Category: 3. Business

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

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

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

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

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

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

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

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

Explore another fair value estimate on Rapport Therapeutics – why the stock might be worth as much as 75% more than the current price!

Disagree with this assessment? Create your own narrative in under 3 minutes – extraordinary investment returns rarely come from following the herd.

• A great starting point for your Rapport Therapeutics research is our analysis highlighting 5 important warning signs that could impact your investment decision.

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

These stocks are moving-our analysis flagged them today. Act fast before the price catches up:

This article by Simply Wall St is general in nature. We provide commentary based on historical data and analyst forecasts only using an unbiased methodology and our articles are not intended to be financial advice. It does not constitute a recommendation to buy or sell any stock, and does not take account of your objectives, or your financial situation. We aim to bring you long-term focused analysis driven by fundamental data. Note that our analysis may not factor in the latest price-sensitive company announcements or qualitative material. Simply Wall St has no position in any stocks mentioned.

Companies discussed in this article include RAPP.

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

Story Continues

• If you have been wondering whether Veolia Environnement is still a smart buy at around €29, you are not alone. This breakdown is aimed squarely at helping you decide if the current price makes sense.

• The stock has been quietly grinding higher, with returns of 0.1% over the last week, 1.0% over the last month, 7.7% year to date and 90.3% over five years. That naturally raises the question of how much upside is left versus the risk.

• Recent headlines have focused on Veolia’s ongoing role in large scale water and waste infrastructure projects, alongside its push into higher margin environmental services. These developments have reinforced the market’s view of it as a long term transition play. At the same time, regulatory and sustainability tailwinds in Europe continue to shape expectations for stable, utility like cash flows with embedded growth optionality.

• On our checklist of six valuation tests Veolia scores a solid 5 out of 6, suggesting the shares still look reasonably priced. Next we will unpack what that means across discounted cash flow, multiples and other lenses, before finishing with a more intuitive way to think about what the market might be missing.

Find out why Veolia Environnement’s 8.6% return over the last year is lagging behind its peers.

A Discounted Cash Flow model estimates what a company is worth by projecting the cash it can generate in the future and discounting those cash flows back to today in € terms.

For Veolia Environnement, the latest twelve month free cash flow stands at about €1.95 billion. Analysts provide detailed forecasts for the next few years, with free cash flow expected to be around €1.60 billion in 2026 and €1.96 billion by 2027. Beyond that, Simply Wall St extrapolates the trend, projecting free cash flow to rise gradually to roughly €2.17 billion by 2035 as the business matures.

Using a 2 Stage Free Cash Flow to Equity model, these cash flows are discounted back to today to arrive at an estimated intrinsic value of about €58.10 per share. Against a current share price near €29, the DCF suggests the stock is roughly 49.5% undervalued. This indicates that the market may be placing a heavy discount on Veolia’s long term cash generation potential.

Result: UNDERVALUED

Our Discounted Cash Flow (DCF) analysis suggests Veolia Environnement is undervalued by 49.5%. Track this in your watchlist or portfolio, or discover 905 more undervalued stocks based on cash flows.

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

For a consistently profitable business like Veolia Environnement, the price to earnings (PE) ratio is a useful yardstick, because it links what investors pay today directly to the company’s current earnings power. In broad terms, companies with faster, more reliable earnings growth and lower perceived risk tend to justify higher PE ratios, while slower growth or higher risk usually calls for a lower multiple.

Veolia currently trades on a PE of about 17.7x, which sits close to the Integrated Utilities industry average of roughly 17.8x and modestly below the broader peer group average of around 19.1x. Simply Wall St’s proprietary Fair Ratio for Veolia is 17.1x, which reflects what the PE “should” be once factors like its earnings growth outlook, profit margins, size, industry positioning and specific risks are all accounted for. This tailored Fair Ratio is more informative than a simple peer or sector comparison, because it adjusts for Veolia’s own fundamentals rather than assuming all utilities deserve the same multiple. With the actual PE of 17.7x only slightly above the Fair Ratio of 17.1x, the shares screen as reasonably valued on an earnings basis.

Result: ABOUT RIGHT

PE ratios tell one story, but what if the real opportunity lies elsewhere? Discover 1442 companies where insiders are betting big on explosive growth.

Earlier we mentioned that there is an even better way to understand valuation, so let us introduce Narratives, a simple framework that lets you write the story behind your numbers by tying your view on a company’s future revenue, earnings and margins to a concrete financial forecast and fair value estimate.

On Simply Wall St’s Community page, Narratives are an easy, accessible tool used by millions of investors to connect a company’s story, the assumptions that flow from that story and the resulting fair value. This helps you clearly see whether your own fair value is above or below today’s share price and decide if Veolia Environnement looks like a buy, hold or sell.

Narratives also update dynamically when new information such as earnings, major contract wins or regulatory changes are released. This helps your fair value view stay in sync with the latest data instead of going stale after you first run the numbers.

For example, one Veolia Narrative might lean into new contracts, higher margins and faster earnings growth to justify a fair value closer to the bullish €45.30 analyst target. A more cautious Narrative, focused on M&A risks, tariff pressure and slower mature market growth, might anchor nearer the bearish €25.30 target instead.

Do you think there’s more to the story for Veolia Environnement? Head over to our Community to see what others are saying!

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 VIE.PA.

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

Story Continues

For profitable banks, the Price to Earnings, or PE, ratio is a useful way to judge value because it links what investors pay today with the profits the business is already generating. In broad terms, higher growth and lower risk justify a higher PE, while slower growth or greater uncertainty usually mean a lower, more cautious multiple is appropriate.

ING Groep currently trades on a PE of about 13.14x, which is above both the European Banks industry average of roughly 10.58x and the peer group average of around 10.03x. On the surface that might imply a premium valuation, but these simple comparisons do not fully reflect company specific growth prospects, profitability or risk.

Simply Wall St’s Fair Ratio for ING Groep is 12.97x, which is our estimate of what a reasonable PE should be once factors like expected earnings growth, the risk profile, profit margins, industry dynamics and market capitalization are all taken into account. Because this Fair Ratio is only slightly below the current PE, the shares look roughly in line with what those fundamentals would justify rather than clearly cheap or expensive.

Result: ABOUT RIGHT

PE ratios tell one story, but what if the real opportunity lies elsewhere? Discover 1442 companies where insiders are betting big on explosive growth.

Earlier we mentioned that there is an even better way to understand valuation, so let us introduce you to Narratives. This is an approach where you combine your view of ING Groep’s story with your own assumptions for future revenue, earnings and margins, and then link that story directly to a financial forecast and a fair value estimate.

On Simply Wall St’s Community page, Narratives make this process accessible by guiding you to set a fair value and compare it to the current price. This helps you decide whether the stock looks like a buy or a sell to you, and then your view is automatically updated as new information such as earnings or major news is released.

For ING Groep, one investor might build a Narrative that leans into digital banking, infrastructure lending and fee income growth with a fair value of around €27.92. Another might be more cautious about regulation, deposits and margins and land closer to €23.28. Narratives turn both of those perspectives into clear, numbers backed roadmaps for action rather than vague opinions.

Do you think there’s more to the story for ING Groep? Head over to our Community to see what others are saying!

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 INGA.AS.

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

(Bloomberg) — Federal Reserve Chair Jerome Powell is expected to push through another quarter-point interest-rate cut this week despite growing unease among fellow policymakers that inflation remains too high.

The Fed delivered a second straight reduction in October driven by the summer’s sudden deterioration in the US labor market. But that was followed by an outburst of hawkish concern from some officials, including five who vote on policy this year, signaling hesitancy or unwillingness to support a third move in December.

That growing division has been exacerbated by the lack of fresh economic data due to a government shutdown that spanned much of October and November. The latest inflation number now in policymakers’ hands, released on Dec. 5, is for September — a report that is unlikely to alter the policy debate.

Against that backdrop and for about a week in mid-November, investors signaled serious doubt over the prospect of another cut. But the unusual level of drama was resolved on Nov. 21 when New York Fed President John Williams, who is seen as closely aligned with Powell, said he saw room for a reduction in the “near term.” The market took the signal and now assigns more than a 90% chance to a move next week.

For more, read Bloomberg Economics’ full Week Ahead for the US Economists polled by Bloomberg then expect the Fed to take a break before two more reductions in 2026, in March and September. And there’s some hope that a flood of new data — as statistical agencies catch up from the shutdown — will resolve the ongoing tension between the Fed’s mandates to contain inflation and maximize employment.

That said, more Fed drama lies on the horizon. President Donald Trump is expected soon to name a successor to Powell, whose term as chair expires in May. Kevin Hasset, a Trump loyalist and senior economic adviser, is the frontrunner. That’s prompted worries among some investors that the next chair will pursue rate cuts at Trump’s direction and risk spurring inflation.

What Bloomberg Economics Says:

“If Powell leans hawkish at the news conference to appease hawkish regional Fed presidents, will it even matter anymore? After all, the next Fed chair — Hassett is the frontrunner — could join the board as soon as February, rendering Powell essentially a lame duck for the last few months of his chairmanship.”

—Anna Wong, Stuart Paul, Eliza Winger, Estelle Ou, Chris G. Collins, Alex Tanzi and Troy Durie. For full analysis, click here

In contrast to the Fed, the Bank of Canada is expected to keep its rate steady at 2.25%. Officials have said that’s “about the right level” as long as economic and inflation forecasts materialize.

While third-quarter growth blew past expectations, that was largely driven by lower imports and a jump in military spending, while household consumption declined. Inflation is close to target at 2.2%, though core measures remain elevated.

Elsewhere, central bank decisions from Australia to Switzerland to Brazil will draw attention, and euro-area finance chiefs are scheduled to elect a new chair.

Click here for what happened last week and below is our wrap of what is coming up in the global economy.

Asia

The week in Asia kicks off with economists expecting Japan to revise third-quarter gross domestic product to show a deeper contraction after recent capital spending data for the period were weak, in a report that will justify the government’s large fiscal stimulus package unveiled last month.

Also Monday, data for October may show real wages falling for a 10th month, underscoring how steady gains in nominal pay aren’t keeping up with inflation.

Data Wednesday are expected to show a modest improvement for China’s price environment in November, with inflation ticking up to 0.7%, the fastest advance since February 2024.

Factory-gate prices are seen falling 2%, in what would be the slowest decline in 15 months. Still, as the CPI got a holiday boost that will likely fade, the figures may prompt Beijing to enact more anti-involution policies to curb price competition.

India also may show a pickup in inflation on Friday, with consumer price gains estimated to have accelerated to 0.75% in November, still well below the Reserve Bank’s 2%-6% target range.

Australia releases the NAB Business Confidence index for November Wednesday and a blast of labor statistics on Thursday that will show if jobs data stayed strong after robust results in October.

New Zealand’s manufacturing PMI gauge may have remained in expansionary territory for a fifth month in November. Trade data are due during the week from China and Taiwan.

In central banks, the Reserve Bank of Australia is seen holding its cash rate steady at 3.6% on Tuesday, extending a pause after three cuts earlier this year.

Focus will be on any signaling that the easing cycle may have run its course, with pricing in the swaps market already mostly reflecting expectations for a hike by September.

In the Philippines, authorities are likely to continue their easing campaign with a cut to the overnight borrowing rate to 4.5% on Thursday.

For more, read Bloomberg Economics’ full Week Ahead for Asia Europe, Middle East, Africa

The Swiss National Bank will draw the spotlight among a series of monetary decisions in the region on Thursday. The outcome will showcase the tradeoff for officials trying to avoid a return to negative borrowing costs in Switzerland.

The central bank is widely expected to keep its rate at zero, but may acknowledge a weaker price outlook after every inflation reading since the last quarterly decision turned out weaker than expected, weighed down by the strength of the franc.

By contrast, Turkish policymakers may cut borrowing costs by as much as 150 basis points in its own final decision of 2025. Growth has slowed more than expected and the latest inflation reading there was lower than any estimate in a Bloomberg survey.

In Serbia, the central bank may extend its rate pause to a fifth quarter as US sanctions shut down the nation’s only refiner, risking a rise in energy prices. And Ukrainian officials will announce their own policy decision after keeping borrowing costs steady for 5 months.

Among data highlights, the UK’s monthly growth number on Friday will focus investors. GDP is predicted by economists to have increased slightly at the start of the fourth quarter, in the last such data release before the Bank of England’s decision. Meanwhile Norwegian inflation is scheduled for Tuesday.

Turning to the euro zone, industrial production numbers in Germany on Monday and Italy on Wednesday will reveal whether manufacturing began staging any sort of recovery at the start of a quarter that officials are hoping will mark a turning point.

Among European Central Bank speakers scheduled are President Christine Lagarde at an event on Wednesday. A blackout period will begin the following day in advance of the monetary decision just over a week later.

In France, the country’s fiscal woes will return to the fore on Tuesday, with a National Assembly vote on social security scheduled for Tuesday. Premier Sebastien Lecornu pulled off a win last week by clinching agreement over the revenue part of that measure.

And euro-zone finance ministers will select one of their own to chair meetings and represent them collectively after the abrupt departure of Ireland’s Paschal Donohoe. Belgium’s Vincent van Peteghem and Greece’s Kyriakos Pierrakakis will face off in a vote when the group meets on Thursday.

For more, read Bloomberg Economics’ full Week Ahead for EMEA Latin America

Mexico’s monthly inflation data will likely see both headline and core readings creep back up from the current 3.57% and 4.28% respectively.

While both are above policymakers’ 3% target ahead of Banxico’s Dec. 18 rate decision, most Mexico watchers expect the lurking threat of recession to win the case for a 12th straight rate cut.

Brazil’s market readout from the central bank may see some additional improvement in inflation expectations for this year and next ahead of Wednesday’s November consumer prices report and rate decision.

The headline reading for last month posted early Wednesday is very likely to have slowed for a second month, and very possibly below the 4.5% top of policymakers’ tolerance range though still well over the 3% target.

Hours later, there’s almost no chance that Banco Central do Brasil does anything but hold at 15% for a fourth meeting, but the odds are much better for some substantive guidance from bank chief Gabriel Galipolo and colleagues.

President Javier Milei’s long slog to bring Argentine inflation to heel continues this week, with the November monthly print expected to slow from October’s 2.3% reading, bringing the annual rate within hailing distance of 30%.

Peruvian central bankers can take a bow for the lowest inflation rate among LatAm’s major economies but won’t likely take that for granted at December’s monetary policy meeting Thursday.

Caution likely has bank chief Julio Velarde and his board keeping the key rate at 4.25% for a third meeting.

For more, read Bloomberg Economics’ full Week Ahead for Latin America –With assistance from Brian Fowler, Laura Dhillon Kane, Robert Jameson, Mark Evans and Piotr Skolimowski.

©2025 Bloomberg L.P.

Public companies that heavily invested in cryptocurrencies are now facing significant financial losses. The once promising investment strategy has seen share prices plummet, leaving firms grappling with the aftermath.

What Happened: Companies that converted their corporate cash into Bitcoin (CRYPTO: BTC) or other digital tokens, inspired by Michael Saylor‘s Strategy Inc., have experienced a severe reversal in fortunes. Digital asset treasuries (DATs) were a popular trend in the first half of 2025, causing share prices to soar.

One such firm, SharpLink Gaming Inc., witnessed its stock surge over 2,600% after declaring a shift to buying Ethereum tokens. However, the stock has since dropped 86% from its peak, reducing the company’s value to less than its digital token holdings.

Bloomberg reports that the median stock price of US and Canadian-listed companies that transitioned to DATs has decreased by 43% this year. The worst hit were those that invested in smaller, more volatile tokens.

Analysts believe the downfall is due to the non-existent yield from these holdings. “Investors took a look and understood that there’s not much yield from these holdings rather than just sitting on this pile of money, and that’s why they contracted,” B. Riley Securities Analyst Fedor Shabalin told the outlet.

Also Read: JPMorgan Forecasts Bitcoin Bottom, Anticipates $28.3 Trillion Challenge To Gold By 2026

With most DATs’ crypto holdings failing to generate any cash flow, these companies are now finding it difficult to make interest and dividend payments on the debt they incurred to purchase the tokens. This has resulted in a decrease in investor enthusiasm and a decline in capital raising opportunities.

Despite the downturn, some DATs are contemplating acquisitions of smaller DATs that are worth less than their holdings, suggesting potential future activity in this sector.

Why It Matters: The downfall of DATs underscores the risks associated with heavy investment in volatile assets like cryptocurrencies. Companies that jumped on the crypto bandwagon, inspired by early successes, are now facing the harsh reality of a market downturn.

With no yield from these holdings and a struggle to meet debt obligations, these companies are facing a crisis of investor confidence.

The potential for acquisitions of smaller DATs indicates that despite the losses, there may still be some belief in the long-term potential of digital assets. However, the immediate future looks challenging for these firms.

LEXINGTON, Mass., Dec. 6, 2025 /PRNewswire/ — Partner Therapeutics, Inc. (PTx), a private, fully-integrated biotechnology company, announced new data from a post hoc analysis of the Phase 2 eNRGy trial (NCT02912949) evaluating zenocutuzumab in patients with treatment-naïve non-small cell lung cancer (NSCLC) harboring a neuregulin 1 (NRG1) gene fusion. Results were presented in a late-breaking oral session at the IASLC-ASCO North America Conference on Lung Cancer (NACLC), in Chicago, Illinois.

The new analysis evaluated the efficacy and safety of zenocutuzumab-zbco in treatment-naïve and previously treated NRG1+ NSCLC. Among 20 treatment-naïve and 121 previously treated patients, zenocutuzumab demonstrated an overall response rate (ORR) of 35% and 31%, respectively. The clinical benefit rate, defined as partial/complete response or stable disease for ≥24 weeks, was 65% in treatment-naïve and 58% in previously treated patients. Median duration of response was 17.1 months in treatment naïve patients, notably longer than in previously treated patients, 7.4 months. All treatment-related adverse events were grade 1 or 2. Zenocutuzumab safety profile was favorable and consistent with prior data.

“These data underscore the potential of zenocutuzumab as a first-line option for patients with NRG1-positive NSCLC, a patient population that typically responds poorly to standard first-line therapy,” said Stephen Liu, MD, of Georgetown University. “Early and durable responses, coupled with a favorable safety profile are encouraging and highlight the importance of targeted therapy in this rare molecular subset.”

“Consistent with other therapies targeting key oncogenic drivers, early intervention can lead to better outcomes — and we see the same with zenocutuzumab,” said Pritesh J. Gandhi, Chief Development Officer at Partner Therapeutics. “These findings strengthen our conviction that early targeted inhibition of the NRG1 pathway with zenocutuzumab has the potential to meaningfully improve outcomes for patients with NRG1+ NSCLC.”

“For patients and families facing NRG1+ lung cancer, these results mark meaningful progress,” said Danielle Hicks, Chief Patient Officer of GO2 for Lung Cancer. “The durable responses and manageable safety profile of zenocutuzumab offer renewed hope and reinforce the need for continued innovation in biomarker-driven lung cancer care.”

The abstract will be available on the Partner Therapeutics website under the research tab following the conference. Additional meeting information can be found on the IASLC-ASCO NACLC website.

In December 2024, zenocutuzumab-zbco (BIZENGRI^®) received U.S. Food and Drug Administration accelerated approval for the treatment of adults with advanced unresectable or metastatic non-small cell lung cancer (NSCLC) and pancreatic adenocarcinoma harboring a neuregulin 1 (NRG1) gene fusion with disease progression on or after prior systemic therapy. The indications were approved under accelerated approval based on ORR and duration of response. Continued approval for these indications may be contingent upon verification and description of clinical benefit in a confirmatory trial(s).

For more information on the eNRGy trial and zenocutuzumab-zbco, please visit www.partnertx.com.

About NRG1 Gene Fusions

NRG1 fusions are unique cancer drivers that create oncogenic chimeric ligands rather than the more widely described chimeric receptors (NTRK, RET, ROS1, ALK, and FGFR fusions). The chimeric ligands bind to HER3, triggering HER2/HER3 heterodimerization and activate downstream signaling pathways that cause cancer cells to grow and proliferate. Zenocutuzumab-zbco is a bispecific antibody that blocks HER2/HER3 dimerization and NRG1 fusion interactions with HER3, resulting in the suppression of these pathways. Comprehensive molecular testing, notably tissue-based RNA next generation sequencing, is essential to identify rare and actionable gene fusions like NRG1.

About BIZENGRI (zenocutuzumab-zbco)

INDICATIONS

BIZENGRI is indicated for the treatment of adults with advanced unresectable or metastatic non-small cell lung cancer (NSCLC) harboring a neuregulin 1 (NRG1) gene fusion with disease progression on or after prior systemic therapy.

BIZENGRI is indicated for the treatment of adults with advanced unresectable or metastatic pancreatic adenocarcinoma harboring a neuregulin 1 (NRG1) gene fusion with disease progression on or after prior systemic therapy.

These indications are approved under accelerated approval based on overall response rate and duration of response. Continued approval for these indications may be contingent upon verification and description of clinical benefit in a confirmatory trial(s).

Important Safety Information

BOXED WARNING: EMBRYO-FETAL TOXICITY

Embryo-Fetal Toxicity: Exposure to BIZENGRI during pregnancy can cause embryo-fetal harm. Advise patients of this risk and the need for effective contraception.

WARNINGS AND PRECUATIONS

Infusion-Related Reactions/Hypersensitivity/Anaphylactic Reactions

BIZENGRI can cause serious and life-threatening infusion-related reactions (IRRs), hypersensitivity and anaphylactic reactions. Signs and symptoms of IRR may include chills, nausea, fever, and cough.

In the eNRGy study, 13% of patients experienced IRRs, all were Grade 1 or 2; 91% occurred during the first infusion.

Administer BIZENGRI in a setting with emergency resuscitation equipment and staff who are trained to monitor for IRRs and to administer emergency medications. Monitor patients closely for signs and symptoms of infusion reactions during infusion and for at least 1 hour following completion of first BIZENGRI infusion and as clinically indicated. Interrupt BIZENGRI infusion in patients with ≤ Grade 3 IRRs and administer symptomatic treatment as needed. Resume infusion at a reduced rate after resolution of symptoms. Immediately stop the infusion and permanently discontinue BIZENGRI for Grade 4 or life-threatening IRR or hypersensitivity/anaphylaxis reactions.

Interstitial Lung Disease/Pneumonitis

BIZENGRI can cause serious and life-threatening interstitial lung disease (ILD)/pneumonitis.

In the eNRGy study, ILD/pneumonitis occurred in 2 (1.1%) patients treated with BIZENGRI. Grade 2 ILD/pneumonitis (Grade 2) resulting in permanent discontinuation of BIZENGRI occurred in 1 (0.6%) patient. Monitor for new or worsening pulmonary symptoms indicative of ILD/pneumonitis (e.g., dyspnea, cough, fever). Immediately withhold BIZENGRI in patients with suspected ILD/pneumonitis and administer corticosteroids as clinically indicated.

Permanently discontinue BIZENGRI if ILD/pneumonitis ≥ Grade 2 is confirmed.

Left Ventricular Dysfunction

BIZENGRI can cause left ventricular dysfunction.

Left ventricular ejection fraction (LVEF) decrease has been observed with anti-HER2 therapies, including BIZENGRI. Treatment with BIZENGRI has not been studied in patients with a history of clinically significant cardiac disease or LVEF less than 50% prior to initiation of treatment.

In the eNRGy study, Grade 2 LVEF decrease (40%-50%; 10 – 19% drop from baseline) occurred in 2% of evaluable patients. Cardiac failure without LVEF decrease occurred in 1.7% of patients, including 1 (0.6%) fatal event.

Before initiating BIZENGRI, evaluate LVEF and monitor at regular intervals during treatment as clinically indicated. For LVEF of less than 45% or less than 50% with absolute decrease from baseline of 10% or greater which is confirmed, or in patients with symptomatic congestive heart failure (CHF), permanently discontinue BIZENGRI.

Embryo-Fetal Toxicity

Based on its mechanism of action, BIZENGRI can cause fetal harm when administered to a pregnant woman. No animal reproduction studies were conducted with BIZENGRI. In post marketing reports, use of a HER2-directed antibody during pregnancy resulted in cases of oligohydramnios manifesting as fatal pulmonary hypoplasia, skeletal abnormalities, and neonatal death. In animal models, studies have demonstrated that inhibition of HER2 and/or HER3 results in impaired embryo-fetal development, including effects on cardiac, vascular and neuronal development, and embryolethality. Advise patients of the potential risk to a fetus. Verify the pregnancy status of females of reproductive potential prior to the initiation of BIZENGRI. Advise females of reproductive potential to use effective contraception during treatment with BIZENGRI and for 2 months after the last dose.

ADVERSE REACTIONS

NRG1 Gene Fusion Positive Unresectable or Metastatic NSCLC

Serious adverse reactions occurred in 25% of patients with NRG1 gene fusion positive NSCLC who received BIZENGRI. Serious adverse reactions in ≥ 2% of patients included pneumonia (n=4) dyspnea and fatigue (n=2 each). Fatal adverse reactions occurred in 3 (3%) patients and included respiratory failure (n=2), and cardiac failure (n=1). Permanent discontinuation of BIZENGRI due to an adverse reaction occurred in 3% of patients. Adverse reactions resulting in permanent discontinuation of BIZENGRI included dyspnea, pneumonitis and sepsis (n=1 each).

In patients with NRG1 gene fusion positive NSCLC who received BIZENGRI, the most common (>20%) adverse reactions, including laboratory abnormalities, were decreased hemoglobin (35%), increased alanine aminotransferase (30%), decreased magnesium (28%), increased alkaline phosphatase (27), decreased phosphate (26%), diarrhea (25%), musculoskeletal pain (23%), increased gamma-glutamyl transpeptidase (23%), increased aspartate aminotransferase (22%), and decreased potassium (21%).

NRG1 Gene Fusion Positive Unresectable or Metastatic Pancreatic Adenocarcinoma

Serious adverse reactions occurred in 23% of patients with NRG1 gene fusion positive pancreatic adenocarcinoma who received BIZENGRI.

There were 2 fatal adverse reactions, one due to COVID-19 and one due to respiratory failure. In patients with NRG1 gene fusion positive pancreatic adenocarcinoma who received BIZENGRI the most common (≥20%) adverse reactions, including laboratory abnormalities, were increased alanine aminotransferase (51%), diarrhea (36%), increased aspartate aminotransferase (31%), increased bilirubin (31%), decreased phosphate (31%), increased alkaline phosphatase (28%), decreased sodium (28%), musculoskeletal pain (28%), decreased albumin (26%), decreased potassium (26%), decreased platelets (26%), decreased magnesium (24%), increased gamma-glutamyl transpeptidase (23%), decreased hemoglobin (23%), vomiting (23%), nausea (23%), decreased leukocytes (21%), and fatigue (21%).

Please see full Prescribing Information, including Boxed Warning

About Partner Therapeutics

Partner Therapeutics, Inc. (PTx), an integrated biotechnology company, focuses on development and commercialization of therapeutics to improve health outcomes in cancer and serious diseases, as well as global health security threats. The company believes in delivering products and supporting medical teams with the purpose of achieving superior outcomes for patients and their families. PTx’s portfolio includes zenocutuzumab-zbco (BIZENGRI^®) and sargramostim (EU: IMREPLYS^®; US: LEUKINE^®; and with Nobelpharma Co. Ltd for JAPAN: SARGMALIN^®). Visit www.partnertx.com.

References:

1. BIZENGRI (zenocutuzumab-zbco) injection [package insert]. Available at: https://www.bizengrihcp.com/pi
2. Schram AM, Goto K, Kim DW, et al. Efficacy of zenocutuzumab in NRG1 fusion–positive cancer. N Engl J Med. 2025;392:566-76. doi: 10.1056/NEJMoa2405008

BIZENGRI^® is a registered trademark of Merus N.V. Under an agreement with Merus, PTx has exclusive rights to develop, manufacture, and commercialize zenocutuzumab-zbco for the treatment of NRG1+ cancer in the U.S. and provide the product on a named-patient basis for this use outside of the U.S. pending future regulatory developments.

PARTNER THERAPEUTICS^®, IMREPLYS^®, and LEUKINE^® are registered trademarks owned by Partner Therapeutics, Inc. ©2025 Partner Therapeutics, All rights reserved.

SOURCE Partner Therapeutics, Inc.

SIMI VALLEY, California, Dec 6 (Reuters) – U.S. President Donald Trump’s plan to take government equity stakes in strategic industries doesn’t apply to major defense firms, the head of Boeing’s defense unit said on Saturday, in contrast to previous comments by a senior government official.

“It really only applies on the supply chain, particularly for the smaller companies coming through where that might be a way forward for them to get some equity,” Steve Parker, Chief Executive Officer of Boeing Defense, Space & Security, said on a panel at the Reagan National Defense Forum, an annual industry event in Simi Valley, California.

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“I don’t think it really applies to the Primes,” Parker added, referring to big legacy defense contractors like Boeing, Lockheed Martin, RTX and Northrop Grumman.

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