Category: 3. Business

  • SpaceX to offer insider shares at record-setting $800 billion valuation

    SpaceX to offer insider shares at record-setting $800 billion valuation

    SpaceX is preparing to sell insider shares in a transaction that would value Elon Musk’s rocket and satellite maker at as much as $800 billion, people familiar with the matter said, reclaiming the title of the world’s most valuable private company. 

    The details, discussed by SpaceX’s board of directors on Thursday at its Starbase hub in Texas, could change based on interest from insider sellers and buyers or other factors, said some of the people, who asked not to be identified as the information isn’t public. SpaceX is also exploring a possible initial public offering as soon as late next year, one of the people said. 

    Another person briefed on the matter said that the price under discussion for the sale of some employees and investors’ shares is higher than $400 apiece, which would value SpaceX at between $750 billion and $800 billion. The company wouldn’t raise any funds though this planned sale, though a successful offering at such levels would catapult it past the record of $500 billion valuation achieved by OpenAI in October.

    Elon Musk on Saturday denied that SpaceX is raising money at a $800 billion valuation without addressing Bloomberg’s reporting on the planned offering of insiders’ shares. 

    “SpaceX has been cash flow positive for many years and does periodic stock buybacks twice a year to provide liquidity for employees and investors,” Musk said in a post on his social media platform X. 

    The share sale price under discussion would be a substantial increase from the $212 a share set in July, when the company raised money and sold shares at a valuation of $400 billion. The Wall Street Journal and Financial Times earlier reported the $800 billion valuation target.

    News of SpaceX’s valuation sent shares of EchoStar Corp., a satellite TV and wireless company, up as much as 18%. Last month, EchoStar had agreed to sell spectrum licenses to SpaceX for $2.6 billion, adding to an earlier agreement to sell about $17 billion in wireless spectrum to Musk’s company.

    Subscribe Now: The Business of Space newsletter covers NASA, key industry events and trends.

    The world’s most prolific rocket launcher, SpaceX dominates the space industry with its Falcon 9 rocket that lifts satellites and people to orbit.

    SpaceX is also the industry leader in providing internet services from low-Earth orbit through Starlink, a system of more than 9,000 satellites that is far ahead of competitors including Amazon.com Inc.’s Amazon Leo.

    Elite Group

    SpaceX is among an elite group of companies that have the ability to raise funds at $100 billion-plus valuations while delaying or denying they have any plan to go public. 

    An IPO of the company at an $800 billion value would vault SpaceX into another rarefied group — the 20 largest public companies, a few notches below Musk’s Tesla Inc. 

    If SpaceX sold 5% of the company at that valuation, it would have to sell $40 billion of stock — making it the biggest IPO of all time, well above Saudi Aramco’s $29 billion listing in 2019. The firm sold just 1.5% of the company in that offering, a much smaller slice than the majority of publicly traded firms make available.

    A listing would also subject SpaceX to the volatility of being a public company, versus private firms whose valuations are closely guarded secrets. Space and defense company IPOs have had a mixed reception in 2025. Karman Holdings Inc.’s stock has nearly tripled since its debut, while Firefly Aerospace Inc. and Voyager Technologies Inc. have plunged by double-digit percentages since their debuts.

    SpaceX executives have repeatedly floated the idea of spinning off SpaceX’s Starlink business into a separate, publicly traded company — a concept President Gwynne Shotwell first suggested in 2020. 

    However, Musk cast doubt on the prospect publicly over the years and Chief Financial Officer Bret Johnsen said in 2024 that a Starlink IPO would be something that would take place more likely “in the years to come.”

    The Information, citing people familiar with the discussions, separately reported on Friday that SpaceX has told investors and financial institution representatives that it’s aiming for an IPO of the entire company in the second half of next year.

    Read More: How to Buy SpaceX: A Guide for the Eager, Pre-IPO

    A so-called tender or secondary offering, through which employees and some early shareholders can sell shares, provides investors in closely held companies such as SpaceX a way to generate liquidity.

    SpaceX is working to develop its new Starship vehicle, advertised as the most powerful rocket ever developed to loft huge numbers of Starlink satellites as well as carry cargo and people to moon and, eventually, Mars.

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  • The housing crisis is pushing Gen Z into crypto and economic nihilism

    The housing crisis is pushing Gen Z into crypto and economic nihilism

    This article picked by a teacher with suggested questions is part of the Financial Times free schools access programme. Details/registration here.

    Read our full range of US High School economics picks here.

    How can young adults build long term wealth even as housing becomes harder to afford, what policies could help make housing more attainable, and how can understanding other investing options give them optimism about their financial future?

    Read the FT article and then answer the questions below.

    The housing crisis is pushing Gen Z into crypto and economic nihilism

    • What economic problem does the article identify as the main force shaping Gen Z’s financial behaviour, and why is this problem especially relevant to young adults today?

    • According to the research cited, what three behaviours are more common among young adults who believe home ownership is unrealistic?

    • Why do young adults who believe home ownership is still possible tend to behave differently?

    • How are incentives and opportunity cost shown in the article in ways that change people’s behaviour as housing affordability changes?

    • Imagine you are designing a policy to improve housing affordability. Based on the article, what type of policy would most directly influence young adults’ incentives to save and work? Explain why

    • The article mentions the need for greater financial literacy for young adults facing a challenging housing market. What specific financial skills will be most important for students who still hope to become future homeowners?

    • Explain why many young adults feel discouraged about saving for a home, and then give and explain three specific policy changes that could increase housing supply and make home ownership more attainable

    Joel Miller and James Redelsheimer, Foundation for Economic Education.
    Click here for FEE FT Classroom Edition with classroom-ready presentations and suggested answers for teachers.

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  • Assessing Valuation After a Recent Pullback in the Share Price

    Assessing Valuation After a Recent Pullback in the Share Price

    CSG Systems International (CSGS) has quietly delivered strong long term returns, and its recent pullback could catch the eye of investors looking for steady growth in communications software and services.

    See our latest analysis for CSG Systems International.

    Despite a modest recent dip in the share price, with CSG Systems International now trading at $77.01, the stock still shows strong momentum, combining a robust year to date share price return with impressive multi year total shareholder returns that point to sustained investor confidence in its growth story.

    If CSGS’s steady climb has you rethinking your watchlist, this could be a smart moment to scan other communications and software names through fast growing stocks with high insider ownership.

    With shares up strongly over one and three years yet still trading below analysts’ targets and our estimate of intrinsic value, is CSG Systems International an underappreciated compounder, or has the market already priced in its next leg of growth?

    With CSG Systems International last closing at $77.01 against a narrative fair value of $80.70, the most widely followed view still sees modest upside and a relatively low risk path to that outcome.

    Ongoing strategic migration to asset-light, SaaS and cloud-based platforms is driving improvements in operating leverage, higher gross and operating margins, and robust free cash flow, as demonstrated by operating margin expanding 250 basis points YoY and guidance being raised for margins and free cash flow growth in both 2025 and 2026.

    Read the complete narrative.

    Curious how steady revenue expectations can still support a richer valuation? The narrative leans on expanding margins, rising earnings power, and a future profit multiple that might surprise you. Want to see which long term assumptions really carry this fair value? Dive in and test whether you agree with the math behind that target.

    Result: Fair Value of $80.70 (UNDERVALUED)

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

    However, persistent telecom headwinds and heavy reliance on Charter and Comcast could pressure growth and quickly challenge the modest upside implied by this narrative.

    Find out about the key risks to this CSG Systems International narrative.

    If the market story here does not quite match your view, you can review the numbers yourself and build a tailored narrative in minutes, Do it your way.

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

    Before you log off, you may wish to scan fresh opportunities on Simply Wall St’s screener so the next quiet outperformer does not pass you by.

    • Capture early stage potential by reviewing these 3574 penny stocks with strong financials that pair smaller market caps with balance sheets and growth trends that can meaningfully influence your portfolio’s trajectory.

    • Position your portfolio for structural change by considering these 30 healthcare AI stocks that are reshaping diagnostics, treatment pathways, and cost efficiency across global health systems.

    • Strengthen your income stream with these 15 dividend stocks with yields > 3% that offer yields above 3 percent while aiming to balance payout reliability with underlying business quality.

    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 CSGS.

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

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  • Should Expeditors’ Rising Role in AI-Driven Logistics Require Action From Expeditors International (EXPD) Investors?

    Should Expeditors’ Rising Role in AI-Driven Logistics Require Action From Expeditors International (EXPD) Investors?

    • In recent days, Expeditors International of Washington was highlighted by BofA for stronger-than-expected demand in customs and airfreight, alongside growth in export airfreight tonnage from North and South Asia and deeper penetration into technology, pharmaceutical, and aviation verticals.

    • An interesting angle is how Expeditors is benefiting from technology customers’ heavy investments in artificial intelligence infrastructure, which is increasing demand for specialized logistics solutions.

    • We’ll now examine how Expeditors’ growing role in AI-related logistics may influence the company’s investment narrative for long-term investors.

    We’ve found 15 US stocks that are forecast to pay a dividend yield of over 6% next year. See the full list for free.

    To sit comfortably as a shareholder in Expeditors, you really have to believe that its asset-light, tech-enabled freight network can keep turning steady cash generation into disciplined dividends and buybacks, even if headline growth is modest. Recent quarters show incremental revenue and earnings progress rather than a breakout, while the stock has already rerated meaningfully this year and trades on richer multiples than many logistics peers. That is why BofA’s latest commentary on stronger customs and airfreight demand, plus Expeditors’ deeper push into technology, pharma, and aviation, matters: it gives near-term catalysts a clearer AI-related angle, with higher-value shipments and tighter customer relationships potentially reinforcing its high returns on equity. At the same time, it also sharpens the key risk if this AI-driven freight cycle cools faster than the market currently expects.

    However, investors also need to watch how much they are paying for that AI-linked growth optionality. Expeditors International of Washington’s shares have been on the rise but are still potentially undervalued by 19%. Find out what it’s worth.

    EXPD Community Fair Values as at Dec 2025

    Three Simply Wall St Community fair value views span roughly US$104 to about US$188, underscoring how far apart private investors can be. Set that against Expeditors’ richer earnings multiple and the AI freight demand story, and you can see why it pays to weigh several risk and reward angles before forming your own view.

    Explore 3 other fair value estimates on Expeditors International of Washington – why the stock might be worth as much as 24% 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.

    Our daily scans reveal stocks with breakout potential. Don’t miss this chance:

    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 EXPD.

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

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  • Does Jamf’s Sluggish Share Price Hide Long Term Value Potential in 2025?

    Does Jamf’s Sluggish Share Price Hide Long Term Value Potential in 2025?

    • Wondering if Jamf Holding at around $12.97 is quietly setting up a value opportunity, or if the market is signaling you should stay cautious? This breakdown is designed to help you decide with confidence.

    • While the stock is roughly flat over the last week (up 0.3%) and month (up 0.8%), it is still down 7.9% year to date and 15.9% over the past year, with a much steeper slide of 40.1% over three years and 59.8% over five years that has many investors asking whether expectations have finally reset.

    • Recent headlines around Jamf have focused on how it is positioning itself as a go to platform for managing Apple devices at scale in enterprises and education, alongside ongoing efforts to sharpen its product offering and customer reach. That mix of strategic investment and market skepticism is a big part of why today’s share price looks so different to where it traded a few years ago.

    • On our framework, Jamf Holding scores a 5 out of 6 valuation score, suggesting the market may be underestimating it across most of our checks. Next, we will unpack what that actually means through multiple valuation lenses, before finishing with a more holistic way to think about value beyond the usual models.

    Find out why Jamf Holding’s -15.9% return over the last year is lagging behind its peers.

    A Discounted Cash Flow, or DCF, model estimates what a business is worth today by projecting the cash it could generate in the future and then discounting those cash flows back to their value in today’s dollars.

    For Jamf Holding, the model starts with last twelve month Free Cash Flow of about $110.1 million and projects how that could grow over time, using analyst estimates for the next few years and then extrapolating further out. On this basis, Jamf’s annual Free Cash Flow is expected to rise to roughly $275.4 million by 2035, which reflects a steady ramp up in cash generation as the business scales.

    Using a 2 Stage Free Cash Flow to Equity approach, those projected cash flows translate into an estimated intrinsic value of about $22.81 per share. Compared with the current share price of roughly $12.97, the DCF suggests the stock is trading at a 43.1% discount, indicating potential upside if the cash flow projections are realized.

    Result: UNDERVALUED

    Our Discounted Cash Flow (DCF) analysis suggests Jamf Holding is undervalued by 43.1%. Track this in your watchlist or portfolio, or discover 907 more undervalued stocks based on cash flows.

    JAMF Discounted Cash Flow as at Dec 2025

    Head to the Valuation section of our Company Report for more details on how we arrive at this Fair Value for Jamf Holding.

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  • KRd Demonstrates Superior PFS vs VRd in Newly Diagnosed Myeloma

    KRd Demonstrates Superior PFS vs VRd in Newly Diagnosed Myeloma

    Carfilzomib (Kyprolis) plus lenalidomide Revlimid) and dexamethasone (KRd) delivered improvements in progression-free survival (PFS) compared with bortezomib (Velcade) plus lenalidomide and dexamethasone (VRd) in patients with newly diagnosed multiple myeloma, according to interim results from the phase 3 COBRA trial (NCT03729804).

    The findings, presented during the 2025 ASH Annual Meeting, demonstrated that KRd (n = 126) reduced the risk of progression or death by 43% vs VRd (n = 124) in the intent-to-treat population (HR, 0.57; 95% CI, 0.37-0.88; P = .0095) at a median follow-up of 53 months. The median PFS was not reached (NR) in the KRd group vs 48.8 months in the VRd arm.

    The data demonstrated consistent directional benefits across cytogenetic subgroups. Among patients with standard-risk disease, KRd (n = 97) achieved a statistically significant improvement in PFS vs VRd (n = 96; HR, 0.59, 95% CI, 0.36-0.98; P = .04); the median PFS was NR in the KRd group compared with 48.8 months for VRd. In this subgroup, 27% of patients treated with KRd experienced progression or death vs 40% with VRd. In the high-risk cohort, KRd (n = 29) again demonstrated favorable outcomes vs VRd (n = 28), with 31% vs 48% of patients experiencing progression or death. The median PFS was NR vs 34.9 months, respectively (HR, 0.52; 95% CI, 0.22-1.22; P = .12).

    “COBRA showed superior efficacy of KRd vs VRd in newly diagnosed multiple myeloma, achieving both co-primary endpoints of MRD-negative CR at 12 months and PFS,” noted presenting author Dominik Dytfeld, MD, PhD. “The PFS benefit of KRd was observed regardless of cytogenetic risk, and KRd produced deeper responses, with higher rates of complete response [CR] and minimal residual disease [MRD]–negativity. KRd [also] demonstrated anticipated toxicity profiles with higher rates of neutropenia and cardiac [adverse effects (AEs)], but less neuropathy. COBRA results support further evaluation of KRd-based induction regimens in newly diagnosed multiple myeloma.”

    Dytfeld is an associate professor of medicine at the Poznan University of Medical Sciences in Poland and founder/chief executive officer of the Polish Myeloma Consortium

    What was the design of the COBRA trial?

    The COBRA trial was a multicenter, randomized, open-label phase 3 study designed to compare KRd with VRd in patients with newly diagnosed multiple myeloma who had an International Myeloma Working Group (IMWG) Frailty Score of less than 2.1,2 Randomization was stratified by cytogenetic risk category (standard vs high risk defined by t(4;14) or del(17p)) and by history of venous thromboembolism (yes vs no). A total of 250 patients were randomly assigned in a 1:1 ratio to the KRd or VRd treatment arms.1

    Patients in the KRd arm received up to 24, 28-day cycles of therapy consisting of carfilzomib at 56 mg/m² administered on days 1, 8, and 15 (with twice-weekly dosing during cycles 1 and 2), lenalidomide at 25 mg on days 1 through 21, and dexamethasone at 40 mg weekly (or 20 mg for patients 75 years of age or older). Stem-cell collection occurred after cycle 4 in this transplant-deferred design. Following completion of induction, patients continued on lenalidomide 5 mg daily as maintenance until disease progression.

    Patients in the VRd arm received eight 28-day cycles of bortezomib at 1.3 mg/m² on days 1, 4, 8, and 11; lenalidomide at 25 mg on days 1 through 14; and dexamethasone at 20 mg on days 1, 2, 4, 5, 8, 9, 11, and 12. After completion of the VRd induction phase, patients transitioned to consolidation with lenalidomide and dexamethasone for eighteen 28-day cycles, followed by lenalidomide 5 mg maintenance until progression.

    The trial’s co-primary end points were the rate of MRD-negative CR rate at a sensitivity of 10⁻⁵ at 12 months and PFS. Secondary end points include MRD rate, sustained MRD negativity, overall response rate (ORR), overall survival (OS), and safety.

    How did KRd and VRd compare in transplant-eligible vs transplant-ineligible patients?

    The subgroup analysis by transplant eligibility showed distinct patterns in PFS favoring KRd among patients considered eligible for autologous stem cell transplant. In the transplant-eligible cohort, KRd reduced the risk of progression or death by 60% relative to VRd (HR, 0.40; 95% CI, 0.21-0.75; P = .003). Only 23% of patients treated with KRd experienced progression or death compared with 45% in the VRd arm. Median PFS was NR with KRd, whereas VRd demonstrated a median PFS of 40.1 months.

    In contrast, outcomes were comparable between the two regimens in the transplant-ineligible population. In this subgroup, both KRd and VRd produced identical progression or death rates of 30%. Median PFS remained NR with KRd vs 52.9 months for VRd, resulting in no statistically significant difference between the arms (HR, 1.06; 95% CI, 0.21-0.75; P = .87).

    What were the safety outcomes of the COBRA trial?

    The safety profile of KRd and VRd in the COBRA trial demonstrated that both regimens were associated with high rates of AEs, although specific toxicity patterns differed between the treatment arms. Grade 3 or higher AEs occurred in 73% of patients receiving KRd and 62% of those receiving VRd, while any-grade AEs were nearly universal across both cohorts (96% with KRd and 94% with VRd). Treatment discontinuation due to AEs occurred in 11% of KRd-treated patients and 8% of VRd-treated patients.

    Grade 5 AEs were infrequent but observed in both arms, occurring in 5 patients (4%) in the KRd arm and 7 patients (6%) in the VRd arm. Reported fatal AEs in the KRd cohort included COVID-19, stroke, pneumonia, sepsis, and acute kidney failure, whereas the VRd arm included deaths from COVID-19, pneumonia, respiratory failure, and two AEs of unknown cause. Neutropenia of any grade occurred in 29% of KRd-treated patients and 17% of VRd-treated patients, with grade 3 or higher neutropenia reported in 21% and 11%, respectively.

    Neuropathy, a known bortezomib-associated toxicity, was more common with VRd: 56% of patients experienced neuropathy of any grade compared with 17% in the KRd arm, although grade 3 or higher neuropathy remained low in both groups (2% in each arm). Cardiac AEs occurred more frequently with KRd (18% any grade; 6% grade ≥3) than with VRd (10% any grade; 2% grade ≥3), consistent with the known cardiovascular risk profile of carfilzomib. Infection rates were high in both groups but were more common in the KRd arm, where 75% experienced infections of any grade and 25% developed grade 3 or higher infections, compared with 60% and 23% in the VRd arm, respectively.

    References

    1. Dytfeld D, Kubicki T, Tyczynska A, et al. Carfilzomib, lenalidomide, and dexamethasone (KRd) versus bortezomib, lenalidomide, and dexamethasone (VRd) in patients with newly diagnosed multiple myeloma: results of the randomized phase III COBRA trial. Blood. 2025;146(suppl 1):99. doi:10.1182/blood-2025-99
    2. Carfilzomib, lenalidomide, and dexamethasone versus bortezomib, lenalidomide and dexamethasone (KRd vs. VRd) in patients with newly diagnosed multiple myeloma (COBRA). ClinicalTrials.gov Updated October 3, 2025. Accessed December 6, 2025. https://clinicaltrials.gov/study/NCT03729804

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  • Musk denies $800 billion SpaceX valuation reports

    Musk denies $800 billion SpaceX valuation reports

    Elon Musk attends the U.S.-Saudi Investment Forum in Washington, D.C., U.S., November 19, 2025.

    Evelyn Hockstein | Reuters

    Elon Musk on Saturday dismissed media reports that SpaceX is raising funds at an $800 billion valuation, calling them inaccurate.

    “SpaceX has been cash flow positive for many years and does periodic stock buybacks twice a year to provide liquidity for employees and investors,” Musk said in a post on X.

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  • Odronextamab Plus CHOP Shows Promise in Early Phase 3 Data for Untreated DLBCL | Targeted Oncology

    Odronextamab Plus CHOP Shows Promise in Early Phase 3 Data for Untreated DLBCL | Targeted Oncology

    The CD20 and CD3 bispecific antibody odronextamab showed compelling early efficacy in combination with standard CHOP chemotherapy as a treatment for patients with previously untreated diffuse large B-cell lymphoma (DLBCL), according to the first results from a small cohort of patients enrolled in part 1 of the phase 3 OLYMPIA-3 study (NCT06091865) presented at the 2025 ASH Annual Meeting.1

    In the early results, the objective response rate (ORR) was 78% with the weekly 80 mg dose of odronextamab plus CHOP and was 100% for the weekly 160 mg dose of odronextamab plus CHOP. The complete response rates were 44% and 100% for each dose, respectively. The median duration of response, duration of complete response, and progression-free survival were not yet reached at the early analysis. Based on the combination of efficacy and safety, the 160 mg dose of odronextamab was selected for further investigation in the randomized portion of the study comparing the bispecific with rituximab (Rituxan).

    “Data from part 1a of OLYMPIA-3 suggest that when combining odronextamab with CHOP in previously untreated patients with DLBCL, rituximab was not required to achieve deep and durable responses,” lead investigator Jean-Marie Michot, MD, from Institute Gustave Roussy, said during a presentation of the results. “The safety profile of fixed duration odronextamab-CHOP treatment was generally manageable in patients with previously untreated DLBCL with high-risk features, with no new safety signals compared with previous reports.”

    OLYMPIA-3 Study Design and Patient Characteristics

    The open-label study was designed with 2 parts. In part 1, the dose of odronextamab was escalated and optimized. Standard CHOP was given on day 1 and 8 of each cycle and odronextamab was administered starting on day 8, initially at a step-up dose of 0.7/4/20 mg and then at varying dose levels including 80 mg or 160 mg weekly and 160 mg and 320 mg every 2 weeks, with data only available for the weekly doses. Part 2 of the study will continue CHOP with patients randomly assigned to receive odronextamab (Odro-CHOP) or rituximab (R-CHOP).

    Across all of part 1, the median age of patients was 66 years (range, 24-81), with nearly a third aged 75 or older (32%). ECOG performance status was 0 (40%), 1 (45%), and 2 (14%). The primary cell of origin was non-GCB (59%), and all patients had de novo DLBCL. IPI score was 3 for 36% and 4 to 5 for 27% of patients. The Lugano stage was III to IV for 95% of patients.

    At the time of the analysis, 77.8% of patients enrolled to the 80 mg dose had completed cycle 1 to 6 (7 of 9). The remainder of patients in this group had discontinued early, due to physician decision (n = 2). In the 160-mg arm (n = 13), all patients had completed cycle 1 and 84.6% had completed cycle 6. Two discontinued early due to physician decision. The relative dose intensity was 87% in the 80-mg group and 77% in the 160-mg group.

    “Most patients completed 6 cycles of odronextamab-CHOP at both dose levels,” said Michot. “There were few dose reductions of odronextamab and no permanent treatment discontinuations due to TEAEs related to odronextamab. There were no clinically important differences in safety between dose levels.”

    Additional Odronextamab Efficacy Findings

    The median duration of follow-up was 9.2 months for those enrolled in the 80 mg dose and was 7.8 months for those in the 160 mg dose. At the assessment, most responses remained ongoing. “CRs appeared durable,” Michot said.

    In a biomarker analysis, B cell counts declined quickly following the initiation of therapy. There was an initial drop with CHOP administration, with B cells being completely cleared with the initiation of odronextamab.

    There was slight T cell margination following the initiation of therapy, but these were transient and like prior reports with odronextamab, Michot said. T cell findings were similar for each dose.

    Odronextamab Safety Profile in OLYMPIA-3

    Grade 3 or higher treatment emergent adverse events (TEAEs) were experienced by all patients treated with the 80 mg and 160 mg doses of odronextamab. Serious TEAEs were seen in 77.8% of those treated with the 80 mg dose and for 92.3% of those administered the 160 mg dose. TEAEs led to treatment interruption or delay for 66.7% of those in the 80-mg arm and for 84.6% of those in the 160-mg group.

    TEAE led to an odronextamab dose reduction for no patients in the 80 mg-arm and for 1 in the 160-mg group. Dose results in CHOP due to TEAEs were needed for 1 patient in the 80-mg group and for 5 in the 160-mg group. TEAEs led to treatment discontinuation for 1 patient in each dose level arm. There was 1 TEAE that led to death in the 160-mg arm. “Of note, there were no dose-limiting toxicities reported,” Michot said.

    Across both doses, the most common TEAE was neutropenia (81.8%), cytokine release syndrome (CRS; 54.5%), anemia (45.5%), and nausea (40.9%). The most common treatment-related adverse events were similar with neutropenia seen in 77.3% of patients, CRS in 54.5%, anemia in 45.5%, and nausea in 36.4%.

    CRS was solely grade 1/2 in severity, with 40.9% of patients having a grade 1 event and 13.6% having a grade 2 event. Tocilizumab was administered to manage CRS for 27.3% of patients and steroids were given for 18.2%. The median CRS duration was 3.8 months and the median time to onset was 9 hours. CRS mostly occurred during the step-up dosing phase at the lowest dose of 0.7 mg, after this initial step-up the rates of CRS were low. There were no cases of immune effector cell–associated neurotoxicity syndrome or tumor lysis syndrome.

    Infections were seen in 81.8% of patients treated across both levels. Of these, 31.8% were grade 3 in severity and 9.1% were grade 4. Opportunistic infections were experienced by 50% of patients, of which only 1 patient had a grade 3 or higher opportunistic infection. The most commonly reported events were CMV infection or reinfection (27% for both) or COVID-19 and oral candidiasis (18% for each).

    Odronextamab Regulatory History and Further Study

    In August of 2025, the FDA issued a complete response letter (CRL) for a biologics license application for odronextamab for the treatment of relapsed/refractory follicular lymphoma following 2 or more lines of systemic therapy.2 Additionally, in March of 2024,3 the agent received 2 CRLs for DLBCL and follicular lymphoma. In both cases, the applications were based on phase 2 findings. The CRL issued in August noted concerns with site inspections completed at a plant ran by Catalent Indiana LLC.

    Odronextamab is the subject of several clinical trials across several disease settings, either as monotherapy or in various combination regimens, including the phase 3 OLYMPIA-2 study (NCT06097364) for follicular lymphoma and the phase 3 OLYMPIA-5 study (NCT06149286) looking at odronextamab plus lenalidomide for follicular lymphoma.

    REFERENCES
    1. Michot J-M, Yagci M, Kargus K, et al. Odronextamab plus chemotherapy in patients with previously untreated diffuse large B-cell lymphoma (DLBCL): First Results from part 1 of the Phase 3 Olympia-3 study. Blood. 2025;146 (Supplement 1):abstract 65. doi:10.1182/blood-2025-65
    2. Regeneron Reports Second Quarter 2025 Financial and Operating Results. News release. Regeneron. August 1, 2025. Accessed December 6, 2025. https://tinyurl.com/bdz4e7ex

    3. Regeneron provides update on biologics license application for odronextamab. News release. Regeneron. March 25, 2024. Accessed December 6, 2025. https://tinyurl.com/mr2w4j8x

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  • RAP-219 Phase 2a Seizure Data and Planned Pivotal Trials Might Change The Case For Investing In Rapport Therapeutics (RAPP)

    RAP-219 Phase 2a Seizure Data and Planned Pivotal Trials Might Change The Case For Investing In Rapport Therapeutics (RAPP)

    • Rapport Therapeutics recently presented new data and post hoc analyses from its Phase 2a trial of RAP-219 in drug-resistant focal onset seizures at the 2025 American Epilepsy Society Meeting, showing consistent clinical benefits, including reductions in seizure severity and improvements in patient-reported outcomes, alongside PET evidence of target engagement in key brain regions.

    • The company now plans an end-of-Phase 2 meeting with the FDA this quarter and is preparing two pivotal Phase 3 trials for RAP-219 in 2026, underscoring its ambition to advance the asset beyond epilepsy into bipolar mania and diabetic peripheral neuropathic pain.

    • With RAP-219 showing consistent efficacy across disease severity and Rapport preparing for pivotal trials, we’ll examine how this shapes its investment narrative.

    Find companies with promising cash flow potential yet trading below their fair value.

    For Rapport Therapeutics, the big-picture belief is that RAP-219 can anchor a focused neurology platform, despite zero revenue and persistent losses. The AES data do not radically change that story, but they do strengthen a key near-term catalyst: the upcoming end-of-Phase 2 FDA meeting, which now rests on a more complete efficacy, safety, and PET target-engagement package. With shares already up sharply this quarter, the bar for future data and regulatory feedback may be higher, and any shift in FDA feedback or Phase 3 design could matter more than before. At the same time, the core risks remain: a single lead asset, a long runway to potential commercialization, continuing cash burn after the US$250,000,000 raise, and shareholder dilution already in the rear-view mirror.

    Although the data help the story, one funding and dilution risk still stands out for investors.

    Our valuation report unveils the possibility Rapport Therapeutics’ shares may be trading at a premium.

    RAPP Earnings & Revenue Growth as at Dec 2025

    The Simply Wall St Community currently offers 1 RAP-219 fair value view, clustered around US$51.50 per share, underscoring how even a single estimate can sit well above today’s price. Set that against the company’s ongoing cash burn and dependence on successful FDA dialogue, and you start to see why exploring multiple viewpoints on risk, timelines and dilution pressure could matter for your own conclusions.

    Explore another fair value estimate on Rapport Therapeutics – why the stock might be worth as much as 75% 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 Rapport Therapeutics research is our analysis highlighting 5 important warning signs that could impact your investment decision.

    • Our free Rapport Therapeutics research report provides a comprehensive fundamental analysis summarized in a single visual – the Snowflake – making it easy to evaluate Rapport Therapeutics’ 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 RAPP.

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

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  • Looking at the New Narrative for Nutanix After Its First Miss and Recalibrated Outlook

    Looking at the New Narrative for Nutanix After Its First Miss and Recalibrated Outlook

    Nutanix’s fair value estimate has been cut from about $85.78 to $70.70 as analysts recalibrate expectations for the company in light of its latest quarter. With the discount rate nudging higher from roughly 8.66% to 8.79% and modeled revenue growth easing from 14.83% to 13.00%, the market narrative is shifting to a more balanced view of Nutanix’s opportunity and execution risk. Read on to see how these changing assumptions are reshaping the story around Nutanix and how you can stay ahead of future narrative shifts.

    Stay updated as the Fair Value for Nutanix shifts by adding it to your watchlist or portfolio. Alternatively, explore our Community to discover new perspectives on Nutanix.

    🐂 Bullish Takeaways

    • Several firms, including Oppenheimer, JPMorgan, Piper Sandler, Barclays, and Needham, maintain positive stances (Outperform, Overweight, Buy) even after trimming price targets. This signals continued confidence in Nutanix’s long term growth and execution.

    • Oppenheimer, with a Street high $90 target, argues Nutanix is well positioned to benefit from the shift to HyperConverged Infrastructure, potential VMware displacement at renewal, and growing demand for unstructured data to power AI applications.

    • JPMorgan, with a modestly lower $78 target, still expects near term revenue and earnings upside from AI related demand. The firm suggests that AI leveraged use cases could support the company’s growth trajectory and valuation over time.

    • Needham, despite cutting its target to $65 from $80, highlights that a greater mix of contracts with future start dates mainly depresses in quarter revenue rather than free cash flow. The firm believes that, absent this timing issue, Nutanix would have exceeded the high end of revenue guidance.

    🐻 Bearish Takeaways

    • Price targets have been broadly revised down, with Piper Sandler moving to $72 from $88, Barclays to $64 from $82, JPMorgan to $78 from $81, and Needham to $65 from $80. These changes reflect tempered expectations for Nutanix’s near term growth and, by implication, its valuation upside.

    • Piper Sandler flags that Nutanix missed expectations for the first time in more than 5 years and cut its FY26 guide by about 3%. This combination has weighed on sentiment and raised questions about the durability of prior growth assumptions.

    • BWG Global has shifted its view to Mixed from Positive, and Northland has downgraded the stock to Market Perform from Outperform. These moves underscore a more cautious stance on risk reward and suggest that some of the upside may already be reflected in the share price.

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