Category: 3. Business

• In a recent announcement, EROAD downgraded its fiscal 2026 revenue guidance, reported up to NZ$150 million in North American asset impairments, and outlined a renewed focus on Australia and New Zealand alongside scaled-back North American activities.

• This shift comes as challenges in North America, including a key customer loss and slower enterprise sales, prompt the company to reallocate resources toward emerging opportunities in its core markets.

• With the company’s refocus on electronic road user charging in Australia and New Zealand, we’ll examine how this shapes EROAD’s investment narrative.

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To be comfortable holding EROAD shares right now, you’d need conviction in its ability to execute a fresh regional pivot following major shortfalls in North America. The company’s reset, moving growth focus and resources to Australia and New Zealand’s road user charging opportunities, marks a fundamental shift in its investment story. While previous catalysts centered on U.S. expansion and telematics innovation, the market’s sharp reaction to asset impairments and guidance cuts suggests near-term growth drivers will depend on how quickly EROAD can win or retain clients and secure contracts linked to new charging regimes in its home markets. The immediate risk is execution: reestablishing momentum in Australia and New Zealand is not guaranteed, and the heavy NZ$150 million impairment underscores uncertainty over any future North American contributions. The recent share price drop signals these risks are now firmly front and center for investors. On the flip side, the road to recovery in core markets comes with its own hurdles investors need to keep front of mind.

Despite retreating, EROAD’s shares might still be trading 43% above their fair value. Discover the potential downside here.

Seven members of the Simply Wall St Community estimate EROAD’s fair value anywhere from NZ$1.20 to NZ$4.96 per share. This wide range reflects big differences in expectations around EROAD’s growth rebound in Australia and New Zealand after its US setback. Comparing such varied outlooks with the company’s new strategic focus, it pays to see how your own view lines up.

Explore 7 other fair value estimates on EROAD – why the stock might be worth over 2x more than the current price!

Disagree with this assessment? Create your own narrative in under 3 minutes – extraordinary investment returns rarely come from following the herd.

• A great starting point for your EROAD research is our analysis highlighting 3 key rewards and 1 important warning sign that could impact your investment decision.

• Our free EROAD research report provides a comprehensive fundamental analysis summarized in a single visual – the Snowflake – making it easy to evaluate EROAD’s overall financial health at a glance.

These stocks are moving-our analysis flagged them today. Act fast before the price catches up:

This article by Simply Wall St is general in nature. We provide commentary based on historical data and analyst forecasts only using an unbiased methodology and our articles are not intended to be financial advice. It does not constitute a recommendation to buy or sell any stock, and does not take account of your objectives, or your financial situation. We aim to bring you long-term focused analysis driven by fundamental data. Note that our analysis may not factor in the latest price-sensitive company announcements or qualitative material. Simply Wall St has no position in any stocks mentioned.

Companies discussed in this article include ERD.nzse.

Have feedback on this article? Concerned about the content? Get in touch with us directly. Alternatively, email editorial-team@simplywallst.com

The combination of pembrolizumab (Keytruda) and lenvatinib (Lenvima) elicited promising progression-free survival (PFS) outcomes in patients with uveal melanoma who were both HLA-A*02:01–negative and –positive with a manageable safety profile, according to findings from the phase 2 PLUME trial (NCT05282901) presented at the 2025 ESMO Congress.¹

The study met its primary end point in both patient cohorts, with an observed PFS rate of 31.8% at 27 weeks (95% CI, 13.9%-54.9%) in patients who were HLA-A*02:01–negative and naïve for treatment with tebentafusp (Kimtrak). In patients who were HLA-A*02:01–positive and were pretreated with tebentafusp, the PFS rate at 27 weeks was 60.7% (95% CI, 40.6%-78.5%).

“It was observed in phase 3 studies of tebentafusp² that treatments administered after tebentafusp might display improved activity compared [with] historical data,” said Manuel Rodrigues, MD, medical oncologist at Institut Curie and presenter of the PLUME data.¹

The combination of lenvatinib and pembrolizumab “showed encouraging activity, especially in patients previously treated with tebentafusp, suggesting potential synergy between these treatments,” Rodrigues added.

Regarding safety, the overall profile was consistent with prior trials involving pembrolizumab and lenvatinib. There were no treatment-related deaths. With lenvatinib, 76% of patients held the dose, 26% had dose reductions, and 4% discontinued. With pembrolizumab, 22% of patients held the dose and 4% discontinued.

The most common any-grade treatment-related adverse events were fatigue (81.8% in the tebentafusp-naive cohort vs 69% in the pretreated cohort), hypertension (77.3% vs 69%), diarrhea (45.5% vs 65.5%), hypothyroidism (45.5% vs 65.5%), arthralgia (40.9% vs 58.6%), cytolytic hepatitis (40.9% vs 58.6%), mucositis (45.5% vs 41.4%), dysphonia (31.8% vs 44.8%), and abdominal pain (27.3% vs 44.8%).

While the findings were promising, Rodrigues urged caution when interpreting the results, due to the small sample size and single-arm design. Rodrigues noted that biomarker analyses and real-world comparisons were ongoing to further refine patient selection.

What Was the Design of the PLUME Study?

PLUME was an academic, monocentric, single-arm phase 2 trial conducted at the Institut Curie in Paris, France.A total of 51 patients who were naïve to immune checkpoint inhibitors were enrolled and split into 2 cohorts by HLA-A*02:01–negative (n = 22) and –positive/pretreated with tebentafusp (n = 29).

Treatment consisted of pembrolizumab 200 mg intravenously every 3 weeks for a maximum of 35 cycles and lenvatinib 20 mg orally daily until progression. Chest, abdomen, and pelvic CT scans and liver MRIs were mandatory every 9 weeks. The primary end point was 27-week PFS (after 9 cycles).

What Was the Rationale for the PLUME Study?

As Rodrigues explained in his presentation, uveal melanoma has a unique biology to melanoma of the skin, with one-third of patients developing metastases and over 90% of those patients developing liver metastases. The current median overall survival (OS)is about 20 months.

Tebentafusp, a bispecific TCR–anti-CD3 fusion protein targeting gp100, was the first therapy to improve OS in patients with metastatic uveal melanoma; however, the benefit is limited to patients who are HLA-A*02:01–positive, which is about 45% of patients. Further, checkpoint inhibitors like pembrolizumab have shown limited efficacy due to low mutational burden and an immunosuppressive microenvironment.

The rationale of adding lenvatinib lies in its VEGFR/FGRF blockade that can normalize vasculature, reduce tumor-associated macrophages, and enhance T-cell infiltration. The combination of lenvatinib and pembrolizumab has shown promise in endometrial and renal cancers, where the combination has outperformed monotherapy.

DISCLOSURES: Rodrigues declared personal financial interests with Immunocore, GSK, AstraZeneca, and Abbvie; institutional financial interests with Johnson & Johnson, Merck, and Daiichi-Sankyo; and nonfinancial interests with Merck, which provided product samples for the PLUME trial.

REFERENCES:

1. Rodrigues M. PLUME: A single-arm phase II trial of pembrolizumab plus lenvatinib in metastatic uveal melanoma (mUM). Presented at: 2025 ESMO Congress; October 17–20, 2025; Berlin, German. Abstract LBA58.

2. Nathan P, Hassel JC, Rutkowski P, et al. Overall Survival Benefit with Tebentafusp in Metastatic Uveal Melanoma. N Engl J Med. 2021 Sep 23;385(13):1196-1206. doi: 10.1056/NEJMoa2103485.

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Celestica (TSX:CLS) shares have moved recently, catching the attention of investors interested in tech services and manufacturing. The company’s strong performance this year prompts a closer look at what is driving returns.

See our latest analysis for Celestica.

Celestica’s impressive surge has fueled fresh optimism among tech investors. While the 1-year share price return stands at a remarkable 189.8%, the 1-year total shareholder return is even higher at 387.5%. Momentum is clearly building, thanks to robust growth and an improving outlook.

If you’re looking to uncover more opportunities in the technology and AI space, the Simply Wall St Tech & AI Growth screener is an excellent next step: See the full list for free.

With shares posting such rapid gains, the key question is whether Celestica remains undervalued today or if the market has already priced in all of its future growth. This leaves investors pondering if there is still a buying opportunity.

Celestica’s widely followed narrative suggests a fair value that sits just above the last close price, hinting the stock may still hold some upside even after rapid gains. With the company’s outlook now shaped by bullish projections and improved profitability, attention is turning to major catalysts that could drive further revaluation.

Accelerated demand for advanced networking and AI infrastructure by hyperscaler customers is driving rapid growth in Celestica’s CCS segment, with multiple new 800G and upcoming 1.6T program ramps. This is supporting robust revenue expansion and greater operating leverage over the next 12 to 24 months.

Read the complete narrative.

Want to know which financial levers are fueling this premium? The key story centers on aggressive profit projections and a rare profit multiple normally reserved for industry leaders. Are these bold future assumptions enough to support such an optimistic valuation? Uncover the figures and see what drives this surprising fair value call.

Result: Fair Value of $402.69 (UNDERVALUED)

Have a read of the narrative in full and understand what’s behind the forecasts.

However, market concentration among top customers and heavy reliance on sustained AI investment could quickly challenge Celestica’s bullish growth assumptions.

Find out about the key risks to this Celestica narrative.

While the fair value estimate hints at Celestica being undervalued, comparing its price-to-earnings ratio presents a different perspective. The company is trading at 59.3x earnings, almost double the industry average of 30.7x and well above the fair ratio of 53.3x. When a stock trades significantly above its peers and what is considered fair, there is a real risk the price could revert or stall if growth expectations slip. Is this future premium fully justified?

See what the numbers say about this price — find out in our valuation breakdown.

If you think there’s another angle to the Celestica story or want to dig into the details yourself, you can shape your own view in just a few minutes by using the following resource: Do it your way

A good starting point is our analysis highlighting 2 key rewards investors are optimistic about regarding Celestica.

Smart investors never settle for just one opportunity. Make the most of your next move and uncover high-potential stocks using these powerful tools today.

This article by Simply Wall St is general in nature. We provide commentary based on historical data and analyst forecasts only using an unbiased methodology and our articles are not intended to be financial advice. It does not constitute a recommendation to buy or sell any stock, and does not take account of your objectives, or your financial situation. We aim to bring you long-term focused analysis driven by fundamental data. Note that our analysis may not factor in the latest price-sensitive company announcements or qualitative material. Simply Wall St has no position in any stocks mentioned.

Companies discussed in this article include CLS.TO.

Have feedback on this article? Concerned about the content? Get in touch with us directly. Alternatively, email editorial-team@simplywallst.com

Open Text (NasdaqGS:OTEX) stock has caught some attention in recent weeks, thanks in part to a steady uptick of 6% over the past month. Investors seem interested in the company’s consistent revenue and growing net income.

See our latest analysis for Open Text.

Momentum is clearly building for Open Text, with the stock posting a 6.35% share price return over the past month and an impressive 37.14% gain in the last 90 days. When you step back, the one-year total shareholder return of 18.94% and a standout 53.44% total return over three years show that investors who have stuck with the company have seen strong long-term rewards.

If steady progress like this has you scanning the horizon, now is the perfect moment to broaden your search and discover fast growing stocks with high insider ownership

The question now is whether Open Text’s recent run suggests there is more value left on the table, or if markets have already priced in the company’s future growth potential. Is there a new buying opportunity emerging?

With the recent close at $39.03 and a consensus fair value of $37.66, the most widely tracked narrative suggests Open Text’s market price now closely matches analysts’ calculated fundamentals. This balance indicates the market may have already caught up to the company’s projected growth story.

“Expanded integration of AI and automation capabilities (e.g., Titanium X and MyAviator platforms) directly into OpenText’s cloud suite is leading to higher per-customer spend and driving pipeline conversion rates. These developments are expected to fuel both top-line revenue acceleration and incremental margin improvement.”

Read the complete narrative.

Craving the full blueprint behind this pricing? Behind the scenes, ambitious growth targets, aggressive AI and cloud overhaul, and bold margin forecasts set the tone. Want to know which key financial levers support this price and where the tensions truly lie? Dive in to see the numbers driving the narrative’s fair value verdict.

Result: Fair Value of $37.66 (ABOUT RIGHT)

Have a read of the narrative in full and understand what’s behind the forecasts.

However, execution risks from leadership transitions and challenges in revitalizing slower-growth business areas could temper Open Text’s momentum if these issues are not carefully managed.

Find out about the key risks to this Open Text narrative.

While multiples suggest Open Text is fairly valued, our SWS DCF model paints a different picture. According to this approach, the stock trades at a hefty 41% discount to its estimated fair value, which is an intriguing disconnect that could signal a hidden opportunity. Could the market be missing something?

Look into how the SWS DCF model arrives at its fair value.

If you have a different perspective, or want to dive deeper into the data and craft your own story, it only takes a few minutes to build your own view. Do it your way.

A great starting point for your Open Text research is our analysis highlighting 4 key rewards and 2 important warning signs that could impact your investment decision.

Give yourself the edge by tapping into new markets and trends. Don’t let tomorrow’s big winners pass you by when smarter opportunities are within reach.

This article by Simply Wall St is general in nature. We provide commentary based on historical data and analyst forecasts only using an unbiased methodology and our articles are not intended to be financial advice. It does not constitute a recommendation to buy or sell any stock, and does not take account of your objectives, or your financial situation. We aim to bring you long-term focused analysis driven by fundamental data. Note that our analysis may not factor in the latest price-sensitive company announcements or qualitative material. Simply Wall St has no position in any stocks mentioned.

Companies discussed in this article include OTEX.

Have feedback on this article? Concerned about the content? Get in touch with us directly. Alternatively, email editorial-team@simplywallst.com

Open Text (NasdaqGS:OTEX) stock has caught some attention in recent weeks, thanks in part to a steady uptick of 6% over the past month. Investors seem interested in the company’s consistent revenue and growing net income.

See our latest analysis for Open Text.

Momentum is clearly building for Open Text, with the stock posting a 6.35% share price return over the past month and an impressive 37.14% gain in the last 90 days. When you step back, the one-year total shareholder return of 18.94% and a standout 53.44% total return over three years show that investors who have stuck with the company have seen strong long-term rewards.

If steady progress like this has you scanning the horizon, now is the perfect moment to broaden your search and discover fast growing stocks with high insider ownership

The question now is whether Open Text’s recent run suggests there is more value left on the table, or if markets have already priced in the company’s future growth potential. Is there a new buying opportunity emerging?

With the recent close at $39.03 and a consensus fair value of $37.66, the most widely tracked narrative suggests Open Text’s market price now closely matches analysts’ calculated fundamentals. This balance indicates the market may have already caught up to the company’s projected growth story.

“Expanded integration of AI and automation capabilities (e.g., Titanium X and MyAviator platforms) directly into OpenText’s cloud suite is leading to higher per-customer spend and driving pipeline conversion rates. These developments are expected to fuel both top-line revenue acceleration and incremental margin improvement.”

Read the complete narrative.

Craving the full blueprint behind this pricing? Behind the scenes, ambitious growth targets, aggressive AI and cloud overhaul, and bold margin forecasts set the tone. Want to know which key financial levers support this price and where the tensions truly lie? Dive in to see the numbers driving the narrative’s fair value verdict.

Result: Fair Value of $37.66 (ABOUT RIGHT)

Have a read of the narrative in full and understand what’s behind the forecasts.

However, execution risks from leadership transitions and challenges in revitalizing slower-growth business areas could temper Open Text’s momentum if these issues are not carefully managed.

Find out about the key risks to this Open Text narrative.

While multiples suggest Open Text is fairly valued, our SWS DCF model paints a different picture. According to this approach, the stock trades at a hefty 41% discount to its estimated fair value, which is an intriguing disconnect that could signal a hidden opportunity. Could the market be missing something?

Look into how the SWS DCF model arrives at its fair value.

If you have a different perspective, or want to dive deeper into the data and craft your own story, it only takes a few minutes to build your own view. Do it your way.

A great starting point for your Open Text research is our analysis highlighting 4 key rewards and 2 important warning signs that could impact your investment decision.

Give yourself the edge by tapping into new markets and trends. Don’t let tomorrow’s big winners pass you by when smarter opportunities are within reach.

This article by Simply Wall St is general in nature. We provide commentary based on historical data and analyst forecasts only using an unbiased methodology and our articles are not intended to be financial advice. It does not constitute a recommendation to buy or sell any stock, and does not take account of your objectives, or your financial situation. We aim to bring you long-term focused analysis driven by fundamental data. Note that our analysis may not factor in the latest price-sensitive company announcements or qualitative material. Simply Wall St has no position in any stocks mentioned.

Companies discussed in this article include OTEX.

Have feedback on this article? Concerned about the content? Get in touch with us directly. Alternatively, email editorial-team@simplywallst.com

A multicenter Phase II clinical trial led by researchers at The University of Texas MD Anderson Cancer Center demonstrated significant tumor shrinkage and disease control in patients with advanced pheochromocytoma and paraganglioma (PPGL), two rare and potentially life-threatening neuroendocrine tumors.

The results of this study, led by Camilo Jimenez, M.D., professor of Endocrine Neoplasia and Hormonal Disorders, were published today in the New England Journal of Medicine and presented concurrently at the 2025 European Society for Medical Oncology (ESMO) Congress (Abstract 1705O).

What was the primary finding of the trial?

The trial demonstrated that the HIF-2α inhibitor belzutifan showed meaningful antitumor activity with a 26% objective response rate, a significant achievement particularly for rare and difficult-to-treat cancers. These effects lasted an average of more than 20 months, indicating a sustained clinical benefit for those who responded to treatment.

It’s notable that nearly one-third of patients (32%) who were taking blood pressure medication were able to reduce their dosage by half for at least six months. This is an important finding, as PPGL tumors often produce excess hormones that raise blood pressure. These results suggest that belzutifan may have also helped manage symptoms related to hormone-secreting tumors.

The primary significance of this study is demonstrating that HIF-2α inhibition with belzutifan can achieve meaningful clinical benefit in patients with advanced, progressive PPGL. In a population with no remaining standard-of-care options, we observed durable disease control and a manageable safety profile, supporting the rationale for HIF-2α as a therapeutic target in this rare tumor type.”

Camilo Jimenez, M.D., Professor of Endocrine Neoplasia and Hormonal Disorders

Why is the LITESPARK-015 trial important?

Pheochromocytoma and paraganglioma (PPGL) are difficult-to-treat cancers that affect roughly 2,000 people annually in the U.S. One of the main drivers of tumor growth in PPGL is the HIF-2α protein. In healthy cells this protein adjusts to changes in oxygen levels, but genetic mutations or changes in cell metabolism can cause HIF-2α to become abnormally active, triggering signals that help the tumor grow and spread.

HIF-2α inhibitors, such as belzutifan, have been successful in shrinking tumors and slowing disease progression in other cancers driven by HIF-2α overactivity, such as kidney cancer and von Hippel-Lindau (VHL) disease. Building on this knowledge, researchers evaluated the effectiveness of these inhibitors in patients with advanced PPGL.

On the LITESPARK-015 Phase II trial, 72 patients with locally advanced, metastatic, unresectable PPGL who had exhausted all other standard-of-care treatment, were treated with belzutifan.

Is belzutifan approved to treat PPGL?

In May 2025, the Food and Drug Administration (FDA) approved belzutifan for the treatment of adult and pediatric patients ages 12 years and older with advanced, unresectable, or metastatic PPGL who do not require immediate surgery. Belzutifan is the first oral and only approved therapy for this disease, making it a new standard of care for this patient population. 

“The approval of belzutifan offers new hope. As an oral treatment, it has been shown to shrink tumors, reduce symptoms, and improve quality of life with low toxicity. It represents a meaningful step forward in care for people living with these rare cancers,” Jimenez said.

Timeline

2025 – FDA approves belzutifan for treatment of adult and pediatric patients 12 years and older with PPGL

2023 – FDA approves belzutifan for advanced renal cell carcinoma (RCC) after treatment with a PD‑1/PD‑L1 inhibitor and a VEGF tyrosine kinase inhibitor (VEGF‑TKI)

2021 – FDA approves belzutifan for adults with von Hippel‑Lindau (VHL) disease who require treatment for associated tumors (RCC, central nervous system hemangioblastomas, or pancreatic neuroendocrine tumors), when surgery is not immediately necessary

In a landmark moment at the ESMO Congress 2025, pivotal studies have unveiled compelling evidence that a new class of anti-cancer agents-antibody-drug conjugates (ADCs)-can dramatically improve outcomes for patients with early-stage HER2-positive breast cancer. 

The results from the phase III DESTINY-Breast05 and DESTINY-Breast11 trials, presented in a Presidential Symposium, mark a paradigm shift in breast cancer treatment, positioning ADCs not only as powerful therapeutic agents when the disease has already progressed but also as potential new standards of care in patients with early disease.  

There is a particular need for therapies to ensure patients with HER2-positive early breast cancer achieve pathological complete response following neoadjuvant therapies-i.e., delivered before surgery-, and a high unmet need to treat residual disease in those who do not, to prevent the development of metastasis.”

Dr. Evandro de Azambuja from the Jules Bordet Institute, Brussels, Belgium

Currently, trastuzumab emtansine (T-DM1) is the only ADC approved for patients with HER2-positive early breast cancer who show residual invasive disease after neoadjuvant therapy and are at a high risk of recurrence. In the DESTINY-Breast05, Trastuzumab deruxtecan (T-DXd), a new-generation ADC delivering a topoisomerase I inhibitor, showed to improve invasive disease-free survival and disease-free survival by 53% compared with T-DM1 (for both: hazard ratio [HR] 0.47; 95% confidence interval [CI] 0.34–0.66; p<0.0001). Also, T-DXd confirmed its high brain activity, demonstrating a clinically meaningful improvement in brain metastasis-free interval over T-DM1 (HR 0.64; 95% CI 0.35–1.17). 

“The generally manageable safety profile and the superior efficacy data suggest that T-DXd should replace T-DM1 as the new standard of care for patients with HER2-positive, residual invasive breast cancer after neoadjuvant therapy,” notes de Azambuja. 

The use of T-DXd also showed impressive findings earlier in the treatment pathway- before surgery- as reported in the DESTINY-Breast11 trial where 927 untreated patients with high-risk HER2-positive early breast cancer received either the ADC followed by standard HER2-targeted therapy (THP) or the conventional anthracycline-based regimen (ddAC-THP). The cycles of T-DXd, sequenced with THP, led to a significant increase in the rate of pathological complete response at surgery (67.3% versus 56.3%; p=0.003). “The T-DXd regimen has also the added advantage of an improved safety profile compared with the anthracycline-containing regimen,” comments de Azambuja noting the relevant reduction in cardiac toxicities which was observed with the ADC compared with the conventional treatment. 

“In conjunction, these two studies establish T-DXd as a critical treatment option for early-stage HER2-positive breast cancer, ultimately providing a new tool for treatment tailoring for what was once considered the most aggressive subtype of breast cancer, and which today represents the one with the highest chance of cure,” highlights Dr Paolo Tarantino from the Dana-Farber Cancer Institute and Harvard Medical School, Boston, MA, USA. 

After having reshaped the treatment of multiple types of metastatic cancers over the last few years, novel ADCs such as T-DXd are now “raising the bar” in the curative setting due to innovations in their design and mechanism of action. However, their use presents new challenges that need to be addressed. “For instance, 

toxicity profiles must be carefully defined and substantial effort to prevent permanent or fatal toxicities is required. Dosing, duration and sequencing of ADCs must also be optimised to achieve maximal efficacy with the least side-effects, and equally critical is the identification of predictive biomarkers that may allow better tailoring of ADC therapy and minimise overtreatment,” clarifies Tarantino. 

The presentation of the DESTINY-Breast05 and DESTINY-Breast11 trials results at the ESMO Congress 2025 cements the event’s role as a catalyst for global oncology progress. With ADCs now demonstrating superiority in both pre- and post-surgical settings, the oncology community stands at the threshold of a new chapter-one defined by smarter targeting, earlier intervention and deeper biological understanding. 

“Besides the immediate practical impact, in fact, data presented today are expected to have a broader impact on the future of ADC research, marking the formal entrance of the new generation of drugs in the curative arena. This is a therapeutic strategy with tremendous potential, which we are only just starting to unleash, promising to reduce rates of recurrence and improve survival across multiple cancers in the years to come,” concludes Tarantino.

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