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Summit Akeso ivonescimab improves survival in Harmoni-6 trial

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Summit Akeso ivonescimab improves survival in Harmoni-6 trial

Piotr Swat | Lightrocket | Getty Images

An experimental lung cancer drug from Akeso and Summit Therapeutics reduced the risk of death by 34% in a closely watched late-stage trial, according to results released Sunday.

When combined with chemotherapy, the drug kept people with squamous non-small-cell lung cancer alive for a median of four months longer than the standard combination of immunotherapy and chemotherapy, a result that was statistically significant, according to an abstract released Sunday ahead of a presentation at the American Society of Clinical Oncology’s annual meeting. The Phase 3 trial was conducted in China, and a global Phase 3 study is ongoing.

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“The fact that it shows an improvement in overall survival in a difficult-to-treat patient population is very encouraging,” said Dr. Suresh Ramalingam, executive director of the Winship Cancer Institute of Emory University. “I’m mindful of the fact that this trial was done exclusively in China, and that brings up the question of how do these data apply to patient populations outside of China, and that will require future investigations.”

Called ivonescimab, the bispecific antibody targets PD-1 — similar to Merck’s best-selling drug Keytruda —and VEGF — similar to Roche’s Avastin. It’s become the subject of intense debate in the oncology and investment communities. Some say ivonescimab and similar drugs could be a successor to Merck’s wildly successful cancer drug Keytruda, while others warn it’ll disappoint like other once-promising ideas such as drugs targeting TIGIT, an immune receptor.

The dueling narratives are reflected in the stock price of U.S.-based Summit Therapeutics, which licensed the rights to ivonescimab outside of China from Akeso. Shares of Summit have skyrocketed nearly 600% in the two years since Summit said ivonescimab more effectively controlled tumors than Keytruda in a separate China trial. The stock has slid in the past month over concerns the drug won’t be as effective in a global population.

Cancer drug targets

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  • PD-1: A protein that helps cancer cells hide from the immune system.
  • VEGF: A protein that promotes the growth of new blood vessels and can help cancer cells thrive.

Previous studies have showed ivonescimab can effectively control tumors, an endpoint known as progression-free survival. That’s typically not enough to seek approval from the U.S. Food and Drug Administration, which wants proof that cancer drugs can keep people alive longer. Older VEGF drugs that effectively controlled tumors struggled to improve survival, which raised doubts that ivonescimab’s early promise would hold.

In the Harmoni-6 trial being presented Sunday, ivonescimab combined with chemotherapy kept people alive for a median of 27.9 months versus 23.7 months for people who received a standalone PD-1 drug and chemotherapy, an improvement of four months.

“It’s not clear how meaningful that is,” said Dr. Deborah Doroshow, associate professor of medicine, hematology and medical oncology at the Icahn School of Medicine at Mount Sinai. “It’s certainly, it’s not two months, but it’s also not a huge difference, and I think in terms of whether or not living four months longer is meaningful absolutely depends on the person who is living it.”

People receiving immunotherapy in the control group lived an average of six months longer than expected, raising questions about whether the trial enrolled a representative patient population and whether the advantage of ivonescimab might be better than reported in the study, said Doroshow, who serves on the steering committee for the ongoing Harmoni-3 global trial of ivonescimab.

One possible reason for the discrepancy is that the study was conducted in China, where people have historically responded better to standalone PD-1 and VEGF drugs, said Emory’s Ramalingam. The only way to determine whether combining the two in one molecule produces different results for broader populations is to run additional studies in the West, he said.

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Until then, Ramalingam called the trial results “good news” for Chinese patients.

“There is a new approach in squamous cell lung cancer that extends survival by about four months, which is a substantial improvement given that this is a patient population where progress has come in small steps,” he said.

Summit plans to report progression-free survival results from squamous patients in the global Harmoni-3 trial in the second half of this year. It expects to share results from non-squamous patients in the first half of next year.

Kateryna Kon/science Photo Library | Science Photo Library | Getty Images

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One purported benefit of PD-1/VEGF-targeting drugs is the ability to give them safely to people with squamous lung cancer, a subset most commonly caused by smoking. These tumors tend to crop up near major blood vessels in the lungs, and blocking VEGF can prevent those blood vessels from repairing themselves, leading to potentially fatal hemorrhaging.

In the trial being presented Sunday, bleeding of any severity occurred in almost one-quarter of people in the ivonescimab group, twice as much as in the control group. Less than 3% of the cases were considered severe versus about 1% of people who received the PD-1 drug tislelizumab, according to slides that will be presented Sunday where the presenter describes ivonescimab’s safety as comparable.

More broadly, drugmakers and investors alike want to know whether PD-1/VEGF drugs will succeed Keytruda and similar drugs like Bristol Myers Squibb’s Opdivo as mainstay treatments. Checkpoint inhibitors like Keytruda have transformed the treatment of lung cancer and are now used in dozens of other cancers. Keytruda alone has 44 indications and generated more than $30 billion in sales for Merck last year.

Replacing Keytruda everywhere it’s used today and potentially expanding into new indications would create “a very large market,” said Leerink Partners analyst Daina Graybosch. That prospect has prompted a rush of dealmaking.

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Licensing deals involving PD-1 drugs reached $30 billion last year, nearly doubling the previous peak of $16 billion in 2017, a few years after Keytruda and Opdivo reached the market. Merck and Bristol Myers Squibb were part of the recent rush, with both companies signing potentially multibillion dollar deals for PD-1/VEGF drugs.

But it’s unlikely that ivonescimab and similar drugs will be as broadly used, said Ethan Smith, oncology director at Norstella, especially as they face more competition from other emerging drugs like antibody drug conjugates than Keytruda had when it entered the market more than a decade ago.

Data from one antibody drug conjugate from Merck and partner Kelun is also being presented this weekend at the ASCO meeting. The experimental drug cut the risk of tumor progression by 65% in a study of lung cancer conducted in China, according to an abstract released ahead of the meeting.

While Merck thinks there will be places for PD-1/VEGF drugs and is excited about the one it’s developing, the company doesn’t expect them to become the next Keytruda, said Dr. Marjorie Green, Merck’s head of global oncology clinical development.

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“It’s an exciting time in oncology,” said Green. “I never thought that we would be in a position in lung cancer to debate about which of the new therapies is the best because there just have not been a lot of advances. Keytruda has just been a cornerstone therapy and people are like, ‘What’s going to displace it?’ And I think it’s good news for people who are unfortunately diagnosed with lung cancer that we’re in position to say, you know what, there might be multiple options of things that we can do, and then hopefully add them together and help even more.”

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Gold rebounds from one-week low as Iran cites progress in peace talks

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Gold rebounds from one-week low as Iran cites progress in peace talks
Gold rose over 1% on Monday, rebounding from a more than one-week low hit in the previous session, as Brent crude oil prices fell after Iran claimed progress in U.S.-Iran peace talks, easing concerns around inflation and higher interest rates.

FUNDAMENTALS

Spot gold was up 1.2% at $4,209.03 per ounce, as of 0112 GMT. U.S. gold futures for ‌August delivery ⁠fell 0.5% ⁠to $4,225.80.

An Iranian foreign ministry spokesperson said good progress has been made during the quadrilateral talks in Switzerland, according to Iran’s Press TV.

Iran-U.S. peace talks in Switzerland stretched into their second day on Monday, after a tense opening marked by Tehran’s announcement it had again closed the Strait of Hormuz and U.S. President Donald Trump repeating his threats to resume attacks on Iran.

⁠Brent crude ‌futures fell 0.5% after Iran claimed progress in peace talks, easing fears of elevated inflation and higher-for-longer global interest rates.

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Federal Reserve ⁠Chair Kevin Warsh’s emphasis on inflation in last week’s press conference, without any more-nuanced commentary about what might clear the bar for a rate hike, led investors to conclude an increase was coming soon and begin bidding up bond yields.
Most global brokerages are betting on the Fed to hold interest rates steady for the rest of 2026, reversing from expectations of two interest rate cuts at the ‌start of the year, as policymakers navigate elevated inflation risks and a resilient labor market.
Gold demand was modest in India last week as prices fell to their ⁠lowest level in two-and-a-half months and remained volatile, while top consumer China flipped to a discount.
Swiss gold exports fell 9% in May from the previous month as lower shipments to India and Hong Kong offset higher deliveries to Britain and China, Swiss customs data showed.

Spot silver rose 2.6% to $66.60 per ounce, platinum gained 1.3% to $1,684.85, and palladium was up 1.5% at $1,276.88.

DATA/EVENTS (GMT)

0100 China Loan Prime Rate 1Y,

5Y Jun 1400 EU Consumer Confid Flash Jun

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Dollar firms as cracks emerge in peace deal, pound dips on Starmer uncertainty

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Dollar firms as cracks emerge in peace deal, pound dips on Starmer uncertainty
The dollar was firm on Monday as uncertainty clouded a tentative U.S.-Iran peace deal following threats from President Donald Trump to restart the war in the Middle East and Tehran’s announcement it had closed the Strait of Hormuz.

Despite rising tensions, U.S.-Iran peace talks stretched into their second day in Switzerland under the terms of a memorandum of understanding reached last week to extend a ceasefire from April for at least another 60 days.

Chris Weston, head of research at ‌Pepperstone, said it ⁠was not ⁠surprising how quickly adherence to the terms of the deal had broken down. “Ultimately, what matters to markets is the flow of cargo through the Strait of Hormuz.”

Shipping data showed the number of ships that passed through the waterway fell sharply on Sunday after Tehran said it had closed the strait. That lifted oil prices with Brent crude futures climbing 1.30% to $81.62 a barrel. [O/R]

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“The physical market remains tight and that should provide some support, but flows in FX and commodities, particularly gold, will continue to be heavily influenced by developments in the energy ⁠complex,” Weston ‌said.


Sterling eased in early trading as traders assessed the political tumult in Britain, where Prime Minister Keir Starmer was considering his political future after rival Andy Burnham’s decisive election victory to ⁠parliament.
The pound was 0.24% weaker at $1.32055, while the euro softened 0.1% to $1.1462. The Australian dollar was last down 0.19% at $0.70035, while the New Zealand dollar last bought $0.573. Markets will be focused on Burnham’s views on fiscal policy and whether there will be any relaxation of the current fiscal rules, Commonwealth Bank of Australia strategists said.

“A loosening in fiscal rules would likely be poorly received by the UK bond market and weigh on pound,” they said in a note.

The Japanese yen slipped to 161.53 per dollar, hovering near a two-year low reached last week. A break beyond 161.96 would take the ‌yen to its weakest level since 1986.

Japanese Finance Minister Satsuki Katayama said on Monday that authorities were prepared to respond appropriately to currency moves at any time, reiterating their previous stance.

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“The MOF may be getting sore necks watching ⁠USD/JPY surge into the 2024 high,” said Matt Simpson, senior market analyst at StoneX. “Yet they may also feel powerless to do anything about it – as intervening against the tide of a hawkish Fed and strong U.S. fundamentals could prove costly and futile.”

The yen has erased gains made after a round of interventions from April 30, as a hawkish tilt by the Federal Reserve has led traders to ramp up bets on rate increases this year.

Treasuries remained under pressure on Monday with yields on 2-year notes rising to their highest since early 2025 at 4.2276%. Traders are anticipating 43 basis points of hikes this year with a 25 bp increase fully priced in by September.

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NHB probing Aavas Financiers over loan classification lapses

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NHB probing Aavas Financiers over loan classification lapses
MUMBAI: The National Housing Bank (NHB) has begun a formal probe into CVC Capital Partners-backed mortgage lender Aavas Financiers after preliminary inquiries uncovered loan classification irregularities, with multiple instances of loans categorised under ineligible refinancing schemes, multiple sources aware of the development told ET.

The sector regulator has recalled refinancing support worth nearly Rs 500 crore —a punitive action that has set off a sweeping leadership overhaul at the company. ET was the first to report on April 13 that managing director and CEO Sachinder Bhinder was being asked to step down, with Manu Singh — former home loans head at Kotak Mahindra Bank — set to take over. A week later, on April 20, the company confirmed Bhinder’s resignation and Singh’s appointment as the new CEO.

The NHB’s investigation found that concessional refinance meant for SC/ST borrowers had been availed against loans where the borrowers did not belong to these categories.

Aavas Financiers sees top-level churn: CFO and CRO to exit, interim replacements named

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Loans were also classified as disbursed in hilly areas even though the underlying properties were not located in such regions, and non-home loans had been misclassified as home loans to access preferential funding — a trifecta of classification failures that triggered the regulator’s action, sources said.


Aavas Financiers confirmed the NHB investigation, though it stopped short of acknowledging the specific findings.
“The NHB, in the ordinary course, conducts periodic audits and inspections of housing finance companies, including Aavas Financiers, and one such inspection is presently underway and has not yet been concluded,” the company said in a statement.The company added that it has not received any direction from NHB requiring it to repay any funding lines.

Sources, however, said the scale of the irregularities went well beyond what might be expected in a routine inspection.

Singapore-based fintech company Aleta aims to expand operations into India

“The regulator’s concerns were not limited to isolated instances. The inspection identified multiple cases where loans were categorised under refinance schemes that they were not eligible for, resulting in the withdrawal of refinance support and prompting a wider review of internal controls,” said a person aware of the development.

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TOP EXECUTIVES TOLD TO RESIGN
CVC Capital Partners, which holds a majority stake of over 50% in Aavas Financiers, has shown the door to chief financial officer Ghanshyam Rawat and chief risk officer Ashutosh Atre in the wake of the NHB’s findings. Sources said both officials were asked to resign on June 15, though the disclosures were made only after a hastily called board meeting on June 21.

The company subsequently informed stock exchanges that it had appointed Ghanshyam Gupta as interim chief financial officer and Punit Purushottam Agarwal as interim chief risk officer, with effect from June 22.

The exits are the latest in a series of senior management departures that paint a troubling picture of how the company was conducting its business.

In the span of barely two months, Aavas Financiers has replaced its MD and CEO, CFO and CRO — an unprecedented churn at the top that reflects the depth of the crisis the company is navigating. Markets have also taken note of the turbulence. With a market capitalisation of approximately Rs 11,673 crore, the stock has declined nearly 32% from its 52-week high of Rs 2,152, trading at around Rs 1,472 — reflecting deepening investor concerns around governance, growth visibility and execution amid the ongoing management churn, according toexchange data.

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Stocks rally in Asia as Iran cites progress in talks

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Stocks rally in Asia as Iran cites progress in talks


Stocks rally in Asia as Iran cites progress in talks

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Labor's reform outlook cools before long winter break

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Labor's reform outlook cools before long winter break

Controversial changes to both the tax system and the NDIS are under negotiation as Labor tries to land a deal with the Greens before parliament breaks.

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More fuel relief for motorists with halfway measure

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More fuel relief for motorists with halfway measure

Motorists will benefit as a cut to fuel taxes is extended for another month, although at half the previous discount.

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Jio Platforms’ debut could give RIL top 2 slots in Indian m-cap league

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Jio Platforms' debut could give RIL top 2 slots in Indian m-cap league
ET Intelligence Group: The Reliance Mukesh Ambani group (RIL) will likely command nearly 7% of the total market capitalisation of companies listed on the BSE after the initial public offering (IPO) of its telecom and digital media arm, Jio Platforms (JioP) compared with the current share of under 4%. This reflects a significant value unlocking for investors. In addition, at the higher end of the anticipated valuation band for JioP, the RIL group will host India’s two largest companies by market cap – Reliance Industries with market cap of ₹17.7 trillion and JioP with an estimated market cap of ₹14 trillion. HDFC Bank, Bharti Airtel, and ICICI Bank with respective market caps of ₹12 trillion, ₹11.6 trillion and ₹9.7 trillion will be next on the ranking tally.

The combined market cap of the two companies of the RIL group is expected to be around ₹32 trillion. It will nearly match the current combined market value of ₹33 trillion for HDFC Bank, Bharti Airtel, and ICICI Bank.

At present, the market cap of the companies listed on the BSE is nearly ₹478 trillion. For the Nifty 50 set of companies, the market cap is ₹194 trillion, which implies that the RIL group’s market cap will be over 16% of the benchmark index’s market value.

JioP’s Debut Could Give Reliance Top 2 Slots in Indian M-Cap LeagueAgencies

Group share of BSE’s m-cap to rise to nearly 7%, and almost match combined value of HDFC Bank, Bharti Airtel & ICICI Bank

Globally, Elon Musk promoted Tesla and SpaceX together account for nearly 5% of the total market cap of the US companies. After a strong debut on Nasdaq on June 12, SpaceX commands a market cap of $2.4 trillion, while Tesla’s is $1.3 trillion. The market cap of listed companies in the US is over $77 trillion, according to the data from Bloomberg.
Internationally, technology led companies have been driving overall market valuations to record levels. For instance, Samsung Electronics and SK Hynix, the top South Korean companies based on market value, account for nearly 50% of the country’s market cap. In the case of Taiwan, chip maker TSMC contributes over 40% to the country’s market cap.

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There are little signs of economy overheating: Saugata Bhattacharya

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There are little signs of economy overheating: Saugata Bhattacharya
Saugata Bhattacharya, external member of the monetary policy committee (MPC), discusses with Rozebud Gonsalves about the second-order impact of input costs, expected financial conditions after the new FCNR(B) deposit and external commercial borrowing (ECB) incentives, and the inflation-growth trade off. Edited excerpts.

With crude oil prices falling, would growth be better than the central bank forecast? If yes, then do you think that the need to hike rates is lesser?

Yes, RBI growth and inflation forecasts were based, among other assumptions, on crude oil prices averaging $95 / barrel, which, based on oil futures, now appear likely to be lower. However, disruptions in supply chains could persist for some time, and hence it is difficult to predict the extent of growth recovery in FY27.

The MPC minutes have said that second-order input cost transmission getting embedded in retail inflation will have to be monitored. What would be the first signs visible via data that would suggest visible impact?
Second order effects are likely to manifest in core (non-food and fuel) CPI components, particularly in underlying components (excluding precious metals), indicating the extent of higher input cost pass through to retail inflation. However, it is difficult to forecast second order effects of higher input costs, which will depend on demand elasticities, input substitution and other pass through variables.The RBI Governor’s statement noted a revised FY27 core inflation at 4.7%, up from 4.4% at the April review, and headline at 5.1%, up from 4.6%. Factoring in price trends in other components, it might be possible to estimate specific inflation components.

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Are current financial conditions already restrictive enough that a rate hike is unnecessary?

Although the policy repo rate is currently only 15 basis points above the FY27 forecast CPI inflation, money market and short term interest rates remain higher. RBI has also maintained system liquidity at appropriate levels. In addition, the gap between the repo rate and longer term bond yields have also risen much beyond steady state levels. Although MPC quarter wise forecasts of CPI inflation peaks in Q3 FY27, close to the upper band of the target, underlying inflation remains much lower and there are little signs of the economy overheating.
Have conditions eased after the FCNR(B) and ECB packages? Would strong inflows from these schemes reduce the need for any future monetary tightening?
Prima facie, the expected foreign currency inflows will add to autonomous domestic liquidity if even some of the inflows are absorbed by the central bank to replenish its foreign currency reserves. However, financial conditions will depend on RBI’s system liquidity management.Can it be said that growth is a bigger concern for the RBI in the current scenario, especially since inflation is projected at 5.1% and the repo rate is at 5.25%?
At the time of the MPC review, there were risks to both inflation and growth. While high frequency indicators suggested continuing resilience, they indicated a loss of momentum. This was the reason FY27 GDP forecast was a lower 6.6%, compared to the then FY26 estimate of 7.6%.

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Softbank-backed robotics firm Coowa plans Hong Kong IPO- WSJ

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Softbank-backed robotics firm Coowa plans Hong Kong IPO- WSJ

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Can Jio and NSE IPOs repeat Maruti feat?

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Can Jio and NSE IPOs repeat Maruti feat?
Mumbai: Few IPO calendars have looked as momentous as the ones shaping up in the US and India. On one side are OpenAI and Anthropic, two mega companies looking to ride the AI frenzy following the jumbo SpaceX issue’s roaring success earlier in June. On the other are India’s long-awaited giant IPOs, Jio Platforms and NSE, which have been part of investors’ wish lists for years.

The biggest difference between the upcoming IPOs in India and the US is not their size but the market mood they are arriving in.

OpenAI and Anthropic are preparing to tap the primary market at a time when enthusiasm over AI has pushed US equities to record highs, creating an almost ideal backdrop for IPOs. In contrast, Jio and NSE are heading to the market in a far less ideal IPO milieu.

While OpenAI and Anthropic enjoy the luxury of launching their IPOs in a market where investors are looking to lap up anything linked to AI, Jio and NSE must do all the heavy lifting, as appetite for Indian equities is far from its peak.

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This difference is consequential. Historically, mega IPOs have signalled market tops as issuers look to capitalise on investor frenzy. The logic here is that investors are willing to pay just about anything to be part of the euphoria, ignoring valuation concerns.


This theory, to some extent, resonates with what’s happening in the US, where the loss-making SpaceX listed at a record valuation of $1.8 trillion, making it one of the most valuable companies. Though SpaceX shares are stuttering after the blockbuster debut, the strong showing in the IPO has set the stage for OpenAI and Anthropic in the coming months. There is nothing, for now, to suggest that their IPOs would not sail through unless investors lose faith in the AI theme as a whole.
Shift focus to India: Jio and NSE are preparing to list at a time when Indian markets have delivered no or marginal returns in the past two years. While foreign investors have fled Indian stocks in large numbers, individual investors-the street’s current backbone-are showing less enthusiasm towards equities. Moreover, most recent listings have been far from inspiring.That’s good news for investors. The IPO valuations of both these issuances are likely to be far more sober, with fewer deviations from their listed peers and in sync with the overall large-cap space. Early indications suggest that global investors are considering deploying money in these IPOs, judging them on a standalone basis rather than as part of an India portfolio, given their dominant presence in sectors with high entry barriers.

Some optimists are counting on the Jio and NSE IPOs to give the secondary market a boost, the way Maruti Suzuki‘s IPO in 2003-04 proved to be a turning point for Indian markets. The carmaker’s IPO, coming after the dot-com bubble burst and in the aftermath of the Ketan Parekh scam, was credited with reviving retail participation in equities and improving investor sentiment, signalling the start of one of India’s best bull runs-between 2003 and 2007.

Whether Jio and NSE can have a similar effect is debatable, given the vastly different market and economic conditions prevailing today. Currently, the market is far more mature, with domestic equity ownership at record levels, creating less scope for the entry of a new army of domestic retail investors.

The real test for the Jio and NSE IPOs will not be whether they get fully subscribed; it will be whether the issues can rekindle foreign investor interest in Indian markets. Maruti’s IPO helped bring domestic investors back to the market. Two decades later, Jio and NSE face a bigger task: persuading global investors to give India another look.

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