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The FDA has granted priority review to a new drug application (NDA) seeking the approval of sonrotoclax (BGB-11417; BeOne Medicines) for the treatment of adult patients with relapsed or refractory mantle cell lymphoma (MCL) who have received prior treatment with a BTK inhibitor.¹

The NDA is backed by findings from the phase 1/2 BGB-11417-201 trial (NCT05471843), which achieved its primary end point of overall response rate (ORR) per independent review committee (IRC) and showed clinically meaningful responses among 125 adult patients with relapsed/refractory MCL who had been previously treated with a BTK inhibitor. Positive outcomes were also seen across several secondary efficacy end points, such as complete response rate, duration of response (DOR), and progression-free survival (PFS). Regarding safety, the trial investigators deemed sonrotoclax to be well tolerated with manageable toxicity risks.

Data supporting the NDA and priority review designation will be presented at the 2025 ASH Annual Meeting.

Previously, in October 2025, the FDA granted sonrotoclax breakthrough therapy designation as a potential therapeutic option for the treatment of patients with relapsed or refractory MCL.²

“Sonrotoclax is advancing with remarkable speed, from breakthrough therapy designation to priority review, all within a short window,” Lai Wang, PhD, global head of Research & Development at BeOne Medicines, stated in a news release.¹ “That pace reflects both the strength of the data and the urgency of the need for patients with relapsed/refractory MCL. With rapid, deep, and durable responses and a manageable safety profile, sonrotoclax is emerging as a potential best-in-class BCL-2 inhibitor, alongside our 2 other transformative hematology assets—BTK inhibitor Brukinsa [zanubrutinib] and investigational BTK degrader BGB-16673.”

What is the design of the BGB-11417-201 trial?

This global, multicenter, single-arm, open-label trial enrolled patients at least 18 years of age with histologically confirmed MCL who had received prior systemic treatment for MCL, including an anti-CD20 agent and a BTK inhibitor.³ Patients needed to have relapsed or refractory disease and the presence of measurable disease. They were also required to have available archival tissue that confirmed their MCL diagnosis or be willing to undergo fresh tumor biopsy. An ECOG performance status of 0 to 2 and adequate organ function were also required.

In part 1 of the trial, patients (n = 22) were treated with sonrotoclax at either 160 mg or 320 mg daily to evaluate the safety and tolerability of the agent and determine the recommended phase 2 dose (RP2D) for part 2.⁴ The primary end points in part 1 included the incidence of dose-limiting toxicities, treatment-emergent adverse effects (TEAEs), serious AEs, and tumor lysis syndrome.³ Secondary end points included pharmacokinetic outcomes.

Secondary end points investigated across both parts included investigator-assessed ORR; DOR, PFS, and time to response as assessed by investigators and the IRC; and overall survival.

Part 2 enrolled 103 patients, who received sonrotoclax at the RP2D of 320 mg daily following ramp-up dosing. The primary end point in part 2 was IRC-assessed ORR. Secondary end points specific to part 2 included the incidence of TEAEs and serious AEs; the number of patients with clinically significant changes from baseline in vital signs and clinical laboratory values; the number of patients with clinically significant physical examination findings; and quality of life measures.

What other regulatory next steps are planned for sonrotoclax?

BeOne Medicines plans to participate in the FDA’s Project Orbis for sonrotoclax. Project Orbis helps facilitate the concurrent submission and review of oncology products between international regulatory bodies.¹ The company also plans to submit data from the BGB-11417-201 trial to other global regulatory agencies, including the European Medicines Agency, for the agent’s potential approval.

References

1. U.S. FDA grants priority review to sonrotoclax for the treatment of relapsed or refractory mantle cell lymphoma. News release. BeOne Medicines Ltd. November 26, 2025. Accessed November 26, 2025. https://ir.beonemedicines.com/news/us-fda-grants-priority-review-to-sonrotoclax-for-the-treatment-of-relapsed-or-refractory-mantle/786f1dad-0c9f-492e-9fce-f9ceadd24989
2. BeOne Medicines’ sonrotoclax granted breakthrough therapy designation by U.S. FDA. News release. BeOne Medicines. October 13, 2025. Accessed November 26, 2025. https://ir.beonemedicines.com/news/beone-medicines-sonrotoclax-granted-breakthrough-therapy-designation-by-us-fda/7a29ff75-4388-4f81-a23e-588149f94f9e
3. Study of BGB-11417 monotherapy in participants with relapsed or refractory mantle cell lymphoma. ClinicalTrials.gov. Updated September 9, 2025. Accessed November 26, 2025. https://clinicaltrials.gov/study/NCT05471843
4. BeOne Medicines announces positive topline results for sonrotoclax in relapsed or refractory mantle cell lymphoma (MCL). News release. BeOne Medicines. August 29, 2025. Accessed November 26, 2025. https://ir.beonemedicines.com/news/beone-medicines-announces-positive-topline-results-for-sonrotoclax-in-relapsed-or-refractory-mantle-cell-lymphoma/9b063914-3787-4b59-95fa-1e0941571f45

By Vivien Lou Chen

A stronger yen and rising Japanese bond yields could pull capital away from the U.S. equity and bond markets

Bank of Japan governor Kazuo Ueda.

Bank of Japan governor Kazuo Ueda delivered a speech on Monday that was heard by investors all around the world.

The BOJ official caused a stir in global markets by suggesting that the central bank could raise interest rates again as soon as later this month. The remark caused Japanese bond yields to rise sharply, while yields on other global sovereign bonds, from the U.S. to Europe and the rest of Asia, quickly followed suit.

Speaking to business leaders in Nagoya, Ueda said that the BOJ “will consider the pros and cons” of raising its policy interest rate at its upcoming policy meeting, which ends Dec. 19. The central bank last raised interest rates to 0.5% from 0.25% in January, bringing borrowing costs to their highest level in 17 years.

Ueda’s remarks, which come at a time when the Japanese economy is experiencing a moderate recovery, triggered a global bond-market selloff that impacted debt trading in Australia and New Zealand, as well as in France, Italy, Greece and the U.S. In the bond market, yields move in the opposite direction to prices, and rise whenever government debt sells off.

“The Bank of Japan is finally signaling an end of an era after decades of ultraloose policy,” said Ryan Jacobs, founder of Florida-based advisory firm Jacobs Investment Management. “American investors should pay close attention. A stronger yen and rising Japanese yields could pull capital away from the U.S. bond and equities markets, tightening financial conditions globally.”

On Monday, Japan’s 2-year yield BX:TMBMKJP-02Y spiked just above 1% and its 10-year yield BX:TMBMKJP-10Y jumped to almost 1.88% – the highest levels in at least 17 years. Meanwhile, the yen (USDJPY) strengthened against the U.S. dollar DXY by about 0.5%.

Yields and currencies tend to move alongside interest-rate expectations for specific countries, and rising Japanese bond rates were stoking concerns about a possible replay of the August 2024 unwind of the yen carry trade, which created a wave of volatility across global markets.

In the U.S., yields on the 10-year BX:TMUBMUSD10Y and 30-year BX:TMUBMUSD30Y Treasurys spiked by 7 basis points each to 4.09% and 4.74%, respectively, data showed. Meanwhile, major U.S. stock indexes DJIA SPX COMP moved lower in afternoon trading.

Between 1999 and early 2024, Japan was known for keeping interests at rock-bottom levels, and even below zero for eight of those years, as it pursued a monetary policy aimed at combating persistent deflation and stoking economic growth.

Before Ueda’s comments on Monday, investors had been more focused on the prospect of aggressive fiscal stimulus under Japan’s first female prime minister, Sanae Takaichi, and the possibility that a subsequent rise in yields might make the country’s bond market look more attractive relative to the U.S. and the rest of the world. But on Monday, Ueda gave investors another reason to push Japanese bond yields even higher.

Read: Why trouble for the biggest foreign buyer of U.S. debt could ripple through America’s bond market

“The market went into the weekend with the expectation that, given the new prime minister in Japan, the BOJ might be more hesitant before deciding its next move. It turned out to be the other way around and the BOJ appears to be ready to hike in December,” said Daniel Tenengauzer, a senior macro analyst at InTouch Capital Markets in New York.

With the yen still undervalued, Ueda’s comments about a potential rate hike were creating a desire by some investors to rebuild long positions in Japan’s currency, according to Tenengauzer. “If the BOJ is somewhat more hawkish, people will want to price this in across other markets.”

The Bank of Japan was not the only thing impacting the Treasury market on Monday, however.

In Tenengauzer’s view, a quarter-point rate cut by the Federal Reserve next week has been mostly priced in, leaving traders with little else to do but unwind long-bond exposures. In addition, anecdotal economic information about the U.S. suggests that “maybe things are not as bad as expected,” he said.

Thirdly, President Trump announced over the weekend that he has made his choice on who will next lead the Fed, and prediction markets are betting that Kevin Hassett, the director of the National Economic Council, will be the president’s pick. Hassett is expected to support aggressive rate cuts, raising some concerns that this may end up inadvertently boosting inflationary pressures.

-Vivien Lou Chen

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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  12-01-25 1348ET
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India’s telecoms ministry has privately asked smartphone makers to preload all new devices with a state-owned cybersecurity app that cannot be deleted, a government order showed, a move likely to antagonise Apple and privacy advocates.

In tackling a recent surge of cybercrime and hacking, India is joining authorities worldwide, most recently in Russia, to frame rules blocking the use of stolen phones for fraud or promoting state-backed government service apps.

Apple, which has previously locked horns with the telecoms regulator over development of a government anti-spam mobile app, is among the companies, such as Samsung, Vivo, Oppo and Xiaomi bound by the new order.

The 28 November order gives major smartphone companies 90 days to ensure that the government’s Sanchar Saathi app is pre-installed on new mobile phones, with a provision that users cannot disable it.

For devices already in the supply chain, manufacturers should push the app to phones via software updates, the ministry said in its order, which was not made public and was sent privately to select companies.

A lawyer specialising in technology matters said India’s move was cause for concern, however.

“The government effectively removes user consent as a meaningful choice,” said Mishi Choudhary, who works on internet advocacy issues.

Privacy advocates criticised a similar requirement by Russia in August for a state-backed messenger app called Max to be pre-installed on phones.

One of the world’s largest telephone markets, India has more than 1.2 billion subscribers, and government figures show the app, launched in January, has helped recover more than 700,000 lost phones, including 50,000 in October alone.

The government said the app was essential to combat “serious endangerment” of telecom cybersecurity from duplicate or spoofed IMEI numbers, which enable scams and network misuse.

Apple’s iOS powered an estimated 4.5% of 735m smartphones in India by mid-2025, with the rest using Android, according to Counterpoint Research.

While Apple pre-installs its own proprietary apps on phones, its internal policies prohibit installation of any government or third-party app before sale of a smartphone, a source with direct knowledge of the matter said.

“Apple has historically refused such requests from governments,” said Tarun Pathak, a research director at Counterpoint.

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“It’s likely to seek a middle ground: instead of a mandatory pre-install, they might negotiate and ask for an option to nudge users towards installing the app.“

Apple, Google, Samsung and Xiaomi did not respond to requests for comment. India’s telecoms ministry also did not respond.

A 14- to 17-digit number unique to each handset, the IMEI, or International Mobile Equipment Identity, is most commonly used to cut off network access for phones reported to have been stolen.

The Sanchar Saathi app is mainly designed to help users block and track lost or stolen smartphones across all telecom networks, using a central registry. It also lets them identify, and disconnect, fraudulent mobile connections.

With more than 5m downloads since its launch, the app has helped block more than 3.7m stolen or lost mobile phones, while more than 30m fraudulent connections have also been terminated.

The government says the software helps prevent cyberthreats and assists tracking and blocking of lost or stolen phones, helping police to trace devices, while keeping counterfeits out of the black market.

Zillow, the US’s largest real estate listing site, has removed a feature that allowed people to view a property’s exposure to the climate crisis, following complaints from the industry and some homeowners that it was hurting sales.

In September last year, the online real estate marketplace introduced a tool showing the individual risk of wildfire, flood, extreme heat, wind and poor air quality for one million properties it lists, explaining that “climate risks are now a critical factor in home-buying decisions” for many Americans.

But Zillow has now deleted this climate index in the wake of complaints from real estate agents and some homeowners that the rankings appeared arbitrary, could not be challenged and harmed house sales. The complaints included those from the California Regional Multiple Listing Service, which oversees a database of property data that Zillow relies upon.

Zillow said it remains committed to help Americans make informed decisions about properties, with listings now containing outbound links to the website of First Street, the nonprofit climate risk quantifier that had provided the on-site tool to Zillow.

Matthew Eby, founder and chief executive of First Street, said that removing the climate risk information means that many buyers will be “flying blind” in an era when worsening impacts of extreme weather are warping the real estate market in the US.

“The risk doesn’t go away; it just moves from a pre-purchase decision into a post-purchase liability,” Eby said. “Families discover after a flood that they should have purchased flood insurance, or discover after the sale that wildfire insurance is unaffordable or unavailable in their area.

“Access to accurate risk information before a purchase isn’t just helpful; it’s essential to protecting consumers and preventing lifelong financial consequences.”

Eby claimed that the push to delist the First Street ratings from Zillow is linked to a challenging real estate environment, with a lack of affordable housing and repeated climate-driven disasters that are causing insurers to raise premiums or even flee states such as California.

“All of that adds pressure to close sales however possible,” he said. “Climate risk data didn’t suddenly become inconvenient. It became harder to ignore in a stressed market.”

As the US, along with the rest of the world, has heated up due to the burning of fossil fuels, worsening extreme weather events have taken their toll directly upon people’s homes, as well as other infrastructure.

Last year, disasters likely amplified by the climate crisis caused $182bn in damages, one of the highest on record, according to a government database since taken offline by the Trump administration.

As a consequence of these mounting risks, the home insurance required for buyers to obtain a mortgage is becoming scarcer and more expensive across much of the US. These changes are running headlong into an opposing trend whereby more Americans are moving to places like Florida and the south-west, which are being increasingly beset by threats such as ruinous hurricanes and punishing heatwaves.

But assigning climate risks to individual properties has been controversial within the real estate industry, as well as some experts who have questioned whether such judgments can be made at such a granular level.

Warnings of such perils deterred some buyers, especially if the home was particularly costly anyway. Last year, a sprawling Florida mansion was put on sale for $295m, making it the most expensive property in the country and in a place also ranked as one of the most at-risk in the US for flooding. After several cuts to the asking price, the house has been taken off the market.

Jesse Keenan, an author and expert in climate risk management at Tulane University, said many scientists and economists have argued that “proprietary risk models that provide highly uncertain assessments can have the perverse effect of undermining the public’s confidence in climate science.”

“There has been a growing bipartisan recognition that the government should play a more active role in supporting and standardizing risk assessment for properties,” Keenan said. “At the same time, the science is limited in its capacity to assess property-by-property assessments.

“I do not believe that this is a sign that the brokerage industry is trying to hide climate risks,” he added. “Brokerage firms know they cannot stop the transmission of climate risk information because climate impacts are already being felt far and wide in the sector.”

Eby defended First Street’s methods and accuracy, pointing out that the models used are built on peer-reviewed science and validated against real-world outcomes.

“So when claims are made that our models are inaccurate, we ask for evidence,” he said. “To date, all the empirical validation shows our science is working as designed and providing better risk insight than the tools the industry has relied on historically.”

Shopify reported Monday that its platform was suffering from multiple service outages, as Cyber Monday sales kicked off.

Some merchants that use Shopify’s service to sell goods online may experience an issue with checkouts through the company’s point-of-sale system, the company said on its status website.

Businesses that run on Shopify could also have trouble logging into their administrative portals.

In 2024, merchants using Shopify services recorded $11.5 billion in sales from Black Friday through Cyber Monday, the company said, with more than 76 million customers buying from businesses powered by the platform.

Shopify provides website design tools, online checkout services and digital advertising products to businesses of all sizes. The company says that millions of merchants use its services.

While Shopify’s share of Cyber Monday sales may be limited, smaller businesses that rely on the company to process their transactions could miss out on crucial sales at the start of the all-important holiday season.

Total Cyber Monday sales are expected to be more than $53 billion, according to Salesforce.

Shopify did not immediately return a request for comment.

As of 1:25p.m. ET, Shopify shares were down 5%.

The future of work is changing fast. Future Focus cuts through the noise with three trends each week that matter most to HR and business leaders. When everything else is in flux, stay focused with Future Focus.

How People Feel About Vaccines Is Now Largely Political (Time) 

What to Know: A new survey of 5,000+ Americans shows vaccine attitudes are sharply polarized: 59% don’t plan to get the latest COVID-19 shot, including 83% of Republicans versus 44% of Democrats. Awareness of the Centers for Disease Control and Prevention (CDC)’s updated COVID-19 guidance is low, and support for school vaccine mandates — especially among Republicans — has fallen despite most still agreeing that vaccines’ benefits outweigh risks.  

Where to Focus: Vaccine sentiment is now a political signal, not just a health preference, making it a potential flashpoint in workplace interactions.  Political differences are among the top 5 sources of workplace incivility, according to the SHRM Q3 2025 Civility Index. This means that vaccine-related health communications and policies can trigger polarized reactions. 

Why Is It So Hard to Pay Cross-Border Employees In Europe (Fast Company)

What to Know: Hiring Europeans remains administratively complex: national labor, tax, and social security rules differ. Layer on inconsistent EU directives and misclassification risks amid the persistent talent shortage, and the hiring regulatory landscape just got a little more complicated. 

Where to Focus: Growth increasingly depends on accessing global talent, yet the operational drag of entity setup, social security coordination, and tax residency rules can erase speed-to-hire advantages. With EU labor shortages expected to worsen and demand for specialized talent up 112% in three years, organizations will need to upskill teams and draw from domestic untapped talent pools to close critical gaps.

Research: The Global Skills Mismatch

How Campbell’s Leaked Audio Turned a Pantry Staple Into a PR Crisis (Fortune)

What to Know: A leaked audio recording of a Campbell executive mocking Indian workers, disparaging customers, and referencing “bioengineered” or “3D” meat triggered swift public backlash over Thanksgiving weekend. The company confirmed the recording’s authenticity and removed the leader, but allegations in a related lawsuit suggest deeper questions about internal reporting culture and leadership oversight. 

Where to Focus: This moment highlights the direct link between leadership conduct and organizational trust. Leaders should revisit reporting pathways along with escalation protocols and prepare for the reality that unguarded moments can shape brand trust in seconds. Reinforcing crisis communications and training leaders on values-aligned behavior are essential steps to prevent isolated misconduct from escalating into an enterprise-level crisis.

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