Category: 3. Business

IDH mutations, which are a major target of interest in acute myeloid leukemia (AML), are also present in a minority of patients with myelodysplastic syndrome (MDS). Due to the durability of response and favorable tolerability of IDH1 inhibitors, targeting these mutations in MDS has been investigated and has shown promise favorable survival outcomes a phase 1/2 study (NCT02719574) with a cohort of 22 patients receiving olutasidenib (Rezlidhia).

These patients were treated in a range of settings with olutasidenib including in combination with azacitidine or as a single agent, and in the front line or after disease relapse, resulting in an overall response rate (ORR) of 59% and a median overall survival (OS) of 27.2 months, demonstrating the potential use of a targeted therapy in MDS.¹

“If you have an IDH1 mutation, that is just so important to know in MDS and should drive therapy decisions,” said Justin Watts, MD, associate professor in the hematology division at the University of Miami Miller School of Medicine.

In an interview with Targeted Oncology, Watts discussed the outcomes in this trial of patients with MDS and how to approach using an IDH1 inhibitor. In the upcoming second part of this interview, Watts discussed the significance of the long-term durability of response with olutasidenib that has been observed in some patients with AML and the next steps in research for IDH-targeted agents in AML and MDS.

Targeted Oncology: Could you describe the background for the use of olutasidenib in MDS?

Justin Watts, MD: Olutasidenib was first developed for patients with relapsed/refractory AML with an IDH1 mutation, and its approval was in that population. We had wanted to look at MDS the whole time. In the phase 2 portion of the study, we developed multiple subcohorts for other populations, including patients with MDS. What we did which I really liked was that we were quite broad, allowing both frontline and relapsed/refractory MDS or HMA [hypomethylating agent] progression, and both single-agent or combination therapy with azacitidine, which had not yet been done in MDS with an IDH1 inhibitor. That was a very good move by us at the time, because MDS is a rare disease, and this is a rare mutation. It allowed us to accrue enough patients early to get a sense of what was happening.

What were your findings in the phase 1/2 study of patients with MDS?

First, I would say that this was a very high-risk MDS population. There were no low-risk patients, and there were only a couple of intermediate-risk patients. Eighty-six percent of the 22 patients were high or very high risk, and some even had AML by new criteria like the International Consensus Classification. That being said, what we have seen in AML is that the patients who do very well tend to have lower blast counts and fewer mutations and lack of signaling pathway mutations—more resembling MDS, just their blasts are over 20%. So we weren’t surprised to see that these patients with MDS overall did very well with a 60% ORR in a mixed population, which…is greater than expected with standard-of-care azacitidine, or HMA alone, using a targeted therapy in both a single-agent and combination setting.¹

The OS was equally impressive, and I think that’s due to both duration of response in the responders and the achievement of transfusion independence even in patients who don’t have a full complete response [CR] or an optimal response, which is also very important for long-term outcomes. There was notable achievement of transfusion independence, or maintenance of transfusion independence if they were independent at baseline on the study, a real lack of myelosuppression, and the [median] OS was around 27 months for the entire population.… But even when you looked at the relapsed/refractory [patients], who historically have OS on the order of 5 or 6 months, it was over 16 months in this group. So that was very encouraging.

How does the approach to treating patients with MDS differ from treating those with AML?

If you have an IDH1 mutation, that is just so important to know in MDS and should drive therapy decisions. There aren’t many targetable mutations in MDS like we see in AML. In fact, IDH1 and IDH2 are really the only 2 that cross over between both MDS and AML—being a little more common in AML than MDS, about twice as common for each one. You don’t see that with NPM1, FLT3, and other kinase mutations that may be targetable, so I think that’s notable.

It’s one of our only targeted therapy options in MDS, so arguably, an IDH1 inhibitor could be incorporated into any frontline approach with or without HMA in MDS. Even in lower-risk patients, we sometimes see them with IDH [mutations]. Some other studies have looked there, and their blood counts get better. IDH-mutated patients are going to respond better to an IDH1 inhibitor if it’s the real driver. In AML, when there’s 9 other mutations or when there’s FLT3…and the IDH is subclonal, not dominant, it’s probably not going to get you what you want, at least not as a single agent.

[In] MDS or low-blast AML, this is not always the case, but usually those are the patients who do better. Those are the patients who I think most benefit from these inhibitors. They can have that long duration of response to either single-agent IDH1 inhibition, or with the addition of HMAs, must also benefit patients with AML. As we know with the frontline ivosidenib [Tibsovo]/azacitidine data, it’s really a synergistic combination, especially if they have other significant driver mutations that need combination therapy.

How do you decide if patients should get an IDH1 inhibitor in the frontline vs relapsed MDS setting?

We’re dealing with a rare mutation in a relatively rare disease. It’s impossible to have randomized controlled trials when it’s in 3% to 5% of patients with MDS. You have to use the data you have at hand, and you have to use your judgment. When you combine the totality of the MDS data [for] ivosidenib, enasidenib [Idhifa]—which is IDH2, but basically the same pathway—and olutasidenib, all 3 of the trials had maybe 20 to 30 patients on them.^1-3 You’re not going to get more than that. And when you look at those collective data, and you look at the ivosidenib/azacitidine data in patients with AML who are older, many who have secondary AML [and receive] the other IDH1 inhibitor, [and see] how good those data are in the frontline setting, why would it not be just as good in the frontline setting in a patient with high-risk MDS? [If] they have 15% blasts vs 25%, [does] that dictate their outcome?

When you have a well-tolerated targeted agent in a patient with higher-risk MDS—and with the failure of venetoclax [Venclexta] in MDS—that IDH [inhibitor] plus azacitidine [or] azacitidine/HMA combinations in the frontline make a lot of sense. They may or may not be on the guidelines. That’s shifting. It’s not approved for that, but ivosidenib is now approved for MDS, and I believe olutasidenib may be in that process.

For a low-risk patient you have other options, and a single agent may be more appropriate. For relapsed/refractory patients [with] active [disease], it depends on what prior therapy they’ve had…their age, how frail they are…. But there are some cases of relapsed/refractory [disease] where you may salvage the response to progression on HMA but continuing the HMA still provides some benefit if they’re not heavily pretreated, and adding the IDH [inhibitor] gets them over the hump. We’ve seen that scenario as well in patients on these clinical trials who basically all had prior HMA, were refractory with that, and they still responded.

I think guidelines try to reflect this. They reflect of that these agents are available, and they may not be category 1 [because] there were not randomized phase 2 trials, but we have to use what we have for these patients, especially when the drugs have such a favorable adverse event profile.

Could you describe the tolerability of IDH1 inhibitors?

Differentiation syndrome can happen even in MDS. It’s less common; it’s usually less severe. Each trial had it [roughly] once. But it is something still to know, especially in a patient with more proliferative MDS. That is the one thing I would keep in mind, and there is that potential risk to monitor for early on. That’s the most clinically significant [adverse event]. The other ones are well tolerated in terms of most AML/MDS drugs and chemotherapy, and they don’t cause excess myelosuppression. There are some drug-drug interactions and QT interval monitoring with [ivosidenib] and some hepatotoxicity, usually manageable with adjustments and so on with [olutasidenib], but those are uncommon and rarely grade 3 or severe enough to make you have to stop therapy. Sometimes the dose needs to be adjusted down, but even that’s rare.

_References:

_{1. Cortes JE, Yang J, Roboz GJ, et al. Olutasidenib alone or combined with azacitidine in patients with mutant IDH1 myelodysplastic syndrome. Blood Adv. Published online July 16, 2025. doi:10.1182/bloodadvances.2025016718}

_{2. DiNardo CD, Roboz GJ, Watts JM, et al. Final phase 1 substudy results of ivosidenib for patients with mutant IDH1 relapsed/refractory myelodysplastic syndrome. Blood Adv. 2024;8(15):4209-4220. doi:10.1182/bloodadvances.2023012302}

_{3. Sebert M, Chevret S, Dimicoli-Salazar S, et al. Enasidenib (ENA) monotherapy in patients with IDH2 mutated myelodysplastic syndrome (MDS), the Ideal phase 2 study by the GFM and Emsco Groups. Blood. 2024;144(suppl 1):1839. doi:10.1182/blood-2024-201317}

This story is part of NBC Select’s New & Notable column, where we highlight our favorite product launches. We will continuously update this article throughout the month with new releases we think you should know about.

Apparel and footwear launches

Outdoor Voices Hike Collection

Outdoor Voices’ Hike Collection includes layerable clothes designed to support outdoor activities, especially if you’re braving inclement weather or rough terrain. You can buy men’s and women’s pieces like track pants with mesh panels for extra ventilation, fleece jackets and vests, waffle long sleeves, fleece dresses, sweatpants and more.

Other notable apparel and footwear launches:

• Reebok Nano Pro Training Shoe

• Superfeet Run Pacer Elite

Tech launches

Oura Ring is Rabinowitz’s favorite smart ring right now, but he wasn’t always a fan of the gold and rose gold colorways. Oura Ring 4 Ceramic could change that. It’s a new version with an outer layer made of zirconia ceramic (instead of titanium). “I saw the ceramic models in person — they are much more colorful and fun than the titanium colorways,” says Rabinowitz.

Alongside the Ceramic version, Oura announced a portable charging case, multi-ring support and upcoming blood panel and Amazon Alexa+ support.

The Google Pixel Watch is our favorite smartwatch for anyone with an Android phone, and the new Pixel Watch 4 has some notable upgrades compared to the previous version. It’s got a brighter screen (3,000 nits, as bright as an Apple Watch Ultra 3), better battery life (up to 40 hours in the larger version) and faster charging. It also now has satellite SOS communication — you can contact emergency services when you’re off-the-grid by connecting to a satellite for messaging. “The list of improvements goes on (better automatic workout tracking, on-device Gemini, etc.), but I think it’s safe to say the Google Pixel Watch 4 is still the Android smartwatch to get,” says Rabinowitz.

Ring, the smart home security brand owned by Amazon, is launching multiple new and updated products this month. The most notable are the “Pro” cameras that are capable of 4K resolution video and 10 times digital zoom, which should make it easier to identify people, objects, pets and more at a distance.

Other notable tech launches:

• Beauty and wellness launches

Rhode just added hydrogel eye patches to its skin care lineup. They target dark circles near the inner corners of your eyes and fine lines around the outer corners using ingredients like caffeine, peptides, sodium PCA and glycerin, which depuff, brighten, moisturize and tighten skin, according to the brand. They also have an inherently cool feel, so you don’t have to refrigerate them beforehand. Rhode recommends wearing the under-eye masks two to three times per week for 10 to 15 minutes at a time.

La Mer’s The Lip Treatment is equal parts skin care and color. It hydrates and plumpens using emollients like plant-based oils and butters, as well as supports the skin’s natural collagen to define the overall look of lips, according to the brand. It leaves behind a shiny look and a soft, smooth feel. It’s available in a sheer bare shade, as well as three buildable colors: rose (pink), honey (peachy beige) and cocoa (neutral brown). You can also use it as a primer under other lipsticks and glosses.

Revlon’s new travel-friendly One-Step Multi-Styler can dry, curl, smooth, shape and volumize hair with its three interchangeable head attachments. You get a volumizer plus a brush that dries hair while adding bounce and volume; a root booster head that makes curls, waves and flips; and a paddle brush head that detangles, smoothes, tames and styles hair. Each attachment has tangle-free bristles, and the multistyler’s ceramic technology and temperature controls protect hair from heat damage, according to the brand.

Other notable beauty and wellness launches:

Travel launches

You can wear Cuyana’s The Dia Bag as an oversized clutch or shoulder bag (it has an included removable shoulder strap), and if you buy the adjustable strap separately, it becomes a crossbody, too. The east-west bag has cinched and magnetic closures, a small interior pocket and a key loop, plus it’s big enough to fit your phone, wallet, sunglasses and a small planner. It’s made from Turkish lambskin leather with jewelry-inspired hardware, and Cuyana sells compatible gold chains separately (a chunkier one and a more delicate looking option) if you want to elevate the bag’s look. The Dia Bag comes in a mini version, too.

Other notable travel launches:

• Fjallraven High Coast Tote
• Fjallraven High Coast Backpack

Home and kitchen launches

The Wonder Oven Pro is a new and improved version of Our Place’s original Wonder Oven. It has a digital control panel, rather than dials, that lets you adjust the appliance’s timer, temperature, oven light and mode (there’s eight modes, including bake, air fry and toast). Its quartz and stainless steel heating elements also cook food faster and more evenly compared to the original model, according to the brand. The Wonder Oven Pro, which has a large 30-liter capacity, comes with a bake pan, air fryer basket, wire rack and crumb tray.

NBC Select reporter Zoe Malin has been using the Wonder Oven Pro for about two weeks. “I loved the original Wonder Oven, but the Wonder Oven Pro is a major upgrade. It heats up and cooks food so much faster than my standard oven — I honestly haven’t turned on my standard oven since I got this,” she says. “I wasn’t able to set an exact time or temperature on the original Wonder Oven due to the dials, which was a major flaw for me. But the Pro’s digital display now makes that possible, and since it’s a bit bigger, I can fit so much food inside. Cooking on two racks is also more efficient in this model — I put fish and veggies on one rack and potatoes on another almost every night for dinner.”

Ruggable’s rugs have always consisted of two pieces: a pad and cover. But the new Ruggable All-in-On combines everything into one piece, eliminating the need for separate layers or assembly. You just take it out of the box and roll it out. The rug is machine-washable and stain-resistant, according to the brand. It has a built-in non-slip backing, too. You can buy Ruggable All-in-One rugs in a variety of colors and styles, and two textures: tufted, which is best for high-traffic spaces, and plush, which is extra soft and has thicker fibers with a cozier look.

Blueair makes some of our favorite air purifiers, and this new model combines its air purification with a sunrise alarm clock. You can customize the air purification, light modes, and alarm from the purifier or through the Blueair app. It also has a USB-C port, so you can plug in your phone or earbuds and charge them from the air purifier. It’s small and light enough to fit on a nightstand or bedside table.

Shark’s latest cordless upright vacuum has the strongest suction yet for an under 7-pound model, according to the brand. A full battery gives you up to 20 minutes of run time, and its charge cycle is about three hours long. The vacuum, which has a 0.74-quart dust cup, is designed with dual-speed brushroll technology — that means it automatically swaps between deeply cleaning carpets and gently cleaning bare floors. Its LED headlights also highlight dirt and dust on your floors so you don’t miss spots, and its anti-clog design ensures consistent airflow and reduced maintenance.

Other notable home and kitchen launches:

Fitness and outdoor launches

The Kettlebell is one of Bala’s newest pieces of strength training equipment, available in 10-, 20- and 30-pound sizes. It has a rigid handle so you can securely grip it (even when you’re sweaty) and a cushioned base that’s gentle on your floors. Bala’s Power Ball is also new. It’s a small, round, handheld weight available in 2- and 3-pound sizes, making it best for yoga, Pilates, aerobics, core training and rehabilitation, according to the brand.

It’s not often a major fitness brand overhauls its entire product lineup, but that’s what Peloton did this month with five new launches. The new fitness machines all have large, built-in swivel touchscreens, so you can rotate them depending on your activity. The plus-series devices have a built-in camera that tracks your movements, reps and weights, and can give you feedback in real time.

All the devices use the new Peloton IQ software, which uses your workout data and history to give personalized recommendations for workouts and fitness plans. You can sync Peloton with your Apple, Garmin or Fitbit accounts.

Other notable fitness and outdoor launches:

• Hyperice Normatec Hip Attachment

Why trust NBC Select?

To round up the best new launches each month, reporters Zoe Malin and Harry Rabinowitz choose products they think NBC Select readers should know about. They include products from brands NBC Select has previously covered, or brands staffers recommend. Malin and Rabinowitz also regularly try new product launches to share their first-hand experiences.

Catch up on NBC Select’s in-depth coverage of tech and tools, wellness and more, and follow us on Facebook, Instagram, Twitter and TikTok to stay up to date.

The use of artificial intelligence in healthcare could create a legally complex blame game when it comes to establishing liability for medical failings, experts have warned.

The development of AI for clinical use has boomed, with researchers creating a host of tools, from algorithms to help interpret scans to systems that can aid with diagnoses. AI is also being developed to help manage hospitals, from optimising bed capacity to tackling supply chains.

But while experts say the technology could bring myriad benefits for healthcare, they say there is also cause for concern, from a lack of testing of the effectiveness of AI tools to questions over who is responsible should a patient have a negative outcome.

Prof Derek Angus, of the University of Pittsburgh, said: “There’s definitely going to be instances where there’s the perception that something went wrong and people will look around to blame someone.”

The Jama summit on Artificial Intelligence, hosted last year by the Journal of the American Medical Association, brought together a panoply of experts including clinicians, technology companies, regulatory bodies, insurers, ethicists, lawyers and economists.

The resulting report, of which Angus is first author, not only looks at the nature of AI tools and the areas of healthcare where they are being used, but also examines the challenges they present, including legal concerns.

Prof Glenn Cohen from Harvard law school, a co-author of the report, said patients could face difficulties showing fault in the use or design of an artificial intelligence product. There could be barriers to gaining information about its inner workings, while it could also be challenging to propose a reasonable alternative design for the product or prove a poor outcome was caused by the AI system.

He said: “The interplay between the parties may also present challenges for bringing a lawsuit – they may point to one another as the party at fault, and they may have existing agreement contractually reallocating liability or have indemnification lawsuits.”

Prof Michelle Mello, another author of the report, from Stanford law school, said courts were well equipped to resolve legal issues. “The problem is that it takes time and will involve inconsistencies in the early days, and this uncertainty elevates costs for everyone in the AI innovation and adoption ecosystem,” she said.

The report also raises concerns about how AI tools are evaluated, noting many are outside the oversight of regulators such as the US Food and Drug Administration (FDA).

Angus said: “For clinicians, effectiveness usually means improved health outcomes, but there’s no guarantee that the regulatory authority will require proof [of that]. Then once it’s out, AI tools can be deployed in so many unpredictable ways in different clinical settings, with different kinds of patients, by users who are of different levels of skills. There is very little guarantee that what seems to be a good idea in the pre-approval package is actually what you get in practice.”

The report outlines that at present there are many barriers to evaluating AI tools including that they often need to be in clinical use to be fully assessed, while current approaches to assessment are expensive and cumbersome.

Angus said it was important that funding was made available for the performance of AI tools in healthcare to be properly assessed, with investment in digital infrastructure a key area. “One of the things that came up during the summit was [that] the tools that are best evaluated have been least adopted. The tools that are most adopted have been least evaluated.”

Greenpeace is threatening to sue King Charles’s property management company, accusing it of exploiting its monopoly ownership of the seabed.

The environmental lobby group alleges the crown estate has driven up costs for wind power developers and boosted its own profits, as well as the royal household’s income, due to the “aggressive” way it auctions seabed rights.

The crown estate, as the legal owner of the seabed around England, Wales and Northern Ireland, is responsible for auctioning offshore wind rights. It has benefited from the huge growth in the industry, commanding hefty option fees from renewable energy developers to secure areas of the seabed to build their windfarms.

It made a £1.1bn profit in its financial year ended in March, double its level just two years ago.

Will McCallum, co-executive director at Greenpeace UK, said the estate should be “managing the seabed in the interest of the nation and the common good, not as an asset to be milked for profit and outrageous bonuses”.

“We should leave no stone unturned in looking for solutions to lower energy bills that are causing misery to millions of households,” he said.

“Given how crucial affordable bills and clean energy are to the government’s agenda, the chancellor should use her powers of direction to ask for an independent review of how these auctions are run. If the problem isn’t fixed before the next round, we may need to let a court decide whether or not what’s happening is lawful.”

Greenpeace argues the crown estate has a legal duty not to exploit its monopoly position as owner of the seabed around England, Wales and Northern Ireland, but that it is now in breach of this.

The lobby group said it was concerned the crown estate was rationing supply of the seabed to protect high prices, and argued this could harm the development of offshore wind power in the UK.

The crown estate has reportedly rejected Greenpeace’s claims, arguing the lobby group has misinterpreted the estate’s legal duties.

About 12% of crown estate profits flow to the monarchy through the sovereign grant to fund its work. This was lowered from 25% in 2023 to offset the rise in profits from offshore wind projects.

The UK’s wind industry is at a critical juncture as the government plans to double onshore wind and quadruple offshore wind power capacity by the end of the decade.

The crown estate, which also includes a portfolio of London properties and rural real estate, is worth £15bn. The property assets in London, which is concentrated around Regent Street and St James’s, are valued at £7.1bn.

A spokesperson for the crown estate said: “Greenpeace has misunderstood the crown estate’s legal duties and leasing processes. Option fees are not fixed by the crown estate. They are set by the developers through open, competitive auctions and reflect market appetite at the time. As our net revenue is returned to the Treasury, option fees help to ensure that taxpayers benefit from the requisite value from the development of our scarce and precious seabed resource.

“The crown estate is accelerating offshore wind in line with government policy to move forward the energy transition at pace and improve energy security.”

A Treasury spokesperson said the crown estate “operates independently and makes its own commercial decisions”, adding that “every penny of profit [that] goes to the Treasury … [helps] pay for vital public services like schools and hospitals”.

Landmark data from the phase 3 SOLO-1 (NCT01844986) and SOLO-2 (NCT01874353) trials collectively established olaparib (Lynparza) as a central component of maintenance therapy for patients with BRCA-mutated ovarian cancer, according to Kevin Elias, MD.^1,2

“Olaparib is still very much one of the treatments of choice for women with somatic or germline [BRCA] mutations who have just finished primary therapy. We have the longest safety and efficacy data for olaparib compared with other PARP inhibitors, and we know that for this subgroup of patients, the benefit is tremendous,” Elias said during an interview with OncLive®. Elias is a gynecologic oncologist and the Lilli and Seth Harris Endowed Chair for Ovarian Cancer Research at the Cleveland Clinic in Ohio.

In the interview, Elias discussed the need for germline and somatic testing at diagnosis, the ongoing investigation of optimal treatment duration, and safety considerations associated with the use of PARP inhibitors.

OncLive: What were the key efficacy findings from the SOLO-1 and SOLO-2 trials?

Elias: The SOLO-1 and SOLO-2 trials were looking at maintenance olaparib therapy. The SOLO studies focused on individuals with germline mutations in the BRCA1 or BRCA2 genes, but in SOLO-1, patients could have somatic mutations in BRCA1 or BRCA2. SOLO-1 was looking at newly diagnosed women who had just finished primary therapy with surgery and a platinum doublet for ovarian cancer and randomized them to either maintenance olaparib therapy, which was [given at a dose of] 300 mg twice daily, or placebo for up to 2 years.

The primary outcome was progression-free survival [PFS], and for women randomized to olaparib, the chances of progression or death were reduced by 70% [compared with placebo]. It was a very positive study.

SOLO-2 was a little bit different [because it looked] at women with recurrent ovarian cancer and only focused on germline mutation carriers. All patients in SOLO-2 had received at least 2 lines of platinum-based chemotherapy and were platinum sensitive in the most recent line. These patients were also randomized to 300 mg of olaparib twice daily or placebo.

Similarly, there was also a strong PFS benefit in that setting, although the magnitude of benefit in the recurrent setting was not quite as great as in the primary setting. In SOLO-2, the median PFS in the olaparib group was 19.1 months vs 5.5 months in the placebo group.

What did the long-term data from SOLO-1 show?

The long-term survival data from SOLO-1 showed that, at 7 years from randomization, the risk of death [was reduced by 45%] for those receiving olaparib vs those in the placebo group. Almost half [45.3%] of patients in the olaparib group were still alive and had not recurred at 7 years, whereas [79.4%] of patients in the placebo group had recurred or died [within that period].

How do these data inform treatment decision-making?

[These data] highlight the importance of understanding underlying germline predisposition in ovarian cancer at initial diagnosis. The earlier we know if someone is a BRCA1 or BRCA2 mutation carrier, either at a germline or somatic level, the sooner we’re able to get them appropriately onto olaparib therapy. We can make a strong recommendation that it alters the treatment trajectory.

What I counsel my patients is that, looking across the studies with olaparib, if they’re a good candidate based on the study criteria, we can cut their risk of relapse or death by more than half by going on [PARP inhibitor] maintenance therapy.

What questions persist regarding olaparib use in ovarian cancer treatment?

We still have questions about olaparib as far as the duration of therapy. In the initial studies, all patients were randomized to 2 years of olaparib therapy. There’s currently a study funded by the NRG that’s randomizing patients to either 2 years or 1 year of maintenance therapy. Two years of therapy was chosen rather empirically, and it could be that patients might benefit from shorter courses, which would be beneficial not only in terms of cost but also [adverse] effects [AEs].

We know these medicines have a risk of myelodysplastic syndrome, and perhaps by exposing patients to shorter durations of therapy, we might reduce one of the most concerning AEs of these drugs.

References

1. DiSilvestro P, Banerjee S, Colombo N, et al. Overall survival with maintenance olaparib at a 7-year follow-up in patients with newly diagnosed advanced ovarian cancer and a BRCA mutation: the SOLO1/GOG 3004 trial. J Clin Oncol. 2023;41(3):609-617. doi:10.1200/JCO.22.01549
2. Poveda A, Floquet A, Ledermann JA, et al. Final overall survival (OS) results from SOLO2/ENGOT-ov21: a phase III trial assessing maintenance olaparib in patients (pts) with platinum-sensitive, relapsed ovarian cancer and a BRCA mutation. J Clin Oncol. 2020;38(suppl 15):6002. doi:10.1200/JCO.2020.38.15_suppl.6002

• The firm order for one Global 8000 aircraft was announced during NBAA-BACE 2025
• Comlux will elevate its ultra-long-range charter capabilities with Bombardier’s flagship aircraft, delivering unmatched performance and refined passenger experience
• Set to enter into service this year, the Global 8000⁽¹⁾is the fastest business jet in the world, offering the longest range in its class and the ability to operate from short runways

Bombardier is proud to announce that Comlux, a leading business aviation company, will take delivery of the industry-defining Global 8000⁽¹⁾ aircraft in 2026. Renowned for its expertise in long-range operations with aircraft such as the Bombardier Global 6000 and Global 6500, Comlux is strategically enhancing its charter offering with Bombardier’s flagship jet. With its industry-leading ultra-long-range capabilities and top speed, the Bombardier Global 8000 aircraft is the ideal complement to Comlux Aviation’s fleet—delivering exceptional performance, comfort, and efficiency for premium global travel.

“The Bombardier Global 8000 aircraft integrates perfectly into our long-range fleet, in between our wide-body fleet and our Global 6500 fleet,” said Comlux Aviation CEO, Andrea Zanetto. He continues: “At Comlux, we offer comfort in ownership and luxury in flight! We have built our reputation on delivering premium global travel solutions and this aircraft allows us to offer ultra-long-range. Comlux continuously elevates its fleet to offer clients an unmatched charter experience across the globe with a diversified fleet. The delivery of the Global 8000 will mark the beginning of an exciting new chapter, as we continue to attract more clients to manage the operation of Global 7500 and Global 8000.”

“The Bombardier Global 8000 jet offers the perfect balance of ultra-long-range performance and refined passenger experience—an ideal fit for Comlux’s discerning clientele,” said Éric Martel, President and CEO, Bombardier. “As our valued business relationship continues to grow, the Global 8000 aircraft will deliver its exceptional performance and signature smooth ride to Comlux’s customers around the world.”

The Global 8000⁽¹⁾, the world’s fastest purpose-built business jet, represents a new era of performance, comfort and innovation. With its unmatched speed and a range of 8,000 nautical miles, the aircraft is designed to meet the needs of the most discerning travelers—delivering seamless connectivity between global cities with exceptional onboard luxury.

Comlux’s upcoming delivery marks a significant milestone in the continued adoption of the Bombardier Global 8000 jet by leading operators worldwide. The aircraft’s advanced technology and refined cabin experience make it a standout choice for those seeking the ultimate in private aviation.

About Bombardier

At Bombardier (BBD-B.TO), we design, build, modify and maintain the world’s best-performing aircraft for the world’s most discerning people and businesses, governments and militaries. That means not simply exceeding standards, but understanding customers well enough to anticipate their unspoken needs.

For them, we are committed to pioneering the future of aviation—innovating to make flying more reliable, efficient and sustainable. And we are passionate about delivering unrivaled craftsmanship and care, giving our customers greater confidence and the elevated experience they deserve and expect. Because people who shape the world will always need the most productive and responsible ways to move through it.

Bombardier customers operate a fleet of more than 5,100 aircraft, supported by a vast network of Bombardier team members worldwide and 10 service facilities across six countries.

 Bombardier’s performance-leading jets are proudly manufactured in aerostructure, assembly and completion facilities in Canada, the United States and Mexico. In 2024, Bombardier was honoured with the prestigious “Red Dot: Best of the Best” award for Brands and Communication Design.     

About Comlux

Comlux Group is one of the leaders in business aviation industry. For over 20 years, the company has been engineering luxury for VIP customers seeking personal and professional management of their private aviation needs, including aircraft sales and acquisitions, aircraft operations and charter management. Headquartered in Switzerland with a global presence around the world, Comlux delivers world-class, Swiss-made business aviation services.

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(Bloomberg) — Wall Street traders lifted stocks as the US and China signaled willingness to keep trade negotiations alive, Middle East tensions cooled while the artificial-intelligence rally powered ahead.

Following its worst rout in six months, the S&P 500 jumped about 1.5% to extend a bull market that’s already added $28 trillion to its value. The benchmark saw its best session since August. A key gauge of chipmakers surged 5%. Broadcom Inc. soared 10% as OpenAI agreed to buy its custom chips and networking equipment in a multiyear agreement.

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With trade jitters easing and investors brushing aside fears of a tech-fueled bubble, the market rebound showed that the buy-the-dip mentality remains firmly in place. That’s just ahead of the unofficial start of the US earnings season, with a barrage of reports from big banks Tuesday.

“Investors remain eager for exposure, and if this recovery holds, it will reinforce the idea that retail investors can’t be easily shaken and another reminder that buying the dip continues to work,” said Mark Hackett at Nationwide.

Risk appetite increased after President Donald Trump’s administration signaled openness to a deal with China to quell fresh trade tensions while China’s Ministry of Commerce urged further negotiations to resolve outstanding issues.

Sentiment was also buoyed as Trump visited the Middle East to celebrate a deal halting the war in Gaza and securing the release of prisoners held by Hamas. Trump said food and aid has begun to flow into Gaza, which has been devastated by the conflict.

Treasury futures edged mildly lower, with the US bond market closed for Columbus Day. The dollar rose 0.2%.

Wall Street’s biggest banks are poised for another strong quarter, buoyed by resilient trading desks and a rebound in deal activity. Bank stocks have surged in recent weeks on optimism that a milder regulatory environment under the Trump administration would jump-start corporate dealmaking and boost advisory revenue.

A record-setting surge in US stocks has traders approaching the start of corporate earnings season with little patience for companies that don’t meet the bar. Investors will also be looking for reassurance on a range of potentially thorny issues, from the durability of AI spending to how elevated tariffs are impacting companies.

“This earnings season is important to gauge the overall health of the bull market. Investors will closely examine technology earnings as AI and data center capex is increasingly being called into question in terms of how this spending may or may not be leading to profits,” said Richard Saperstein at Treasury Partners.

Meantime, equity analyst sentiment toward corporate profits is losing momentum at a time when US stocks are trading near record highs, suggesting the rally could face speed bumps this earnings season.

A Citigroup Inc. index tracking US earnings revisions — the number of analysts upgrading versus downgrading estimates — has turned flat for the first time since August. At the same time, the S&P 500 is trading around 22 times forward earnings, above the average over the past decade of nearly 19 times.

Investors should buy cheap stocks with the highest track record of beating both revenue and earnings expectations ahead of the third-quarter reporting season, according to a team of strategists led by Evercore ISI’s Julian Emanuel.

With the S&P 500 already at high valuation multiples and investors bracing for tariff negotiations between US and China, earnings reactions will likely be varied and violent for stocks, the strategists said.

The rally in US stocks is likely to pause if momentum in corporate profits fades in the third quarter, RBC Capital Markets strategists wrote in a note.

“If the strong sentiment around earnings that was seen in the last reporting season can’t be maintained, we think it will be difficult for the major indices to avoid a period of digestion in very near term,” the team led by Lori Calvasina said.

The bull market in US stocks saw its third anniversary on Sunday, but if history is any guide it needs to broaden out soon to keep running.

Of the 13 prior bull markets since World War II, seven completed a fourth year, with an average total gain of 88%. This one has essentially done that in three years, putting the S&P 500’s trailing price-to-earnings ratio at 25 — the highest ever for a bull market in its third year, said Wall Street veteran and CFRA chief investment strategist Sam Stovall.

Even as Stovall thinks the bull market has a good chance of celebrating its fourth birthday, history says it may be a volatile one, he noted.

“More generally, we think that the bull market will remain intact, so pullbacks should offer an opportunity for investors who are underallocated to equities to consider adding long-term exposure,” said Ulrike Hoffmann-Burchardi at UBS Global Wealth Management.

Bull markets that made it to year four have tended to perform very well during that year, according to Jeff Buchbinder and Adam Turnquist at LPL Financial.

For the seven bull markets since 1950 that lasted at least four years, the S&P 500 has, on average, gained 12.8% during the fourth year, they said. Six of the seven mature bull markets had positive year fours, with stocks falling during the fourth year of the first bull market after World War II that began in June 1949.

While this bull market has enjoyed a strong three years, history suggests it probably has more room to run, the LPL strategists noted.

“First, we need economic growth. Recessions kill bull markets, and thankfully, we don’t see one on the horizon. The Fed is in the middle of a rate-cutting cycle and inflation appears to be under control despite increased tariffs,” they concluded.

Corporate Highlights:

Broadcom Inc. shares jumped after OpenAI agreed to buy the company’s custom chips and networking equipment in a multiyear deal, part of an ambitious plan by the startup to add artificial intelligence infrastructure. As part of the pact, OpenAI will design the hardware and work with Broadcom to develop it, according to a joint statement on Monday. The plan is to add 10 gigawatts’ worth of AI data center capacity, with the companies beginning to deploy racks of servers containing the gear in the second half of 2026. Amazon.com Inc. plans to hire 250,000 workers during its peak season — unchanged from the previous two years — making the online retailer a standout in an otherwise bleak holiday labor market. Apple Inc. is bringing its superthin iPhone Air to China after a pause that allowed local carriers to prepare for the eSIM-only device. Exxon Mobil Corp. Chief Executive Officer Darren Woods renewed criticism of the European Union’s energy policies while praising US President Donald Trump’s approach. JPMorgan Chase & Co. vowed to funnel $1.5 trillion into industries that bolster US economic security and resiliency over the next 10 years — an initiative that will invest billions of dollars in companies and hire bankers and other professionals. Oracle Corp. will get a chance this week to reassure investors that a rally which has added roughly $370 billion to its market value this year is on stable footing. The software maker is hosting a four-day AI World conference starting Monday in Las Vegas, where much of the focus will be on Oracle’s cloud computing business. Beyond Meat Inc. tumbled after the troubled plant-based protein producer said nearly all creditors had accepted a debt swap that will lead to a substantial dilution of shareholders. Keurig Dr Pepper Inc. jumped after the Financial Times reported that Starboard Value had built a stake in the beverage company. Walt Disney Co. will air a six-part docuseries on the behind-the-scenes action of Taylor Swift’s Eras Tour, the highest-grossing concert tour of all time. First Brands Group’s Chief Executive Officer Patrick James has resigned from the company. James will be replaced by Charles Moore as interim CEO, according to a company statement. Jefferies Financial Group Inc. defended its dealings with First Brands Group and said its exposure to the bankrupt auto-parts supplier was small, as the investment bank sought to revive investor confidence after a sharp selloff in its stock. Douglas Lebda, the founder and chief executive officer of LendingTree Inc., died Sunday following an all-terrain vehicle accident. He was 55. Airbus SE is opening additional assembly lines in the US and China for its bestselling A320neo family as the company tries to reach production of 75 jets a month amid a massive backlog. Virgin Atlantic Airways Chief Executive Officer Shai Weiss will step down after a seven-year tenure marked by returning the UK airline to an annual profit. Brookfield will acquire the remaining parts of distressed-debt specialist Oaktree Capital Management it doesn’t already own, adding further heft to its credit business that’s emerged as a key driver of growth in recent years. Tata Capital Ltd. advanced in its Mumbai trading debut after the shadow lender wrapped up its 155-billion-rupee ($1.7 billion) initial public offering, India’s biggest this year. What Bloomberg Strategists say…

“In the absence of official data, what banks can say about credit card losses, loan losses, credit quality and the pulse of the consumer will go a long way toward filling the data void.”

– Edward Harrison, Macro Strategist, Markets Live. For the full analysis, click here.

Some of the main moves in markets:

Stocks

The S&P 500 rose 1.4% as of 2:58 p.m. New York time The Nasdaq 100 rose 2% The Dow Jones Industrial Average rose 1.1% The MSCI World Index rose 1% Bloomberg Magnificent 7 Total Return Index rose 2.2% Philadelphia Stock Exchange Semiconductor Index rose 4.7% The Russell 2000 Index rose 2.6% Broadcom rose 9.5% Currencies

The Bloomberg Dollar Spot Index rose 0.2% The euro fell 0.4% to $1.1568 The British pound fell 0.2% to $1.3333 The Japanese yen fell 0.7% to 152.31 per dollar Cryptocurrencies

Bitcoin rose 0.2% to $115,203.04 Ether rose 2.2% to $4,231.59 Bonds

Germany’s 10-year yield was little changed at 2.64% Britain’s 10-year yield declined two basis points to 4.66% Commodities

West Texas Intermediate crude rose 1% to $59.47 a barrel Spot gold rose 2.1% to $4,101.02 an ounce ©2025 Bloomberg L.P.

PARIS LA DÉFENSE, France, Oct. 13, 2025 /PRNewswire/ — Nexans announces that its Board of Directors has resolved to appoint Julien Hueber as the new Chief Executive Officer and to part ways with Christopher Guérin. These decisions will take effect immediately; Christopher will be available to Julien until October 31^st, 2025.

The Board of Directors wishes to create a new momentum to further optimize performance while executing the roadmap which was presented during the last Capital Market Day. The Appointments & Corporate Governance Committee has conducted a comprehensive process to propose a successor for the role of Chief Executive Officer, in line with its established succession plan approach and with the support of a leading executive search firm.

Julien Hueber, Executive Managing Director of Power Grid & Connect Europe, oversees a €2.6 billion business spanning 23 manufacturing plants. A member of Nexans’ Executive Committee since 2018, he joined the company in 2002. Julien brings extensive expertise in supply chain and procurement, as well as deep regional knowledge of Asia-Pacific, particularly China and South Korea, where he spent several years leading operations. He later headed Nexans’ global “Industrial Cables – Industry Solutions & Projects” business.

Jean Mouton, Chairman of the Board of Directors, stated: “Over the past 23 years, Julien has demonstrated exceptional leadership and a profound understanding of Nexans’ business, operating model, and culture. He combines a strategic vision for future technologies with a strong record of operational excellence, as evidenced by the remarkable acceleration of the PWR Grid & Connect Europe segment under his leadership. I have complete confidence in his ability to lead Nexans in this new phase of focused acceleration, in line with the goals announced during the last Capital Markets Day.”

The Board concluded that Julien Hueber’s extensive experience, proven leadership, and deep understanding of Nexans made him the ideal choice to lead the Company. His strong track record in shaping vision, defining strategy, and driving successful execution further reinforced this decision. The Board of Directors unanimously and enthusiastically endorsed his appointment.

The Board would like to express its deep gratitude to Christopher Guérin for his exceptional contribution to Nexans during his seven years as Chief Executive Officer. Beyond the strong financial results, Christopher has profoundly transformed Nexans into a focused leader in sustainable electrification, giving meaning and direction to its mission. He has brought innovation, responsibility, and simplicity to the heart of the company, while restoring confidence across teams worldwide. His leadership and passion have left a lasting mark on the Group and its people.

Jean Mouton, Chairman of the Board of Directors, said: “I would like to warmly thank Christopher for his remarkable commitment and his essential contribution to the transformation of Nexans. He has restored a sentiment of pride to be part of the Nexans family. We wish him every success in his future endeavours.”

About Nexans

Nexans is the global pure player in sustainable electrification, building the essential systems that power the world’s transition to a connected, resilient, and low-carbon future. From offshore and onshore renewable energies to smart cities and homes, Nexans designs and delivers advanced cable solutions, accessories and services that electrify progress safely, efficiently, and sustainably.

With over 140 years of history, through three core businesses: PWR Transmission, PWR Grid, and PWR Connect, Nexans blends deep industry expertise with cutting-edge innovation to accelerate the energy transition and better meet its customers’ needs. Its unique E3 model, focused on Environment, Economy and Engagement, drives every action, aligning performance with purpose.

Nexans operates in 41 countries with 28,500 people and generated €7.1 billion in standard sales in 2024. As recognized climate action leader, Nexans is committed to Net-Zero emissions by 2050 aligned with the Science Based Targets initiative (SBTi) and expanding energy access through the Foundation Nexans.

Nexans is listed on Euronext Paris, Compartment A.
www.nexans.com | #ElectrifyTheFuture

SOURCE Nexans