEK, Fla. and NEW YORK — January 5, 2026 — Willis Lease Finance Corporation (NASDAQ: WLFC) (“WLFC” or the “Company”), the leading lessor of commercial aircraft engines and a global provider of aviation services, and Blackstone Credit & Insurance (“BXCI”) announced a strategic aircraft engine leasing partnership with plans to deploy over $1 billon in the next two years in current and next generation aircraft engines and select aircraft. This unique partnership brings together a leading engine leasing specialist with Blackstone’s scaled private credit business to focus on the engine asset class.
 
The partnership leverages WLFC’s established position as a pioneer in aircraft engine leasing and its growing asset management platform. WLFC has identified a seed portfolio and near-term pipeline of high-quality engine assets that are expected to close into the partnership, providing immediate scale and diversification across engine types and airline customers globally.
 
“We are excited to partner with BXCI, whose scale and long-term capital commitment will accelerate the growth of our asset management business,” said Austin C. Willis, CEO of WLFC. “Blackstone is a leader in asset-based credit, and their investment demonstrates the strength of our position in aircraft engine leasing and their belief in our ability to generate attractive returns through disciplined asset selection and active management.”
 
Scott Flaherty, CFO of WLFC, added “the Blackstone relationship provides further capital diversification to the Willis platform. We are excited about this new relationship and the growth opportunities this brings to our business.”
 
“Willis is a leading lessor of commercial aircraft engines and brings unparalleled technical expertise, deep customer relationships and a proven track record,” said Aneek Mamik, Senior Managing Director, Blackstone Credit & Insurance. “This opportunity is consistent with BXCI’s objectives of building programmatic, differentiated origination in large addressable markets with a focus on hard assets and strong downside protection.”
 
“We look forward to partnering with the WLFC team to support the growth of their platform and deliver essential engine solutions for the global aviation fleet,” added Alex Buck, Principal, Blackstone Credit & Insurance.
 
BXCI’s Infrastructure and Asset Based Credit group manages over $100 billion and has over 80 investment professionals, as of September 30, 2025. The platform is focused on providing investment grade credit, non-investment grade credit, and structured investments across the real economy in sectors such as infrastructure, commercial finance, fund finance, consumer finance, and residential real estate loans.
 
BNP Paribas served as sole structuring agent and advisor to BXCI.
 
About Willis Lease Finance Corporation
Willis Lease Finance Corporation leases large and regional spare commercial aircraft engines, auxiliary power units and aircraft to airlines, aircraft engine manufacturers and maintenance, repair and overhaul providers worldwide. These leasing activities are integrated with various end-of-life solutions for engines and aviation materials provided through Willis Aeronautical Services, Inc. Additionally, through Willis Engine Repair Center®, Jet Centre by Willis, and Willis Aviation Services Limited, the Company’s service offerings include Part 145 engine maintenance, aircraft line and base maintenance, aircraft disassembly, parking and storage, airport FBO and ground and cargo handling services. Willis Sustainable Fuels intends to develop, build and operate projects to help decarbonize aviation.
 
About Blackstone Credit & Insurance
Blackstone Credit & Insurance (“BXCI”) is one of the world’s leading credit investors. Our investments span the credit markets, including private investment grade, asset-based lending, public investment grade and high yield, sustainable resources, infrastructure debt, collateralized loan obligations, direct lending and opportunistic credit. We seek to generate attractive risk-adjusted returns for institutional and individual investors by offering companies capital needed to strengthen and grow their businesses. BXCI is also a leading provider of investment management services for insurers, helping those companies better deliver for policyholders through our world-class capabilities in investment grade private credit.
 
Contacts
Willis Lease Finance Corporation
Lynn Kohler
[email protected]
(415) 328-4798
 
Blackstone
David Vitek
[email protected]
(212) 583-5291

Tovorafenib (Ojemda) has further solidified its place in the treatment landscape of relapsed/refractory pediatric low-grade glioma (pLGG) following updated data from the phase 2 FIREFLY-1 trial (NCT04775485), according to Cassie Kline, MD, MAS.

Findings from the updated 3-year analysis of FIREFLY-1 presented during the 2025 Society of Neuro-Oncology Annual Meeting demonstrated that efficacy-evaluable patients with relapsed/refractory pLGG who received tovorafenib in arm 1 (n = 76) achieved an overall response rate (ORR) of 53%.¹ The median duration of response (DOR) was 19.4 months (95% CI, 13.8-27.2) and the median time to response was 5.4 months (range, 1.6-17.5). The median time to next treatment (TTNT) was 42.6 months (95% CI, 36.7-not estimable).

“We were able to identify a very long period of TTNT [with] additional follow-up, [with] no new safety signals,” Kline said in an interview in OncLive®. “We now have a cohort, although [it’s] still small numbers, that have also entered a retreatment arm after coming off of the drug and seeing tumor changes that warranted retreatment. We were excited to see the response of the 3-year follow up data that are adding on to what was previously presented and published.”

Updated Results From the Phase 2 FIREFLY-1 Trial

• Efficacy-evaluable patients with relapsed/refractory pLGG who received tovorafenib in arm 1 (n = 76) achieved an ORR of 53%.

• The median DOR was 19.4 months (95% CI, 13.8-27.2), the median time to response was 5.4 months (range, 1.6-17.5), and the median TTNT was 42.6 months (95% CI, 36.7-not estimable).

• No new safety signals were identified.

In the interview, Kline, an attending physician and director of clinical research in the Department of Neuro-Oncology at Children’s Hospital of Philadelphia in Pennsylvania, discussed the design of FIREFLY-1, the mechanism of action of tovorafenib, and the significance of the key findings from the study.

OncLive: What was the rationale and study design characteristics of FIREFLY-1?

Kline: The trial was designed for [patients with] recurrent pLGG. There’s also a solid tumor cohort. As a pediatric-neuro oncologist, I [am] focused on the pLGG cohort, [which] was designed to identify the clinical benefit and efficacy of tovarafinib.

What is the mechanism of action of tovorafenib?

Tovarafinib [is a] pan-RAF inhibitor. Many of our agents target a single step in the active pathways of these tumors, whereas as a pan RAF inhibitor, [tovarafinib] is targeting the pathway in its entirety. Another unique [characteristic of] the agent is that it’s once-weekly oral dosing, which is nice for patients and families in terms of quality of life.

What prior data have been reported with tovorafenib?

[Tovarafinib] seemed to provide clinical benefit and disease response in our patients with pLGG. That was promising in comparison with other agents that were currently being utilized in this setting.

What were the key data that were shared in the 3-year update?

The [median] TTNT being over 40 months is giving our patients and families a long period of not necessarily needing additional therapies. We also saw that most patients, once they stopped treatment after 26 cycles, were able to remain treatment-free for up to a year, and that the majority of patients too were able to finish the 26 cycles of therapy also. All of that is very promising in terms of the potential clinical benefit, the tolerability of this agent, and then, ideally, the ongoing disease control once the patients have come off of treatment.

What are the next steps for this research?

It’s going to continue to be to [monitor] these long-term outcomes in terms of how long we’re able to maintain disease control. There are other long term toxicities that we’re all interested in exploring as well. Those will really be critical next steps.

Another question in the setting of pLGG is this question of rebound growth that can happen after targeted agents are stopped. We’re going to be very comprehensive in also exploring the incidence of rebound growth and what that means for our patients and families with tovorafenibspecifically

In light of the updated data from FIREFLY-1, what is the current role of tovorafenib in pLGG?

Right now, we’re in the setting of an FDA indication for recurrent disease.² Many in our community are readily utilizing that [indication] and at the first step of disease recurrence or primary or upfront treatment failure. It’s certainly fitting nicely in that paradigm. There are ongoing studies that are exploring randomization between the agent with standard chemotherapy. [Determining] where this fits in the upfront treatment schema will be a next rational step as we’re thinking about how we’re utilizing this agent to treat our [patients].

References

1. Kline C, Hargrave D, Khong-Quang DA, et al. Clinical stability following tovorafenib treatment in relapsed/refractory pediatric low-grade glioma: updated results from the phase 2 FIREFLY-1 trial. Presented at 2025 Society of Neuro-Oncology Annual Meeting; November 19-23, 2025; Honolulu, HI. Abstract CTP-17.
2. FDA grants accelerated approval to tovorafenib for patients with relapsed or refractory BRAF-altered pediatric low-grade glioma. FDA. Updated May 22, 2024. Accessed January 2, 2026. https://www.fda.gov/drugs/resources-information-approved-drugs/fda-grants-accelerated-approval-tovorafenib-patients-relapsed-or-refractory-braf-altered-pediatric

• Transaction strengthens balance sheet and liquidity with cash proceeds of $1.15 billion before customary closing adjustments

HOUSTON and LONDON, Jan. 05, 2026 (GLOBE NEWSWIRE) — Baker Hughes (NASDAQ: BKR, “the Company”), an energy technology company, announced Monday the successful closing of the sale of its Precision Sensors & Instrumentation (PSI) product line to Crane Company (NYSE: CR, “Crane”). PSI includes the Druck, Panametrics and Reuter-Stokes brands, and the Company had announced the divesture in July 2025.

With the recently announced formation of a joint venture for its surface pressure control product line, these transactions represent an important milestone in Baker Hughes’ value-creation strategy, reinforcing the Company’s commitment to disciplined portfolio management, operational execution and capital efficiency. The transactions enhance earnings and cash flow durability, enable the redeployment of capital toward higher-return opportunities, and provide cash proceeds to further strengthen the balance sheet, all within a rigorous, returns-focused approach to capital allocation.

About Baker Hughes
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Source: Baker Hughes

Efforts by Telford and Wrekin Council to reduce its carbon emissions are ahead of target but further reductions are becoming “more challenging”, according to the authority.

In 2019 the council was among many authorities to declare a “climate emergency” and set out a target to become carbon neutral by 2030.

A council report said that by the end of March 2025, emissions had been reduced by 63% since 2018/19, thanks to a range of measures in homes, leisure centres, and offices. The authority said that put it eight per cent ahead of where it was expecting to be at this stage.

The council has set itself a target of reaching a 70 per cent reduction by 2026/27.

“We have made strong progress in reducing the council’s emissions so far, but we recognise that it is getting harder and more challenging to do,” the report stated.

Measures taken include making homes more energy-efficient and increasing the number of solar panels on council buildings.

The council owns the Wheat Leasows solar farm which last year produced 3,144 MWh of electricity, enough energy to power 1,084 homes.

It said it was looking at the possibility of more solar energy and improving connections to the national electricity network.

In addition, the authority said it was taking measures to prepare the area for the impact of climate change.

It said risks included damage to roads and trees from flooding, heat and wind, with heat also recognised as a threat to public health and the smooth running of IT systems.