Category: 3. Business

This November has already provided many exciting developments across the multidisciplinary oncology world. Within the first half of the month alone, the FDA has been busy issuing new approvals and regulatory nods across different breast cancer, leukemia, and gynecologic malignancy populations. Additionally, presentations from the recent 2025 Society for Immunotherapy of Cancer Annual Meeting showcased novel treatment modalities that may show utility across various treatment settings.

CancerNetwork^® reported on these latest potential shakeups across oncology. Here are the top 5 takeaways of the week that may influence the future of the field.

#1: FDA Approves Pertuzumab Biosimilar in Breast Cancer Indications

The FDA approved an interchangeable biosimilar formulation of pertuzumab (Perjeta) known as pertuzumab-dpzb (Poherdy), a HER2-neu receptor agonist, in different breast cancer populations.¹

Based on various comparisons of parameters related to safety and efficacy, pharmacokinetic data, clinical immunogenicity findings, and supportive clinical data, the agency determined that the biosimilar exhibited sufficient similarity to the reference product. The biosimilar is indicated for use in combination with agents like trastuzumab (Herceptin) across different treatment settings, including adults with HER2-positive metastatic breast cancer who have not received prior anti-HER2 treatment or chemotherapy for metastatic disease.

#2: FDA Approves Ziftomenib in R/R NPM1-Mutated Acute Myeloid Leukemia

Another key regulatory decision was the FDA’s approval of ziftomenib (Komzifti) for patients with relapsed/refractory acute myeloid leukemia (AML) harboring NPM1 mutations, based on data from the phase 1b/2 KOMET-001/KO-MEN-001 trial (NCT04067336).²

Topline results from the study showed that 21.4% (95% CI, 14.2%-30.2%) of evaluable patients achieved a complete response (CR) or CR with partial hematologic recovery. Additionally, in 66 patients with red blood cell and/or platelet transfusion dependence at baseline, transfusion independence at any 56-day post-baseline period occurred in 14 (21.2%).

#3: Mecbotamab Vedotin Shows Positive OS Results in Soft Tissue Sarcoma

Data presented at SITC 2025 showed that treatment with mecbotamab vedotin (Mec-V) elicited an overall survival (OS) benefit for those with treatment-refractory leiomyosarcoma, liposarcoma, or undifferentiated pleomorphic sarcoma in a phase 2 trial (NCT03425279).³

Across the overall population, the median OS was 18.4 months (95% CI, 7.2-not evaluable [NE]) with Mec-V alone and 22.9 months (95% CI, 14.2-NE) with Mec-V plus nivolumab (Opdivo). Across different subgroups, the median OS was 19.0 months (95% CI, 7.9-29.9) for patients with leiomyosarcoma, 21.7 months (95% CI, 3.7-NE) for those with liposarcoma, and 21.5 months (95% CI, 5.0-NE) for those with undifferentiated pleomorphic sarcoma.

#4: Novel T-Cell Therapies Yield Decade-Long Remission in Epithelial Cancer

In other presentations shared at SITC 2025, investigational cellular therapies demonstrated various benefits across different epithelial cancer populations.

Findings from one single-center phase 2 trial (NCT05686226) showed that T cell receptor (TCR)–T-cell therapy could produce responses in a small cohort of patients with metastatic HPV-associated cancers.⁴ Moreover, another presentation on a different phase 2 trial (NCT01585428) highlighted 2 patients with metastatic cervical cancer who remained in CR for at least 10 years following a single infusion of tumor-infiltrating lymphocyte therapy.⁵

#5: FDA Approves Diagnostic Tool for Pembrolizumab Combo in Endometrial Cancer

In another notable decision from the FDA, the agency approved the Promega OncoMate^® MSI Dx Analysis System as a companion diagnostic for identifying patients with microsatellite-stable endometrial carcinoma who may benefit from treatment with pembrolizumab (Keytruda) in combination with lenvatinib (Lenvima).⁶

Previously, the agency approved pembrolizumab/lenvatinib for this endometrial carcinoma population in July 2021.⁷ This decision was based on findings from the phase 3 KEYNOTE-775 study (NCT03517449).

References

1. FDA approves new interchangeable biosimilar to Perjeta. News release. FDA. November 13, 2025. Accessed November 14, 2025. https://tinyurl.com/2vzwt6ej
2. FDA approves ziftomenib for relapsed or refractory acute myeloid leukemia with a NPM1 mutation. News release. FDA. November 13, 2025. Accessed November 14, 2025. https://tinyurl.com/2mcsxzuv
3. Druta M, Pollack SM, Conley AP, et al. Median OS of 21.5 months among 44 patients with treatment-refractory leiomyosarcoma, liposarcoma, and undifferentiated pleomorphic sarcoma treated with mecbotamab vedotin, an AXL-targeting ADC. Presented at the Society for Immunotherapy of Cancer (SITC) 2025 Annual Meeting; National Harbor, MD; November 5-9, 2025.
4. Norberg SM, Doran SL, Cao J, et al. Complete tumor regression of metastatic epithelial cancer following T cell receptor (TCR)-T cell therapy. Presented at the Society for Immunotherapy of Cancer (SITC) 2025 Annual Meeting; National Harbor, MD; November 5-9, 2025. Abstract 366.
5. Norberg SM, Biswas A, Krishnamurthy S, et al. Decade-long epithelial cancer remissions from cellular therapy. Presented at the Society for Immunotherapy of Cancer (SITC) 2025 Annual Meeting; National Harbor, MD; November 5-9, 2025. Abstract 377.
6. FDA approves Promega OncoMate MSI Dx Analysis System as companion diagnostic for KEYTRUDA in combination with LENVIMA in advanced endometrial carcinoma. News release. Promega. November 11, 2025. Accessed November 14, 2025. https://tinyurl.com/2jdnn7r7
7. FDA grants regular approval to pembrolizumab and lenvatinib for advanced endometrial carcinoma. FDA. July 21, 2021. Accessed November 14, 2025. https://tinyurl.com/49hzfsvh

SEOUL, South Korea — SEOUL, South Korea (AP) — Samsung Electronics and other major South Korean companies on Sunday announced fresh domestic investment plans at a meeting with President Lee Jae Myung, who hopes the moves will counter concerns that the firms would prioritize U.S. investments under a trade deal.

Lee’s meeting with business leaders came days after his government finalized a trade deal with the United States, in which Seoul pledged to invest $350 billion in U.S. industries in exchange for averting the Trump administration’s highest tariffs.

Samsung, a global leader in computer chips, said it will invest 450 trillion won ($310 billion) over the next five years to expand its domestic operations, including building another production line at its Pyeongtaek manufacturing hub to meet surging global semiconductor demands fueled by artificial intelligence.

Samsung said the new line, set to begin operations in 2028, is part of its broader effort to secure additional production capacity in anticipation of rising mid- to long-term demands for memory chips. The company also plans to build AI data centers in the country’s southwest South Jeolla Province and the southeastern city of Gumi to support government efforts to reduce the development gap between the greater Seoul metropolitan area and other regions.

Hyundai Motor Group, South Korea’s largest automaker, said it plans to invest 125 trillion won ($86.3 billion) from 2026 to 2030 to expand domestic research and development and advance new technologies such as AI, robotics and self-driving cars.

SK Group, another semiconductor powerhouse, and shipbuilders Hanwha Ocean and HD Hyundai also announced plans to increase their domestic investments. Both are central to South Korean commitments to boost the U.S. shipbuilding industry, a sector highlighted by President Donald Trump in negotiations with Seoul.

In his meeting with the companies’ chiefs, Lee credited the business sector for helping his government negotiate the trade deal with Washington but urged the companies to maintain strong domestic investments to ease concerns they might cut spending at home to invest more in America. He said his government is exploring various policy steps, including easing regulations, to help create a more favorable business environment for the companies.

SK Chair Chey Tae-won, whose group plans to invest at least 128 trillion won ($88.3 billion) domestically through 2028 with a focus on AI, said the finalization of trade talks with the United States eases uncertainties and paves way for bolder domestic investment.

The two governments on Friday released the details of the trade agreement, including $150 billion in South Korean investments in the U.S. shipbuilding sector and an additional $200 billion in other American industries, which Seoul says will be capped at $20 billion per year to prevent financial instability.

The United States agreed to reduce tariffs on South Korean cars and auto parts from 25% to 15%, and to apply tariffs on South Korean semiconductors on terms “no less favorable” than those granted to comparable competitors in the future.

According to a new report from the International Energy Agency, the world will spend $580 billion on data centers this year — $40 billion more than will be spent finding new oil supplies.

Those numbers help to illustrate some big shifts in the global economy, and comparing data centers and oil seems particularly apt given concerns about how generative AI might accelerate climate change.

Kirsten Korosec, Rebecca Bellan, and I discussed the report’s findings on the latest episode of TechCrunch’s Equity podcast.

There’s no question that these new data centers are going to be hungry for power, and that they could place even more stress on already taxed electrical grids. But Kirsten pointed to a potential upside, with solar poised to power many of these new projects, which could also create new opportunities for startups pursuing innovative approaches to renewable energy.

We also discussed how these projects will be funded, with OpenAI saying it has committed  $1.4 trillion to building data centers, Meta committing $600 billion, and Anthropic recently announcing a $50 billion data center plan.

You can read a preview of our conversation, edited for length and clarity, below.

Kirsten: Here’s what I think is the potential upside. So Tim De Chant, who’s our climate tech reporter, has done a ton of reporting about not just data centers, but actually how a lot of data centers are turning to renewables because in terms of regulatory [hurdles] and cost, they are the go-to. It’s a lot easier to get a permit to throw up a bunch of solar panels adjacent to a data center.

So to me, the one upside is that it could really mean a positive for any kind of company that is doing interesting things around renewables or data center design and some of the technology to reduce the global emissions component of it.

But of course, the sheer number to me is what really stood out. As a former energy reporter myself, I know how much is spent on trying to find new oil.

Rebecca: I mean, it’s a lot. And a lot of that’s coming from the U.S. I think that report found that half of the electricity demand will be coming from the U.S., and the rest is a mix of China and Europe.

And another thing that struck me about it was that most of the data centers are coming to cities, or near cities, like populations of a million people, roughly. So that means there’s a lot more challenge with the grid connection and with connection pathways. I think that, to your point, renewables will have to [be a focus] — it’s just good business, it’s not because of any environmentally friendly policies.

Kirsten: Redwood Materials’ new business unit, Redwood Energy, is going to be an interesting company to watch with this. A few months ago, I went to their big reveal, and they’re taking the old EV batteries that aren’t quite ready to be recycled, and then they’re creating these microgrids, and then specifically going after AI data centers. And that, to me, would alleviate the problem or the concern that you just mentioned.

The question is: Are other companies going to do this? Are there other Redwood Energies out there that are trying to do the same thing? And how much of an impact could they make? Because I do think that like the pressure on the electrical grid, especially during certain times of the year, like in the middle of the summer, for instance, places like Texas that have rolling brownouts and blackouts, that is going to be a real concern. And it could spur a whole new kind of investment into companies doing what Redwood is doing.

Anthony: It also underlines this question about what is that going to do to the spaces that we live in? Even if they’re not in cities themselves, I feel like the landscape is definitely going to be transformed by construction at this scale.

And then, of course, there’s also this question of how much of [the planned data centers are]  actually going to get built because there’s definitely very ambitious plans that require huge amounts of spending.

To start with OpenAI, that’s a company that a lot of people have been talking about, how much money are they actually making versus the trillions of dollars of capital commitments they have for the next decade. And then there was this whole controversy over their CFO saying, “The government should backstop our loans to build these data centers.” And then she’s like, “No, no, no, no, no, I didn’t mean backstop, that was a poor choice of words,” but it does look like they have been asking for an expansion of tax credits from the CHIPS Act. 

I think that this is going to be an effort that’s not just going to fall on the companies, but also on the government — or at least that’s going to be a question that the government is considering over the next few years.

The USDA report released after the government reopened showed only two Chinese purchases of American soybeans since the summit in South Korea that totaled 332,000 metric tons. That’s well short of the 12 million metric tons that Agriculture Secretary Brooke Rollins said China agreed to purchase by January and nowhere near the 25 million metric tons she said they would buy in each of the next three years.

American farmers were hopeful that their biggest customer would resume buying their crops. But CoBank’s Tanner Ehmke, who is its lead economist for grains and oilseed, said there isn’t much incentive for China to buy from America right now because they have plenty of soybeans on hand that they have bought from Brazil and other South American countries this year, and the remaining tariffs ensure that U.S. soybeans remain more expensive than Brazilian beans.

“We are still not even close to what has been advertised from the U.S. in terms of what the agreement would have been,” Ehmke said.

Beijing has yet to confirm any detailed soybean purchase agreement but only that the two sides have reached “consensus” on expanding trade in farm products. Ehmke said that even if China did promise to buy American soybeans it may have only agreed to buy them if the price was attractive.

Trump said his team spoke with Chinese officials today and they assured the White House they would be purchasing more soybeans, but he didn’t offer any details of how much.

“They’re in the process of doing not only a little bit but they’ll be doing a lot of soybean purchases,” he told reporters.

The Chinese tariff on American beans remains high at about 24%, despite a 10-percentage-point reduction following the summit.

Soybean prices fell sharply by 23 cents to $11.24 per bushel Friday. Ehmke said “that’s the market being shocked by the lack of Chinese demand that was confirmed in USDA data today.” Prices are still higher than they were before the agreement when they were selling for $10.60 per bushel, but the price may continue to drop unless there are significant new purchases.

Before the trade agreement, Trump had promised farmers would receive an aid package to help them survive the trade war with China. That was put on hold during the shutdown, and now it’s not clear whether the administration will offer farmers aid like Trump did in his first administration.

American farmers have been through this before after Trump’s first trade war with China. The trade agreementChina signed with the United States in 2020 promised massive purchases of U.S. crops. But the COVID-19 pandemic disrupted trade between the two nations just as the agreement went into effect. In 2022, U.S. farm exports to China hit a record, but then fell.

Soybean prices are actually still a little higher than they were a year ago even without China’s normal purchases of roughly one-quarter of the U.S. crop. That’s because this year’s soybean crop is a little smaller while domestic demand remained strong with the continued growth in biodiesel production.

But farmers are dealing with the soaring cost of fertilizer, seed, equipment and labor this year, and that is hurting their profits. The Kentucky farmer who is president of the American Soybean Association, Caleb Ragland, has said he worries that thousands of farmers could go out of business this year without significant Chinese purchases or government aid.

Ragland said he’s still optimistic that China will follow through on the purchases, but it’s hard to be confident in that right now with so few sales reported.

“We don’t want to assume they won’t. But it’s going to be a wonderful day when we actually deliver those soybeans, and when there’s my money in hand and so forth and the transaction’s complete,” Ragland said.

China is the world’s largest buyer of soybeans. China bought more than $12.5 billion worth of the nearly $24.5 billion worth of U.S. soybeans that were exported last year.

But China quit buying American soybeans this year after Trump imposed his tariffs and continued to shift more of their purchases over to South America. Even before the trade war, Brazilian beans accounted for more than 70% of China’s imports last year, while the U.S. share fell to 21%, World Bank data shows.

Ragland said that every vender he talks to has told him they are increasing their prices for next year, which will continue to put pressure on farmers.

“We’re still looking at sharp losses and the red ink as we figure budgets for 26 is still very much in play,” he said.

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Nexxen International (NasdaqGM:NEXN) has seen a wave of attention after it lowered its full-year 2025 financial guidance. The move follows Q3 results that landed in line with expectations but showed some mixed signals.

See our latest analysis for Nexxen International.

The lowered financial guidance and cautious analyst commentary have certainly weighed on Nexxen International’s momentum. The share price has slipped by 27.3% over the past month and 40.5% year-to-date. While the stock has faced near-term pressure, its five-year total shareholder return still stands strong at over 78%, suggesting that longer-term holders have fared much better than recent buyers.

If you want to see what other companies are catching investors’ attention amid shifting forecasts, now is a perfect time to check out fast growing stocks with high insider ownership.

So after a sharp drop in shares and new analyst targets below previous highs, does Nexxen International now trade at a compelling discount? Or is the market already reflecting slower growth in its current price?

Nexxen International’s last close at $6.43 is well below the most widely followed fair value estimate of $16.14. This raises questions about what’s behind such a significant gap in expectations.

The expanded, long-term partnership with VIDAA secures exclusive access to valuable CTV inventory and ACR data. This enables Nexxen to uniquely monetize North American and international connected TV audiences as VIDAA grows its global footprint, which could drive higher revenues and a larger addressable market starting in 2026.

Read the complete narrative.

Curious why a digital advertising company would warrant such a premium? The narrative focuses on ambitious growth assumptions and aggressive future profit multiples. Something in Nexxen’s financial trajectory may surprise you. Ready to discover what’s fueling this major valuation call?

Result: Fair Value of $16.14 (UNDERVALUED)

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

However, weaker-than-expected CTV revenue growth and rising data privacy regulations remain notable risks that could challenge bullish expectations in the future.

Find out about the key risks to this Nexxen International narrative.

If the current story doesn’t fit your view, or you want to dive in yourself, you can shape your own analysis in just a few minutes. So why not Do it your way?

A good starting point is our analysis highlighting 4 key rewards investors are optimistic about regarding Nexxen International.

If you want every chance at finding your next big winner, don’t wait on the sidelines. Use the Screener to spot where momentum is building now.

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 NEXN.

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