SPDR Dow Jones Industrial Average ETF

SPDR S&P 500 ETF Trust

Invesco QQQ Trust Series 1

AST Spacemobile, Inc. engages in building a broadband cellular network in space to operate directly with standard, unmodified mobile devices based on an extensive IP and patent portfolio. It focuses on providing mobile broadband services with global coverage to all end-users, without the need to purchase special equipment. The company was founded by Abel Avellan on May 31, 2017 and is headquartered in Midland, TX.

AST SpaceMobile Inc - Ordinary Shares - Class A

AST SpaceMobile Inc

AST SpaceMobile is trending after successfully unfurling its BlueBird 6 satellite, the largest commercial communications array deployed in low Earth orbit, coupled with FCC approval for US testing with major carriers. This milestone is seen by bulls as a significant derisking event validating its direct-to-device technology, while bears anticipate a "sell the news" reaction, citing perceived overvaluation and competition in the sector.

Robinhood Markets, Inc is a financial services platform, which engages in the provision of retail brokerage and offers trading in U.S. listed stocks and Exchange Traded Funds, related options, and cryptocurrency trading, as well as cash management, which includes debit cards services. The company was founded by Vladimir Tenev and Baiju Prafulkumar Bhatt in 2013 and is headquartered in Menlo Park, CA.

Robinhood Markets Inc - Ordinary Shares - Class A

Robinhood Markets Inc

Robinhood is trending after its Q4 earnings revealed an EPS beat but a revenue miss, primarily impacted by declining crypto trading. This has polarized the community, with some anticipating further downside due to crypto volatility, while others view it as a buying opportunity, highlighting growth in Gold subscribers and its expanding prediction market business.

Mattel, Inc. engages in the ownership of children's and family entertainment franchises. It operates through the following segments: North America, International, and American Girl. The North America and International segments focus on marketing and selling toys and consumer products. The American Girl segment includes marketing, retailing, and publishing dedicated to its mission to help girls grow up with confidence and character. The company was founded by Elliot Handler, Ruth Handler, and Harold Matson in 1945 and is headquartered in El Segundo, CA.

Mattel, Inc.

Mattel (MAT) is seeing a dramatic sell-off after reporting a significant earnings miss and soft forward guidance, leading to community debate over whether the massive price drop is an overreaction given the announced $1.5 billion share buyback program.

SSgA Active Trust - SPDR Dow Jones Industrial Average ETF

The SPDR Dow Jones Industrial Average ETF (DIA) is reaching new all-time highs, driven by a rotation of capital from high-growth tech and crypto into more traditional blue-chip stocks, though community discussion is split between celebrating this milestone and expressing caution about market overextension.

Lyft, Inc. engages in the provision and management of an online social rideshare community platform. It offers access to a network of shared bikes and scooters for shorter rides and first mile and last-mile legs of multimodal trips, information about nearby public transit routes, and Lyft Rentals to offer riders a view of transportation options when planning any trip. The company was founded by Marcus Cohn, John Zimmer, Rajat Suri, Matt van Horn, and Logan Green in 2007 and is headquartered in San Francisco, CA.

Lyft Inc - Ordinary Shares Cls A

Lyft Inc

Lyft is trending after a post-earnings sell-off that the community largely views as an algorithmic overreaction, arguing the company posted a revenue beat when accounting for a one-time adjustment, paired with a significant EPS beat and a new $1 billion share buyback.

Cloudflare, Inc. engages in the provision of cloud-based services to secure websites. It offers various products for performance and reliability, video streaming and delivery, advanced security, insights, Cloudflare for developers, domain registration, and Cloudflare marketplace. It operates through the United States and Rest of the World geographical segments. The company was founded by Matthew Prince, Michelle Zatlyn, and Lee Holloway in July 2009 and is headquartered in San Francisco, CA.

Cloudflare Inc - Ordinary Shares - Class A

Cloudflare Inc

Cloudflare is trending after surpassing revenue expectations and positioning itself as a pivotal infrastructure provider for the "agentic internet" and AI workloads, fueling community discussion about its distinction from typical software companies amidst broader market trends.

HOPPY is a memecoin launched on Ethereum as a tribute to the frog from the famous comic book «The Night Riders», published in 2012 by artist and illustrator Matt Furie, which has gained popularity.   HOPPY appeals to the cryptocurrency community with its no-tax policy and transparent acknowledgment of its lack of utility, maintaining the essence of a pure and simple memecoin.

Hoppy

$HOPPY is trending as the "second frog" in the popular "three frog narrative" alongside $PEPE and $FEFE, fueling community excitement for its potential as a beta play in the meme coin sector. Despite some confusion regarding multiple tokens, its strong community believes in massive upside and accumulating, viewing it as a resilient asset poised for significant growth.

Fermi, Inc. engages in the development of energy infrastructure. It intends to develop an energy and data center development campus to support the needs of to-be-built AI infrastructure. The company was founded by Rick Perry, Toby Neugebauer and Griffin Perry on January 10, 2025 and is headquartered in Amrillo, TX.

Fermi Inc

Fermi LLC

Fermi is trending sharply lower after its first key tenant terminated a $150 million funding agreement for the Project Matador AI data center campus. The community is divided, with many viewing the sell-off as an overreaction and a buying opportunity for a company positioned to meet critical AI power demands, while skeptics point to ongoing lawsuits and zero revenue.

Critical Metals Corp. engages in the mining, exploration, and development of lithium metals. It owns Wolfsberg Project and Tanbreez Project. The company was founded on October 24, 2022 and is headquartered in British Virgin Islands.

Critical Metals Corp.

Critical Metals Corp. is trending due to recent ultra high-grade drill results from its Tanbreez project, which confirm significant heavy rare earth content and resource expansion. The community is actively discussing the project's strategic importance for Western supply chains, potential undervaluation based on its Preliminary Economic Assessment, and anticipating further government funding or strategic partnerships amid rising global demand for critical minerals.

Gilead Sciences, Inc. is a biopharmaceutical company, which engages in the research, development, and commercialization of medicines in areas of unmet medical need. The firm's primary areas of focus include human immunodeficiency virus, acquired immunodeficiency syndrome, liver diseases, hematology, oncology, and inflammation and respiratory diseases. It offers antiviral products under Harvoni, Genvoya, Epclusa, Truvada, Atripla, Descovy, Stribild, Viread, Odefsey, Complera/Eviplera, Sovaldi, and Vosevi brands. The company was founded by Michael L. Riordan on June 22, 1987 and is headquartered in Foster City, CA.

Gilead Sciences, Inc.

Gilead Sciences is drawing significant attention after its earnings report, which, despite beating on adjusted EPS and revenue and raising its dividend, provided an outlook that disappointed some investors, fueling community discussion around the stock's pullback and potential entry points amidst ongoing developments in its HIV and oncology pipelines.

statis crypto Watchlist

Bitcoin

Ethereum

Solana

Ripple

Dogecoin

Cardano

statis IN Watchlist

Nifty 50

Nifty Bank

Reliance Industries Ltd.

Zomato Ltd.

Tata Consultancy Services

Tata Motors Ltd.

HDFC Bank Ltd.

ITC Ltd.

Adani Enterprises Ltd

Axis Bank Ltd

Bajaj Finance Ltd

statis US Watchlist

SPDR S&P 500 ETF

Apple Inc.

Tesla Inc

Microsoft Corporation

NVIDIA Corp

 Hey, I want to invite you to join Stocktwits. It’s the largest global community of active traders. You’ll get access to the real-time market insights, news, discussion and much more! You can sign up using my unique link below 
 


 has invited you to join Stocktwits

<ul class="summary-bullets"><li>The FDA cited uncertainty regarding the study’s eligibility criteria to define a population with neuronopathic disease versus attenuated disease as one of the reasons for its denial.&nbsp;</li><li>The FDA also pointed to how closely the natural history external control matched the trial’s patient population.</li><li>Last month, the FDA placed a clinical hold on two of the company’s experimental gene therapy programs for the treatment of rare childhood diseases, including RGX-121.</li></ul>Shares of REGENXBIO Inc. (RGNX) plummeted about 19% after-hours on Monday after the U.S. Food and Drug Administration (FDA) denied approval for its gene therapy in treating Hunter syndrome, an ultra-rare neurodegenerative disease.The company said on Monday that the FDA outlined several reasons for not approving the gene therapy in a Complete Response Letter (CRL).REGENXBIO was seeking approval for RGX-121 (clemidsogene lanparvovec) in the treatment of Mucopolysaccharidosis II, an ultra-rare neurodegenerative disease also known as Hunter syndrome.The FDA had previously accepted the RGX-121 under an accelerated approval pathway in May 2025.<h2 class="st-heading-2">Reasons For Denial</h2>In the CRL dated Feb. 7, 2026, the FDA said that the previous agreement to the study protocol had been in principle.The U.S. federal agency cited uncertainty regarding the study’s eligibility criteria to define a population with neuronopathic disease versus attenuated disease as one of the reasons for its denial.The FDA also pointed to how closely the natural history external control matched the trial’s patient population and agreed that CSF HS D2S6 is an appropriate surrogate marker that is reasonably likely to predict real clinical benefit."This decision is devastating for the families of boys living with this progressive, life-threatening disease," said Curran Simpson, President and CEO of REGENXBIO."We are concerned about FDA's feedback regarding the overall development path and evaluation of the data in the context of the urgent need for this irreversible ultra-rare disease. We remain confident in the quality and volume of evidence demonstrating the long-term potential of RGX-121 to positively change the trajectory of Hunter syndrome," Simpson added.Last month, the FDA placed a <a href="https://stocktwits.com/news-articles/markets/equity/why-is-rgnx-stock-falling-today/cmyg4cKR404">clinical hold</a> on two of the company’s experimental gene therapy programs for the treatment of rare childhood diseases, including RGX-121.<h2 class="st-heading-2">Path Forward</h2>The CRL listed several potential paths forward, including a new study, treating additional patients, conducting longer-term follow-up, and using an untreated control arm, the company said.The company said it is planning to meet with the FDA to address the complete response letter, gather expert input and longer-term clinical data to better define the eligible patient population, and work toward resubmitting its application as quickly as possible.Hunter syndrome is a rare genetic disorder that mostly affects males and causes complex sugars to build up in cells, which can impact physical and/or cognitive development.<h2 class="st-heading-2">How Did Stocktwits Users React?</h2>On Stocktwits, retail sentiment around <a href="https://stocktwits.com/symbol/RGNX">RGNX shares</a> was in the ‘extremely bearish’ territory over the past 24 hours amid ‘extremely high’ message volumes.One bearish user said it was a blessing to be able to exit with only a 28% haircut, after two failed drugs.<stembedurl>https://stocktwits.com/TheBlackBerrry/message/644510500</stembedurl>&nbsp;Shares of RGNX have gained over 30% in the past year.For updates and corrections, email newsroom[at]stocktwits[dot]com.Also Read: <a href="https://stocktwits.com/news-articles/markets/equity/on-shares-falling-after-hours-q4-2025/cZbvgzzR4oq">Why Are ON Shares Falling After-Hours Today?</a>

The stock has gained over 26% for the year-to-date period.

Why Did RGNX Shares Plummet 19% After-Hours Today?

REGENXBIO said on Monday that the U.S. Food and Drug Administration (FDA) denied approval for its gene therapy in treating Hunter syndrome, outlining several reasons for the denial.

Equity

<ul class="summary-bullets"><li>The first product on the list is Hydrelix, a Type 1 collagen powder that provides the bioactive components of collagen at the wound site.</li><li>The second product is NovaForm Wound Matrix, a bioglass- and collagen-based wound dressing intended for the management of partial- and full-thickness wounds.</li><li>Summit will also distribute G4Derm Plus, a flowable peptide matrix engineered for rapid, protected wound closure.</li></ul>MiMedx Group Inc. (MDXG) shares gained around 5% in Wednesday morning’s trade after the company entered into an exclusive distribution agreement with Summit Products Group for three of its 510(k) cleared products.According to the agreement, Summit will distribute Hydrelix, NovaForm, and G4Derm Plus, designed to complement MiMedx’s portfolio of leading surgical and wound products.Retail sentiment on Stocktwits around&nbsp;<a href="https://stocktwits.com/symbol/MDXG">MiMedx</a> was in the ‘bullish’ territory, with message volumes at ‘extremely high’ levels.<h2 class="st-heading-2">What Will Summit Distribute?</h2>The three products included in the agreement are intended to care for and enhance the closure of wounds.The first product in the list is Hydrelix, which is a Type 1 collagen powder that allows the bioactive components of collagen to be readily available at the wound site, facilitating a more direct and efficient therapeutic effect.The second product is NovaForm Wound Matrix, which is a bioglass and collagen-based wound dressing intended for use in the management of partial and full-thickness wounds. NovaForm can be used for pressure ulcers, venous ulcers, diabetic ulcers, and surgical wounds.&nbsp;The company says NovaForm is designed to maintain a moist environment that supports the body’s natural healing process while protecting the wound.Lastly, Summit will also distribute G4Derm Plus, a flowable peptide matrix engineered for rapid, protected wound closure, spurring tissue regrowth, and controlling bioburden. The company stated that G4Derm Plus mimics the human extracellular matrix (ECM) and acts as a barrier against bacteria.“These are innovative xenograft and synthetic products that strengthen our ability to serve the Surgical &amp; Wound markets,” said MiMedx’s Chief Commercial Officer, Kim Moller.<h2 class="st-heading-2">What Does MiMedx Do?</h2>MiMedx is a Marietta, Georgia-based company with a portfolio of surgical and wound care products designed to help clinicians manage chronic and other hard-to-heal wounds.In December 2025, the company entered into an exclusive agreement with Regen Lab USA LLC to distribute the latter’s RegenKit-Wound Gel in the U.S.<a href="https://stocktwits.com/symbol/MDXG">MDXG stock</a> is down 24% year-to-date and 40% over the past 12 months.Also See:&nbsp;<a href="https://stocktwits.com/news-articles/markets/equity/amazon-openai-in-talks-to-customize-ai-models/cZbjTCvR4Zu">Amazon, OpenAI In Talks To Customize AI Models To Power E-commerce Giant's Products Such As Alexa: Report</a>For updates and corrections, email newsroom[at]stocktwits[dot]com.

MDXG Stock Rises As MiMedx Enters Into Exclusive Distribution Agreement For Three Products

According to the agreement, Summit Products Group will distribute Hydrelix, NovaForm, and G4Derm Plus, designed to complement MiMedx’s portfolio of leading surgical and wound products.

<ul class="summary-bullets"><li>The company said that the FDA hold has impacted two experimental gene therapies, RGX-111 and RGX-121.</li><li>REGENXBIO added that the tumor was identified during a routine brain MRI of an asymptomatic five-year-old participant in its RGX-111 trial.</li><li>The company said that the participant had received intracisternal RGX-111 four years prior.</li></ul>REGENXBIO Inc.’s (RGNX) shares tumbled more than 29% in Wednesday’s&nbsp;opening trade after the company announced an update from the U.S. Food and Drug Administration (FDA).REGENXBIO stated that the FDA has placed a clinical hold on the company’s experimental gene therapy program for the treatment of rare childhood diseases.The company said that the FDA hold has impacted two experimental gene therapies, RGX-111 and RGX-121.<h2 class="st-heading-2">Why Did FDA Place A Clinical Hold?</h2>REGENXBIO stated that the FDA’s clinical hold was placed after a brain tumor was found in one patient in the trial.The company added that the tumor was identified during a routine brain magnetic resonance imaging (MRI) of an asymptomatic five-year-old participant in its RGX-111 trial. REGENXBIO said that the participant had received intracisternal RGX-111 four years prior.The company said that an investigation into whether this serious adverse event (SAE) is drug-related is ongoing, and that causality has not been established yet.While the SAE involved a patient in the RGX-111 trial, the FDA has also placed a hold on the RGX-121 gene therapy, citing the similarities in products, study populations, and shared risk between the clinical studies, the company said.“These are separate therapies, and the positive safety profile of RGX-121 in more than 30 patients treated, including those dosed nearly seven years ago, remains unchanged,” said REGENXBIO CEO Curran Simpson.<h2 class="st-heading-2">What Did REGENXBIO’s Experimental Therapies Treat?</h2>The RGX-111 gene therapy is aimed at treating MPS I, also known as Hurler syndrome. This is a genetic disorder that results in the buildup of large sugar molecules in lysosomes, causing damage to several organ systems.The RGX-121 gene therapy is aimed at treating MPS II, also known as&nbsp;Hunter syndrome, which results in the buildup of large sugar molecules in body tissues. This causes abnormalities in body organs, including the heart, skeleton, and respiratory system.<h2 class="st-heading-2">How Did Stocktwits Users React?</h2>Retail sentiment on Stocktwits around&nbsp;<a href="https://stocktwits.com/symbol/RGNX">REGENXBIO</a> was in the ‘bearish’ territory, with message volumes at ‘extremely high’ levels at the time of writing.One user thinks that the stock decline is an “overreaction.”<stembedurl>https://stocktwits.com/Longbuy1/message/643122172</stembedurl><a href="https://stocktwits.com/symbol/RGNX">RGNX stock</a> is down 34% year-to-date, but up 25% over the past 12 months.Also See:&nbsp;<a href="https://stocktwits.com/news-articles/markets/equity/trump-signals-military-escalation-toward-iran-as-markets-brace-for-big-tech-earnings-fed-decision/cmygPjOR40T">Trump Signals Military Escalation Toward Iran As Markets Brace For Big Tech Earnings, Fed Decision</a>For updates and corrections, email newsroom[at]stocktwits[dot]com.

Trading digital board showing the data on global stock market crash. | Image source: Getty Images

RGNX Stock Is Falling Today — What Is The FDA Update On REGENXBIO's Gene Therapy?

REGENXBIO stated that the FDA has placed a clinical hold on the company’s experimental gene therapy program for the treatment of rare childhood diseases.

<ul class="summary-bullets"><li>Shiong added that “median overall survival” is a scientific endpoint that is used to measure survival, which currently stands at six months for patients with brain tumors.</li><li>Explaining what this means, he said that half of the patients at this stage do not survive beyond six months.</li><li>The Culver City, California-based immunotherapy company stated in an update on Friday that it had not yet achieved median survival among patients receiving Anktiva + CAR-NK in the trial.</li></ul>ImmunityBio Inc. (IBRX) shares were up more than 5% in Monday’s pre-market trade after a volatile session on Friday following the company’s Phase 2 glioblastoma trial update.The Culver City, California-based immunotherapy company&nbsp;<a href="https://stocktwits.com/news-articles/markets/equity/ibrx-stock-volatility-after-immunitybio-phase-2-glioblastoma-trial-update/cmyR7VnR4gk">stated</a> in an update on Friday that it had not yet achieved median survival among patients receiving Anktiva + CAR-NK in the trial. The company said that as of Jan. 22, 2026, it had enrolled 23 patients in the Phase 2 glioblastoma trial, of which four deaths have been reported so far, while 14 patients have evaluable clinical data.<h2 class="st-heading-2">ImmunityBio Founder Issues Clarification</h2>However, Patrick Soon Shiong, ImmunityBio’s founder,&nbsp;<a class="st-link-external" target="_blank" rel="noopener noreferrer nofollow" href="https://x.com/DrPatrick/status/2015148449059201385">took</a> to X on Saturday to clarify what the update signified.“The fact that we have patients alive still at 12 months and that the ‘median has NOT YET&nbsp; been reached’ IS a positive and promising finding to date with our chemo free treatment in which patients have failed current standards of care,” he said.He added that “median overall survival” is a scientific endpoint that is used to measure survival, which currently stands at six months for patients with brain tumors. Explaining what this means, he said that half of the patients at this stage do not survive beyond the timeframe of six months or longer.<figure class="image"><img src="https://news.stocktwits-cdn.com/Patrick_post_jpg_65b0607bff.webp" alt="Dr. Pat Soon-Shiong's post on X" width="727" height="500"><figcaption>Dr. Pat Soon-Shiong's post on X | @DrPatrick/X</figcaption></figure><h2 class="st-heading-2">How Stocktwits Users Reacted</h2>Retail sentiment on Stocktwits around&nbsp;<a href="https://stocktwits.com/symbol/IBRX">ImmunityBio</a> was in the ‘extremely bullish’ territory, with message volumes at ‘extremely high’ levels at the time of writing.One bullish user said that they believe IBRX should trade at a market capitalization of $10 billion, while adding that ImmunityBio represents a “complete shift in standard of care of cancer.” The company’s current market capitalization is $6.35 billion.<stembedurl>https://stocktwits.com/BixbyKnolls/message/642850960</stembedurl>Another user wondered why any investor would not hold the IBRX stock with “so many approvals on the horizon.”<stembedurl>https://stocktwits.com/Nate711/message/642846497</stembedurl><a href="https://stocktwits.com/symbol/IBRX">IBRX stock</a> is up 226% year-to-date and 107% over the past 12 months.Also See:&nbsp;<a href="https://stocktwits.com/news-articles/markets/equity/peter-schiff-silver-gold-price-rally-people-clueless-slv-gld-etf-soar-pre-market/cmy7FWpR4Wx">Peter Schiff Says Most People Are 'Clueless' And In For A 'Shock' As Gold, Silver Scale New Highs: SLV, GLD ETFs Soar Pre-Market</a>For updates and corrections, email newsroom[at]stocktwits[dot]com.

In this photo illustration, an ImmunityBio company logo is seen displayed on a smartphone screen. (Photo Illustration by Piotr Swat/SOPA Images/LightRocket via Getty Images)

IBRX Stock Gains Pre-Market After A Volatile Trading Session Following Phase 2 Glioblastoma Trial Update: Retail Backs ImmunityBio’s Cancer Research

Patrick Soon Shiong, ImmunityBio’s founder, took to X on Saturday to clarify what the update signified.

<ul class="summary-bullets"><li>The revised label provides clearer starting-dose guidance for adult patients switching from multiple daily injections or insulin pump therapy.</li><li>The update is supported by clinical results from the Dose Optimization study and the INHALE-3 trial.</li><li>Previously, MannKind filed a supplemental FDA application to expand Afrezza’s use to patients aged four to 17, with a decision anticipated by May 29, 2026.</li></ul>Shares of MannKind Corp. (MNKD) gained more than 7% in pre-market trading on Monday after the company announced that the U.S. Food and Drug Administration (FDA) approved an update to the prescribing information for Afrezza, its inhaled mealtime insulin used to improve glycemic control in adult patients with diabetes mellitus.The revised label provides clearer starting-dose guidance for adult patients switching from multiple daily injections or insulin pump therapy. The update is supported by clinical results from the Dose Optimization study and the INHALE-3 trial, which showed significantly improved post-meal glucose control after conversion to Afrezza, as recommended by the new dosing recommendations.“We expect that this label update will help support healthcare providers by providing clearer starting dose guidance when transitioning patients to inhaled insulin from subcutaneous mealtime insulin—whether injections or insulin pumps. We believe this refinement to the label helps support appropriate initiation of therapy while reinforcing Afrezza’s established clinical profile,” said Kevin Kaiserman, Senior Vice President, Therapeutic Area Head, Diabetes at MannKind Corporation.&nbsp;<h2 class="st-heading-2">Q3 Revenue Boosted By Afrezza Sales</h2>In November, the company posted a 17% increase in third-quarter (Q3) total revenue to $82.13 million, driven by strong growth in sales of its Afrezza inhaled insulin. Afrezza revenue climbed 23% to $18.5 million, supported by higher pricing and rising demand, while royalty income rose to $33.3 million.MannKind also submitted a supplemental application to the FDA seeking approval of Afrezza for patients aged four to 17. A regulatory decision is expected by May 29, 2026.<h2 class="st-heading-2">How Did Retail React?</h2>Retail sentiment for <a href="https://stocktwits.com/symbol/MNKD">MNKD</a> on Stocktwits remained in the ‘bullish’ zone over the past 24 hours, accompanied by ‘high’ message volumes. MNKD was among the top trending tickers at the time of writing.<figure class="image"><img src="https://news.stocktwits-cdn.com/MNKD_jpg_fd37ecdc2d.webp" alt="MNKD.jpg" width="930" height="85"><figcaption>MNKD's Sentiment Meter and Message Volumes at Premarket on Jan. 26, 2026 | Source: Stocktwits</figcaption></figure>Meanwhile, one user didn’t see the FDA update as a major catalyst.<stembedurl>https://stocktwits.com/firefox2778/message/642859216</stembedurl>The stock has declined around 4.7% year-to-date and over 10.5% in the past year.Read also: <a href="https://stocktwits.com/news-articles/markets/equity/ag-asml-hl-stocks-soar-silver-prices-record-high-110/cmy78kuR4WC">AG, ASM, HL Stocks Soar Pre-Market As Silver Blasts Past $110</a>For updates and corrections, email newsroom[at]stocktwits[dot]com.

Mannkind Corp and the company's inhalable insulin product. Company employee demonstrating how the device is used. (Photo by Lawrence K. Ho/Los Angeles Times via Getty Images)

Why Did MNKD Stock Jump Over 7% In Pre-Market Today?

The U.S. FDA approved an update to the prescribing information for Afrezza inhalation powder to treat adults with diabetes mellitus.

MNKD Stock Gets A Pre-Market Boost From FDA Label Revision For Afrezza

Biotech ETF (XBI) Hits New 52-Week High

XBI surges to a 52-week high, nearly doubling from its low, fueled by biotech momentum, AI adoption and easing macro trends.

<ul class="summary-bullets"><li>The deal provides Novavax with an upfront payment of $30 million, along with the opportunity to earn up to $500 million in additional development and sales milestones.</li><li>Matrix-M adjuvant is a proprietary vaccine ingredient, used in several marketed vaccines to improve effectiveness and help the immune system better recognize and remember disease targets.</li><li>Novavax is eligible to receive tiered royalties in the high mid-single digit range on sales of any Pfizer products that use Matrix-M.</li></ul>Novavax, Inc. (NVAX) shares climbed 6% higher in pre-market trading on Tuesday after the company signed a licensing agreement with Pfizer, granting the pharmaceutical giant non-exclusive rights to use Novavax’s Matrix-M adjuvant in up to two disease areas.Matrix-M adjuvant is a proprietary vaccine ingredient that improves the body’s immune response. It is made from naturally derived compounds and is used in several marketed vaccines to improve effectiveness and help the immune system better recognize and remember disease targets, according to Novavax.<h2 class="st-heading-2">What Is The Novovax-Pfizer Deal?</h2>The deal provides Novavax with an upfront payment of $30 million, along with the opportunity to earn up to $500 million in additional development and sales milestones. Novavax is also eligible to receive tiered royalties in the high mid-single digit range on sales of any Pfizer products that use Matrix-M.Under the agreement, Pfizer will take full responsibility for the development and commercialization of its products, while Novavax will supply the Matrix-M adjuvant. The partnership strengthens Novavax’s long-term revenue potential.This comes after Novavax completed the transfer of U.S. and European marketing authorizations for its COVID-19 vaccine, Nuvaxovid, to Sanofi in November. The move resulted in a second $25 million milestone payment to Novavax, following the completion of the European Union marketing authorization transfer in October 2025.Novavax is expected to receive additional milestone payments and royalties tied to Nuvaxovid, Sanofi-developed combination products, and new vaccines that use Novavax’s Matrix-M adjuvant. Novavax also has long-standing partnerships with Japan’s Takeda and the Serum Institute of India.<h2 class="st-heading-2">How Did Stocktwits Users React?</h2>Retail sentiment for <a href="https://stocktwits.com/symbol/NVAX">NVAX</a> on Stocktwits remained in the ‘extremely bullish’ zone, amid ‘extremely high’ message volumes. NVAX was also among the top three trending tickers on the platform at the time of writing.<img src="https://news.stocktwits-cdn.com/NVAX_jpg_1f4183eedd.webp" alt="NVAX.jpg">One bullish user said that the stock is undervalued.<stembedurl>https://stocktwits.com/ejaXstoXX/message/642272237</stembedurl>Another user was bullish about Matrix-M’s market potential.<stembedurl>https://stocktwits.com/P38FTD/message/642271830</stembedurl>The stock has declined around 6% over the past year.Read also: <a href="https://stocktwits.com/news-articles/markets/equity/why-ivf-stock-soaring-premarket/cmUum0oR4ap">INVO Fertility’s 350% Spike Puts Microcap IVF Stocks Back On Retail Radar</a>For updates and corrections, email newsroom[at]stocktwits[dot]com.

In this photo illustration, a medical syringe is displayed on a screen, and the logo of Novavax in the background. (Photo Illustration by Nikos Pekiaridis/SOPA Images/LightRocket via Getty Images)

Why NVAX Stock Is Popping Pre-Market – And What Does Pfizer Have To Do With It?

The company signed a licensing agreement with Pfizer, granting it non-exclusive rights to use Matrix-M adjuvant in up to two disease areas.

NVAX Stock Rises Pre-Market As Pfizer Licenses Its Vaccine Technology

<ul class="summary-bullets"><li>The trial compares Bacillus Calmette-Guérin (BCG) therapy alone with BCG combined with ANKTIVA.</li><li>Preliminary analysis showed that ANKTIVA plus BCG significantly extended the duration of complete response in BCG-naïve cancer patients.</li><li>ImmunityBio plans to submit a biologics license application to the FDA by the end of 2026.</li></ul>ImmunityBio, Inc. (IBRX) shares jumped 24% in premarket trading on Friday after the company reported a faster than expected enrollment for its QUILT-2.005 bladder cancer drug trial.The company said that enrollment has surpassed internal expectations and is now more than 85% complete, with full enrollment of the planned study population expected by the second quarter of 2026.&nbsp;Based on current progress, ImmunityBio plans to submit a biologics license application to the U.S. Food and Drug Administration (FDA) by the end of 2026.“We look forward to the final accrual of this important registrational randomized trial in patients with BCG-naïve non-muscle-invasive bladder cancer, which represents a substantial proportion of newly diagnosed bladder cancer cases. The interim analysis is encouraging and consistent with findings in the approved BCG-unresponsive setting, where the duration of complete response has exceeded 47 months,” said Patrick Soon-Shiong, M.D., Founder, Executive Chairman, and Global Chief Medical and Scientific Officer of ImmunityBio.Based on current progress, ImmunityBio plans to submit a biologics license application to the FDA by the end of 2026.<h2 class="st-heading-2">What Is The Trial About?</h2>The QUILT-2.005 is a clinical trial for Bacillus Calmette-Guérin (BCG) naïve non-muscle-invasive bladder cancer (NMIBC) that compares standard BCG therapy alone versus BCG combined with ANKTIVA, an Interleukin-15 (IL-15) receptor agonist. IL-15 is an immune system protein that helps develop and activate key cells that work to destroy cancer cells.In 2023, the FDA requested an interim analysis of the randomized trial to evaluate the added benefit of ANKTIVA when combined with BCG, focusing on complete response rates and the durability of response versus BCG alone.The analysis showed that ANKTIVA plus BCG significantly extended the duration of complete response in BCG-naïve NMIBC patients. At six months, 85% of patients receiving the combination maintained a complete response, compared with 57% in the BCG-only group. At nine months, response rates were 84% with combination therapy versus 52% with BCG alone.<h2 class="st-heading-2">How Did Retail React?</h2>Retail sentiment for <a href="https://stocktwits.com/symbol/IBRX">IBRX</a> on Stocktwits remained in the ‘extremely bullish’ zone over the past 24 hours, amid ‘extremely high’ message volumes.<img src="https://news.stocktwits-cdn.com/IBRX_jpg_3d2f27a76b.webp" alt="IBRX.jpg">One user was bullish about the company’s potential.<stembedurl>https://stocktwits.com/Amit18/message/642024906</stembedurl>Another user saw the stock as a long-term runner.<stembedurl>https://stocktwits.com/LeftyT/message/642025351</stembedurl>Over the past year, the stock has gained more than 60%.Read also: <a href="https://stocktwits.com/news-articles/markets/equity/rklb-stock-set-for-all-time-high-morgan-stanley-boost/cmUlAaBR4B7">RKLB Stock Is On Track For Record Open – Here’s What’s Driving The Rally</a>For updates and corrections, email newsroom[at]stocktwits[dot]com.

Why IBRX Stock Is One Of The Biggest Pre-Market Movers Today 

The company said that enrollment for its randomized registrational QUILT-2.005 trial has surpassed internal expectations and is now more than 85% complete.

 IBRX Stock Rallies As Its Bladder Cancer Study Nears Full Enrollment 

<ul class="summary-bullets"><li>ImmunityBio plans to establish a regional office in Saudi Arabia to support its expansion across the Middle East and North Africa.</li><li>The company will also partner with regional pharmaceutical firm BioPharma Cigalah.</li><li>Enrolment for the QUILT-2.005 study evaluating ANKTIVA with BCG in earlier-stage bladder cancer is expected to be completed by the second quarter.</li></ul>ImmunityBio, Inc. (IBRX) drew retail attention on Wednesday as the stock jumped 8% after the Saudi Food and Drug Authority approved ANKTIVA in combination with the BCG (Bacillus Calmette-Guérin) vaccine to treat adults with BCG-unresponsive non-muscle invasive bladder cancer.The approval marks a major regulatory milestone, adding to existing authorizations in the United States and the United Kingdom, as well as conditional approval in the European Union.“We are pleased to bring ANKTIVA to Saudi patients with NMIBC, who otherwise have no viable options but life-altering surgery,” said Rich Adcock, Chief Executive Officer, ImmunityBio.<h2 class="st-heading-2">ImmunityBio’s Expansion Plans</h2>ImmunityBio plans to establish a regional office in Saudi Arabia to support its expansion across the Middle East and North Africa. The company will also partner with regional pharmaceutical firm BioPharma Cigalah. Management cited the rising incidence of bladder and other cancers in the region as a key driver behind the strategy.ANKTIVA is an Interleukin-15 (IL-15) receptor agonist. IL-15 is an immune system protein that helps develop and activate key cells that work to destroy cancer cells.<h2 class="st-heading-2">ANKTIVA Developments</h2>Beyond bladder cancer, ANKTIVA is also drawing attention for its broader oncology potential. <a href="https://stocktwits.com/news-articles/markets/equity/why-did-ibrx-stock-surge-today/cmUXXCjR4Ig">Recent clinical data</a> from the QUILT-2.023 and QUILT-3.055 trials in non-small cell lung cancer (NSCLC) showed improved immune recovery and extended survival when ANKTIVA was combined with checkpoint inhibitors.Responding patients achieved a median survival of up to 21.1 months, significantly outperforming traditional chemotherapy outcomes.Meanwhile, enrolment for the company’s QUILT-2.005 study evaluating ANKTIVA with BCG in earlier-stage bladder cancer is expected to be completed by the second quarter (Q2) of 2026 and a potential biologics license application (BLA) by the end of the year.<h2 class="st-heading-2">How Did Stocktwits Users React?</h2>Retail sentiment on Stocktwits around ImmunityBio remained in the ‘extremely bullish’ zone, amid ‘extremely high’ message volumes.<img src="https://news.stocktwits-cdn.com/IBRX_jpg_1a3db9b5f3.webp" alt="IBRX.jpg">One user speculated that the approval could double the product revenue for the company.<stembedurl>https://stocktwits.com/Bc3345/message/641787673</stembedurl>One user sees the stock climb to $5 in the short term and $15-25 in the medium term.<stembedurl>https://stocktwits.com/AshvsEvilDead/message/64178170</stembedurl><a href="https://stocktwits.com/AshvsEvilDead/message/641781706">6</a>Over the past year, <a href="https://stocktwits.com/symbol/IBRX">IBRX shares</a> have risen around 21%.Read also: <a href="https://stocktwits.com/news-articles/markets/equity/why-clsk-stock-rising-premarket-texas-data-centre-deal/cmULgA7R4e0">CLSK Stock Receives Premarket Boost On Texas Data Center Deal</a>For updates and corrections, email newsroom[at]stocktwits[dot]com.

IBRX Stock Finds Retail Cheer After Company’s Immunotherapy For Bladder Cancer Gets Saudi FDA Approval

The approval in Saudi Arabia follows authorizations in the U.S. and the U.K., as well as a conditional approval in the European Union.

<ul class="summary-bullets"><li>The move is a major step toward FDA approval of NRX-100, its investigational drug.</li><li>Currently, no FDA-approved medications exist specifically to treat suicidal thoughts, with electroshock therapy remaining the only sanctioned option.</li><li>Earlier, Osmind presented data from a 20,000-patient subset at the 2024 American Society of Clinical Psychopharmacology meeting.</li></ul>NRx Pharmaceuticals, Inc. (NRXP) on Wednesday announced that it has licensed Real World Evidence (RWE) from more than 70,000 U.S. patients who received either intravenous ketamine or nasal S-ketamine as part of their treatment.The move is a major step toward FDA approval of its investigational drug, NRX-100 (preservative-free ketamine), aimed at treating suicidal ideation in patients with depression and suicidal tendencies.&nbsp;<h2 class="st-heading-2">Collaboration With Osmind</h2>The RWE data comes from Osmind, a neuropsychiatry technology platform used across U.S. clinics, providing detailed, regulatory-grade patient records. This joint effort allows NRx to submit a comprehensive dataset to the FDA in support of Accelerated Approval for NRX-100 under its Fast Track Designation.&nbsp;The approach could mark a breakthrough, as currently no FDA-approved medications exist specifically to treat suicidal thoughts, with electroshock therapy remaining the only sanctioned option.Following the update,&nbsp;<a href="https://stocktwits.com/symbol/NRXP">NRx Pharmaceuticals' stock&nbsp;</a>traded over 21% higher in Wednesday’s premarket.&nbsp;On Stocktwits, retail sentiment around the stock jumped to ‘bullish’ territory from ‘bearish’ the previous day. Message volume shifted to ‘high’ from ‘normal’ levels in 24 hours.&nbsp;<h2 class="st-heading-2">Preliminary Findings And Expectations</h2>Earlier, Osmind presented data from a 20,000-patient subset at the 2024 American Society of Clinical Psychopharmacology meeting. Results suggested rapid improvement in depression and suicidal ideation with intravenous ketamine.&nbsp;NRx anticipates that analysis of the full 70,000-patient dataset will provide even stronger evidence to support the FDA submission.<blockquote>“An American commits suicide every 11 minutes and ketamine has become widely used off label as a drug that has been seen to reduce suicidal ideation in clinical trials.”-Jonathan Javitt, Chairman and CEO, NRx Pharmaceuticals</blockquote>NRXP stock has declined by over 58% in the last 12 months.&nbsp;Also See:&nbsp;<a href="https://stocktwits.com/news-articles/markets/equity/why-did-nrxp-stock-surge-pre-market-today/cmULXc2R4eL">Why Did NRXP Stock Surge 21% Pre-Market Today?</a>For updates and corrections, email newsroom[at]stocktwits[dot]com.

In this photo illustration, a hand holding a medical syringe seen displayed in front of the NRx Pharmaceuticals logo.

Why Did NRXP Stock Surge 21% Pre-Market Today?

The company is using a large US real-world evidence dataset to support its accelerated FDA approval for its ketamine-based drug.

SPDR Series Trust - State Street SPDR S&P Biotech ETF

Beat EPS and revenue

Beat EPS, miss revenue

Miss EPS, beat revenue

Miss EPS and revenue

What do you expect from $SHOP earnings on Wednesday?

XBI
SPDR S&P Biotech ETF

Feed

News

Sentiment

Fundamentals

Info

Latest XBI News

XBISPDR S&P Biotech ETF