Market Signal Briefing

The past 48 hours have reshaped the narrative around ZCash (ZEC), turning volatility into an opportunity for traders and long-term believers. After nosediving to $190 on October 17 as Bitcoin dropped below $105,000, ZEC attracted swift attention, not just from retail speculators, but from serious institutional players. What’s behind this dramatic rebound and what can we expect next? Here’s my take.

ZEC Price Analysis:On the heels of a brutal 20% intraday drop, ZEC’s price hovered with critical Fibonacci support around $201.68. That same session saw the 14-day RSI collapse to 37, signaling deeply oversold conditions. By the next day, momentum reversed sharply, boosted by traders stepping in around the 38.2% retracement—to push ZEC up 7.16% in a single session. The token is now resting at $216.15 and sporting a $3.52 billion market cap.

But here’s where it gets interesting, Grayscale’s ZCash Trust reported new inflows totaling $46 million this month. And shielded transactions reached 4.42 million ZEC, about 27% of the entire circulating supply. If you follow institutional footprints, this is crucial, big money is eyeing ZEC. With the shielded pool now valued at $1.12 billion, liquid supply is dwindling, which naturally puts a floor under prices and could amplify future surges.

Despite this momentum, caution remains. The 23.6% Fibonacci retracement at $238.11 is now a clear resistance, while bulls need consistent closes above the $220 pivot to confirm that a real reversal is in play. If ZEC can break and sustain above $220, it could rapidly target $238 and even $265, with failure to hold $190 opening the door for retests of deeper support near $157.

FAQsWhy did ZCash suddenly drop and then rebound?

ZEC plunged alongside Bitcoin’s fall but rebounded as traders bought at oversold levels and institutions accumulated more ZEC, particularly around the $200 mark.

How significant are shielded transactions for ZCash’s price?

Growth in shielded pool usage reduces liquid supply, which can create upward price pressure, especially as institutional interest climbs.

What’s the key level to watch now for ZEC?

Consistent closes above $220 are vital to confirm a trend reversal, with $238 and $265 as immediate upside targets, and $190/$157 as support.

Trust with CoinPedia:CoinPedia has been delivering accurate and timely cryptocurrency and blockchain updates since 2017. All content is created by our expert panel of analysts and journalists, following strict Editorial Guidelines based on E-E-A-T (Experience, Expertise, Authoritativeness, Trustworthiness). Every article is fact-checked against reputable sources to ensure accuracy, transparency, and reliability. Our review policy guarantees unbiased evaluations when recommending exchanges, platforms, or tools. We strive to provide timely updates about everything crypto & blockchain, right from startups to industry majors.

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Journalist

Posted: October 18, 2025

Key Takeaways
What’s driving Mantle’s recent price drop?
A sharp 16% decline, driven by dominant selling pressure and a break below key support at $1.45.

Could MNT recover from here?
A rebound is possible if buying pressure returns and the $1 level holds as a psychological support.

Mantle [MNT] has come under sharp selling pressure over the past five days, recording a steep 16% drop, at press time, in the last 24 hours alone. The decline marks one of MNT’s most aggressive pullbacks in recent weeks.

As a result, the decline has wiped out short-term gains and shaken investor sentiment across the market. The token recently swept its key support level at $1.45, a zone that had previously acted as a strong demand area for buyers. 

With the price now hovering above the $1 milestone, traders and investors are closely watching whether MNT can stabilize, or if further downside is inevitable.

Source: TradingView

Retail traders remain active, but sellers dominate
Interestingly, the sell-off has not been marked by a lack of participation. CryptoQuant’s data indicates that retail traders remain heavily active, yet their presence has not been enough to offset the dominant bearish momentum.

This imbalance suggests that while smaller traders continue to engage the market, larger players and institutional participants might be offloading positions or hedging against broader volatility. 

Source: CryptoQuant

Despite accumulating buy orders, sellers continue to dominate MNT’s spot and futures markets, indicating that the sell-off may persist. 

This appears to be a structural decline, driven by deliberate distribution rather than panic selling.

Source: CryptoQuant

Market sentiment turns cautious
MNT’s current dip may be part of a broader reset phase for MNT after its earlier price rallies.

If the $1.45 support fails to reclaim strength as a pivot zone, the next key test lies around the $1 psychological level, which could serve as both a potential bounce point and a sentiment gauge.

However, if buying pressure returns and short liquidations occur, a temporary rebound could follow. 

XRP has entered a consolidation phase after a recent recovery, currently trading below $2.50 as bulls and bears battle for control. The price is attempting to climb above the $2.420 zone, showing early signs of bullish momentum.

The American company for non-fungible tokens (NFTs) has announced that it will launch its own token. The company co-founder and chief executive officer, Devin Finzer, confirmed that the SEA, its native token, will be launched by the first quarter of 2026. 

Distribution & Timing of OpenSea’s SEA According to the official announcement, SEA is scheduled for Q1 2026, under the OpenSea Foundation, which will oversee distribution and community engagement. The firm confirmed that 50% of the total supply will be allocated to the community, with more than half of that community share will be distributed through the initial claim. 

Moreover, at launch, 50% of OpenSea’s platform revenue will directly go toward buying back SEA tokens. This strategy is designed to support the token’s value and liquidity while reinforcing long-term ecosystem growth.  

Finzer said, “$SEA isn’t the destination, but it’s a crucial moment everyone will be watching. You only get one TGE. While the Foundation is wrapping up the final details, we’re getting OpenSea ready.” 

OpenSea Expands Beyond NFTThis month, the firm recorded $2.6 billion in trading volume, with 90% activity driven by token trading, highlighting its expansion beyond NFTs. In the first two weeks of October 2025, the startup company handled $1.6 billion in crypto trades and $230 million in NFT transactions. 

Finzer also hinted at an imminent broader rollout aimed at bringing the on-chain economy to users’ phones. He revealed the company‘s plans to introduce perpetual contracts (perps) trading, diversifying OpenSea’s functionality into derivatives markets. 

Earlier, Finzer said that the goal is to make trading as intuitive as Robinhood. The firm seeks to offer fully custodial services, meaning users will be able to control their assets across chains. 

OpenSea now offers users to trade any tokens, including NFTs, memecoins, or cryptocurrencies, across 22 blockchains. After seeing all these developments the firm has made so far and the ones underway, it is safe to say that OpenSea’s 2.0 vision is advancing. 

Never Miss a Beat in the Crypto World!Stay ahead with breaking news, expert analysis, and real-time updates on the latest trends in Bitcoin, altcoins, DeFi, NFTs, and more.

FAQsWhen is the OpenSea token (SEA) being released?

The OpenSea SEA token is scheduled to be launched in the first quarter of 2026, as confirmed by the company’s CEO, Devin Finzer.

How can I get the new OpenSea SEA token?

Over 50% of the community’s allocation will be distributed through an initial claim. The OpenSea Foundation will oversee the distribution process.

Is OpenSea only for NFTs now?

No, OpenSea has expanded. Recent data shows 90% of its trading volume comes from token trading, including cryptocurrencies and memecoins, across 22 blockchains.

Trust with CoinPedia:CoinPedia has been delivering accurate and timely cryptocurrency and blockchain updates since 2017. All content is created by our expert panel of analysts and journalists, following strict Editorial Guidelines based on E-E-A-T (Experience, Expertise, Authoritativeness, Trustworthiness). Every article is fact-checked against reputable sources to ensure accuracy, transparency, and reliability. Our review policy guarantees unbiased evaluations when recommending exchanges, platforms, or tools. We strive to provide timely updates about everything crypto & blockchain, right from startups to industry majors.

Investment Disclaimer:All opinions and insights shared represent the author's own views on current market conditions. Please do your own research before making investment decisions. Neither the writer nor the publication assumes responsibility for your financial choices.

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On October 17, both US spot crypto ETFs, Bitcoin and Ethereum, recorded strong outflows. According to SoSoVlaue, Bitcoin ETFs saw $366.59 million outflows, while Ethereum reported $232.28 million. 

Bitcoin ETF Breakdown Bitcoin ETFs recorded a net outflow of $366.59 million, with BlackRock IBIT leading at $268.61 million. Other major funds like Fidelity FBTC and Grayscale GBTC also posted withdrawals of $67.37 million and $25.04 million, respectively. Valkyrie BRRR posted the smallest outflow of the day with $5.57 million. 

Neither of the four ETFs posted any inflows for the day. The total trading value surged to $8.20 billion, slightly higher than yesterday. Total net assets came in at $143.93billion, representing 6.75% of the Bitcoin market cap. 

Ethereum ETF Breakdown Ethereum ETFs saw a net outflow of $232.28 million, with six out of nine ETFs posting withdrawals. BlackRock ETHA led with $146.06 million, and Fidelity FETH followed at $30.61 million. Additional sell-offs were recorded by Grayscale ETHE of $26.13 million and Bitwise ETHW of $20.59 million. 

Grasycale ETH  $4.69 million and VanEck ETHV $4.21 million reported the smallest outflows for the day. None of the ETFs posted any gains on Friday. The total trading value reached $2.49 billion with net assets of $25.98 million. This marks5.58% of the Ethereum market capitalization. 

Market Context Bitcoin price has plummeted to $106,743.06, marking a 5.8% decline from last week. Its market cap also slipped to $2.12 trillion, while the 24-hour trading volume surged to $99.48 billion. 

Meanwhile, Ethereum hit $3,855.61 on Saturday, showing a 2% drop in 24 hours. Its daily trading volume reached $56.16 billion, with its market cap of $464.93 billion, signalling a weak momentum. 

The bullish trend prediction for October has turned extremely bearish as both assets continue to face price decline, with ETF sell-offs. 

Trust with CoinPedia:CoinPedia has been delivering accurate and timely cryptocurrency and blockchain updates since 2017. All content is created by our expert panel of analysts and journalists, following strict Editorial Guidelines based on E-E-A-T (Experience, Expertise, Authoritativeness, Trustworthiness). Every article is fact-checked against reputable sources to ensure accuracy, transparency, and reliability. Our review policy guarantees unbiased evaluations when recommending exchanges, platforms, or tools. We strive to provide timely updates about everything crypto & blockchain, right from startups to industry majors.

Investment Disclaimer:All opinions and insights shared represent the author's own views on current market conditions. Please do your own research before making investment decisions. Neither the writer nor the publication assumes responsibility for your financial choices.

Sponsored and Advertisements:Sponsored content and affiliate links may appear on our site. Advertisements are marked clearly, and our editorial content remains entirely independent from our ad partners.

BTC slumped below $104,000 on Friday.

Remember the ‘Uptober’ narrative? October, the month that kicks off Q4, is promised to be a bullish one. There were high hopes for the 2025 edition as well.

And it all started on the right foot as BTC exploded out of the gate and peaked above $126,000 to chart a new all-time high. Thus, it had added over $16,000 of value in the span of just 10 days. However, things reversed just as quickly, and it lost even more ground against the greenback in the following 10 days. Here are some of the possible reasons behind this massive crash.

Trump-Led Uncertainty
The most significant price collapse, which occurred at the end of the previous business week, was largely attributed to global political uncertainty prompted by US President Donald Trump. The POTUS threatened China with a new wave of tariffs after accusing its authorities of a lack of transparency in certain areas.

Although such threats have taken place occasionally ever since he took office, BTC reacted with an immediate correction from over $122,000 to under $117,000. The situation worsened in the following hours, especially since futures positions started to get wrecked in an overly leveraged market.

The results were violent to say the least as bitcoin slumped to $110,000 on some exchanges, and all the way down to $101,000 on others. What’s particularly interesting here is that the entire calamity might have been one big misunderstanding between the two superpowers. Reports started to emerge that it was exaggerated, and the tension eased in the following days. With it, BTC’s price recovered to $116,000.

The focus then turned to another flammable geopolitical scene – the Ukraine/Russia war. On Thursday, Trump met with Russia’s Putin, and BTC started to lose traction as the meeting was taking place. On Friday, the POTUS was visited by Ukraine’s Volodymyr Zelenskyy. Reports indicated that the Ukrainian leader might not receive the requested Tomahawk cruise missiles.

It’s also worth mentioning the US government shutdown, which has continued for over two weeks now.

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US Banking Crisis?
The US banking system saw shades of the 2023 failure of Silicon Valley Bank when two regional organizations – Zions Bancorp and Western Alliance – published some controversial data that stirred fear into investors. The former disclosed a $50 million charge-off tied to two commercial loans in California, while the latter initiated a fraud lawsuit against a borrower, which fueled doubts about its loan portfolio quality.

Investors were spooked not only in the US but also in Asia and Europe, as evidenced by the drop in stock prices on Friday for major banks such as Deutsche Bank, Barclays, and Société Générale.

Although BTC is supposed to be the answer to cracks in the traditional financial system, such crises typically harm it, especially in the short term.

ETF Exodus
After an impressive 9-day period that started in late September, in which the spot Bitcoin ETFs attracted nearly $6 billion, the trend reversed at the end of the previous business week, with a minor net outflow of $4.5 million.

However, the withdrawals intensified on Monday ($326.4 million), Wednesday ($104.1 million), and particularly on Thursday when more than $530 million left these financial products. Friday was also in the red, with more than $366 million leaving the funds.

The total amount withdrawn from the US-based ETFs exceeded $1.2 billion for the week, which undoubtedly increases the pressure on the underlying asset.

Gold Up, BTC Down
In times of uncertainty, investors tend to flock to safe-haven assets. Although this year has had its ups and downs, they have shown a somewhat different approach. Gold has been the preferred investment tool for many, which is evident from its massive rally in 2025.

It charts new all-time highs almost daily, with the latest being at almost $4,400/oz on Friday. At the same time, BTC’s performance has been quite underwhelming lately. This could prove critics like Peter Schiff right (at least for the moment) that the precious metal is still the preferred choice, even though many BTC proponents have argued in the past decade that the cryptocurrency is ‘digital gold.’

Journalist

Posted: October 18, 2025

Key takeaways
Is Bitcoin headed for a new all-time high?
Possibly. Cycle models show BTC could top out between $143K and $146K if re-accumulation continues.

Why are traders shorting while Bitcoin supply keeps dropping?
Despite heavy shorting in Futures, LTHs are accumulating, draining BTC from exchanges with the chance of a possible squeeze.

Bitcoin [BTC] is giving off mixed signals.

Traders are betting against it, with Open Interest (OI) up 30% and Funding Rates deeply negative. But LTHs aren’t selling.

Since January, BTC supply on exchanges and OTC desks has dropped from 4.5 million to 3.1 million. Despite new highs, people are still buying, and some analysts say Bitcoin could reach $143K to $146K this cycle.

Leverage ramps up as shorts crowd in

Source: CryptoQuant

Over the past week, OI on Binance jumped by more than 30%, making it one of the steepest climbs in recent months. At the same time, Funding Rates turned negative, indicating a surge in short positions.

Source: CryptoQuant

In simple terms, traders are heavily betting against the market, expecting prices to fall. But usually, when funding gets this bearish and leverage piles in, it often makes way for a short squeeze.

This would force bearish traders to buy back in.

Supply dries up
BTC is vanishing from exchanges and OTC desks at a rapid pace: supply has dropped from 4.5 million to just 3.1 million coins since January 2024.

Source: CryptoQuant

That’s a big shift.

Miners aren’t selling, and LTHs won’t budge, even as prices break into new highs. Unlike past cycles, there’s no rush to take profits. Instead, BTC is being pulled into cold storage.

Where’s the top?
According to Joao Wedson, CEO of Alphractal, Bitcoin’s current price action still fits within its long-term cycle structure.

If BTC is in a re-accumulation phase, Wedson projects the top of this cycle between $143,700 and $146,300, consistent with historical performance decay across previous cycles.

Source: Alphractal

However, if recent highs around $126K marked a distribution phase, the cycle top may already be in. Still, Wedson notes that,

“The data isn’t acting like we’ve topped…”

Time will soon tell which narrative plays out.

US spot Bitcoin ETFs registered more than $1.2 billion in outflows to end this week. The eleven spot BTC ETFs saw a total outflow of $366 million on Friday.

Jack Mallers says Bitcoin may outperform every other currency if the government chooses to print money.

As the global market for secondhand luxury items surges, authentication has become the defining factor separating credible platforms from the rest.

The resale market for fashion and luxury items is expanding at an annual rate of 10%, three times faster than the firsthand market, according to a report released Oct. 9 by Boston Consulting Group and luxury resale platform Vestiaire Collective.

The report projects the global resale market could reach up to $360 billion by 2030, from about $210 billion today.

With more shoppers buying pre-owned designer brands, trust has become paramount. "As counterfeit manufacturing becomes increasingly sophisticated, even luxury brands themselves sometimes fail to detect fakes, in some cases, unknowingly repairing counterfeit items," said Jaewha Choi, CEO of South Korean online marketplace Bunjang.

Horror stories abound online of people paying thousands for fake Hermès bags or a Rolex Oyster Perpetual watches with swapped parts. Some counterfeits are so convincing they are dubbed "superfakes," reportedly made with materials from the same leather suppliers as the original brands.

Buyer bewareHowever, as the resale market expands, authentication has become a growing concern. The secondhand industry has long operated under the rule of "caveat emptor," or buyer beware.

To counter increasingly realistic "superfakes," resale platforms are pouring resources into verification. Singapore-based online marketplace Carousell opened its first brick-and-mortar store for luxury items in downtown Singapore this year, allowing sellers to have their items graded by one of the company's appraisers before listing them for resale.

The verification team inspects not only the material of a bag but also details like stitching and stamping, Tresor Tan, Director of Sales, Marketing and Client Relations at Carousell Luxury, told CNBC.

"At the end of the day, it's our reputation at stake as well," Tan said. "And because of that confidence, we also offer our buyers a money-back guarantee on authenticity."

watch now

The company has built a proprietary database covering almost 500 product styles, and higher-valued items go through multiple checks. In cases where the authenticity is in doubt, the items will not be listed, Tan said.

South Korea's Bunjang has also followed in the same vein, developing its own proprietary authentication system that combines traditional visual inspections with scientific equipment and artificial intelligence "trained on hundreds of thousands of data points," Choi told CNBC.

Bunjang claims a 99.9% authentication accuracy rate in identifying genuine goods, and its verification system can continuously learn and adapt to counterfeiting methods by leveraging AI.

Trust fuels salesBoth Carousell and Bunjang said verification has boosted business.

Bunjang said luxury goods now make up more than a quarter of its platform's $1.1 billion in annual gross merchandise value. Transactions and total value for luxury goods rose 30% year on year in the first half of 2025, Choi said.

Carousell's Tan did not disclose specific figures but said the luxury segment has seen "very strong interest" and has recorded "great growth."

This growth that began with Carousell's 2012 launch as an online platform eventually led to the opening of its first physical store.

"When someone is buying and selling a $100,000 watch on the platform, it definitely catches our attention," she said, saying that users wanted Carousell's oversight in high-value transactions.

Along with its verification process, the store also offers a money-back guarantee for its products. Tan said that while prices may not always be the lowest in the market, the store aims to offer "fair value."

"We may be, say, $200 more expensive than what someone else is offering, but [consumers] will still ultimately weigh the different options for $200 savings," she said. "Am I better off with a bit of assurance?"

Next wave of luxury consumersAffordability is the top reason for buying secondhand luxury items, cited by 80% of respondents, according to BCG's report.

But it's not just about saving money. Shoppers are increasingly drawn to rare or discontinued collections that are no longer available in stores, Samantha Virk, Chief Marketing Officer and U.S. CEO of Vestiaire Collective, told CNBC.

"These motivations are getting stronger across the board as compared to surveys in previous years, showing that secondhand shopping is becoming a deeply ingrained part of how people engage with fashion today," Virk said.

watch now

Younger shoppers, with their limited spending power, prefer to buy, enjoy and quickly resell items, Bunjang's Choi said.

"This remarkable growth reflects a fundamental shift in how Millennials and Gen Z, the next wave of luxury consumers, perceive and engage with luxury goods."

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October 18, 2025 03:00 ET

 | Source:

Olema Oncology

Palazestrant in combination with ribociclib demonstrated encouraging activity across all dose cohorts and subgroups Median PFS was 15.5 months in the 120 mg palazestrant cohort across all patientsIn the 120 mg palazestrant cohort among patients with prior CDK4/6i treatment, median PFS was 9.2 months in patients with ESR1 wild-type tumors and 13.8 months in patients with ESR1 mutant tumorsCombination continues to demonstrate favorable tolerability and a safety profile consistent with the known profiles of each drug Data support the ongoing Phase 3 OPERA-02 trial of palazestrant in combination with ribociclib in frontline advanced or metastatic breast cancer SAN FRANCISCO, Oct. 18, 2025 (GLOBE NEWSWIRE) -- Olema Pharmaceuticals, Inc. (“Olema” or “Olema Oncology”, Nasdaq: OLMA), a clinical-stage biopharmaceutical company focused on the discovery, development, and commercialization of targeted therapies for breast cancer and beyond, today announced updated data from the Phase 1b/2 study of palazestrant in combination with ribociclib in patients with estrogen receptor-positive (ER+), human epidermal growth factor receptor 2-negative (HER2-) advanced or metastatic breast cancer. These findings will be presented in a poster session on October 20 at the European Society for Medical Oncology (ESMO) Congress 2025 in Berlin, Germany.

“We are very pleased with these latest data showing compelling progression-free survival and favorable tolerability of palazestrant plus ribociclib, further reinforcing this regimen’s potential as a new standard of care in metastatic breast cancer,” said Sean P. Bohen, M.D., Ph.D., President and Chief Executive Officer of Olema Oncology. “These data showcase the activity of the combination in both ESR1 mutant and wild-type tumors, an important component for effective frontline treatment, and underscore the importance of complete ER antagonism in the treatment of ER-positive breast cancer. As we work to transform the breast cancer treatment paradigm, we are increasingly confident in palazestrant’s potential to become a best-in-class, backbone endocrine therapy and are excited to now have our second Phase 3 trial, OPERA-02, underway evaluating palazestrant with ribociclib in the frontline setting.”

Key Findings from the Phase 1b/2 Study of Palazestrant in Combination with Ribociclib
As of July 8, 2025, 72 patients were enrolled across the 90 mg and 120 mg palazestrant dose cohorts. 56 patients received 120 mg once-daily palazestrant and 16 patients received 90 mg once-daily palazestrant, all with the approved dose of ribociclib for metastatic breast cancer of 600 mg daily. 45 (63%) patients had prior treatment with cyclin-dependent kinase 4/6 inhibitors (CDK4/6i) with endocrine therapy for advanced disease. 33% (15/45) of patients who had prior treatment with CDK4/6i in the advanced setting (2/3L) had an ESR1 mutation at baseline.

Efficacy

In the 90 mg palazestrant dose cohort, with a median follow-up of 10.8 months, median progression-free survival (PFS) was not reached.In the 120 mg palazestrant dose cohort, with a median follow-up of more than 19 months, median PFS are mature. Median PFS was 15.5 months for all patients. Median PFS was 12.2 months for those who received prior treatment with CDK4/6i, including 9.2 months for patients with ESR1 wild-type tumors and 13.8 months for patients with tumors with ESR1 mutations. Safety and Pharmacokinetics

Across 72 patients treated, 90 mg or 120 mg of palazestrant combined with 600 mg of ribociclib daily was well tolerated with no new safety signals or increase in toxicity.Palazestrant and ribociclib did not demonstrate any drug-drug interactions and the overall safety profile was consistent with the established safety profile of ribociclib plus an endocrine therapy.The majority of treatment-emergent adverse events were grade 1 or 2, and the severity and incidence of adverse events were consistent with the expected safety profile of each drug. “Despite recent advances in the treatment of ER+/HER2- metastatic breast cancer, there remains a significant need for therapies that can overcome endocrine resistance, particularly following treatment with a CDK4/6 inhibitor,” said Dr. Nancy Lin, Associate Chief of the Division of Breast Oncology, Susan F. Smith Center for Women’s Cancers, at the Dana-Farber Cancer Institute. “I am very encouraged by these new data showing the novel palazestrant-ribociclib combination compares favorably to other endocrine therapy-CDK4/6 inhibitor combinations. With a compelling median PFS in the challenging post-CDK4/6 inhibitor setting, I believe palazestrant has the potential to serve as an important combination agent in the metastatic setting.”

Poster Presentation Details
Title: Palazestrant (OP-1250) plus ribociclib in patients with estrogen receptor-positive,
human epidermal growth factor receptor 2-negative (ER+, HER2-) advanced breast cancer (ABC)
Poster Number: 502P
Session: Breast Cancer, Metastatic Session
Date/Time: Monday, October 20, 2025, from 12:00-12:45pm CEST / 6:00-6:45am ET

Additional information can be found on the ESMO 2025 website, including abstracts. A copy of the poster will be made available on the Publications page of Olema’s website in alignment with the ESMO 2025 embargo policy.

About Olema Oncology
Olema Oncology is a clinical-stage biopharmaceutical company committed to transforming the standard of care and improving outcomes for patients living with breast cancer and beyond. Olema is advancing a pipeline of novel therapies by leveraging our deep understanding of endocrine-driven cancers, nuclear receptors, and mechanisms of acquired resistance. Our lead product candidate, palazestrant (OP-1250), is a proprietary, orally available complete estrogen receptor antagonist (CERAN) and a selective estrogen receptor degrader (SERD), currently in two Phase 3 clinical trials. In addition, Olema is developing OP-3136, a potent lysine acetyltransferase 6 (KAT6) inhibitor, now in a Phase 1 clinical study. Olema is headquartered in San Francisco and has operations in Cambridge, Massachusetts. For more information, please visit www.olema.com.

About Palazestrant (OP-1250)
Palazestrant (OP-1250) is a novel, orally available small molecule with dual activity as both a complete estrogen receptor antagonist (CERAN) and selective estrogen receptor degrader (SERD). It is currently being investigated in patients with recurrent, locally advanced or metastatic ER-positive (ER+), human epidermal growth factor receptor 2-negative (HER2-) breast cancer. In clinical studies, palazestrant completely blocks ER-driven transcriptional activity in both wild-type and mutant forms of metastatic ER+ breast cancer and has demonstrated anti-tumor efficacy along with attractive pharmacokinetics and exposure, favorable tolerability, central nervous system penetration, and combinability with cyclin-dependent kinase 4/6 (CDK4/6) inhibitors. Palazestrant has been granted U.S. Food and Drug Administration (FDA) Fast Track designation for the treatment of ER+/HER2- metastatic breast cancer that has progressed following one or more lines of endocrine therapy with at least one line given in combination with a CDK4/6 inhibitor. It is being evaluated as a single agent in the ongoing pivotal Phase 3 clinical trial, OPERA-01 and in combination with ribociclib in the ongoing pivotal Phase 3 clinical trial, OPERA-02. Palazestrant is also being evaluated in multiple Phase 1/2 studies in combination with ribociclib, palbociclib, alpelisib, everolimus, and atirmociclib.

Forward-Looking Statements
Statements contained in this press release regarding matters that are not historical facts are “forward-looking statements” within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. Words such as “anticipate,” “believe,” “could,” “expect,” “goal,” “may,” “plan,” “potential,” “seek,” “upcoming,” “will,” and similar expressions (as well as other words or expressions referencing future events, conditions or circumstances) are intended to identify forward-looking statements. These statements include those related to the potential beneficial characteristics, safety, tolerability, efficacy, and therapeutic effects of palazestrant as a single agent or in combination therapy, the timing for initiation, enrollment, and results of Olema’s existing and planned clinical trials, including OPERA-01 and OPERA-02, the potential of palazestrant to become a standard of care for metastatic breast cancer, Olema’s potential to transform the metastatic breast cancer treatment paradigm, the potential of palazestrant to become a best-in-class, backbone endocrine therapy for metastatic breast cancer, and the potential for palazestrant to serve as an important combination agent in the metastatic setting. Because such statements deal with future events and are based on Olema’s current expectations, they are subject to various risks and uncertainties, and actual results, performance or achievements of Olema could differ materially from those described in or implied by the statements in this press release. These forward-looking statements are subject to risks and uncertainties, including, without limitation, those discussed in the section titled “Risk Factors” in Olema’s Quarterly Report on Form 10-Q for the quarter ended June 30, 2025, and other filings and reports that Olema makes from time to time with the U.S. Securities and Exchange Commission. Except as required by law, Olema assumes no obligation to update these forward-looking statements, including in the event that actual results differ materially from those anticipated in the forward-looking statements.

Media and Investor Relations Contact
Courtney O’Konek
Vice President, Corporate Communications
Olema Oncology
[email protected]

NX-1607 demonstrated on-target peripheral immune activation characteristic of an active immune-oncology agent with a novel immune checkpoint mechanism distinct from PD-1/PD-L1 therapies

NX-1607 demonstrated evidence of monotherapy anti-tumor activity with reductions in tumor biomarkers, tumor shrinkage, long-term stable disease, and a confirmed partial response in heavily pretreated patients

Data support initiation of expansion cohorts at the two highest doses tested as monotherapy or combination for the treatment of advanced solid tumors

SAN FRANCISCO, Oct. 18, 2025 (GLOBE NEWSWIRE) -- Nurix Therapeutics, Inc. (Nasdaq: NRIX), a clinical-stage biopharmaceutical company focused on the discovery, development and commercialization of targeted protein degradation medicines, today announced the presentation of new clinical data from its first-in-human Phase 1a study of NX-1607, a first-in-class oral inhibitor of the E3 ligase Casitas B-lineage lymphoma proto-oncogene B (CBL-B) in patients with relapsed/refractory solid tumors. The data are being presented at the European Society for Medical Oncology Congress (ESMO 2025), taking place October 17–21, 2025, in Berlin, Germany.

“As a first-in-class oral inhibitor of CBL-B, NX-1607 may offer a novel therapeutic approach to treat solid tumors by targeting a previously unaddressed pathway in immune regulation affecting not only T cells, but also multiple immune cell types, including dendritic cells and natural killer cells, which all play critical roles in the tumor microenvironment,” said Paula O’Connor, M.D., chief medical officer of Nurix. “These data highlight NX-1607’s activity as an immuno-oncology agent, showing promising signs of biologic activity and clinical benefit, and supporting its continued development as an innovative next generation checkpoint inhibitor therapy designed to improve outcomes for cancer patients.”

In a poster titled: First-in-Class CBL-B Inhibitor NX-1607: Phase 1a Data in Patients with Advanced Solid Tumors, data were presented from a total of 82 patients with eleven different tumor types treated across six once-daily (QD) and five twice-daily (BID) dosing regimens ranging from 5 mg to 80 mg total daily dose. Patients were heavily pre-treated with a median of 3 prior regimens including a median of 1 prior chemo/immunotherapy regimen. NX-1607 demonstrated dose-dependent exposure, increases in proximal and distal biomarkers, evidence of peripheral immune activation, and reductions in tumor volume and cancer biomarkers. Despite the advanced stages of disease and the broad range of tumor types included in the trial, NX-1607 demonstrated evidence of clinical activity including reductions in tumor-specific biomarkers (prostate-specific antigen (PSA) in prostate cancer and carcinoembryonic antigen (CEA) in colorectal cancer), long-term stable disease, and a confirmed partial response in a patient with micro-satellite stable colorectal cancer (MSS CRC), a tumor type typically unresponsive to immune checkpoint therapy. As of the 26 July 2025 data cut, 71 patients were evaluable for response, with a disease control rate (DCR) of 49.3%. With respect to duration of response, 7 patients achieved either stable disease (SD) or partial response (PR) for ≥5 months on treatment and 1 patient with MSS CRC achieved a PR and was treated for 27 months. Further supporting the dose-dependent activity of NX-1607, the greatest reductions in PSA among the prostate cancer patients were achieved in the BID dosing groups with 6/13 patients having PSA reductions of ≥50%.

NX-1607 was shown to be tolerable at pharmacologically active doses and has a safety profile comparable to approved immuno-oncology agents, with most adverse events Grade 2 or less in severity. Immune-related adverse events were observed in 6 patients, indicating on-target immune activation, similar to what is observed with PD-1/PD-L1 therapies. The most common treatment emergent adverse events included nausea and vomiting, which were mitigated by both BID dosing and the introduction of a step-up dosing regimen where patients were initially treated at lower doses and increased to the target dose during the first cycle of treatment.

“NX-1607 has demonstrated potent single agent activity preclinically and now most importantly, we see clear signals of anti-tumor activity in patients with advanced disease. The results are particularly intriguing in MSS colorectal cancer and metastatic prostate cancer, two important indications where current immunotherapies have failed to demonstrate efficacy,” said Arthur T. Sands, M.D., Ph.D., president and chief executive officer of Nurix. “We look forward to further exploring the broad therapeutic potential of NX-1607 while we advance our lead asset bexobrutideg, an oral BTK degrader, into pivotal trials in patients with relapsed or refractory chronic lymphocytic leukemia.”

About NX-1607
NX-1607 is an investigational first-in-class oral inhibitor of the E3 ligase Casitas B-lineage lymphoma proto-oncogene B (CBL-B) being developed for immuno-oncology indications, including a range of solid tumor types. CBL-B is a cytoplasmic E3 ubiquitin ligase that negatively regulates T cell activation, making it an attractive target for immuno-oncology and offering a novel therapeutic approach to treat solid tumors. Inhibition of CBL-B in preclinical studies reverses T cell exhaustion, alleviates tumor-induced immunosuppression, and may also exert direct antitumor effects. Nurix is evaluating NX-1607 in an ongoing Phase 1 trial in adults in a range of oncology indications. This study includes a thorough investigation of both dose and schedule in the Phase 1a portion. Additional information on the NX-1607 clinical trial can be accessed at www.clinicaltrials.gov (NCT05107674).

About Nurix Therapeutics, Inc.
Nurix Therapeutics is a clinical stage biopharmaceutical company focused on the discovery, development and commercialization of targeted protein degradation medicines, the next frontier in innovative drug design aimed at improving treatment options for patients with cancer and inflammatory diseases. Nurix’s wholly owned, clinical stage pipeline includes degraders of Bruton’s tyrosine kinase (BTK), a B-cell signaling protein, and inhibitors of Casitas B-lineage lymphoma proto-oncogene B (CBL-B), an E3 ligase that regulates activation of multiple immune cell types including T cells and NK cells. Nurix also is advancing multiple potentially first-in-class or best-in-class degraders and degrader antibody conjugates (DACs) in its preclinical pipeline. Nurix’s partnered drug discovery pipeline consists of a preclinical stage degrader of STAT6, a clinical stage degrader of IRAK4, as well as multiple additional programs under collaboration agreements with Gilead Sciences, Inc., Sanofi S.A. and Pfizer Inc., within which Nurix retains certain options for co-development, co-commercialization and profit sharing in the United States for multiple drug candidates. Powered by a fully AI-integrated discovery engine capable of tackling any protein class, and coupled with unparalleled ligase expertise, Nurix’s dedicated team has built a formidable advantage in translating the science of targeted protein degradation into clinical advancements. Nurix aims to establish degrader-based treatments at the forefront of patient care, writing medicine’s next chapter with a new script to outmatch disease. Nurix is headquartered in San Francisco, California. For additional information visit http://www.nurixtx.com.

Forward-Looking Statements
This press release contains statements that relate to future events and expectations and as such constitute forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. All statements that reflect Nurix’s expectations, assumptions or projections about the future are forward-looking statements, including, without limitation, statements regarding the therapeutic potential of NX-1607, Nurix’s plans for the clinical development of NX-1607, Nurix’s plans for its other clinical assets, including bexobrutideg, and the planned timing for the provision of updates and findings from Nurix’s clinical trials. Forward-looking statements reflect Nurix’s current beliefs, expectations, and assumptions. Although Nurix believes the expectations and assumptions reflected in such forward-looking statements are reasonable, Nurix can give no assurance that they will prove to be correct. Forward-looking statements are not guarantees of future performance and are subject to risks, uncertainties and changes in circumstances that are difficult to predict, which could cause Nurix’s actual activities and results to differ materially from those expressed in any forward-looking statement. Such risks and uncertainties include, but are not limited to: (i) whether Nurix will be able to advance, obtain regulatory approval of and ultimately commercialize NX-1607; (ii) whether Nurix will be able to fund development activities and achieve development goals; (iii) whether Nurix will be able to protect intellectual property and (iv) other risks and uncertainties described under the heading “Risk Factors” in Nurix’s Quarterly Report on Form 10-Q for the fiscal quarter ended August 31, 2025, and other SEC filings. Accordingly, readers are cautioned not to place undue reliance on these forward-looking statements. The statements in this press release speak only as of the date of this press release, even if subsequently made available by Nurix on its website or otherwise. Nurix disclaims any intention or obligation to update publicly any forward-looking statements, whether in response to new information, future events, or otherwise, except as required by applicable law.

Contacts:

Investors
Kris Fortner
Nurix Therapeutics, Inc.
mailto:[email protected]

Elizabeth Wolffe, Ph.D.
Wheelhouse Life Science Advisors
[email protected]

Media
Aljanae Reynolds
Wheelhouse Life Science Advisors
[email protected] 

October 18, 2025 03:23 ET

 | Source:

Kura Oncology, Inc.

FTI mechanism addresses innate and adaptive resistance pathways common to targeted oncology therapies

Early clinical and preclinical data support darlifarnib’s potential to enhance clinical benefit of PI3Kα-, KRAS- and tyrosine kinase inhibitors

50% objective response rate and 80% disease control rate in renal cell carcinoma (RCC) cohort of darlifarnib plus cabozantinib in ongoing dose-escalation clinical trial

Kura Oncology to host a virtual investor event today, October 18, 2025, at 10:30 a.m. PT / 1:30 p.m. ET / 7:30 p.m. CEST

SAN DIEGO, Oct. 18, 2025 (GLOBE NEWSWIRE) -- Kura Oncology, Inc. (Nasdaq: KURA), a clinical-stage biopharmaceutical company committed to realizing the promise of precision medicines for the treatment of cancer, today announced new preliminary data from its farnesyl transferase inhibitor (FTI) programs – darlifarnib (KO-2806) and tipifarnib – presented at the 2025 European Society for Medical Oncology (ESMO) Congress in Berlin, Germany, from October 17 – 21, 2025.

“Kura Oncology is pioneering the use of FTIs in combination with tyrosine kinase inhibitors (TKIs), PI3Kα inhibitors and KRAS inhibitors to address mechanisms of innate and adaptive resistance, thereby enhancing and extending the clinical benefit of these single-agent targeted therapies,” said Troy Wilson, Ph.D., J.D., President and Chief Executive Officer of Kura Oncology. “The clinical data reported here at ESMO 2025 build on our preclinical presentation from last month and underscore darlifarnib’s transformative potential as a versatile combination partner to major classes of precision medicines.”

Darlifarnib as Monotherapy in Advanced Solid Tumors – FIT-001 Phase 1 Trial

HRAS-mutant (HRAS-m) tumors are sensitive to FTIsManageable safety and tolerability profile at doses from 3 to 10 mg per dayEncouraging antitumor activity in advanced HRAS-m solid tumors across multiple dose levels, demonstrating on-target activity and a broad therapeutic windowData support further evaluation of KO-2806 in combinations across tumor types Darlifarnib + Cabozantinib in Renal Cell Carcinoma – FIT-001 Phase 1 Trial

FTI mechanism blocks hyperactivated mTORC1 signaling in tumor endothelial cellsManageable safety profile in RCC patients across multiple doses, including at the full label dose of cabozantinibAntitumor activity observed across all doses in RCC, including in prior cabozantinib-exposed patients ORR: 33%–50% in ccRCC (17-50% in patients with prior cabozantinib exposure)DCR: 80%–100% in ccRCC Dose-escalation study ongoing and Phase 1b dose-expansion planned to assess optimal biologically active dose for combination Tipifarnib + Alpelisib in PIK3CA-altered Head and Neck Squamous Cell Carcinoma – KURRENT-HN Phase 1 Trial

FTI mechanism blocks hyperactivated mTORC1 signaling in squamous tumor cellsManageable safety profile in HNSCC patients across multiple dosesRobust antitumor activity was observed in heavily pretreated patients with relapsed or metastatic HNSCC with PIK3CA alterations ORR: 47% was observed at a daily dose of tipifarnib 1200 mg + alpelisib 250 mgAlpelisib monotherapy provides modest clinical benefit (ORR: 0%; BOR: SD)1 and tipifarnib monotherapy not expected to provide clinical benefit in this population Data generation options for darlifarnib + PI3Kα inhibitor combinations in solid tumors are being assessed “These results highlight the potential of FTIs to meaningfully enhance the clinical activity of PI3Kα inhibitors in molecularly selected patients,” said Glenn Hanna, M.D., Director, Center for Cancer Therapeutic Innovation, Medical Oncologist, Center for Head & Neck Oncology, Dana-Farber Cancer Institute, and Associate Professor of Medicine, Harvard Medical School – an investigator on both the FIT-001 and KURRENT-HN trials. “Darlifarnib demonstrates robust activity in HRAS-mutant solid tumors, which are typically very challenging to treat using existing therapies. In addition, the combination of tipifarnib and alpelisib demonstrated robust antitumor activity in heavily pretreated patients with relapsed or metastatic HNSCC with PIK3CA alterations — a population where monotherapy alpelisib provides only modest clinical benefit. These combination data are very exciting and set the stage for combining darlifarnib with PI3Kα inhibitors.”

Juric et al. J Clin Oncol 2018;36(13):1291-9.  Presentations
The presentations are available on Kura’s website at www.kuraoncology.com under the Posters and Presentations tab in the Farnesyl Transferase Inhibition section, and in the ESMO Congress 2025 online program.

Virtual Investor Event
Kura will host a webcast and conference call today, October 18, 2025, at 10:30 a.m. PT / 1:30 p.m. ET / 7:30 p.m. CEST featuring management and Glenn A. Hanna, M.D., Director, Center for Cancer Therapeutic Innovation Medical Oncologist, Center for Head & Neck Oncology, Dana-Farber Cancer Institute and Associate Professor of Medicine, Harvard Medical School.

The live webcast and replay will be available on the Company’s website at www.kuraoncology.com under the Investors tab in the Events and Presentations section.

About Kura Oncology
Kura Oncology is a clinical-stage biopharmaceutical company committed to realizing the promise of precision medicines for the treatment of cancer. The Company’s pipeline of small molecule drug candidates is designed to target cancer signaling pathways and address high-need hematologic malignancies and solid tumors. Kura is developing ziftomenib, a menin inhibitor targeting certain genetic drivers of acute myeloid leukemias, and continues to pioneer advancements in menin inhibition for acute leukemias and solid tumors and in farnesyl transferase inhibition to address mechanisms of adaptive and innate resistance in the treatment of solid tumors. For additional information, please visit the Kura website at https://kuraoncology.com/ and follow us on X and LinkedIn.

Forward-Looking Statements 
This news release contains certain forward-looking statements that involve risks and uncertainties that could cause actual results to be materially different from historical results or from any future results expressed or implied by such forward-looking statements. Such forward-looking statements include, among other things, statements regarding the potential of FTIs to address resistance mechanisms in cancer, the potential benefits of combining FTIs with targeted therapies, and the potential of FTIs to impact patients with cancer. Factors that may cause actual results to differ materially include the risk that compounds that appeared promising in early research or clinical trials do not demonstrate safety and/or efficacy in later preclinical studies or clinical trials, the risk that Kura may not obtain approval to market its product candidates, uncertainties associated with performing clinical trials, regulatory filings, and other interactions with regulatory bodies, and other risks associated with the process of discovering, developing and commercializing drugs that are safe and effective for use as human therapeutics, and in the endeavor of building a business around such drugs. You are urged to consider statements that include the words “may,” “will,” “would,” “could,” “should,” “believes,” “estimates,” “projects,” “promise,” “potential,” “expects,” “plans,” “anticipates,” “intends,” “continues,” “designed,” “goal,” or the negative of those words or other comparable words to be uncertain and forward-looking. For a further list and description of the risks and uncertainties Kura faces, please refer to Kura’s periodic and other filings with the Securities and Exchange Commission, which are available at www.sec.gov. Such forward-looking statements are current only as of the date they are made, and Kura assumes no obligation to update any forward-looking statements, whether as a result of new information, future events or otherwise. 

Conflict of Interest Disclosure
Dr. Hanna's disclosures include institutional research support and an advisory role with Kura Oncology, Inc.

Kura Contact
Investors and Media:
Greg Mann
858-987-4046
[email protected]

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Buying this passively managed ETF is still one of the simplest ways to start investing.

Most investors hope to outperform the S&P 500 over the long run. But according to SPIVA Scorecards, a whopping 89.5% of all professionally managed funds actually underperformed the benchmark index over the past 10 years. That's why Vanguard's founder, John Bogle, who launched the first public index fund for simply tracking the S&P 500 in 1976, thought it was smarter to match the market instead of trying to beat it.

The S&P 500 has generated an average annual return of about 10% since its inception in 1957. A $10,000 investment in the original Vanguard S&P 500 Index Fund (VFIAX -0.63%) with reinvested dividends would be worth $2.23 million today. But like other mutual funds, that index fund could only be bought or sold once a day.

Image source: Getty Images.

In 2010, Vanguard launched the exchange-traded fund (ETF) version, which could be actively traded like a stock throughout the day. A $10,000 investment in that Vanguard S&P 500 ETF (VOO 0.60%) on its first day with reinvested dividends would be worth $79,400 today.

Therefore, it makes a lot of sense to simply buy VOO, set its dividends to be reinvested, and forget about it as other investors try to time and beat the market. But even after its latest tariff-induced pullback, the S&P 500 is still hovering near its record highs and looks historically expensive at 31 times earnings -- so it might not seem like the best time to start a new position in VOO.

Yet I think it's still one of the smartest long-term investments for three simple reasons.

1. Instant diversification
The S&P 500 includes the 500 largest U.S. companies. Its top stocks are Nvidia (7.95% of the fund's holdings), Microsoft (6.73%), Apple (6.60%), and Amazon (3.72%). Information technology stocks account for 34.8% of the index's holdings, while financial, consumer discretionary, and communication services stocks also hold double-digit percentages.

In other words, VOO gives its investors instant exposure to all of the top U.S. stocks that have a median market cap of $403.2 billion. That diversification makes it a great one-stop solution for investors who are too busy to track and analyze individual stocks.

2. Low fees
VOO is passively managed, which means it automatically tracks the S&P 500's holdings without an active fund manager. That's why it only charges a tiny expense ratio of 0.03%, which means you're only paying $0.30 annually for every $1,000 invested in the ETF.

According to Vanguard, similar ETFs charge a higher average expense ratio of 0.74%. Meanwhile, the average hedge fund -- which often struggles to outperform the S&P 500 over the long run -- charges an expense ratio of 1.5% while charging a 20% "performance fee" on investors' total profits.

3. Dollar cost averaging will smooth out your returns
In the 68 years since its inception, the S&P 500 has weathered 10 U.S. recessions. It's bounced back every time and soared to new heights. That's because the S&P 500 is rebalanced four times each year to add stronger stocks and shed its weaker ones. Therefore, the index should keep rising as the U.S. economy keeps growing.

If you're reluctant to start a new position in VOO as the S&P 500 trades at historically high valuations, then you can spread out your investment over several years to smooth out your returns with dollar-cost averaging. So, instead of investing $10,000 in one lump sum, you can break it up into 10 annual investments of $1,000 over the next 10 years.

By committing a fixed amount to the ETF every year, you'll buy more shares when its price is lower and fewer shares when its price is higher. That disciplined approach will keep you invested while reducing its long-term volatility. So if you want to get invested today but don't know where to begin, the Vanguard S&P 500 ETF is still a great place to start.

Leo Sun has positions in Amazon and Apple. The Motley Fool has positions in and recommends Amazon, Apple, Microsoft, Nvidia, and Vanguard S&P 500 ETF. The Motley Fool recommends the following options: long January 2026 $395 calls on Microsoft and short January 2026 $405 calls on Microsoft. The Motley Fool has a disclosure policy.

MGM looked primed to land one of the three New York City-area casino licenses, but it surprisingly dropped out of the fray. That could be a long-term positive for investors.

There are surprises and there are outright shockers. Put MGM Resorts International's (MGM -0.39%) decision to drop out of the race for a New York City casino license in the latter category.

First, a quick history lesson. The largest operator of casino hotels on the Las Vegas Strip in 2018 announced an $850 million deal to buy Empire City Casino in Yonkers, New York, closing that transaction in January 2019. That acquisition was validated because MGM rapidly turned the slots-only venue into one of the highest-grossing regional casinos in the country, and in 2022, New York lawmakers approved plans to issue three licenses for Las Vegas-style gaming venues in the Big Apple.

That process ramped up in earnest last year, and throughout, consensus wisdom among gaming industry experts and Empire State political observers was that Empire City was a lock to land one of the three permits. After all, MGM has an established track record with state regulators and under its stewardship, Empire City delivered billions of dollars in tax receipts to state coffers.

Image source: MGM Resorts International.

In other words, surprise may not even scratch the surface of MGM's decision -- a notion arguably amplified when considering that some analysts describe New York as the casino industry's biggest opportunity in years. Throw in speculation that the Big Apple's casino market could eventually exceed that of Las Vegas in revenue, and it's all the more stunning that MGM bowed out.

MGM could save and redirect a lot of money with the New York decision
MGM didn't take lightly the decision to drop out of the New York license competition, but let's be honest -- money played a part. The company pledged a $2.3 billion revamp of Empire City if it was awarded one of the licenses, and those permits are expected to cost $500 million apiece.

Speaking of the license terms, MGM says it went into the bidding process expecting a 30-year license, but new guidance from New York indicated that term would be halved to 15 years. Translation: Had the gaming company won a license this year, it would've been confronted with renewing that permit, likely at a higher price point, sooner than expected.

But at the end of the day, it looks like MGM is saving a minimum of $2.8 billion by not pursuing its Gotham ambitions. That's a decent chunk of change, and it could be deployed in any number of ways, including reducing debt or extending share buybacks.

The company could also use some of that conserved capital to bolster BetMGM (it owns half of the online gaming entity), which could be a smart move when accounting for the higher margins offered by iGaming and the pressure on online sports betting by way of prediction markets.

MGM may not need New York
There's no denying that domestic casino growth opportunities are hard to come by and that New York is undisputedly the most attractive untapped frontier, but that doesn't mean MGM doesn't have other growth levers it can pull.

Ground has been broken on the $10.24 billion MGM Osaka integrated resort. MGM is on the hook for about a third of the project's increased costs. This indicates that the cost savings realized in New York could be material in Japan because when the Osaka venue opens in 2030, it's expected to become one of the region's top casino hotels.

MGM also has its eyes on Dubai. It has a non-gaming hotel there, and executives note that the company has set aside substantial space for a casino, so if regulators in the United Arab Emirates (UAE) approve more gaming licenses, MGM could be in pole position to land one and quickly ramp up a gaming venue in a market with significant growth potential.

The operator has also expressed interest in Thailand, which could be a compelling casino market in its own right, provided politicians there approve related legislation.

MGM surprise could spell opportunity
It's understandable that investors who bought MGM shares banking on the New York license morphing into a catalyst may be frustrated today. There's nothing wrong with feeling that way, but now may be an opportune time to view MGM through a non-New York lens.

If Las Vegas Strip visitation bounces back next year and the company executes on other growth initiatives while effectively deploying capital previously held for New York, investors could like what they see.

Todd Shriber has no position in any of the stocks mentioned. The Motley Fool has no position in any of the stocks mentioned. The Motley Fool has a disclosure policy.

MINNEAPOLIS, Oct. 18, 2025 (GLOBE NEWSWIRE) -- Celcuity Inc. (Nasdaq: CELC), a clinical-stage biotechnology company pursuing development of targeted therapies for oncology, today announced updates on the status of the PIK3CA mutant cohort of the Phase 3 VIKTORIA-1 clinical trial evaluating gedatolisib plus fulvestrant with and without palbociclib versus alpelisib and fulvestrant in adults with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative, PIK3CA mutant (“MT”) tumors, locally advanced or metastatic breast cancer, following progression on, or after, treatment with a CDK4/6 inhibitor and an aromatase inhibitor. Analysis of data from a Phase 1b clinical trial that evaluated gedatolisib combined with palbociclib and fulvestrant in the same population was also provided.

Clinical benefit of the gedatolisib regimens was consistent across patient subgroups 
Hyperglycemia was reported in only 9.2% of patients treated with gedatolisib + palbociclib + fulvestrant (“gedatolisib triplet”) and in 11.5% of patients treated with gedatolisib + fulvestrant (“gedatolisib doublet”)
Study treatment discontinuation due to treatment related adverse events was reported in 2.3% of patients treated with the gedatolisib triplet and 3.1% of patients with the gedatolisib doublet
Management to host webcast and conference call October 20, 2025, at 8:00 a.m. ET MINNEAPOLIS, Oct. 18, 2025 (GLOBE NEWSWIRE) -- Celcuity Inc. (Nasdaq: CELC), a clinical-stage biotechnology company pursuing development of targeted therapies for oncology, today announced detailed efficacy and safety results from the PIK3CA wild-type (“WT”) cohort of the Phase 3 VIKTORIA-1 clinical trial of gedatolisib, an investigational pan-PI3K/mTORC1/2 inhibitor, in adults with hormone receptor positive (“HR+”), human epidermal growth factor receptor 2 negative (“HER2-“), PIK3CA WT, advanced breast cancer (“ABC”), following progression on, or after, treatment with a CDK4/6 inhibitor and an aromatase inhibitor. As previously announced, the gedatolisib triplet demonstrated a statistically significant and clinically meaningful improvement in median progression-free survival (“PFS”) versus fulvestrant, reducing the risk of disease progression or death by 76%. The gedatolisib doublet reduced the risk of progression or death by 67% versus fulvestrant.

The detailed study results were presented at a late breaking oral presentation at the European Society for Medical Oncology (ESMO) Congress today, Saturday, October 18 at 4:25 a.m. ET/10:25 a.m. CEST.

In the trial, median PFS with the gedatolisib triplet was 9.3 months versus 2.0 months with fulvestrant, an incremental improvement of 7.3 months (HR=0.24; 95% CI: 0.17-0.35; p<0.0001). The objective response rate (“ORR”) of the gedatolisib triplet was 31.5% compared to 1% with fulvestrant and the median duration of response (“DOR”) was 17.5 months. For the gedatolisib doublet, the median PFS was 7.4 months versus 2.0 months with fulvestrant, an incremental improvement of 5.4 months (HR=0.33; 95% CI: 0.24-0.48; p<0.0001). The ORR of the gedatolisib doublet was 28.3% and the median DOR was 12.0 months. The median DOR was not determinable for fulvestrant because there was only one objective response.

The topline efficacy data from the VIKTORIA-1 PIK3CA WT cohort established several new milestones in the history of drug development for HR+/HER2- ABC:

The hazard ratios for the gedatolisib triplet and doublet are more favorable than have ever been reported by any Phase 3 trial for patients with HR+/HER2- ABC.The 7.3- and 5.4-months incremental improvements in median PFS for the gedatolisib triplet and gedatolisib doublet over fulvestrant, respectively, are higher than have ever been reported by any Phase 3 trial for patients with HR+/HER2- ABC receiving at least their second line of an endocrine therapy-based regimen.Gedatolisib is the first inhibitor targeting the PI3K/AKT/mTOR (“PAM”) pathway to demonstrate positive Phase 3 results in patients with HR+/HER2-/PIK3CA WT ABC whose disease progressed on or after treatment with a CDK4/6 inhibitor.The median DOR and incremental ORR improvement relative to control for the gedatolisib triplet and doublet are the highest reported for an endocrine therapy-based regimen in 2L HR+/HER2- ABC. The median PFS benefit of the gedatolisib triplet and doublet compared to fulvestrant was consistent across subgroups with the gedatolisib triplet showing higher clinical benefit in nearly all subgroups compared to the gedatolisib doublet, particularly for patients who were pre/perimenopausal, endocrine therapy resistant, or had visceral metastases. For patients enrolled in the United States and Canada, median PFS was 19.3 months (HR=0.13; 90% CI: 0.07-0.29) for the gedatolisib triplet and 14.9 months (HR=0.35; 90% CI: 0.17-0.76) for the gedatolisib doublet.

Sara Hurvitz, MD, Senior Vice President, Clinical Research Division, Fred Hutchinson Cancer Center, Smith Family Endowed Chair in Women’s Health, Professor and Head, Division of Hematology and Oncology, University of Washington, Department of Medicine and co-principal investigator for the trial, said: “VIKTORIA-1 is the first study to demonstrate a statistically significant and clinically meaningful improvement in median PFS with inhibition of the PI3K/AKT/mTOR pathway in patients with PIK3CA wild-type disease, all of whom previously received a CDK4/6 inhibitor. With these results, the gedatolisib regimens represent a new potential standard of care for patients with HR+, HER2-negative, PIK3CA wild-type advanced breast cancer whose disease progressed on or after treatment with a CDK4/6 inhibitor.”

The gedatolisib triplet and doublet were generally well tolerated in the trial with mostly low-grade treatment-related adverse events (“TRAEs”). The most common grade 3 TRAEs for the gedatolisib triplet, gedatolisib doublet, and fulvestrant groups included neutropenia (52.3%, 0%, and 0.8% of patients, respectively); stomatitis (19.2%, 12.3%, and 0%) rash (4.6%, 5.4%, and 0%); and hyperglycemia (2.3%, 2.3%, and 0%). The primary grade 4 TRAEs for the gedatolisib triplet and gedatolisib doublet groups were neutropenia (10.0% and 0.8%, respectively), leukopenia (0.8% in the gedatolisib triplet group) and pneumonitis (0.8% in gedatolisib doublet group). TRAEs led to the discontinuation of study treatment in 2.3% of patients in the gedatolisib triplet group, 3.1% in the gedatolisib doublet group, and 0% in the fulvestrant group.

Overall survival, a key secondary endpoint in VIKTORIA-1, while immature at the time of the analysis, with less than one-half of the required number of events having occurred, showed promising trends for both the gedatolisib triplet and doublet.

Igor Gorbatchevsky, MD, Chief Medical Officer of Celcuity, said: “We are very excited that treatment with gedatolisib combined with fulvestrant with or without palbociclib was well-tolerated by the VIKTORIA-1 patients and that only a few patients discontinued treatment due to an adverse event. This safety profile combined with the 7.3 and 5.4-months incremental improvement in median PFS relative to fulvestrant for the gedatolisib regimens, offer potentially paradigm shifting results for patients with HR-positive, HER2-negative, PIK3CA wild-type advanced breast cancer.”

Celcuity initiated a rolling New Drug Application (“NDA”) submission in conjunction with the U.S. Food and Drug Administration’s (“FDA”) Real-Time Oncology Review program, based on data from the PIK3CA wild-type cohort of the Phase 3 VIKTORIA-1 clinical trial. Completion of the NDA submission is targeted for the fourth quarter of 2025. The PIK3CA mutant cohort of the Phase 3 VIKTORIA-1 trial is 100% enrolled and is expected to report topline data for this cohort in late Q1 2026 or during Q2 2026.

Webcast and Conference Call Information

The Celcuity management team will host a webcast/conference call on Monday, October 20, 2025, at 8:00 a.m. ET to discuss the additional results from the Phase 3 VIKTORIA-1 trial. Those who would like to participate may access the live webcast here or register in advance for the teleconference here. A replay of the webcast will be available on the Celcuity website following the live event.

Notes
HR+/HER2- Breast cancer
Breast cancer is the second most common cancer and one of the leading causes of cancer-related deaths worldwide.1 More than two million breast cancer cases were diagnosed globally in 2022.1 While survival rates are high for those diagnosed with early breast cancer, approximately 30% of patients who are diagnosed with or who progress to metastatic disease are expected to live five years after their diagnosis.2 HR+/HER2- breast cancer is the most common subtype of breast cancer, accounting for approximately 70% of all breast cancers.2

Three interconnected signaling pathways, estrogen, cyclin D1-CDK4/6, and PI3K/AKT/mTOR (PAM), are primary oncogenic drivers of HR+, HER2- breast cancer.3 Therapies inhibiting these pathways are approved and used in various combinations for advanced breast cancer. Currently approved inhibitors of the PAM pathway for breast cancer target a single PAM pathway component, such as PI3Kα, AKT, or mTORC1.4,5,6,7 However, resistance to CDK4/6 inhibitors and current endocrine therapies develops in many patients with advanced disease.8 Optimizing the inhibition of the PAM pathway is an active area of focus for breast cancer research.

VIKTORIA-1
VIKTORIA-1 is a Phase 3 open-label, randomized clinical trial to evaluate the efficacy and safety of gedatolisib in combination with fulvestrant with or without palbociclib in adults with HR+/HER2- ABC whose disease progressed on or after prior CDK4/6 therapy in combination with an aromatase inhibitor. The clinical trial is fully enrolled. The trial enrolled subjects regardless of PIK3CA status while enabling separate evaluation of subjects according to their PIK3CA status. Subjects who met eligibility criteria and did not have confirmed PI3KCA mutations (WT) were randomly assigned (1:1:1) to receive a regimen of either gedatolisib, palbociclib, and fulvestrant, gedatolisib and fulvestrant, or fulvestrant. Subjects who met eligibility criteria and had confirmed PI3KCA mutations (MT) were randomly assigned (3:3:1) to receive a regimen of either the gedatolisib triplet, alpelisib and fulvestrant, or the gedatolisib doublet.

Gedatolisib
Gedatolisib is an investigational, multi-target PAM inhibitor that potently targets all four class I PI3K isoforms, mTORC1, and mTORC2 to induce comprehensive blockade of the PAM pathway.9,10,11 As a multi-target PAM inhibitor, gedatolisib’s mechanism of action is highly differentiated from currently approved single-target inhibitors of the PAM pathway.11 Inhibition of only a single PAM component gives tumors an escape mechanism through cross-activation of the uninhibited targets. Gedatolisib’s comprehensive PAM pathway inhibition ensures full suppression of PAM activity by eliminating adaptive resistance cross-activation that occurs with single-target inhibitors. Unlike single-target inhibitors of the PAM pathway, gedatolisib has demonstrated equal potency and comparable cytotoxicity in PIK3CA-mutant and wild-type breast tumor cells in nonclinical studies and early clinical data.11,12

About Celcuity

Celcuity is a clinical-stage biotechnology company pursuing development of targeted therapies for treatment of multiple solid tumor indications. The company's lead therapeutic candidate is gedatolisib, a potent, pan-PI3K and mTORC1/2 inhibitor that comprehensively blockades the PAM pathway. Its mechanism of action and pharmacokinetic properties are differentiated from other currently approved and investigational therapies that target PI3Kα, AKT, or mTORC1 alone or together. A Phase 3 clinical trial, VIKTORIA-1, evaluating gedatolisib in combination with fulvestrant with or without palbociclib in patients with HR+/HER2- ABC has completed enrollment and reported topline data for the PIK3CA WT cohort and has completed enrollment of patients for the PIK3CA mutant cohort. A Phase 3 clinical trial, VIKTORIA-2, evaluating gedatolisib plus a CDK4/6 inhibitor and fulvestrant as first-line treatment for patients with HR+/HER2- ABC is currently enrolling patients. A Phase 1/2 clinical trial, CELC-G-201, evaluating gedatolisib in combination with darolutamide in patients with metastatic castration resistant prostate cancer, is ongoing. More detailed information about Celcuity’s active clinical trials can be found at ClinicalTrials.gov . Celcuity is headquartered in Minneapolis. Further information about Celcuity can be found at www.celcuity.com . Follow us on LinkedIn and X .

Forward-Looking Statements

This press release contains statements that constitute “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995 including statements relating to the potential therapeutic benefits of gedatolisib; the size, design and timing of our clinical trials; our interpretation of topline clinical trial data; and other expectations with respect to gedatolisib. Words such as, but not limited to, “look forward to,” “believe,” “expect,” “anticipate,” “estimate,” “intend,” "confidence," "encouraged," “potential,” “plan,” “targets,” “likely,” “may,” “will,” “would,” “should” and “could,” and similar expressions or words identify forward-looking statements. The forward-looking statements included in this press release are based on management's current expectations and beliefs which are subject to a number of risks, uncertainties and factors, including that our topline results are based on a preliminary analysis of key efficacy and safety data, and such data may change following a more comprehensive review of the data related to the clinical trial; unforeseen delays in our clinical trials; and unanticipated developments that may impact the design of our clinical trials. In addition, all forward-looking statements are subject to other risks detailed in our Annual Report on Form 10-K for the year ended December 31, 2024, as such risks may be updated in our subsequent filings with the Securities and Exchange Commission. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. All forward-looking statements are qualified in their entirety by these cautionary statements, and we undertake no obligation to revise or update this press release to reflect events or circumstances after the date hereof.

References:
1.   Sung H, et al. Global Cancer Statistics 2020: GLOBOCAN Estimates of Incidence and Mortality Worldwide for 36 Cancers in 185 Countries. CA Cancer J Clin. 2021;10.3322/caac.21660.
2.   National Cancer Institute. Surveillance, Epidemiology and End Results Program (Accessed July 2025).
      https://seer.cancer.gov/statfacts/html/breast-subtypes.html
3.   Alves, C. L., & Ditzel, H. J. Drugging the PI3K/AKT/mTOR Pathway in ER+ Breast Cancer. Int J Mol Sci, 2023;24(5),4522. https://doi.org/10.3390/ijms24054522
4.   United States Package Insert, US FDA, ITOVEBI
5.   United States Package Insert, US FDA, PIQRAY
6.   United States Package Insert, US FDA, TRUCAP
7.   United States Package Insert, US FDA, AFINITOR
8.   Lloyd M R, et al. Mechanisms of Resistance to CDK4/6 Blockade in Advanced Hormone Receptor-positive, HER2-negative Breast Cancer and Emerging Therapeutic Opportunities. Clin Cancer Res. 2022;28(5):821-30
9.   Venkatesan, A. M., et al. Bis(morpholino-1,3,5-triazine) derivatives: potent adenosine 5'-triphosphate competitive phosphatidylinositol-3-kinase/mammalian target of rapamycin inhibitors: discovery of compound 26 (PKI-587), a highly efficacious dual inhibitor. J Med Chem, 2010;53(6), 2636-2645. https://doi.org/10.1021/jm901830p
10.   Mallon, R., et al. Antitumor efficacy of PKI-587, a highly potent dual PI3K/mTOR kinase inhibitor. Clin Cancer Res, 2011;17(10), 3193-3203. https://doi.org/10.1158/1078-0432.CCR-10-1694
11.   Rossetti, S., et al. Gedatolisib shows superior potency and efficacy versus single-node PI3K/AKT/mTOR inhibitors in breast cancer models. NPJ Breast Cancer, 2024;10(1), 40. https://doi.org/10.1038/s41523-024-00648-0
12.   Layman, R., et al. Gedatolisib in combination with palbociclib and endocrine therapy in women with hormone receptor-positive, HER2-negative advanced breast cancer: results from the dose expansion groups of an open-label, phase 1b study. Lancet Oncol, 2024;25(4), 474-487. https://doi.org/10.1016/S1470-2045(24)00034-2

View source version of release on GlobeNewswire.com

Contacts: 

Celcuity Inc. 
Brian Sullivan, [email protected] 
Vicky Hahne, [email protected] 
(763) 392-0123 

ICR Healthcare
Patti Bank, [email protected]
(415) 513-1284

SummaryEthan Allen Interiors faces inflation and housing market headwinds but maintains profitability through cost controls and a strategic domestic footprint.ETD may benefit from lower tariffs and labor costs in Honduras, supporting competitive pricing and mitigating industry-wide inflationary pressures.Strong liquidity, a debt-free balance sheet, and consistent cash flows ensure dividend sustainability and operational resilience for ETD.Upgrading ETD from hold to buy, as valuation is reasonable with potential upside; technicals are neutral but show renewed buying opportunities after recent overselling. Morsa Images/DigitalVision via Getty Images

It’s been three months since my first analysis of Ethan Allen Interiors, Inc. (NYSE:ETD). And after a 6.2% stock price decrease, my hold rating was justified. I also think it helped that my projected revenue

Analyst’s Disclosure:I/we have no stock, option or similar derivative position in any of the companies mentioned, but may initiate a beneficial Long position through a purchase of the stock, or the purchase of call options or similar derivatives in ETD over the next 72 hours. I wrote this article myself, and it expresses my own opinions. I am not receiving compensation for it (other than from Seeking Alpha). I have no business relationship with any company whose stock is mentioned in this article.

Seeking Alpha's Disclosure: Past performance is no guarantee of future results. No recommendation or advice is being given as to whether any investment is suitable for a particular investor. Any views or opinions expressed above may not reflect those of Seeking Alpha as a whole. Seeking Alpha is not a licensed securities dealer, broker or US investment adviser or investment bank. Our analysts are third party authors that include both professional investors and individual investors who may not be licensed or certified by any institute or regulatory body.

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XRP trading at $2.27 on the 1D chart | Source: XRPUSDT on Tradingview.com
Featured image from iStock, chart from Tradingview.com