Category: 3. Business

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
Baker Hughes (NASDAQ: BKR) is an energy technology company that provides solutions to energy and industrial customers worldwide. Built on a century of experience and conducting business in over 120 countries, our innovative technologies and services are taking energy forward – making it safer, cleaner and more efficient for people and the planet. Visit us at bakerhughes.com.

For more information, please contact:

Media Relations

Adrienne M. Lynch+1 713-906-8407
adrienne.lynch@bakerhughes.com 

Investor Relations

Chase Mulvehill+1 346-297-2561
investor.relations@bakerhughes.com 

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.

With the rise of AI summaries for health information and the introduction of AI mode, a group of health charities, including the BHF, have raised concerns about access to trustworthy information. 

The charities, including end of life charity Marie Curie, the Patient Information Forum (PIF), Macmillan Cancer Support, Cancer Research UK and us, have urged the public to look beyond AI health summaries and visit trusted, evidence-based, UK-verified sources for additional information and context.

A report from Marie Curie, Macmillan and PIF, which represents health organisations, published earlier this year raised concerns over AI-generated health summaries on search engines such as Google.

Concerns highlighted by organisations include:

• Gynae cancer charity The Eve Appeal highlighted that a search for ‘vaginal cancer symptoms and tests’ produced an AI summary that listed a PAP test as a test for vaginal cancer, which is incorrect.     
• An AI-generated summary advised people with pancreatic cancer to avoid high-fat foods. However, Pancreatic Cancer UK said this advice is the opposite of recommendations for people affected by pancreatic cancer. 
• Searches for information on what a ‘normal’ range is for liver blood tests returned AI-generated summaries which don’t account for a person’s sex, age or ethnicity. The British Liver Trust said this made the information inaccurate for some people.

These concerns arise as a recent survey of PIF members revealed that almost half (49%) have seen inaccuracies or misinformation about their topic area in AI overviews.

More than 6 out of 10 health charities have observed a decline in traffic to their websites since the rollout of health summaries.

This has sparked concerns that the public is not accessing source information and could be missing out on vital additional professional support and context when it is most needed. 

The coalition is calling on Google and other search engine providers to take immediate action to reduce potential harm, including:

• Clear signposting to NHS-approved advice and support services
• Prioritised verified UK-based sources with links to further information
• Clear disclaimers that AI-generated content cannot substitute medical advice.

Dr Charmaine Griffiths, our Chief Executive, said: “Being diagnosed with cardiovascular disease is one of those moments in life where having access to need reliable, evidence-based information and advice is priceless.

“Each year millions of heart patients and their families turn to the internet in search of answers to their questions, and we have a duty as a society to ensure they access only the highest quality information and advice online.

“This is why it is so vital that verified sources such as the BHF website remain a first port of call for those in need of trustworthy, unbiased and accurate information about heart disease.” 

Sophie Randall, Director of the Patient Information Forum, said: “We know there are concerns about the results in some AI Overview results. PIF has a mission to promote trusted health information to the public, which is why we are making our report available to the public. 

“To stay safe when searching for health information online, we encourage the public to use trusted sources such as www.nhs.uk, look for the PIF TICK, the UK’s only quality mark for reliable health content, and add ‘UK’ to their searches to help surface relevant, UK-based information.” 

HOW WE CREATE OUR HEALTH INFORMATION

The latest UK weather forecast: Snow flurries to ease but cold days aheadpublished at 10:03 GMT

10:03 GMT

Sarah Keith-Lucas
Broadcast Meteorologist, BBC Weather

Cold Arctic air remains
across all parts of the UK today.

Further snow showers are
expected for areas exposed to the northerly winds, especially northern
Scotland, Northern Ireland, west Wales, south-west England and parts of eastern
England.

The Met Office has issued various yellow warnings for snow and ice warnings
in these regions.

While many places will
stay dry with wintry sunshine, it will feel cold with icy stretches for all.
Maximum temperatures will reach just -2C across parts of Scotland, and
typically 1 to 3C elsewhere.

Most snow flurries will
gradually ease away later this afternoon and evening, to leave a cold
night with a sharp frost and ice.

Tuesday will turn a
little milder, but further hill snow is possible over the higher ground of
Scotland and northern England.

Later in the day and through the night, another
area of rain, sleet and hill snow will affect the southern half of the UK.

Any
snowfall by Tuesday is not expected to be as heavy or disruptive as it has been
over the past few days.

As a reminder, you can check the forecast for your area on BBC Weather.

Agreement supports development and commercialization of higher-dose, subcutaneous administration strategies for nimacimab

SAN DIEGO, Jan. 5, 2026 /PRNewswire/ — Halozyme Therapeutics, Inc. (Nasdaq: HALO) and Skye Bioscience, Inc. (Nasdaq: SKYE) today announced the companies entered into a non-exclusive global collaboration and license agreement in December 2025. Under the collaboration, Skye has licensed Halozyme’s ENHANZE^® drug delivery technology for the development and potential commercialization of a subcutaneous formulation of nimacimab for the treatment of obesity. The collaboration is intended to support Skye’s evaluation of higher nimacimab subcutaneous doses through delivery of larger injection volumes.

“Our collaboration with Skye Bioscience expands the reach of our ENHANZE technology into the growing obesity market, a therapeutic area with significant long-term potential,” said Dr. Helen Torley, President and Chief Executive Officer of Halozyme. “This agreement reinforces the scalability of ENHANZE across diverse indications and supports our strategy to drive sustainable royalty growth with new partnerships and innovations.”

“To fully evaluate nimacimab’s potential, we need to test higher doses and we need a practical way to deliver them subcutaneously,” said Punit Dhillon, President and Chief Executive Officer of Skye. “Partnering with Halozyme to co-formulate nimacimab with ENHANZE gives us a validated approach to evaluate multiple dose-ranging strategies, including in combination with GLP-1 receptor agonists.”

Skye will make milestone payments tied to the achievement of certain development and commercialization events. Halozyme will also be entitled to mid-single digit royalties on net sales of nimacimab developed with ENHANZE^® for at least 10 years.

Skye is planning to initiate a Phase 2b clinical trial in obesity for nimacimab with ENHANZE in the middle of 2026. This study will also assess the combination of nimacimab and a GLP-1R agonist.

About Halozyme

Halozyme is a biopharmaceutical company advancing disruptive solutions to improve patient experiences and outcomes for emerging and established therapies.

As the innovators of ENHANZE^® drug delivery technology with the proprietary enzyme rHuPH20, Halozyme’s commercially validated solution facilitates the subcutaneous delivery of injected drugs and fluids, reducing treatment burden and improving convenience. ENHANZE^® has touched more than one million patient lives through ten commercialized products across over 100 global markets and is licensed to leading pharmaceutical and biotechnology companies including Roche, Takeda, Pfizer, Janssen, AbbVie, Eli Lilly, Bristol-Myers Squibb, argenx, ViiV Healthcare, Chugai Pharmaceutical, Acumen Pharmaceuticals, and Merus N.V.

Halozyme is also developing Hypercon™ to expand the breadth of its drug delivery technology portfolio. Hypercon™ is an innovative microparticle technology that is expected to set a new standard in hyper concentration of drugs and biologics that can reduce the injection volume for the same dosage and expands opportunities for at-home and health care provider administration. The addition of Hypercon™ enhances our ability to transform the patient treatment experience by enabling the creation and delivery of highly concentrated biologics, substantially broadening the scope of therapeutics that can be delivered subcutaneously. The Hypercon™ technology has been licensed to leading biopharmaceutical partners, including Johnson & Johnson, Eli Lilly, and argenx.

Halozyme also develops, manufactures, and commercializes drug-device combination products using advanced auto-injector technologies designed to improve convenience, reliability, and tolerability, enhancing patient comfort and adherence. The Company has two proprietary commercial products, Hylenex^® and XYOSTED^®, partnered commercial products, and ongoing development programs with Teva Pharmaceuticals and McDermott Laboratories Limited, an affiliate of Viatris Inc.

Halozyme is headquartered in San Diego, CA, with offices in Ewing, NJ; Minnetonka, MN; and Boston, MA. Minnetonka is also the site of its operations facility.

For more information, visit http://www.halozyme.com and connect with us on LinkedIn and Twitter.

About Skye Bioscience

Skye is focused on unlocking new therapeutic pathways for metabolic health through the development of next-generation molecules that modulate G-protein coupled receptors. Skye’s strategy leverages biologic targets with substantial human proof of mechanism for the development of potential first-in-class therapeutics with potential clinical and commercial differentiation. Skye is conducting a Phase 2a clinical trial (ClinicalTrials.gov: NCT06577090) in obesity for nimacimab, a negative allosteric modulating antibody that peripherally inhibits CB1. This study is also assessing the combination of nimacimab and a GLP-1R agonist (Wegovy^®). For more information, please visit: www.skyebioscience.com. Connect with us on X and LinkedIn.

Forward-Looking Statements 

In addition to historical information, the statements set forth above include forward-looking statements including, without limitation, statements concerning royalty revenue growth, potential new partnerships and innovations, the possible activity, benefits and attributes of ENHANZE^®, the possible method of action of ENHANZE^®, its potential application to aid in the dispersion and absorption of other injected therapeutic drugs and statements concerning certain other potential benefits of ENHANZE^® including facilitating more rapid delivery and administration of larger volumes of injectable medications through subcutaneous delivery and potentially lowering the treatment burden and improving the treatment experience for patients. These forward-looking statements also include statements regarding the product development and commercialization efforts of Skye (including the potential regulatory approval and launch of nimacimab as a result of such efforts and the potential future market opportunity for such products) and Halozyme’s potential receipt of payments associated with achievement of certain development, regulatory and sales-based milestones, and royalties on sales of commercialized products. These forward-looking statements involve risks and uncertainties that could cause actual results to differ materially from those in the forward-looking statements. The forward-looking statements are typically, but not always, identified through use of the words “believe,” “enable,” “may,” “will,” “could,” “intends,” “estimate,” “anticipate,” “plan,” “predict,” “probable,” “potential,” “possible,” “should,” “continue” and other words of similar meaning. Actual results could differ materially from the expectations contained in forward-looking statements as a result of several factors, including risks and uncertainties concerning whether development, regulatory and sales-based milestones will be achieved, uncertainties concerning whether collaborative products are ultimately developed, approved or commercialized and the potential future market for such products, unexpected levels of revenue growth, expenditures and costs, unexpected results or delays in development and regulatory review, unexpected regulatory approval requirements, unexpected adverse events or patient outcomes and competitive conditions. These and other factors that may result in differences are discussed in greater detail in Halozyme and Skye’s most recent Annual and Quarterly Reports filed with the Securities and Exchange Commission. Except as required by law, Halozyme and Skye undertake no duty to update forward-looking statements to reflect events after the date of this release.

Contacts

Halozyme
Tram Bui
VP, Investor Relations and Corporate Communications
609-359-3016
[email protected]

Skye Investor & Media Relations
[email protected]
(858) 410-0266

LifeSci Advisors
Mike Moyer
[email protected]
(617) 308-4306

SOURCE Halozyme Therapeutics, Inc.