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TMC the metals co., Inc. is a deep-sea minerals exploration company focused on the collection and processing of polymetallic nodules found on the seafloor in international waters of the Clarion Clipperton Zone in the Pacific Ocean (CCZ). These nodules contain high grades of four metals (nickel, copper, cobalt, manganese) which can be used as (i) feedstock for battery cathode precursors (nickel, cobalt and manganese sulfates, or intermediate nickel-copper-cobalt matte) for electric vehicles (EV) and renewable energy storage markets, (ii) copper cathode for EV wiring, energy transmission and other applications and (iii) manganese silicate for manganese alloy production required for steel production. The company was founded in 2021 and is headquartered in Vancouver, Canada.

TMC the metals company Inc

TMC the metals company Inc. is experiencing significant investor attention following recent U.S. regulatory advancements, including modernized deep-sea mining permits and an upcoming Congressional hearing featuring its CEO. The community is highly optimistic, interpreting these moves as strong government alignment to expedite critical mineral recovery for national security, anticipating substantial upside for the company.

GameStop Corp. engages in offering games and entertainment products through its ecommerce properties and stores. The firm’s stores and ecommerce sites operate primarily under the names GameStop, EB Games, and Micromania. It operates through the following geographical segments: United States, Canada, Australia, and Europe. The company was founded by Daniel A. DeMatteo in 1996 and is headquartered in Grapevine, TX.

Gamestop Corporation - Ordinary Shares - Class A

GameStop Corp

GameStop is dominating financial discussions after Chairman Ryan Cohen expanded his stake, acquiring an additional 500,000 shares. This bold insider buy has ignited fervent community speculation about a potential market catalyst, renewing hopes for a significant move in the high short interest stock. While some express frustration over muted price action, many view Cohen's increasing ownership as a definitive signal of underlying value and a potential turning point.

Sandisk Corp. engages in the development, manufacture, and provision of storage devices and solutions based on NAND flash technology. Its products include solid state drives, memory cards, and USB flash drives. The company was founded on February 5, 2024 and is headquartered in Milpitas, CA.

Sandisk Corp

SanDisk is experiencing an extraordinary rally, driven by analyst upgrades and surging demand for memory and data storage in the AI infrastructure sector, notably influenced by Nvidia's new chip requirements. This rapid ascent has ignited fierce debate within the community, with many celebrating its "unstoppable" momentum while an equally vocal segment warns of an unsustainable "bubble" and impending correction.

Moderna, Inc. engages in the development of transformative medicines based on messenger ribonucleic acid. The firm's product pipeline includes the following modalities: prophylactic vaccines, cancer vaccines, intratumoral immuno-oncology, localized regenerative therapeutics, systemic secreted therapeutics, inhaled pulmonary therapeutics and systemic intracellular therapeutics. It operates through the following geographical segments: United States, Europe, and Rest of World. The company was founded by Noubar B. Afeyan, Robert S. Langer, Jr., Derrick J. Rossi, and Kenneth R. Chien in 2010 and is headquartered in Cambridge, MA.

Moderna Inc

Moderna is surging due to promising long-term follow-up data for its personalized cancer vaccine for melanoma, developed in partnership with Merck, which has shown sustained improvement in patient outcomes. This breakthrough is fueling widespread community discussion about the transformative potential for cancer treatment, a significant new revenue stream, and strong speculation around the stock being undervalued and poised for substantial upside or even a buyout, intensifying a short squeeze.

Novavax, Inc. Is a biotechnology company, which engages in the discovery, development, and commercialization of recombinant vaccines. The company was founded in 1987 and is headquartered in Gaithersburg, MD.

Novavax, Inc.

Novavax Inc

Novavax is currently trending following a significant licensing deal with Pfizer, which is widely seen as a major validation for its Matrix-M adjuvant technology. This news has ignited intense community discussion around the stock's substantial short interest, with many anticipating a potential squeeze and predicting further partnerships that could establish Matrix-M as a pivotal asset in the vaccine industry.

Advanced Micro Devices, Inc. engages in the provision of semiconductor businesses. It operates through the following segments: Data Center, Client, Gaming, and Embedded. The Data Center segment includes server-class CPUs, GPUs, AI accelerators, DPUs, FPGAs, SmartNICs, and Adaptive SoC products. The Client segment refers to the computing platforms, which are a collection of technologies that are designed to work together to provide a more complete computing solution. The Gaming segment is a fundamental component across many products and can be found in APU, GPU, SoC or a combination of a discrete GPU with another product working in tandem. The Embedded segment focuses on the embedded CPUs, GPUs, APUs, FPGAs, and Adaptive SoC products. The company was founded by W. J. Sanders III on May 1, 1969 and is headquartered in Santa Clara, CA.

Advanced Micro Devices Inc.

Advanced Micro Devices Inc

Advanced Micro Devices is trending strongly, demonstrating remarkable resilience and outperformance compared to peers like NVIDIA and Intel, even amidst broader market weakness. This momentum is driven by growing community conviction in AMD's increasing market share within the burgeoning AI and data center sectors, ahead of anticipated earnings. While many celebrate its upward trajectory and foresee new highs, some investors caution about potential overvaluation and a possible bull trap.

New Era Energy & Digital, Inc. is an exploration and production company, which engages in selling oil and natural gas products. The company was founded on February 6, 2023 and is headquartered in Midland, TX.

New Era Energy & Digital Inc.

New Era Energy & Digital (NUAI) is trending due to its recent strategic partnership with Primary Digital Infrastructure to develop a significant AI data center campus in West Texas, alongside the finalization of a key acquisition. The community is actively discussing an imminent hyperscale tenant announcement, fueling speculation about major tech firms and the potential for a short squeeze within the rapidly expanding AI infrastructure sector.

Intel Corp. engages in the design, manufacture, and sale of computer products and technologies. It delivers computer, networking, data storage, and communications platforms. The firm operates through the following segments: Client Computing Group (CCG), Data Center and AI (DCAI), Network and Edge (NEX), Mobileye, Accelerated Computing Systems and Graphics (AXG), Intel Foundry Services (IFS), and All Other. The CCG segment consists of platforms designed for notebooks, 2-in-1 systems, desktops, tablets, phones, wireless and wired connectivity products, and mobile communication components. The DCAI segment delivers solutions to cloud service providers and enterprise customers, along with silicon devices for communications service providers and high-performance computing customers. The NEX segment offers computing system solutions from inflexible fixed-function hardware to general-purpose compute, acceleration, and networking devices running cloud native software on programmable hardware. The Mobileye segment develops driving assistance and self-driving solutions. The AXG segment provides products and technologies designed to help customers solve the toughest computational problems. Its products include CPUs for high-performance computing and GPUs targeted for a range of workloads and platforms, from gaming and content creation on client devices to delivering media and gaming in the cloud, and the most demanding high-performance computing and AI workloads on supercomputers. The IFS segment refers to full stack solutions created from the foundry industry ecosystem. The All Other segment represents results from other non-reportable segments and corporate-related charges. The company was founded by Robert Norton Noyce and Gordon Earle Moore on July 18, 1968 and is headquartered in Santa Clara, CA.

Intel Corp.

Intel Corp

Intel is experiencing a significant surge ahead of its upcoming quarterly report, fueled by recent analyst upgrades, growing optimism for its turnaround strategy, and strong demand for server CPUs. The community is abuzz with speculation regarding potential major partnerships and government contracts, leading to intense debates about whether the positive news is already priced in or if a further breakout is imminent. This renewed confidence highlights Intel's strategic importance in domestic chip manufacturing and its progress in advanced process technology.

PAVmed, Inc. is a multi-product life sciences company, which engages in the innovation, development, acquisition, and commercialization of products that target unmet medical needs with large addressable market opportunities. Its products include Lucid Diagnostics and Veris Health. The company was founded by Lishan Aklog and Brian J. deGuzman on June 26, 2014 and is headquartered in New York, NY.

PAVmed Inc

PAVmed (PAVM) is trending after its subsidiary, Lucid Diagnostics, secured a significant U.S. Department of Veterans Affairs contract for its EsoGuard Esophageal DNA Test. This news has ignited intense community debate, with discussions centered on the stock's low float and high volatility, alongside speculation about short squeeze potential versus concerns over dilution and profit-taking. Traders are actively evaluating the contract's long-term valuation impact amid rapid price movements.

ImmunityBio, Inc. is a clinical stage immunotherapy company. It develops next generation therapies that drive immunogenic mechanisms for defeating cancers and infectious diseases. The company's immunotherapy platform activates both the innate and adaptive immune systems to create long term immunological memory. ImmunityBio was founded by Patrick Soon-Shiong in 2014 and is headquartered in San Diego, CA.

ImmunityBio Inc

ImmunityBio (IBRX) is trending as a clear FDA resubmission pathway for ANKTIVA in bladder cancer, coupled with recent Saudi FDA approval for lung cancer, de-risks its regulatory future. The community is highly engaged, actively discussing a potential short squeeze fueled by rapidly increasing cost-to-borrow rates and a strong conviction in the company's revolutionary cancer therapies, particularly as key figures hint at broader awareness initiatives.

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<ul class="summary-bullets"><li>It is now unclear when the company would apply for approval of the gene therapy, it said.</li><li>uniQure, however, added that it intends to communicate with the FDA to determine a path forward toward approval of the therapy.&nbsp;</li><li>uniQure CEO termed the meeting outcome “unexpected.”<br>&nbsp;</li></ul><p>uniQure N.V. (QURE) no longer believes that the U.S. Food and Drug Administration considers data from an early-to mid-stage trial of its investigational gene therapy for Huntington’s disease sufficient for approval, the company said on Monday.</p><p>The company recently met with the agency, and although the minutes of the meeting have not been received, the company <a class="st-link-external" target="_blank" rel="noopener noreferrer nofollow" href="https://www.globenewswire.com/news-release/2025/11/03/3179114/0/en/uniQure-Provides-Regulatory-Update-on-AMT-130-for-Huntington-s-Disease.html">believes</a> that the FDA no longer considers the data from the AMT-130 trial adequate to provide primary evidence in support of an application for approval.</p><p>As a result, it is now unclear when the company would apply for approval of the gene therapy, it said. uniQure, however, added that it intends to communicate with the FDA to determine a path forward toward approval of the therapy.</p><h2 class="st-heading-2">CEO Reacts</h2><p>uniQure CEO termed the meeting outcome “unexpected.”</p><p>“We are surprised by the FDA’s feedback at the recent pre-BLA meeting, which is a drastic change from the guidance the FDA provided in November 2024 that data from the ongoing Phase I/II studies, compared to a natural history external control, may serve as the primary basis for a BLA submission under the Accelerated Approval pathway,” CEO Matt Kapusta said.</p><p>The company also stated that it intends to engage in further communications with other regulatory agencies while working with the FDA.</p><h2 class="st-heading-2">Expert Take</h2><p>Stifel analyst Annabel Samimy said that the news regarding the FDA's reversal on the approvability of uniQure's AMT-130 based on early to mid-stage trial data on the surface injects another layer of uncertainty into the workings of the FDA and their receptivity to gene therapy, more specifically.</p><p>The analyst, however, does not expect this to impact Regenxbio’s (RGNX) rare disease programs. Meanwhile, Raymond James added that it does not expect the meeting outcome to impact Biohaven (BHVN) either.</p><h2 class="st-heading-2">How Did Stocktwits Users React?</h2><p>QURE stock traded 55% lower at the time of writing. On Stocktwits, retail sentiment around <a href="https://stocktwits.com/symbol/QURE">QURE stock</a> fell from ‘neutral’ to ‘bearish’ territory over the past 24 hours, while message volume stayed at ‘low’ levels.</p><p>QURE stock is up 72% this year and approximately 445% over the past 12 months.&nbsp;</p><p>Read also: <a href="https://stocktwits.com/news-articles/markets/equity/tg-therapeutics-stock-soars-after-company-ups-guidance-for-multiple-sclerosis-drug/cL2NEPSR3zl">TG Therapeutics Stock Soars After Company Ups Guidance For Multiple Sclerosis Drug</a></p><p><i>For updates and corrections, email newsroom[at]stocktwits[dot]com.</i></p>

In this photo illustration, the uniQure logo is seen displayed on a smartphone screen. (Photo Illustration by Thomas Fuller/SOPA Images/LightRocket via Getty Images)

uniQure Stock Tumbled 55% Today: What’s The FDA Angle?

The company recently met with the FDA and believes that the agency no longer considers the data from an early-to-mid-stage trial of its investigational gene therapy sufficient for approval.

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Alger Funds - Alger Mid Cap 40 ETF

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Current Price	$22.00
Prev Close	$21.75
Open	$21.86
Dividend Yield	N/A
50-Day Moving Average	$21.21
Beta	N/A
Avg. Volume	60,172.18
PE Ratio	N/A

52-Week High	$23.36
52-Week Low	$13.56
Market Capitalization	N/A
EPS (Annual)	N/A
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Revenue Per Employee	N/A
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