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  • Institutional owners may consider drastic measures as CAR Group Limited’s (ASX:CAR) recent AU$814m drop adds to long-term losses

    Institutional owners may consider drastic measures as CAR Group Limited’s (ASX:CAR) recent AU$814m drop adds to long-term losses

    • Given the large stake in the stock by institutions, CAR Group’s stock price might be vulnerable to their trading decisions

    • A total of 25 investors have a majority stake in the company with 50% ownership

    • Analyst forecasts along with ownership data serve to give a strong idea about prospects for a business

    We’ve found 21 US stocks that are forecast to pay a dividend yield of over 6% next year. See the full list for free.

    Every investor in CAR Group Limited (ASX:CAR) should be aware of the most powerful shareholder groups. And the group that holds the biggest piece of the pie are institutions with 49% ownership. That is, the group stands to benefit the most if the stock rises (or lose the most if there is a downturn).

    And institutional investors endured the highest losses after the company’s share price fell by 6.2% last week. The recent loss, which adds to a one-year loss of 17% for stockholders, may not sit well with this group of investors. Also referred to as “smart money”, institutions have a lot of sway over how a stock’s price moves. As a result, if the downtrend continues, institutions may face pressures to sell CAR Group, which might have negative implications on individual investors.

    Let’s delve deeper into each type of owner of CAR Group, beginning with the chart below.

    Check out our latest analysis for CAR Group

    ASX:CAR Ownership Breakdown December 7th 2025

    Institutional investors commonly compare their own returns to the returns of a commonly followed index. So they generally do consider buying larger companies that are included in the relevant benchmark index.

    As you can see, institutional investors have a fair amount of stake in CAR Group. This implies the analysts working for those institutions have looked at the stock and they like it. But just like anyone else, they could be wrong. When multiple institutions own a stock, there’s always a risk that they are in a ‘crowded trade’. When such a trade goes wrong, multiple parties may compete to sell stock fast. This risk is higher in a company without a history of growth. You can see CAR Group’s historic earnings and revenue below, but keep in mind there’s always more to the story.

    earnings-and-revenue-growth
    ASX:CAR Earnings and Revenue Growth December 7th 2025

    CAR Group is not owned by hedge funds. Our data shows that State Street Global Advisors, Inc. is the largest shareholder with 7.2% of shares outstanding. BlackRock, Inc. is the second largest shareholder owning 6.2% of common stock, and The Vanguard Group, Inc. holds about 6.0% of the company stock.

    A deeper look at our ownership data shows that the top 25 shareholders collectively hold less than half of the register, suggesting a large group of small holders where no single shareholder has a majority.

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  • BRUIN Final Analysis: Pirtobrutinib Durable in Post-Covalent BTK CLL/SLL | Targeted Oncology

    BRUIN Final Analysis: Pirtobrutinib Durable in Post-Covalent BTK CLL/SLL | Targeted Oncology

    The noncovalent Bruton tyrosine kinase (BTK) inhibitor pirtobrutinib (Jaypirca) elicited objective response rate (ORR) of 81.6% (95% CI, 76.5%–85.9%) in patients with chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL) previously treated with a covalent BTK inhibitor, according to findings from the final analysis of the phase 1/2 BRUIN trial (NCT03740529) that were presented at the 2025 ASH Annual Meeting.1

    Best responses included complete response (CR; n = 11; 3.9%), CR with incomplete blood count recovery (n = 1; 0.4%), non–partial response (PR; n = 3; 1.1%), PR (n = 189; 67.0%), and PR with lymphocytosis (n = 26; 9.2%). In subgroup analysis, the highest ORRs were seen in patients with deletion 11q (n = 47; ORR, 91.5%; 95% CI, 79.6%–97.6%), complex karyotype (n = 33; ORR, 90.9%; 95% CI, 75.7%–98.1%), and 17p deletion and/or TP53 mutation (n = 104; ORR, 87.5%; 95% CI, 79.6%–93.2%). The populations that appeared to derive the least benefit were patients with mutated PLCg2 (n = 18; ORR, 55.6%; 95% CI, 30.8%–78.5%), unmutated BTK C481 (n = 97; ORR, 74.2%; 95% CI, 64.3%–82.6%), and mutated IGHV (n = 32; ORR, 75.0%; 95% CI, 56.6%–88.5%).

    “Pirtobrutinib continues to show favorable efficacy and promising overall survival [OS],” William G. Wierda, MD, PhD, lead study author and Endowed Distinguished Professor Jane and John Justin Distinguished Chair in Leukemia Research in the Department of Leukemia, Division of Cancer Medicine at The University of Texas MD Anderson Cancer Center in Houston, and coauthors wrote in the poster.

    Unmet Needs

    Intolerance or treatment resistance remains an issue with covalent BTK inhibitors despite their valued integration into the CLL/SLL armamentarium. Pirtobrutinib is a selective, noncovalent BTK inhibitor that was designed to work against common mechanisms associated with resistance to covalent inhibitors.

    Earlier findings from the BRUIN trial illustrated the agent’s efficacy and safety in patients with relapsed/refractory disease, including those with prior exposure to covalent inhibition. Data from the trial led to the agent’s accelerated approval from the FDA in December 2023, which was converted to full approval on December 3, 2025.2,3

    The phase 1 dose-escalation and -expansion portion of the trial modeled a 3+3 design, which allowed for intra-patient dose escalation, cohort expansion at doses deemed safe, and treatment with 25 to 300 mg of once daily pirtobrutinib via 28-day cycles.1 In phase 2, patients received 200 mg of once-daily pirtobrutinib.

    A total of 778 patients were enrolled: 166 with mantle cell lymphoma, 317 with CLL/SLL, and 295 with other malignancies. Of the 317 patients with CLL/SLL, 35 were BTK naive, and 282 had been exposed to covalent BTK inhibition. Of the latter group, 154 patients were BCL2 naive, and 128 had received BCL2 inhibition.

    Eligible patients were at least 18 years old and had previously treated, active disease in need of therapy, and an ECOG performance status between 0 and 2.

    Key end points included safety/tolerability, determination of the maximum tolerated dose/recommended phase 2 dose, pharmacokinetics, ORR, progression-free survival (PFS), time to next treatment (TTNT), and OS.

    Baseline characteristics across the board of patients with prior exposure to covalent BTK inhibition, BCL2 inhibition, and those naive to BCL2 inhibition revealed that most were male; had received prior BTK inhibition, anti-CD20 therapy, and chemotherapy; had discontinued treatment because of progressive disease; and had unmutated IGHV.

    Efficacy of Pirtobrutinib

    The median duration of response (DOR) was 18.4 months (95% CI, 14.8–20.3), and the 36-month DOR rate was 28.0% (95% CI, 21.6%-34.7%). At median follow-up of 49.9 months the median TTNT was 23.2 months (95% CI, 20.3-29.4). The 12-, 24-, 36-, 48-, and 60-month TTNT rates were 74.7%, 49.9%, 34.1%, 23.3%, and 21.5%, respectively.

    Median PFS was 18.7 months (95% CI, 16.6–21.8) at median follow-up of 44.2 months. The 12-, 24-, 36-, 48-, and 60-month PFS rates were 67.1%, 38.1%, 25.0%, 21.6%, and 17.6%, respectively. PFS was also subdivided between patients who were BCL2 naive and exposed. The median PFS was 15.9 months (95% CI, 13.6–17.5) in the exposed population and 22.3 months (95% CI, 19.3-27.6) in the naive population. The 12-, 24-, 36-, 48-, and 60-month PFS rates in the exposed cohort were 60.8%, 25.0%, 14.0%, 14.0%, and 14.0%, respectively. The 12-, 24-, 36-, 48-, and 60-month PFS rates in the naive cohort were 72.1%, 47.9%, 32.9%, 27.7%, and 21.7%, respectively.

    In all patients who received covalent BTK inhibition, the median OS was not estimable (95% CI, 47.8 months-NE) at a median follow-up of 46.5 months. The 12-, 24-, 36-, 48-, and 60-month OS rates were 85.5%, 72.2%, 62.0%, 56.0%, and 54.2%, respectively.

    Safety Profile

    The median time on treatment was 20.0 months (IQR, 9.6-37.7). TRAEs leading to dose reduction and discontinuation occurred in 11 (3.9%) and 9 (3.2%) patients, respectively.

    All-cause adverse effects (AEs) that occurred in at least 20% of patients included fatigue (any grade, 38.7%; grade ≥3, 1.8%), neutropenia (35.8%; 29.8%), diarrhea (30.5%; 0.4%), cough (29.8%; 0%), contusion (27.7%; 0%), COVID-19 (28.4%; 6.0%), dyspnea (23.4%; 2.5%), nausea (23.4%; 0%), and abdominal pain (21.6%; 2.1%). AEs of interest included infections (76.2%; 36.5%), bruising (31.2%; 0%), rash (25.2%; 1.1%), arthralgia (23.0%; 1.4%), hemorrhage (25.2%; 3.2%), hypertension (16.0%; 5.3%), and atrial fibrillation/flutter (5.0%; 2.1%).

    Treatment-related adverse effects (TRAEs) that occurred in at least 20% of patients included fatigue (any grade, 3.9%; grade ≥3, 0%), neutropenia (20.6%; 16.3%), diarrhea (8.9%; 0%), cough (2.1%; 0%), contusion (18.8%; 0%), COVID-19 (0.7%; 0%), dyspnea (0.7%; 0.4%), nausea (3.9%; 0%), and abdominal pain (2.1%; 0.4%). AEs of interest included infections (14.9%; 5.7%), bruising (20.2%; 0%), rash (5.7%; 0.4%), arthralgia (4.6%; 0%), hemorrhage (8.2%; 1.4%), hypertension (3.9%; 0.7%), and atrial fibrillation/flutter (1.4%; 0.7%).

    “Pirtobrutinib remains well tolerated with low rates of dose reduction or discontinuation due to TRAEs and low rates of grade 3 or greater hypertension, hemorrhage/hematoma, and atrial fibrillation/atrial flutter, which are risks with covalent BTK inhibitor treatment,” the authors concluded.

    DISCLOSURES: No disclosures were listed.

    REFERENCES
    1. Wierda W, Brown J, Ghia P, et al. Pirtobrutinib in post-BTKi CLL/SLL: final update from the phase 1/2 BRUIN study with more than 5-years follow-up. Blood. 2025;146(suppl 1):2115. doi:10.1182/blood-2025-2115
    2. FDA grants accelerated approval to pirtobrutinib for chronic lymphocytic leukemia and small lymphocytic lymphoma. FDA. Updated December 7, 2023. Accessed December 7, 2025. https://tinyurl.com/mec3c3t3
    3. FDA grants traditional approval to pirtobrutinib for chronic lymphocytic leukemia and small lymphocytic lymphoma. FDA. December 3, 2025. Accessed December 7, 2025. https://tinyurl.com/46522682

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  • Assessing Valuation After A$139m Discounted Raise to Accelerate Green Bay Project

    Assessing Valuation After A$139m Discounted Raise to Accelerate Green Bay Project

    FireFly Metals (ASX:FFM) has just locked in over A$139 million via discounted follow on equity raisings, giving it the firepower to accelerate drilling and de risk its Green Bay copper gold project in Canada ahead of a potential 2026 investment decision.

    See our latest analysis for FireFly Metals.

    Those fresh placements and conference appearances come after a strong run, with FireFly’s share price delivering a 90 day share price return of 50.0 percent and a year to date share price return of 103.39 percent. The 3 year total shareholder return of 114.29 percent suggests momentum has been building rather than fading.

    If FireFly’s latest raise has you thinking about what else could be gearing up for the next leg higher, it might be worth exploring fast growing stocks with high insider ownership.

    With FireFly trading just below analyst targets after a powerful rerating, are investors still being paid for execution and project risk here, or has the market already baked in the next leg of Green Bay driven growth?

    FireFly’s last close at A$1.80 equates to a 3.8 times price to book ratio, leaving the stock looking cheaper than many direct peers but still richer than the broader Australian metals and mining space.

    The price to book ratio compares a company’s market value to its net assets on the balance sheet. It is often a key yardstick for early stage explorers that are yet to generate meaningful revenue or profits. For FireFly, this multiple effectively tells investors how much of a premium the market is placing on its Green Bay development plans and broader exploration portfolio versus the underlying accounting value of its assets.

    On one hand, FireFly is considered good value relative to a peer average multiple of 25.7 times. This suggests the market is not assigning the sort of blue sky premium reserved for the most hyped growth stories in the sector. On the other hand, the stock screens as expensive against the wider Australian metals and mining industry, where the average price to book ratio sits at 2.2 times, implying investors are already paying a notable premium for its project pipeline and execution track record.

    While the absence of a fair ratio estimate means there is no regression based anchor for where the multiple could normalise to, the current 3.8 times level clearly embeds higher expectations than the sector overall, even if it remains a fraction of the peer group headline figure.

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

    Result: Price to book of 3.8x (ABOUT RIGHT)

    However, investors still face permitting, funding and execution risks at Green Bay, where delays or cost blowouts could quickly challenge the current premium valuation.

    Find out about the key risks to this FireFly Metals narrative.

    If you prefer to dig into the numbers yourself and stress test the assumptions, you can build a bespoke view in under three minutes: Do it your way.

    A great starting point for your FireFly Metals research is our analysis highlighting 3 important warning signs that could impact your investment decision.

    Before you stop at FireFly, lock in your edge by scanning fresh opportunities on Simply Wall St, where curated screeners surface ideas many investors overlook.

    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 FFM.AX.

    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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  • Pirtobrutinib Delivers Strong Responses and Durable Benefit in Pretreated CLL/SLL in Final BRUIN Analysis

    Pirtobrutinib Delivers Strong Responses and Durable Benefit in Pretreated CLL/SLL in Final BRUIN Analysis

    Treatment with the noncovalent BTK inhibitor pirtobrutinib (Jaypirca) led to an objective response rate (ORR) of 81.6% (95% CI, 76.5%-85.9%) in patients with chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL) previously treated with a covalent BTK inhibitor, according to findings from the final analysis of the phase 1/2 BRUIN trial (NCT03740529) that were presented at the 2025 ASH Annual Meeting.1

    Best responses included complete response (CR; n = 11; 3.9%), CR with incomplete blood count recovery (n = 1; 0.4%), non–partial response (PR; n = 3; 1.1%), PR (n = 189; 67.0%), and PR with lymphocytosis (n = 26; 9.2%). In subgroup analysis, the highest ORRs were seen in patients with deletion 11q (n = 47; ORR, 91.5%; 95% CI, 79.6%-97.6%), complex karyotype (n = 33; ORR, 90.9%; 95% CI, 75.7%-98.1%), and 17p deletion and/or TP53 mutation (n = 104; ORR, 87.5%; 95% CI, 79.6%-93.2%). The populations that appeared to derive the least benefit were patients with mutated PLCg2 (n = 18; ORR, 55.6%; 95% CI, 30.8%-78.5%), unmutated BTK C481 (n = 97; ORR, 74.2%; 95% CI, 64.3%-82.6%), and mutated IGHV (n = 32; ORR, 75.0%; 95% CI, 56.6%-88.5%).

    “Pirtobrutinib continues to show favorable efficacy and promising overall survival [OS],” William G. Wierda, MD, PhD, lead study author and Endowed Distinguished Professor Jane and John Justin Distinguished Chair in Leukemia Research in the Department of Leukemia, Division of Cancer Medicine at The University of Texas MD Anderson Cancer Center in Houston, and coauthors wrote in the poster.

    What Stands Out From the Final BRUIN Dataset

    1. Pirtobrutinib achieved an ORR of 81.6% in patients previously treated with covalent BTK inhibitors, with promising durability and survival outcomes.
    1. The agent remained well tolerated, showing low rates of treatment-related discontinuation and fewer high-grade toxicities than typically seen with covalent BTK inhibitors.
    1. Efficacy was consistent across subgroups, although responses were lower in patients with PLCg2 mutations, unmutated BTK C481, and mutated IGHV.

    What challenges drive the need for a non-covalent BTK inhibitor like pirtobrutinib?

    Intolerance or treatment resistance remains an issue with covalent BTK inhibitors despite their valued integration into the CLL/SLL armamentarium. Pirtobrutinib is a selective, noncovalent BTK inhibitor that was designed to work against common mechanisms associated with resistance to covalent inhibitors.

    Earlier findings from the BRUIN trial illustrated the agent’s efficacy and safety in patients with relapsed/refractory disease, including those with prior exposure to covalent inhibition. Data from the trial led to the agent’s accelerated approval from the FDA in December 2023, which was converted to full approval on December 3, 2025.2,3 

    The phase 1 dose-escalation and -expansion portion of the trial modeled a 3+3 design, which allowed for intra-patient dose escalation, cohort expansion at doses deemed safe, and treatment with 25 to 300 mg of once daily pirtobrutinib via 28-day cycles.1 In phase 2, patients received 200 mg of once-daily pirtobrutinib.

    A total of 778 patients were enrolled: 166 with mantle cell lymphoma, 317 with CLL/SLL, and 295 with other malignancies. Of the 317 patients with CLL/SLL, 35 were BTK naive, and 282 had been exposed to covalent BTK inhibition. Of the latter group, 154 patients were BCL2 naive, and 128 had received BCL2 inhibition.

    Eligible patients were at least 18 years old and had previously treated, active disease in need of therapy, and an ECOG performance status between 0 and 2.

    Key end points included safety/tolerability, determination of the maximum tolerated dose/recommended phase 2 dose, pharmacokinetics, ORR, progression-free survival (PFS), time to next treatment (TTNT), and OS.

    Baseline characteristics across the board of patients with prior exposure to covalent BTK inhibition, BCL2 inhibition, and those naive to BCL2 inhibition revealed that most were male; had received prior BTK inhibition, anti-CD20 therapy, and chemotherapy; had discontinued treatment because of progressive disease; and had unmutated IGHV.

    How effective is pirtobrutinib after prior covalent BTK inhibition?

    The median duration of response (DOR) was 18.4 months (95% CI, 14.8-20.3), and the 36-month DOR rate was 28.0% (95% CI, 21.6%-34.7%). At median follow-up of 49.9 months the median TTNT was 23.2 months (95% CI, 20.3-29.4). The 12-, 24-, 36-, 48-, and 60-month TTNT rates were 74.7%, 49.9%, 34.1%, 23.3%, and 21.5%, respectively.

    Median PFS was 18.7 months (95% CI, 16.6-21.8) at median follow-up of 44.2 months. The 12-, 24-, 36-, 48-, and 60-month PFS rates were 67.1%, 38.1%, 25.0%, 21.6%, and 17.6%, respectively. PFS was also subdivided between patients who were BCL2 naive and exposed. The median PFS was 15.9 months (95% CI, 13.6-17.5) in the exposed population and 22.3 months (95% CI, 19.3-27.6) in the naive population. The 12-, 24-, 36-, 48-, and 60-month PFS rates in the exposed cohort were 60.8%, 25.0%, 14.0%, 14.0%, and 14.0%, respectively. The 12-, 24-, 36-, 48-, and 60-month PFS rates in the naive cohort were 72.1%, 47.9%, 32.9%, 27.7%, and 21.7%, respectively.

    In all patients who received covalent BTK inhibition, the median OS was not estimable (95% CI, 47.8 months-NE) at a median follow-up of 46.5 months. The 12-, 24-, 36-, 48-, and 60-month OS rates were 85.5%, 72.2%, 62.0%, 56.0%, and 54.2%, respectively.

    What does the safety profile reveal about pirtobrutinib’s tolerability?

    The median time on treatment was 20.0 months (IQR, 9.6-37.7). TRAEs leading to dose reduction and discontinuation occurred in 11 (3.9%) and 9 (3.2%) patients, respectively.

    All-cause adverse effects (AEs) that occurred in at least 20% of patients included fatigue (any grade, 38.7%; grade ≥3, 1.8%), neutropenia (35.8%; 29.8%), diarrhea (30.5%; 0.4%), cough (29.8%; 0%), contusion (27.7%; 0%), COVID-19 (28.4%; 6.0%), dyspnea (23.4%; 2.5%), nausea (23.4%; 0%), and abdominal pain (21.6%; 2.1%). AEs of interest included infections (76.2%; 36.5%), bruising (31.2%; 0%), rash (25.2%; 1.1%), arthralgia (23.0%; 1.4%), hemorrhage (25.2%; 3.2%), hypertension (16.0%; 5.3%), and atrial fibrillation/flutter (5.0%; 2.1%).

    Treatment-related adverse effects (TRAEs) that occurred in at least 20% of patients included fatigue (any grade, 3.9%; grade ≥3, 0%), neutropenia (20.6%; 16.3%), diarrhea (8.9%; 0%), cough (2.1%; 0%), contusion (18.8%; 0%), COVID-19 (0.7%; 0%), dyspnea (0.7%; 0.4%), nausea (3.9%; 0%), and abdominal pain (2.1%; 0.4%). AEs of interest included infections (14.9%; 5.7%), bruising (20.2%; 0%), rash (5.7%; 0.4%), arthralgia (4.6%; 0%), hemorrhage (8.2%; 1.4%), hypertension (3.9%; 0.7%), and atrial fibrillation/flutter (1.4%; 0.7%).

    “Pirtobrutinib remains well tolerated with low rates of dose reduction or discontinuation due to TRAEs and low rates of grade 3 or greater hypertension, hemorrhage/hematoma, and atrial fibrillation/atrial flutter, which are risks with covalent BTK inhibitor treatment,” the authors concluded.

    Disclosures: No disclosures were listed.

    References

    1. Wierda W, Brown J, Ghia P, et al. Pirtobrutinib in post-BTKi CLL/SLL: final update from the phase 1/2 BRUIN study with more than 5-years follow-up. Blood. 2025;146(suppl 1):2115. doi:10.1182/blood-2025-2115
    2. FDA grants accelerated approval to pirtobrutinib for chronic lymphocytic leukemia and small lymphocytic lymphoma. FDA. Updated December 7, 2023. Accessed December 7, 2025. https://www.fda.gov/drugs/resources-information-approved-drugs/fda-grants-accelerated-approval-pirtobrutinib-chronic-lymphocytic-leukemia-and-small-lymphocytic
    3. FDA grants traditional approval to pirtobrutinib for chronic lymphocytic leukemia and small lymphocytic lymphoma. FDA. December 3, 2025. Accessed December 7, 2025. https://www.fda.gov/drugs/resources-information-approved-drugs/fda-grants-traditional-approval-pirtobrutinib-chronic-lymphocytic-leukemia-and-small-lymphocytic

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  • “Smart” Strategy of Up-front Targeted Therapy Reduces Need for Chemo in LBCL

    “Smart” Strategy of Up-front Targeted Therapy Reduces Need for Chemo in LBCL

    More than half of patients with newly diagnosed large B-cell lymphoma (LBCL) may reduce or remove chemotherapy with a targeted therapy–first strategy, according to data from the primary analysis of the Smart Stop trial (NCT04978584) presented at the 2025 ASH Annual Meeting.1 Further, the “smart” strategy of utilizing targeted therapy first appeared to be successful and preserve curative intent and did not impact patient response to chemotherapy.

    “In this study, we showed very promising outcomes, both in terms of response rates and durability of response,” Jason Westin, MD, professor in the Department of Lymphoma and Myeloma, director of the Lymphoma Clinical Research Program, executive leader of the Lymphoma & Myeloma Service Line, and chief of Aggressive and Indolent Lymphoma at The University of Texas MD Anderson Cancer Center, in Houston, said during a presentation of the data.

    How effective is the “smart” strategy in treating LBCL?

    In the study, 61 patients were treated in 21-day cycles with 25 mg lenalidomide (Revlimid) daily on days 1 through 10; 12mg/kg intravenous (IV) tafasitamab (Monjuvi) weekly on day 1, 8, and 15; 375 mg/m2 IV rituximab (Rituxan) on day 1; and 100 mg oral acalabrutinib (Calquence) twice daily on days 1 to 21 (LTRA). Patients received LTRA only for the first 4 cycles. All patients continued the LTRA regimen for 6 additional cycles, which included 6 cycles of CHOP if patients did not achieve an initial CR (groups B and D). In cohort 1, those in CR received only 2 cycles of CHOP (group A); in cohort 2, those in CR continued without CHOP (group C).

    After 4 cycles of the LTRA regimen, the overall response rate (ORR) was 90%, including complete response (CR) and partial response (PR) rates of 57% and 33%, respectively. In addition, the CR rate at the end of treatment was 96.7%.

    In particular, cohort 1 experienced a 100% ORR, which included CR and PR rates of 63% and 37%, respectively. “Remember, these patients already had a complete response at the end of LTRA, so they maintain that throughout the duration of their treatment,” Westin said. Cohort 2 demonstrated CR and PR rates of 52% and 29%, respectively.

    The 2-year progression-free survival (PFS) and overall survival (OS) rates were 86.5% and 98.4%, respectively, after a median follow-up of 25.3 months. “In patients who had the two cycles of CHOP, their progression-free survival has been outstanding,” Westin explained.

    After a median follow-up of 19 months, 12 patients are ongoing with a CR. Westin noted that all 4 patients who had progression have achieved a complete response with subsequent frontline chemotherapy regimens.

    Among those who had less than a CR after 4 cycles of LTRA and went on to receive CHOP plus LTRA therapy for 6 cycles, CR rate was 92%. “This is important. This shows that lack of response to the target therapy did not compromise the ability to deliver and have a promising result to the chemotherapy,” Westin said.

    Why focus on administering targeted therapy first in newly diagnosed LBCL?

    Westin noted that the CHOP regimen, although successful over the past 50 years, fails to cure 1 in 3 patients with newly diagnosed LBCL. “It’s poorly targeted,” he said, adding that the current classification system is also limiting in this disease setting. “We don’t have access to our current classification systems in real time to make treatment decisions, and I would also argue that they have limited utility in determining which treatment will benefit which patient.”

    However, he acknowledged that the budding problem in the LBCL space may be a good one to have, in that there are a variety of emerging therapies. “We have an emerging problem in large B-cell lymphoma of an incredible wealth of new agents that are [are being evaluated] in phase 3 [trials]. But effectively, these studies are all 1970s chemotherapy vs 1970s chemotherapy with a novel agent added to it,” Westin said. “But I would argue we’ve got a coming challenge, which I like to call a coming chaos of choice. We have so many cool new drugs coming along that we are going to enter an era very soon [where] all of these great new agents showing promise in phase 3 trials [will be met] with uncertainty as to which patient will benefit from which therapy.”

    With that, he added that the question of the role of chemotherapy in this era of emerging therapies remains. To this end, the investigators conducted the Smart Stop trial, which was designed to evaluate whether chemotherapy could be reduced or removed in patients with newly diagnosed LBCL who respond to initial targeted therapy.

    How was the Smart Stop trial conducted?

    The phase 2, open-label, single center trial enrolled patients with newly diagnosed LBCL who were at least 18 years of age, had an ECOG performance status of less than 3, and had adequate organ and bone marrow function. Patients were ineligible if they had central nervous system involvement with their lymphoma. The primary objectives of the study were to determine the ORR after 4 cycles of LTRA and CR at the end of therapy with LTRA, with or without CHOP.

    The median patient age was 61 years (range, 23-91). More than half of patients reported with an ECOG performance status of 1 (56%), 70% had elevated lactate dehydrogenase, 75% of patients reported with stage III or IV disease, and, of note, 56% had an International Prognostic Index score of 3 to 5, with 72% of patients being high risk in the study. Further, Westin noted that there was an enrichment for the non–Germinal Center B-cell (GCB)–like subtype. “However, more than one-third of patients had the GCB subtype on this study, and notably via FISH testing, we had 16% of patients with MYC and BCL2 or BCL6 translocations, aka double hit.”

    Preliminary results from cohort 1 (n = 30), previously reported at the 2023 ASH Annual Meeting,2 showed that 63% of patients achieved a CR by PET/CT and 33% had undetectable circulating tumor DNA using the phasED-Seq assay after 4 cycles of targeted therapy. Further, at end of treatment, 100% of patients experienced a CR.

    The majority of planned doses of lenalidomide (88%), tafasitamab (93%), and acalabrutinib (100%) were received. The median number of LTRA cycles delivered was 10 (range, 1-10).1

    What was the safety profile of the Smart Stop approach?

    The most common any-grade adverse effects were anemia (90%), neutropenia (87%), platelet count decreased (77%), fatigue (67%), maculopapular rash (46%), transaminitis (43%), nausea (38%), headache (36%), increased creatinine (36%), infections and infestations (33%), infusion-related reaction (31%), constipation (31%), edema (28%), peripheral sensory neuropathy (23%), COVID infection (21%), cough (18%), dizziness (16%), diarrhea (15%), vomiting (15%), oral mucositis (12%), and febrile neutropenia (7%).

    “The smart strategy of targeted therapy first is successful, and it preserves curative intent,” Westin said. “In this study, we showed very promising outcomes, both in terms of response rates and durability of response. The smart strategy of targeted therapy first showed that more than half of patients may reduce or remove chemotherapy for newly diagnosed diffuse large B-cell lymphoma…Smart strategy, targeted therapy first does not impact the response to chemotherapy. So, for those patients who did not achieve a complete response or had a complete response and ultimately had progression of their disease, they had very favorable outcomes when they received CHOP regimens.”

    What are the next steps for this research?

    Next, Westin noted that the investigators plan to expand the Smart Stop trial to a multisite trial, as well as evaluate glofitamab (Columvi), polatuzumab (Polivy), and golcadomide as a smart strategy.

    “We’re also very optimistic about the potential for multiple randomized trials using the smart strategy of targeted therapy combinations, saving chemotherapy for those who don’t benefit, randomized against our chemotherapy,” Westin concluded.

    Disclosures: Westin disclosed serving in a consultancy role for Allogene Therapeutics, AbbVie/Genmab, Regeneron, Genentech/Roche, AstraZeneca, Chugai Pharma, ADC Therapeutics, Bristol Myers Squibb, Nurix, Kite/Gilead, Morphosys/Incyte, Novartis, Pfizer, and Janssen. Research funding was provided by Allogene Therapeutics, Regeneron, Genentech/Roche, AstraZeneca, ADC Therapeutics, Bristol Myers Squibb, Nurix, Kite/Gilead, Morphosys/Incyte, Novartis, and Janssen.

    References

    1. Westin J, Fayad L, Steiner R, et al. Primary analysis of the smart stop trial: Lenalidomide, tafasitamab, rituximab, and acalabrutinib alone and with combination chemotherapy in newly diagnosed diffuse large B-cell lymphoma. Blood. 2025;146(suppl 1):abstract 477. doi:10.1182/blood-2025-477
    2. Westin J, Steiner RE, Chihara D, et al. Smart Stop: Lenalidomide, tafasitamab, rituximab, and acalabrutinib alone and with combination chemotherapy for the treatment of newly diagnosed diffuse large B-cell lymphoma. Blood. 2023;142(suppl 1):856. doi:10.1182/blood-2023-180381

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  • Exclusive: Ben & Jerry's board chair does not plan to resign as pressure mounts from Unilever unit – Reuters

    1. Exclusive: Ben & Jerry’s board chair does not plan to resign as pressure mounts from Unilever unit  Reuters
    2. Exclusive: Unilever-backed audit finds deficiencies in financial controls, governance at Ben & Jerry’s Foundation  Reuters
    3. Ben & Jerry’s founders told to ‘hand over to a new generation’ by Magnum boss  Financial Times
    4. Ben, Jerry Told to “Hand Over” Ben & Jerry’s by Corporate Big Wigs  Mother Jones
    5. Ben & Jerry’s pro-Gaza stance risks derailing £7bn spin-off  The Telegraph

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  • Owning 36% in Magnetic Resources NL (ASX:MAU) means that insiders are heavily invested in the company’s future

    Owning 36% in Magnetic Resources NL (ASX:MAU) means that insiders are heavily invested in the company’s future

    • Significant insider control over Magnetic Resources implies vested interests in company growth

    • 51% of the business is held by the top 8 shareholders

    • Past performance of a company along with ownership data serve to give a strong idea about prospects for a business

    AI is about to change healthcare. These 20 stocks are working on everything from early diagnostics to drug discovery. The best part – they are all under $10bn in marketcap – there is still time to get in early.

    To get a sense of who is truly in control of Magnetic Resources NL (ASX:MAU), it is important to understand the ownership structure of the business. We can see that individual insiders own the lion’s share in the company with 36% ownership. Put another way, the group faces the maximum upside potential (or downside risk).

    So it follows, every decision made by insiders of Magnetic Resources regarding the company’s future would be crucial to them.

    In the chart below, we zoom in on the different ownership groups of Magnetic Resources.

    See our latest analysis for Magnetic Resources

    ASX:MAU Ownership Breakdown December 7th 2025

    Institutions typically measure themselves against a benchmark when reporting to their own investors, so they often become more enthusiastic about a stock once it’s included in a major index. We would expect most companies to have some institutions on the register, especially if they are growing.

    Institutions have a very small stake in Magnetic Resources. That indicates that the company is on the radar of some funds, but it isn’t particularly popular with professional investors at the moment. So if the company itself can improve over time, we may well see more institutional buyers in the future. It is not uncommon to see a big share price rise if multiple institutional investors are trying to buy into a stock at the same time. So check out the historic earnings trajectory, below, but keep in mind it’s the future that counts most.

    earnings-and-revenue-growth
    ASX:MAU Earnings and Revenue Growth December 7th 2025

    Hedge funds don’t have many shares in Magnetic Resources. Our data shows that Chimseng Oan is the largest shareholder with 12% of shares outstanding. Target Range Pty Ltd is the second largest shareholder owning 10% of common stock, and Hian Chan holds about 10% of the company stock. Hian Chan, who is the third-largest shareholder, also happens to hold the title of Member of the Board of Directors. Additionally, the company’s CEO George Sakalidis directly holds 2.7% of the total shares outstanding.

    We did some more digging and found that 8 of the top shareholders account for roughly 51% of the register, implying that along with larger shareholders, there are a few smaller shareholders, thereby balancing out each others interests somewhat.

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  • HP’s chief commercial officer predicts the future will include AI PCs that don’t use the cloud

    HP’s chief commercial officer predicts the future will include AI PCs that don’t use the cloud

    Increased focus on “privacy and security” may open the door for AI-enabled devices rather than rely entirely on cloud computing and remote data centers. 

    “In a world where sovereign data retention matters, people want to know that if they input data to a model, the model won’t train on their data,” David McQuarrie, HP’s chief commercial officer, told Fortune in October. Using an AI locally provides that reassurance.

    HP, like many of its devicemaking peers, is exploring the use of AI PCs, or devices that can use AI locally as opposed to in the cloud. “Longer term, it will be impossible not to buy an AI PC, simply because there’s so much power in them,” he said. 

    More broadly, smaller companies might be served just as well by a smaller model running locally than a larger model running in the cloud. “A company, a small business, or an individual has significant amounts of data that need not be put in the cloud,” he said. 

    Asian governments have often had stricter rules on data sovereignty. China, in particular, has significantly tightened its regulations on where Chinese user data can be stored. South Korea is another example of an Asian country that treats some locally sourced data as too sensitive to be housed overseas. 

    Governments the world over, and particularly in Asia, are also investing in local sovereign AI capabilities, trying to avoid relying entirely on systems and platforms housed wholly overseas. South Korea, for example, is partnering with local tech companies like search giant Naver to build its own AI systems. Singapore is investing in projects like the Southeast Asian Languages in One Network (SEA-LION), which are better tailored to Southeast Asian countries. 

    Asian AI adoption

    Asia is HP’s smallest region, but also its fastest-growing. Revenue from Asia-Pacific and Japan grew by 7% over the company’s 2025 fiscal year, which ended in October, to hit $13.3 billion. That’s around a quarter of HP’s total revenue of $55.3 billion. (HP’s other two regions are the Americas; and Europe, the Middle East, and Africa.)

    McQuarrie also suggested that there was an opportunity to be “disruptive” in Asia. While many business leaders have been eager to embrace AI, at least rhetorically, actual adoption is proving more difficult. A recent survey from McKinsey reports that two-thirds of companies are still in the experimentation phase of AI. 

    But McQuarrie believed that AI adoption in Asia could be “just as quick, if not quicker,” than other regions. 

    Asia seems to be more comfortable with the use of AI, at least when it comes to users. An October survey from Pew found that fewer people in countries like India, South Korea and Japan reported feeling “more concerned than excited” about AI compared to the U.S. 

    When it comes to convincing more companies to adopt AI, let alone AI PCs, McQuarrie said the answer was to make AI functions as seamless as possible, so “that it doesn’t really matter whether you understand that you’re embracing AI or not.”

    “What we’re doubling down on is the future of work,” McQuarrie said. “The future of work is a device that makes your experience better and your productivity greater.”

    “The fact that we’re using AI in the background? They don’t need to know that.”

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  • Bond Traders Defy Fed and Spark Heated Debate on Wall Street

    Bond Traders Defy Fed and Spark Heated Debate on Wall Street

    (Bloomberg) — The bond market’s reaction to the Federal Reserve’s interest-rate cuts has been highly unusual. By some measures, a disconnect like this, with Treasury yields climbing as the central bank lowers rates, hasn’t been seen since the 1990s.

    What the divergence indicates is a matter of heated debate. Opinions are all over the place, from the bullish (a sign of confidence that recession will be averted) to the more neutral (a return to pre-2008 market norms) to the favorite culprit of the so-called bond vigilantes (investors are losing confidence the US will ever rein in the constantly swelling national debt).

    Most Read from Bloomberg

    But one thing is clear: the bond market isn’t buying President Donald Trump’s idea that faster rate cuts will send bond yields sliding down and, in turn, slash the rates on mortgages, credit cards and other types of loans.

    With Trump soon able to replace Chair Jerome Powell with his own nominee, on top of everything else is the risk of the Fed squandering its credibility by caving to political pressure to ease policy more aggressively — which could backfire by fanning already elevated inflation and pushing yields higher.

    “Trump 2.0 is all about getting long-term yields down,” Steven Barrow, head of G10 strategy at Standard Bank in London. “Putting a political figure at the Fed will not get bond yields down.”

    The Fed started pulling its benchmark rate down from a more than two-decade high in September 2024 and has since cut it by 1.5 percentage points to a range of 3.75% to 4%. Traders see another quarter point cut after the next meeting on Wednesday as virtually assured and are pricing in two more such moves next year, which would bring its rate to around 3%.

    Yet, key Treasury yields — which serve as the main baseline for the borrowing costs paid by American consumers and corporations — haven’t come down at all. Ten-year yields have risen nearly half a percentage point to 4.1% since the Fed started easing policy and 30-year yields are up over 0.8 percentage point.

    Normally, when the Fed moves short-term policy rates up and down, long-term bond yields tend to follow. Even in the only two easing cycles outside of recessions over the past four decades – in 1995 and 1998, when the Fed cut only 75 basis points each time — the 10-year yield dropped outright or rose less than they have during the current episode.

    Jay Barry, head of global rates strategy at JPMorgan Chase & Co., sees two factors behind it. The scale of the Fed’s hikes during the post-pandemic inflation surge was so steep that markets started pricing-in the Fed’s about-face well before it started, with 10-year yields peaking in late 2023. That blunted the impact once it began.

    Moreover, by slashing interest rates even when inflation remains elevated, he said, the Fed is lessening the risk of a recession, limiting the scope for yields to fall.

    “The Fed is looking to sustain this expansion, not end it,” said Barry. “That’s why rates have not moved aggressively lower.”

    Others see a less benign interpretation in the so-called term premium, a measure of the extra yield investors demand in return for holding long-term bonds.

    That compensates them for potential risks down the line — like elevated inflation or an unsustainable federal debt load. And that premium has risen nearly a full percentage point since the rate-cut cycle began, according to the New York Fed estimates.

    For Jim Bianco, president of Bianco Research, it’s a signal that bond traders are worried that the Fed is cutting rates even as inflation remains stubbornly above its 2% target and the economy keeps defying recession fears.

    “The market is really concerned about the policy,” said Bianco. “The concern is that the Fed has gone too far.”

    If the Fed continues to cut rates, the mortgage rates will go “vertical,” he added.

    There’s also angst that Trump — after breaking sharply from his predecessor’s deference to the Fed’s independence — will succeed in pressuring policymakers to continue cutting rates. Kevin Hassett, the White House National Economic Council Director and a Trump loyalist, is the betting market’s favorite to succeed Powell when his term ends in May.

    What Bloomberg Strategists say…

    If rate cuts increase the likelihood of stronger growth, they won’t be met with lower yields. We’ll end up with higher ones. In many respects, this is because we’re going back to a normal interest rate regime, where 2% real returns and a 2% Fed inflation target produces a 4% floor for long-term yields. Add in stronger growth and the numbers go higher from there.

    —Ed Harrison, Bloomberg Markets Live strategist. Read more here.

    So far, though, the broader bond market has remained relatively stable, with 10-year yields hovering not far from 4% over the past few months. And breakeven rates — a main gauge of the bond market’s inflation expectations — have been stable as well, indicating that fears of a Fed-fueled inflation surge down the line may be overstated.

    Robert Tipp, chief investment strategist fixed income at PGIM, said it looks more than anything like a return to the normal levels seen before the Global Financial Crisis, which ushered in a long era of unusually low interest rates that abruptly ended after the pandemic.

    “We’re back at the normal level of rates world,” he said.

    Standard Bank’s Barrow said the Fed’s lack of control over the longer-term yields reminds him of a similar — if opposite — bind the central bank faced in the mid-2000s that became known as the Greenspan conundrum.

    At that time, Chair Alan Greenspan was puzzled why the long-term yields remained low even as he jacked up the short-term policy rate. Greenspan’s successor Ben Bernanke later attributed the conundrum to too much savings from overseas flooding into Treasuries.

    Today, Barrow said, that dynamic is reversed as governments around major economies are borrowing too much. That saving glut, in other words, has turned into a bond-supply glut that’s keeping consistently upward pressure on yields.

    “It’s possibly a structural move that bond yields are not going down,” Barrow said. “At the end of the day, central banks don’t determine the long term rate.”

    What to Watch:

    (Updates wording of first and second paragraphs.)

    Most Read from Bloomberg Businessweek

    ©2025 Bloomberg L.P.

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  • Lilly's Jaypirca (pirtobrutinib) met its primary endpoint in first-of-its-kind, head-to-head Phase 3 study versus Imbruvica (ibrutinib) – Eli Lilly and Company

    1. Lilly’s Jaypirca (pirtobrutinib) met its primary endpoint in first-of-its-kind, head-to-head Phase 3 study versus Imbruvica (ibrutinib)  Eli Lilly and Company
    2. Targeted BTK Therapy Improves Survival in Untreated CLL/SLL  Physician’s Weekly
    3. At ASH, Lilly makes case to widen Jaypirca use in leukemia, lymphoma  BioPharma Dive
    4. FDA Approves Pirtobrutinib for Relapsed or Refractory Chronic Lymphocytic Leukemia  Pharmacy Times
    5. Jaypirca shows promise as a frontline treatment for CLL/SLL patients | ASH 2025  Managed Healthcare Executive

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