Category: 3. Business

The addition of nab-paclitaxel to relacorilant (Abraxane) further improved progression-free survival (PFS) vs nab-paclitaxel alone in patients with platinum-resistant ovarian cancer, meeting the primary end point of the phase 3 ROSELLA trial (NCT05257408) and demonstrating the potential for this combination to improve upon the current standard of care (SOC), according to Domenica Lorusso, MD, PhD.¹

Data from the study, which were previously presented at both the 2025 ASCO Annual Meeting and the 2025 ESMO Gynecological Cancers Congress, revealed that the median PFS in the overall population was 6.54 months (95% CI, 5.55-7.43) and 5.52 months (95% CI, 3.94-5.88) with relacorilant plus nab-paclitaxel (n = 188) vs nab-paclitaxel (n = 193), respectively (HR, 0.70; 95% CI, 0.54-0.91; P = .0076). At 6 months, the respective PFS rates were 52% vs 42%. At 12 months, respective PFS rates were 25% vs 13%.

“More than 60% of these patients had [previously] received PARP inhibitors,” Lorusso explained during an interview with OncLive®. “We know that these patients are very difficult to treat, as [many] of these patients are [not only] resistant to PARP [inhibitors], but are also resistant to platinum[-based chemotherapy]. It’s a huge unmet clinical need to identify treatments that are effective for patients progressing during PARP [inhibitor therapy].”

In the interview, Lorusso discussed the background of the ROSELLA trial, efficacy and safety data from the study, potential clinical implications, and next steps for evaluating the relacorilant-based regimen.

Lorusso is the director of the Gynecological Oncology Unit at Humanitas Hospital San Pio X in Milan, as well as a full professor of Obstetrics and Gynecology at Humanitas University in Rozzano, Italy.

OncLive: What was the rationale and design of the ROSELLA trial?

Lorusso: We have discovered that glucocorticoid receptor signaling can reduce sensitivity to chemotherapy. Preclinical and early clinical data suggest that ovarian cancer expresses the glucocorticoid receptor, which is a marker of poor prognosis. The data suggest that when cortisol activates the glucocorticoid receptor, it can induce the transcription of anti-apoptotic genes that are involved in epithelial-mesenchymal transition and resistance to chemotherapy. This is why targeting this receptor with relacorilant, a selective glucocorticoid receptor antagonist, is interesting. We have phase 2 data suggesting that when we combine intermittent relacorilant with nab-paclitaxel, we can increase PFS and overall survival [OS] in platinum-resistant ovarian cancer. We chose nab-paclitaxel instead of weekly paclitaxel, which is more commonly used in ovarian cancer because nab-paclitaxel does not require corticosteroid premedication. Because relacorilant is a glucocorticoid receptor antagonist, we only combine drugs that do not require a glucocorticoid receptor.

The ROSELLA trial is a randomized phase 3 trial comparing nab-paclitaxel with relacorilant plus nab-paclitaxel in platinum-resistant and refractory patients, [which we defined as] patients [whose disease] progressed between 1 and 3 months [after] prior platinum[-based therapy]. We are analyzing the data of the efficacy of the drug in patients progressing during PARP [inhibitor therapy]. These patients could not have received more than 3 prior lines of therapy, and prior bevacizumab [Avastin] was required. The trial has 2 primary end points: PFS, as evaluated according to RECIST 1.1 criteria by a blinded independent central review, and OS.

What were the key efficacy data?

The trial met its primary [PFS] end point, [with] a significant increase in PFS reported in patients treated with relacorilant/nab-paclitaxel. The median PFS was 5.5 months with nab-paclitaxel vs 6.5 months with relacorilant plus nab-paclitaxel. The HR was 0.70, suggesting a 30% reduction in the risk of [disease] progression [or death]. [Data from] the interim analysis for OS [showed that] the median OS increased from 11.5 months in the nab-paclitaxel arm to 15.97 months in the relacorilant plus nab-paclitaxel arm, with a HR of 0.69. [These data are] not yet mature; we have to wait for the final OS data.

Interestingly, there was a slight improvement in overall response rate [ORR], [with a] 7% improvement. [The ORR was] 30.1% with nab-paclitaxel and 36.9% with relacorilant plus nab-paclitaxel. [Regarding] the clinical benefit rate, there was a 12% [improvement with the relacorilant combination].

What was the safety profile of relacorilant in this study?

The safety profile of the drug was manageable. The most frequently reported adverse effects [AEs] were neutropenia, anemia, and fatigue in patients treated with the relacorilant plus nab-paclitaxel arm. Hematologic AEs included neutropenia and anemia. [Interestingly], the duration of exposure was different in patients receiving nab-paclitaxel or nab-paclitaxel plus relacorilant. When we adjusted the hematological toxicity of neutropenia and anemia for the duration of exposure, the incidence and rates of neutropenia and anemia were very comparable between the 2 treatment arms. We can conclude that the toxicity profile is mainly hematological, but manageable.

What are the potential clinical implications of these findings?

[Nab-paclitaxel plus relacorilant] can be easily considered a new SOC for our patient with platinum-resistant and refractory ovarian cancer. [What was interesting about] the trial is that the comparator arm was nab-paclitaxel. According to the indirect trial comparison data we have, [this is] as effective as weekly paclitaxel, [which] we consider [to be] the most effective drug in the platinum-resistant setting. What we demonstrate with the ROSELLA trial is that when we add relacorilant to the best drug in the platinum-resistant setting, we further increase PFS.

What future investigations are planned based on this research?

We are now running the BELLA trial [NCT06906341], which is a single-arm phase 2 trial combining nab-paclitaxel and relacorilant with bevacizumab. In the ROSELLA trial, all the patients should have received prior bevacizumab; therefore, we only have the data of nab-paclitaxel plus relacorilant. In the BELLA trial, we have both cohorts: the patients who have previously received bevacizumab, and patients who have not previously received bevacizumab. All these patients are treated with the triplet regimen of nab-paclitaxel, relacorilant, and bevacizumab.

Reference

Lorusso D, Gladieff L, Gilbert L, et al. Phase III results of relacorilant + nab-paclitaxel vs nab-paclitaxel in platinum-resistant ovarian cancer (PROC) (ROSELLA, GOG-3073, ENGOT-ov72): secondary endpoints. Ann Oncol. 2025;10(suppl 5):105332. doi:10.1016/j.esmoop.2025.105332

How are we thinking about the July 2025 U.S. CPI report?

Core CPI for July came in at +0.3% m/m, up from +0.2% m/m in June and in-line with consensus. Beneath the surface, we see more settled housing inflation, sustained inflation in non-shelter services categories, but moderate upward pressures on goods prices. Importantly, however, we do not see tariff-related inflation leading to a ‘spiral’ higher for inflation expectations. A key anchor, we believe, is that shelter (>40% of Core CPI) has now settled below its 2018-2019 run-rate. At the same time, mid-/high-income consumers are still spending on discretionary items, which makes us think that consumer finances are in okay shape despite a drag from higher tariffs.

Looking at the bigger picture, we continue to view the market as a glass half full: The technical bid remains strong, and fundamentals are solid enough to push markets slightly higher. The big stories, however, remain the productivity enhancements we are seeing as well as the coordinated global easing cycle (despite the global economy having an asynchronous economic recovery). Against this backdrop, our key themes remain the Security of Everything, Productivity/Worker Retraining, Collateral-Based Cash Flows, and Capital Heavy to Capital Light.

By Steve Gelsi

Circle’s stock surges as investors shrug off a one-time quarterly loss and focus on a big jump in revenue and stablecoins in circulation

Circle Internet’s stock is up after it reported a wider-than-expected loss but beat analysts’ revenue estimates.

Circle Internet Group Inc.’s stock rallied Tuesday, as investors focused on the stablecoin issuer’s stronger-than-expected revenue instead of its loss in its first quarterly earnings update since its blockbuster initial public offering.

Circle’s (CRCL) results impressed Wall Street with a 53% jump in second-quarter revenue and bullish comments on the outlook for stablecoins, which are a type of digital currency pegged one-to-one to the U.S. dollar DXY or another reserve asset.

“We are seeing accelerating interest in building on stablecoins and partnering with Circle across every significant sector of the financial industry,” Circle Chief Executive Jeremy Allaire said in a statement.

The stock was climbing 2.9% in early-afternoon trading at $166.12 a share – roughly double where it closed on its first day of trading on June 5, at $83.23. Circle’s IPO had priced at $31.

Looking ahead, Circle may take aim at “careful and deliberate” acquisitions but Allaire doesn’t expect any big, complex deals at the current time.

“We only want to do things that really fit clearly in that kind of product mandate,” Allaire said. “We’ve got a lot of organic development happening now and we’re excited to deliver on that.”

Circle said circulation of its USDC stablecoin (USDCUSD) was $61.3 billion as of June 30, up 90% from a year ago. Since then, it has increased another 6.4% to $65.2 billion as of Aug. 10.

The company’s second-quarter revenue increased to $658.1 million from $430.03 million a year ago and topped the analyst estimate of $645.7 million.

Circle said it swung to a loss $482.1 million, or $4.48 a share, in its second quarter ending June 30. In the year-ago quarter, it earned $32.92 million, with no common stock outstanding at the time.

Wall Street analysts expected Circle to lose 97 cents a share, according to FactSet data.

The reason why Wall Street appeared not to care so much about the larger-than-expected loss was that it included one-time, noncash charges of $591 million related to its IPO, including $424 million for stock-based compensation related to vesting conditions.

During the quarter, Circle debuted its Circle Payments Network, a product to help financial firms make payments with stablecoins.

It also inked payments alliances Corpay Inc. (CPAY), Fiserv Inc. (FI) and crypto exchange Binance Holdings Ltd.

Circle CEO Allaire said the company has been growing its relationship with Binance, among the largest trading platforms for crypto assets.

“They’ve been a great partner and they’re leaning into both the technology and really driving USDC growth,” Allaire said.

Circle said it’s planning a test launch this fall of Arc, which the company described as an open layer-one blockchain network and a foundation for capital markets, foreign exchange and payments using the USDC stablecoin. It’s planning to formally roll out the service by the end of the year.

“We are at the fulcrum of a massive mainstream embrace of stablecoins in the financial system, and firms are racing to build on this infrastructure,” Allaire said. “Until now, the blockchain infrastructure needed to meet the most intense demands of major financial firms and enterprises has simply not existed.”

-Steve Gelsi

This content was created by MarketWatch, which is operated by Dow Jones & Co. MarketWatch is published independently from Dow Jones Newswires and The Wall Street Journal.

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  08-12-25 1330ET
Copyright (c) 2025 Dow Jones & Company, Inc.

Updated August 12, 2025 at 10:35 AM EDT

Inflation continued to dog shoppers last month, as consumers were forced to shoulder more of the cost of President Trump’s tariffs.

Consumer prices in July were up 2.7% from a year ago, according to a report Tuesday from the Labor Department. The annual increase was similar to the month before.

Rising prices on imported items such as toys and furniture contributed to the higher cost of living. That was partially offset by a sharp drop in the price of gasoline.

Stripping out volatile food and energy prices, “core” inflation for the 12 months ending in July was 3.1%. That’s up from 2.9% for the 12 months ending in June.

Consumers will likely continue paying more

Since April, Trump has imposed tariffs of 10%-30% on nearly everything the U.S. imports. Taxes on goods from many countries are ratcheting even higher this month as the average tariff rate now tops 18%.

Importers have absorbed some of that cost or negotiated price breaks with their foreign suppliers. But with the government collecting tens of billions of dollars a month in tariffs, consumers are sure to see higher prices.

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The only questions are: How much higher and for how long?

Federal Reserve Governor Chris Waller has argued that tariffs will cause a one-time jump in prices, but won’t continue to fuel inflation month after month. Fed Chairman Jerome Powell says while that’s a reasonable expectation, the central bank must guard against the risk that inflation proves more persistent.

The Fed held interest rates steady at its last policy meeting in July. But amid signs of weakness in the labor market, investors are betting the Fed will lower its benchmark rate by a quarter-percentage point when policymakers meet next month.

Copyright 2025 NPR

The FDA has approved brensocatib (Brinsupri; Insmed) for the treatment of non–cystic fibrosis bronchiectasis, making it both the first approved therapy for this patient population and the first dipeptidyl peptidase 1 (DPP1) inhibitor approved to treat a neutrophil-mediated disease.¹

Brensocatib is a small-molecule, oral, reversible DPP1 inhibitor.² By blocking DPP1, it reduces the activation of neutrophil serine proteases, which are key drivers of inflammation and tissue damage in chronic lung diseases, such as bronchiectasis.

“This FDA approval represents a potential paradigm shift in how we approach non-cystic fibrosis bronchiectasis,” Doreen Addrizzo-Harris, M.D., FCCP, the Fiona and Stanley Druckenmiller Professor of Pulmonary, Critical Care and Sleep Medicine at NYU Grossman School of Medicine and Director of the NYU Langone Health Bronchiectasis and NTM Program, and ASPEN investigator, said in a statement. “For the first time, we have a treatment that directly targets neutrophilic inflammation and addresses a root cause of bronchiectasis exacerbations. Based on the strength of the data and the impact we’ve seen in patients, I believe this could become the new standard in non-cystic fibrosis bronchiectasis care.” 

This newly approved therapy offers hope for the approximately 500,000 individuals in the US affected by this chronic lung disease, which is characterized by permanently dilated bronchi resulting from a cycle of infection, inflammation, and lung tissue damage. Patients often experience frequent pulmonary exacerbations, involving chronic cough, excessive sputum production, shortness of breath, and repeated respiratory infections.

ASPEN Trial Shows Brensocatib Reduces Exacerbations, Preserves Lung Function

Today’s approval was supported by data from the ASPEN trial (NCT04594369), the largest bronchiectasis clinical trial conducted to date.³ The phase 3, double-blind trial randomized adults (1:1:1) and adolescents (2:2:1) to receive once-daily brensocatib at either 10 mg or 25 mg or placebo.²

The primary end point was the annualized rate of adjudicated pulmonary exacerbations over 52 weeks. Secondary end points included time to first exacerbation, the percentage of patients remaining exacerbation-free at week 52, changes in forced expiratory volume in 1 second (FEV₁), annualized rate of severe exacerbations, and changes in quality of life.

The study enrolled 1721 patients, which included 1680 adults and 41 adolescents. Of these, 583 received 10 mg of brensocatib, 575 received 25 mg, and 563 received a placebo. The annualized exacerbation pulmonary rates were 1.02 with 10 mg, 1.04 with 25 mg, and 1.29 with placebo. Compared with placebo, the rate ratio (RR) was 0.79 (95% CI, 0.68-0.92; adjusted P = .004) for 10 mg and 0.81 (95% CI, 0.69-0.94; adjusted P = .005) for 25 mg.

Brensocatib also significantly reduced the risk of first exacerbation compared with placebo, with HRs of 0.81 (95% CI, 0.70-0.95; adjusted P = .02) for 10 mg and 0.83 (95% CI, 0.70-0.97; adjusted P = .04) for 25 mg. At week 52, 48.5% of patients in both brensocatib groups remained exacerbation-free, compared with 40.3% in the placebo group. The RR for remaining exacerbation-free was 1.20 (95% CI, 1.06-1.37; adjusted P = .02) for 10 mg and 1.18 (95% CI, 1.04-1.34; adjusted P = .04) for 25 mg.

Additionally, at week 52, FEV₁ had declined by 50 mL in the 10-mg group, 24 mL in the 25-mg group, and 62 mL in the placebo group. Compared with placebo, the least-squares mean difference in FEV₁ was 11mL (95% CI, -14 to 37; adjusted P = .38) with 10 mg and 38 mL (95% CI, 11-65; adjusted P = .04) with 25 mg.

“Our trial showed that treatment with brensocatib led to a lower annualized rate of exacerbations than placebo in patients with bronchiectasis, and the decline in lung function was less with the 25-mg dose of brensocatib than with placebo,” the authors concluded.

ASPEN Subgroup Analyses Confirm Efficacy Across Key Populations

Subgroup analyses presented at the American Thoracic Society International Conference in San Francisco this past May more closely examined outcomes in adolescents, as well as effects based on maintenance macrolide use and blood eosinophil count.⁴

In adolescents, annualized exacerbation rates were 0.35 and 0.64 with 10 mg and 25 mg of brensocatib, respectively, vs 0.87 with placebo.⁵ Also, 59% of patients in both dose groups remained exacerbation-free vs 35% on placebo. Lung function, as measured by FEV₁, improved with both brensocatib doses, while it declined with placebo.

The second subgroup analysis found that brensocatib was effective regardless of maintenance macrolide use. Compared with placebo, patients treated with either dose experienced fewer exacerbations and a greater likelihood of remaining exacerbation-free.

Lastly, in patients with both high (≥ 300/mm³) and low (< 300/mm³) baseline blood eosinophil counts, both brensocatib doses reduced exacerbation rates, prolonged time to first exacerbation, and increased the likelihood of remaining exacerbation-free. The 25 mg dose, in particular, reduced lung function decline and showed numerical improvement in the Quality of Life-Bronchiectasis Respiratory Symptoms Domain score (QOL-B RSS) at week 52 vs placebo.

“It is critical that we understand not only how brensocatib performed across the full ASPEN population, but also how it works within individual subgroups,” James D. Chalmers, MBChB, PhD, lead investigator of the ASPEN trial, said in a press release.⁵ “These new analyses offer evidence of consistent efficacy and safety in key patient types…reinforcing the potential of brensocatib as a foundational treatment for this complex and heterogeneous disease.”

References

1. FDA approves Brinsupri (brensocatib) as the first and only treatment for non-cystic fibrosis bronchiectasis, a serious, chronic lung disease. News release. Insmed. August 12, 2025. Accessed August 12, 2025. https://investor.insmed.com/2025-08-12-FDA-Approves-BRINSUPRI-TM-brensocatib-as-the-First-and-Only-Treatment-for-Non-Cystic-Fibrosis-Bronchiectasis,-a-Serious,-Chronic-Lung-Disease
2. Chalmers JD, Burgel PR, Daley CL, et al. Phase 3 trial of the DPP-1 inhibitor brensocatib in bronchiectasis. N Engl J Med. 2025;392(16):1569-1581. doi:10.1056/NEJMoa2411664
3. A study to assess the efficacy, safety, and tolerability of brensocatib in participants with non-cystic fibrosis bronchiectasis (ASPEN). ClinicalTrials.gov. Updated November 12, 2024. Accessed August 12, 2025. https://clinicaltrials.gov/study/NCT04594369
4. Bonavitacola J, Steinzor P, Chalmers J. ASPEN trial shows efficacy of brensocatib in different dosages. AJMC. May 31, 2025. Accessed August 12, 2025. https://www.ajmc.com/view/aspen-trial-shows-efficacy-of-brensocatib-in-different-dosages-james-chalmers-md
5. Brensocatib show consistent efficacy and safety across three prespecified subgroups in new data from landmark ASPEN study. News release. Insmed. May 21, 2025. Accessed August 12, 2025. https://investor.insmed.com/2025-05-21-Brensocatib-Shows-Consistent-Efficacy-and-Safety-Across-Three-Prespecified-Subgroups-in-New-Data-from-Landmark-ASPEN-Study

Saudi Arabia is undergoing a mobility transformation, one that mirrors the ambitions of Vision 2030 and the expectations of a digitally native, innovative-driven population. As cities expand and lifestyles evolve, the Kingdom is investing heavily in sustainable, tech-forward transportation solutions that match its bold economic and environmental goals. 

TASARU Mobility Investments is enabling the development of a smarter, greener transport ecosystem through strategic investments in partners like Blacklane. As a wholly owned entity of Saudi Arabia’s Public Investment Fund, TASARU supports the transformation of the Kingdom’s mobility sector by accelerating electrification, digitalization, and service excellence. Through this enabling role, TASARU is helping shape a new era of transport in Saudi Arabia in line with the goals of Vision 2030. 

TASARU’s flagship collaboration is with Blacklane, the global chauffeur service renowned for premium, sustainable rides, which is now operating in Riyadh, Jeddah, Dammam, Madinah and Makkah. Blacklane blends global standards with local expectations in a market actively redefining luxury mobility. “Saudi Arabia is setting the pace for how luxury mobility will evolve globally,” said Jens Wohltorf, founder and CEO of Blacklane. “Together with TASARU, we’re delivering seamless, high-quality experiences that blend luxury with sustainability values that resonate deeply with our guests and Vision 2030.” 

Blacklane’s expansion is underpinned by a growing fleet of electric vehicles and a commitment to local innovation. The company is working closely with Lucid Motors, whose Lucid Air and upcoming Gravity SUV will soon be integrated into Blacklane towards the end of 2025, bringing cutting-edge EV performance to the streets of Saudi Arabia. 

Meanwhile, EVIQ, the Kingdom’s EV infrastructure leader, is providing the charging backbone for this EV expansion. In addition to building out charging networks, EVIQ is co-developing training programs through Blacklane’s Chauffeur Training Academy, ensuring drivers are equipped with the latest in EV safety, charging, and service excellence. 

Blacklane’s vision for premium mobility is expanding beyond the road, with new initiatives seamlessly connecting air and ground travel. A key example is the partnership with Riyadh Air, Saudi Arabia’s national airline, which offers complimentary chauffeur services within a 50 km radius of King Khalid International Airport. The service is available to Business Elite, Business Class, and eligible loyalty members, delivering a world-class hospitality experience from touchdown to final destination. 

The company’s services are already seeing strong traction. Airport transfers and city-to-city travel is performing exceptionally well, with intercity bookings showing sustained growth. Blacklane is also piloting a new “faster-pickups” service in Riyadh’s King Abdullah Financial District, designed to reduce wait times and enhance convenience for business travelers. 

“This is just the beginning of a long-term commitment to sustainable innovation in the Kingdom,” said Adib Samara, general manager for Saudi Arabia at Blacklane. “We’re listening closely to the market and evolving with it.” 

The evolution is being enabled by TASARU, whose strategic backing has supported Blacklane’s expansion across the Kingdom. The partnership is grounded in a shared commitment to a smarter, greener future aligned with Vision 2030. 

“TASARU’s investment in Blacklane reflects our mission to power a new era of mobility in Saudi Arabia. By enabling sustainable transport solutions and nurturing local capabilities, we are building a future-ready ecosystem fully aligned with Vision 2030,” said Michael Müller, CEO of TASARU Mobility Investments.