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Asset Entities, Inc. engages in providing social media marketing and content delivery services. It offers its services to Discord, TikTok, and other social media platforms. It also designs, develops and manages servers for communities on Discord. The company was founded by Arshia Sarkhani, Jackson Fairbanks, Arman Sarkhani and Kyle Fairbanks on August 1, 2020 and is headquartered in Dallas, TX.

Asset Entities Inc - Ordinary Shares - Class B

Asset Entities Inc.

Asset Entities Inc. is trending due to the approval of its merger with Strive Enterprises, paving the way for a Bitcoin treasury company. The community is excited about the potential for a short squeeze, with some drawing comparisons to other high-flying crypto plays. With potential access to significant capital post-merger, discussions are centered around the stock's potential valuation and ability to outperform Bitcoin itself.

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 trending due to a surprise announcement of a warrant dividend for shareholders, sparking discussions around share lending and potential for a short squeeze. The community is analyzing the implications of these warrants, particularly how they may impact shorts and the stock's price movement. Positive earnings are adding fuel to the fire, with many expecting significant price swings.

Oracle Corp. engages in the provision of products and services that address aspects of corporate information technology environments, including applications and infrastructure technologies. It operates through the following business segments: Cloud and License, Hardware, and Services. The Cloud and License segment markets, sells, and delivers enterprise applications and infrastructure technologies through cloud and on-premise deployment models including cloud services and license support offerings. The Hardware segment provides infrastructure technologies including Oracle Engineered Systems, servers, storage, industry-specific hardware, operating systems, virtualization, management, and other hardware-related software. The Services segment offers consulting, advanced support, and education services. The company was founded by Lawrence Joseph Ellison, Robert Nimrod Miner, and Edward A. Oates on June 16, 1977 and is headquartered in Austin, TX.

Oracle Corp.

Oracle's stock is trending following its earnings report, despite missing estimates, due to strong forward guidance and significant growth in cloud infrastructure revenue, particularly from multi-cloud databases. The community is focused on the company's massive backlog and potential for future growth in the AI space, leading to a debate about whether the stock's surge is justified or if it's a sign of a market bubble. Discussions also revolve around the potential impact on other tech stocks and Oracle's position in the cloud computing sector.

QMMM Holdings Ltd. engages in the provision of digital advertising services. It offers interactive design, animation, art-tech and virtual technologies used in commercial campaigns. It has worked with domestic and international banks, real estate developers, amusement parks, international sports apparel, footwear brands, luxury cosmetic products, and international brands. The company was founded by Bun Kwai on July 29, 2022 and is headquartered in Hong Kong.

QMMM Holdings Ltd. - Ordinary Shares - Class A

QMMM Holdings Ltd.

QMMM is trending due to a massive short squeeze following news of a new crypto treasury strategy, leading to extreme volatility and significant gains for some traders. Community discussions revolve around the potential for continued upward momentum versus an imminent pullback, with comparisons to other high-flying stocks in the sector. Speculation abounds regarding market manipulation and the risks associated with China-based stocks.

CaliberCos, Inc. operates as an asset management firm. It provides various support services including asset management & fund set-up services, as well as lending support, construction & development management, and real estate brokerage services. The company was founded by John Christopher Loeffler II and Jennifer Schrader in January 2009 and is headquartered in Scottsdale, AZ.

CaliberCos Inc - Ordinary Shares - Class A

CaliberCos Inc 

CaliberCos ($CWD) is trending due to a volatile trading day, with discussions focusing on potential manipulation and short squeezes after a large intraday price swing. Community members are debating whether the stock will recover or if it's a pump and dump, while also comparing it to other high-flying stocks like $QMMM and $OCTO. The company's recent announcement of investing in Chainlink tokens is also a key point of discussion.

Armada Acquisition Corp. I operates as a blank check company. It was formed for the purpose of entering into a merger, share exchange, asset acquisition, stock purchase, recapitalization, reorganization, or other similar business combination with one or more businesses or entities. The company was founded on November 5, 2020 and is headquartered in Philadelphia, PA.

Rezolve AI PLC .

Rezolve AI Limited

Rezolve AI ($RZLV) is trending amid growing investor interest in AI and e-commerce, with discussions around its potential for high growth and comparisons to other AI companies. The community is actively debating entry points, holding strategies, and the impact of upcoming earnings, while also highlighting the company's partnerships and patented technology. Some are expressing concerns about dilution and short selling, while others are very bullish for a run to double digits.

Synopsys, Inc. engages in the provision of electronic design automation (EDA) software that engineers use to design and test integrated circuits (ICs). It also offers semiconductor intellectual property (IP) products. It operates through the following segments: Design Automation, Design IP, and Software Integrity. The Design Automation segment includes silicon design, verification products and services, system integration products and services, digital, custom, and FPGA IC design software, verification software and hardware products, and manufacturing software products. The Software Integrity segment includes a solution for building security and compliance testing into the customers' software development lifecycle and supply chain. The company was founded by Aart J. de Geus, Bill Krieger, Dave Gregory, and Rick Rudell in December 1986 and is headquartered in Sunnyvale, CA.

Synopsys, Inc.

Synopsys is trending due to mixed reactions to its recent earnings report and future outlook, with investors focused on the company's exposure to macro uncertainties and the potential impact of its pending acquisition of Ansys. While some community members express confidence in the company's long-term prospects and AI-driven growth, others are concerned about the conservative guidance and its effect on the stock's valuation.

Rubrik, Inc. engages in the provision of cloud data management solutions. Its solutions include backup and recovery, VM backup, Microsoft 365, ransom ware recovery, database backup, cloud solutions, and Polaris sonar. Rubrik products include data protection, data threat analytics, data security posture and cyber recovery. The company was founded by Bipul Sinha, Arvind Jain, Soham Mazumdar, and Arvind Nithrakashyap in December 2013 and is headquartered in Palo Alto, CA.

Rubrik Inc. - Ordinary Shares - Class A

Rubrik Inc. - Class A

Rubrik is trending as investors discuss its upcoming earnings report and the potential impact on the stock's valuation, with the community weighing positive analyst sentiment against concerns about profitability. A key point of discussion revolves around the company's position in the cybersecurity sector relative to competitors and potential for long-term growth. Some traders are also focused on short-term strategies, anticipating volatility around the earnings release.

Apple, Inc. engages in the design, manufacture, and sale of smartphones, personal computers, tablets, wearables and accessories, and other varieties of related services. It operates through the following geographical segments: Americas, Europe, Greater China, Japan, and Rest of Asia Pacific. The Americas segment includes North and South America. The Europe segment consists of European countries, as well as India, the Middle East, and Africa. The Greater China segment comprises China, Hong Kong, and Taiwan. The Rest of Asia Pacific segment includes Australia and Asian countries. Its products and services include iPhone, Mac, iPad, AirPods, Apple TV, Apple Watch, Beats products, AppleCare, iCloud, digital content stores, streaming, and licensing services. The company was founded by Steven Paul Jobs, Ronald Gerald Wayne, and Stephen G. Wozniak in April 1976 and is headquartered in Cupertino, CA.

Apple Inc

Gitlab, Inc. provides code hosting and collaboration platform services. It offers continuous integration, source code management, out-of-the-box pipelines, agile development, and value stream management. The company was founded by Dmitriy Zaporozhets and Sid Sijbrandij in 2011 and is headquartered in Dover, DE.

Gitlab Inc - Ordinary Shares - Class A

Gitlab Inc

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Anavex Life Sciences Corp. (AVXL) on Tuesday announced that its experimental Alzheimer’s drug demonstrated cognitive stabilization in patients with early Alzheimer’s disease in a study.After 48 weeks, patients receiving 30 mg once-daily oral Blarcamesine in a precision medicine population demonstrated barely detectable cognitive decline on all standard scales for measuring cognitive decline, comparable to the minimal decline in pre-dementia aging adults.Shares of the company rose 2% on Tuesday morning at the time of writing. On Stocktwits, retail sentiment around <a href="https://stocktwits.com/symbol/AVXL">AVXL stock</a> jumped from ‘bearish’ to ‘neutral’ territory over the past 24 hours, while message volume rose from ‘low’ to ‘normal’ levels.The company <a target="_blank" rel="noopener noreferrer nofollow" href="https://www.anavex.com/post/anavex-life-sciences-announces-oral-blarcamesine-cognitive-resilience-results-approximating-normal-a">said</a> that the drug caused about an 84.7% reduction in cognitive decline as compared to placebo on a standardized neuropsychological test used in Alzheimer's disease research to measure cognitive function.“Today’s new clinical efficacy data update from our Phase IIb/III trial is critical, as it adds contemporary context to Precision Medicine data showing strong protection from Alzheimer’s disease with an oral once-daily potential solution with the aim to alleviate significant medical and economic burden,” said Juan Carlos Lopez-Talavera, Head of Research and Development of Anavex.Anavex will continue to evaluate trial data, which will be published and presented at international conferences, the company said.Anavex is also studying Blarcamesine, its lead candidate, in dementia caused by Parkinson's disease, a neurodegenerative brain condition, and in patients with Rett syndrome, a rare genetic neurological and developmental disorder that affects the way the brain develops.AVXL stock is down 12% this year but up approximately 84% over the past 12 months.&nbsp;Read also: <a href="https://stocktwits.com/news-articles/markets/equity/ford-recalls-nearly-1.5-million-vehicles-in-us/chwKduPRdte">Ford Draws Retail Investor Concerns After It Recalls Nearly 1.5M Vehicles In US Over Rear View Camera Display Issues</a>For updates and corrections, email newsroom[at]stocktwits[dot]com.

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Anavex Life Sciences Stock Rises After Experimental Alzheimer’s Drug Slows Cognitive Decline In Study

After 48 weeks, patients receiving 30 mg once-daily oral Blarcamesine demonstrated barely detectable cognitive decline, the company said. 

Equity

After 48 weeks, patients receiving 30 mg once-daily oral Blarcamesine demonstrated barely detectable cognitive decline, the company said. 


Craig-Hallum initiated coverage of Immunome (IMNM) on Friday with a ‘Buy’ rating and a $26 price target, noting that the shares could trade up 45% or more in the firm's bull cases.The target implies an upside of about 165% from the stock’s closing price on Thursday. Shares of the company rose 7% at the time of writing.Heading into Varegacestat's late-stage topline data in desmoid tumors due in the second half and IM-1021's early-stage go/no-go proof of concept data in hematological and solid tumors late in the year or in early 2026, the firm believes these catalysts "skew risk/reward to the upside" and sees an attractive entry point, as per TheFly.On Stocktwits, retail sentiment around <a href="https://stocktwits.com/symbol/IMNM">IMNM stock</a> stayed within ‘bullish’ territory over the past 24 hours, while message volume stayed at ‘normal’ levels.<figure class="image"><img style="aspect-ratio:575/59;" src="https://news.stocktwits-cdn.com/Screenshot_2025_09_05_at_9_42_56_AM_png_dda0252eb1.webp" alt="IMNM's Sentiment Meter and Message Volume as of 9:45 a.m. ET on Sept. 5, 2025 | Source: Stocktwits" width="575" height="59"><figcaption>IMNM's Sentiment Meter and Message Volume as of 9:45 a.m. ET on Sept. 5, 2025 | Source: Stocktwits</figcaption></figure> In August, Immunome said that it expects to report data from a late-stage study of Varegacestat “before the end of 2025” and that it is “well-positioned” to support a new drug application for it. &nbsp;The investigational drug received an Orphan Drug Designation from the U.S. Food and Drug Administration in November 2023. The designation is granted to a drug or biological product intended to prevent, diagnose, or treat a rare disease or condition, and Varegacestat aims to treat desmoid tumors, a rare, locally aggressive growth in the body's fibrous connective tissue.As for IM-1021, the company said last month that patients were recently dosed at the third dose level in an early-stage dose-escalation trial.According to data from Koyfin, all ten analysts covering IMNM rate it either ‘Buy’ or ‘Strong Buy’. The stock has an average price target of $23.56.IMNM stock is down 2% this year and approximately 26% over the past 12 months.&nbsp;Read also: <a href="https://stocktwits.com/news-articles/markets/equity/why-is-biontech-rising-pre-market-today/chwIXnPRdqb">Why Did BioNTech Stock Surge 10% Pre-Market Today?</a>For updates and corrections, email newsroom[at]stocktwits[dot]com.

Immunome Stock Rises After Craig-Hellum Initiates Coverage With $26 Price Target: Here’s Why The Analyst Sees An ‘Attractive Entry Point’

Craig-Hellum’s price target of $26 represents an upside of about 165% from the stock’s closing price on Thursday.

Novavax, Inc. (NVAX) announced on Thursday that its COVID-19 vaccine, Nuvaxovid, has been approved in Japan, triggering a milestone payment from Japanese pharmaceutical company Takeda.The vaccine was approved for initial immunization (first and second vaccinations) in individuals aged six years or older, and as a booster immunization (following the third vaccination) in individuals aged 12 years or older in the country.On Stocktwits, retail sentiment around <a href="https://stocktwits.com/symbol/NVAX">NVAX stock</a> stayed within ‘bearish’ territory over the past 24 hours, while message volume stayed at ‘low’ levels.Under Novavax’s <a target="_blank" rel="noopener noreferrer nofollow" href="https://ir.novavax.com/press-releases/2025-09-04-Nuvaxovid-R-Now-Approved-in-Japan-Triggering-Takeda-Milestone-Payment">deal</a> with Takeda, the company is also eligible to receive royalties on net sales of Nuvaxovid from Takeda in this vaccination season. The company did not disclose specific payment amounts, saying that it is bound by contractual confidentiality agreements.Novavax and Takeda updated the terms of their 2020 collaboration and licensing agreement for Nuvaxovid in May. The amended deal includes an upfront payment, a payment related to the 2024-2025 season, annual milestones associated with regulatory approvals, and royalties on net sales earned every season moving forward, the company stated. In the second quarter, the company reported $27 in licensing, royalties, and other revenue from Takeda.Novavax got the U.S. Food and Drug Administration’s approval for Nuvaxovid in May for the prevention of COVID-19 in adults 65 years and older and individuals aged 12 through 64 years who have at least one underlying condition that puts them at high risk for severe outcomes from the disease. The FDA then requested the company to conduct a postmarketing commitment (PMC) study.However, Novavax <a href="https://stocktwits.com/news-articles/markets/equity/novavax-cfo-says-sanofi-to-cover-majority-of-future-nuvaxovid-study-costs/chrScEpRd50">stated</a> last month that the study will not impact its operating profit for 2025, as its partner, Sanofi, will cover the majority of the expenses.NVAX stock is down 9% this year and approximately 38% over the past 12 months.&nbsp;Read also: <a href="https://stocktwits.com/news-articles/markets/equity/this-burger-chain-stock-has-gained-9-this-year-bmo-capital-sees-another-14-upside/chwdEPGRdYl">This Burger Chain Stock Has Gained 9% This Year And BMO Capital Sees Another 14% Upside – Find Out More</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)

Novavax COVID-19 Vaccine Approved In Japan, Triggers Milestone Payment From Partner Takeda

The vaccine was approved for initial immunization in individuals aged six years or older and as a booster immunization in those aged 12 years or older in the country. 

Aquestive Therapeutics (AQST) on Thursday said that the U.S. Food and Drug Administration has informed the Company that an advisory committee meeting is not required for Anaphylm Sublingual Film.Anaphylm Sublingual Film is a polymer matrix-based epinephrine prodrug product candidate. It is similar in size to a postage stamp and begins to dissolve on contact. No water or swallowing is required for administration.According to Aquestive, Anaphylm has the potential to be the first and only orally delivered epinephrine product for the treatment of severe allergic reactions in the U.S., doing away with the need for injections. The FDA is expected to decide on Aquestive’s application for approval of the sublingual film by January 31, 2026.Aquestive CEO Dan Barber <a target="_blank" rel="noopener noreferrer nofollow" href="https://investors.aquestive.com/news-releases/news-release-details/aquestive-therapeutics-announces-fda-will-not-require-advisory">said</a> that the company is encouraged by the FDA’s decision to waive a meeting and added that the company is “well-positioned” for launch. Shares of the company traded 17% higher in the premarket session.On Stocktwits, retail sentiment around <a href="https://stocktwits.com/symbol/AQST">AQST stock</a> stayed within ‘bearish’ territory over the past 24 hours, while message volume stayed at ‘low’ levels. A Stocktwits user opined that the stage is now set for approval of Anaphylm.<stembedurl>https://stocktwits.com/BioAmerica/message/627450441</stembedurl>Last month, Aquestive <a href="https://stocktwits.com/news-articles/markets/equity/aquestive-therapeutics-enters-75-million-dollar-funding-agreement/chsRkEVRdOO">said</a> that it entered into a $75 million strategic funding agreement with funds managed by RTW Investments, LP. The financing will become available upon approval of Anaphylm by the FDA and satisfaction of certain refinancing and other customary conditions. Barber said that the financing will support the company through 2027 and allow it to successfully bring Anaphylm to market.RTW, meanwhile, will receive a tiered single-digit percentage of annual net sales of Anaphylm in the U.S. for the treatment of type I allergic reactions, including anaphylaxis, subject to a cap.AQST stock is up by 11% this year but down by about 7% over the past 12 months.&nbsp;Read also: <a href="https://stocktwits.com/news-articles/markets/cryptocurrency/ethereum-outperforms-bitcoin-while-broader-crypto-market-slips/chwd22IRdYJ">Ethereum Outperforms Bitcoin, While Broader Crypto Market Slips</a>For updates and corrections, email newsroom[at]stocktwits[dot]com.

FDA Says No Advisory Committee Meeting Needed For Aquestive’s Oral Epinephrine Film

 The FDA is expected to decide on Aquestive’s application for approval of the sublingual film by January 31, 2026. 

Shares of Tectonic Therapeutic (TECX) soared about 6% in Wednesday’s pre-market after Oppenheimer initiated coverage of the company with an ‘Outperform’ rating.Oppenheimer has an $80 price target on Tectonic, representing an upside of over 380% from the stock’s closing price on Tuesday. The firm stated that it likes the prospects of Tectonic's lead asset, TX45, for addressing prevalent and progressive cardiovascular disorders that are currently inadequately treated.The analyst is optimistic ahead of next year's mid-stage study data readout in pulmonary hypertension with heart failure with preserved ejection fraction, which it believes could pave the way for a multi-billion-dollar global sales opportunity, according to TheFly.On Stocktwits, retail sentiment around <a href="https://stocktwits.com/symbol/TECX">Tectonic</a> jumped from ‘bearish’ to ‘extremely bullish’ territory over the past 24 hours, while message volume rose from ‘normal’ to ‘extremely high’ levels.<figure class="image"><img style="aspect-ratio:577/62;" src="https://news.stocktwits-cdn.com/Screenshot_2025_09_03_at_7_02_32_AM_png_aa449b866b.webp" alt="TECX's Sentiment Meter and Message Volume as of 7:02 a.m. ET on Sept. 3, 2025 | Source: Stocktwits" width="577" height="62"><figcaption>TECX's Sentiment Meter and Message Volume as of 7:02 a.m. ET on Sept. 3, 2025 | Source: Stocktwits</figcaption></figure>Tectonic shares closed down 35% on Tuesday following Eli Lilly's (LLY) data presentation and publication from its failed study in heart failure patients with preserved ejection fraction using a recombinant long-acting relaxin mimetic, Volenrelaxin. Tectonic’s lead candidate also seeks to treat similar cardiovascular disorders.According to Truist analyst Danielle Brill, the negative news "represents another hit to the emerging relaxin class of drugs." Still, the firm also notes that read-through should be limited as the population enrolled in Lilly's trial is distinct from those enrolled in Tectonic's.The firm, which believes Tectonic's approach to targeting Combined Post- and Pre-Capillary Pulmonary Hypertension has "the strongest rationale" and calls the selloff "overdone," maintained a ‘Buy’ rating and a $64 price target on Tectonic shares.TECX stock is down by 64% this year and by about 13% over the past 12 months.&nbsp;Read also: <a href="https://stocktwits.com/news-articles/markets/equity/cybersecurity-vendor-zscaler-s-stock-rises-premarket-what-s-fueling-upside/chwTMR0Rd89">Cybersecurity Vendor Zscaler’s Stock Rises Premarket: What’s Fueling The Upside?</a>For updates and corrections, email newsroom[at]stocktwits[dot]com.

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Tectonic Stock Soars Pre-market After Tuesday’s Sell-Off: Oppenheimer Is Hopeful About Company’s Lead Candidate

Oppenheimer stated that it likes the prospects of Tectonic's lead asset, TX45, to address prevalent and progressive cardiovascular disorders that are inadequately treated.

The U.S. Food and Drug Administration (FDA) announced on Thursday that it is withdrawing its approval of the new drug application (NDA) for Amylyx Pharmaceuticals’ (AMLX) Relyvrio.Amylyx has voluntarily requested that the FDA withdraw approval of this application and has waived its opportunity for a hearing, the agency <a target="_blank" rel="noopener noreferrer nofollow" href="https://public-inspection.federalregister.gov/2025-16646.pdf">said</a>. The FDA approved the application for Relyvrio for the treatment of amyotrophic lateral sclerosis (ALS) in adults in September 2022. Amyotrophic lateral sclerosis (ALS), or Lou Gehrig's disease, is a progressive, fatal neurodegenerative disorder that causes muscle weakness and paralysis by destroying motor neurons, the cells that control voluntary muscle movement.&nbsp;However, last year, the company reported to the agency that a late-stage trial evaluating the drug in patients living with ALS did not meet its prespecified goals. It also notified the agency that it plans to discontinue marketing of Relyvrio as of Oct. 31, 2024.On Stocktwits, retail sentiment around <a href="https://stocktwits.com/symbol/AMLX">AMLX stock</a> stayed within ‘extremely bullish’ territory over the past 24 hours, while message volume remained at ‘extremely high’ levels. Shares of the company traded 1% lower at the time of writing.<figure class="image"><img style="aspect-ratio:625/61;" src="https://news.stocktwits-cdn.com/Screenshot_2025_08_28_at_2_17_49_PM_png_ec4ad4caa5.webp" alt="AMLX's Sentiment Meter and Message Volume as of 2:18 p.m. ET on Aug. 28, 2025 | Source: Stocktwits" width="625" height="61"><figcaption>AMLX's Sentiment Meter and Message Volume as of 2:18 p.m. ET on Aug. 28, 2025 | Source: Stocktwits</figcaption></figure>Bank of America analyst Tim Anderson raised the firm's price target on Amylyx to $14 from $10 while keeping a ‘Buy’ rating on the shares after the company <a href="https://stocktwits.com/news-articles/markets/equity/amylyx-discontinues-investigative-therapy-program-in-rare-neurological-disorder/chsUG7LRdkv">reiterated</a> earlier this week that it has a cash runway until the end of 2026 on the heels of discontinuing its AMX0035 program in adults living with progressive supranuclear palsy.The decision to discontinue the program was made after it failed to show differences compared to the placebo on primary or secondary outcomes at week 24 in a mid-stage trial. The company will not initiate the late-stage portion of the program, it then said.AMLX stock is up 148% this year and approximately 349% over the past 12 months.&nbsp;Also See: <a href="https://stocktwits.com/news-articles/markets/equity/li-auto-announces-lower-q3-delivery-outlook-despite-new-vehicle-launches/chs60e1RdZ2">Li Auto Announces Lower Q3 Delivery Outlook Despite New Vehicle Launches: Retail Sees i8, i6 Selling Like ‘Hot Cakes’</a>For updates and corrections, email newsroom[at]stocktwits[dot]com

US FDA Withdraws Approval For Amylyx’s Neurodegenerative Disorder Drug, But BofA Hikes Price Target

Bank of America analyst Tim Anderson raised the firm's price target on Amylyx to $14 from $10 while keeping a ‘Buy’ rating on the shares after the company reiterated earlier this week that it has a cash runway until the end of 2026.

Amylyx Pharmaceuticals Inc. (AMLX) on Wednesday said that it is discontinuing its AMX0035 program in adults living with progressive supranuclear palsy.AMX0035 is an oral, fixed-dose combination of sodium phenylbutyrate and taurursodiol. The decision to discontinue the program was made after it failed to show differences compared to the placebo on primary or secondary outcomes at week 24 in a mid-stage trial. The company will not initiate the late-stage portion of the program, it <a target="_blank" rel="noopener noreferrer nofollow" href="https://investors.amylyx.com/news-releases/news-release-details/amylyx-pharmaceuticals-discontinue-orion-program-amx0035">said</a>.Progressive Supranuclear Palsy (PSP) is a rare, progressive neurological disorder characterized by problems with balance, eye movements, speech, and swallowing, often leading to frequent and unpredictable falls. According to Amylyx, the disease affects about seven in 100,000 people worldwide.On Stocktwits, retail sentiment around the <a href="https://stocktwits.com/symbol/AMLX">AMLX stock</a> jumped from ‘bullish’ to ‘extremely bullish’ territory over the past 24 hours, while message volume remained at ‘high’ levels. Shares of the company are down by 2% in the pre-market session.“While we are disappointed in these results, we believe these data will inform the PSP trial literature as well as deepen scientific understanding of this devastating disease,” said Camille L Bedrosian, Chief Medical Officer at Amylyx.Co-CEOs of Amylyx, Joshua Cohen and Justin Klee, said that the company’s priority remains on the late-stage trial of Avexitide, with enrollment expected to be completed in 2025 and topline data anticipated in the first half of 2026.Avexitide is an investigational, glucagon-like peptide-1 (GLP-1) receptor antagonist that has been evaluated in clinical trials for post-bariatric hypoglycemia (PBH) and has also been studied in congenital hyperinsulinism.The company is also continuing development of AMX0035 in Wolfram syndrome, a rare, inherited genetic disorder, they said. Amylyx continues to expect its cash runway to extend through the end of 2026.AMLX stock is up by 142% this year and has jumped 330% over the past 12 months.&nbsp;Read also: <a href="https://stocktwits.com/news-articles/markets/equity/ford-recalls-nearly-356000-vehicles-in-us/chsUG1SRdkx">Ford Issues Nearly 356,000 Vehicles Recall In U.S., But Retail Investors Spot Emerging Catalysts</a>For updates and corrections, email newsroom[at]stocktwits[dot]com.

Amylyx Discontinues Investigative Therapy Program In Rare Neurological Disorder

The decision to discontinue the program was made after AMX0035 did not show differences compared to placebo on primary or secondary outcomes at week 24 in a mid-stage trial.

Axogen, Inc. (AXGN) announced on Monday that the U.S. Food and Drug Administration (FDA) has postponed the date by which it would decide on the company’s application requesting approval for Avance Nerve Graft.Shares of the company tumbled 15% in Monday’s pre-market session after the company <a target="_blank" rel="noopener noreferrer nofollow" href="https://ir.axogeninc.com/press-releases/detail/1007/axogen-provides-update-on-fda-review-timeline-for-avance">announced</a> that the agency pushed the date of the decision by three months to Dec. 5, 2025. Avance Nerve Graft is a biologically active off-the-shelf processed human nerve allograft for bridging severed peripheral nerves.An "off-the-shelf" processed human nerve allograft is a biologically active implant made from donated human nerve tissue that is surgically treated to remove cellular and non-cellular debris, preserving the native nerve's structural integrity. Unlike traditional autografts, allografts are "off-the-shelf," meaning they are immediately available for surgical use.On Stocktwits, retail sentiment around <a href="https://stocktwits.com/symbol/AXGN">AXGN stock</a> fell from ‘neutral’ to ‘bearish’ territory over the past 24 hours while message volume remained at ‘low’ levels.The company said that it received communication from the FDA on August 22, indicating that the information it submitted in response to an FDA information request was deemed a major amendment to its initial application filed in September 2024 and accepted by the agency in November. The company submitted fresh data, including substantial new manufacturing and facility data, in response to the request.FDA subsequently extended the date for making its decision, allowing for additional time to review the submission. The FDA also told the company that it now expects to provide feedback on product labelling in November.CEO Michael Dale said that the company looks forward to continuing engagement with the FDA to get Avance approved.AXGN stock is down by 1% this year but up by about 28% over the past 12 months.&nbsp;Also See: <a href="https://stocktwits.com/news-articles/markets/cryptocurrency/bitcoin-slides-to-july-levels-ethereum-retreats-from-weekend-highs/chssNkNRd1i">Bitcoin Slides To July Levels, Ethereum Retreats From Weekend Highs – $840M Liquidated In Crypto Selloff</a>For updates and corrections, email newsroom[at]stocktwits[dot]com

Stock market down on a black background. | Image source: Yuichiro Chino via Getty Images

Why Is Axogen Stock Down 15% In Pre-Market Today?

Axogen stock tumbled after the company announced that the U.S. FDA pushed the date of the decision regarding approval for Avance Nerve Graft by three months.

The stock tumbled after the company announced that the U.S. FDA pushed the date of the decision regarding approval for Avance Nerve Graft by three months.


Precigen, Inc. (PGEN) said on Friday that the US Food and Drug Administration (FDA) has approved its immunotherapy Papzimeos for the treatment of adults with recurrent respiratory papillomatosis (RRP).Recurrent respiratory papillomatosis (RRP) is a rare condition where benign, wart-like tumors, called papillomas, grow in the respiratory tract, most commonly the larynx or the voice box. The disease can lead to severe voice disturbance, a compromised airway, and recurrent post-obstructive pneumonias. According to Precigen, there are about 27,000 adult RRP patients in the U.S.Papzimeos is now the first and only FDA-approved therapy for the treatment of adults with RRP, the company <a target="_blank" rel="noopener noreferrer nofollow" href="https://www.prnewswire.com/news-releases/precigen-announces-full-fda-approval-of-papzimeos-zopapogene-imadenovec-drba-the-first-and-only-approved-therapy-for-the-treatment-of-adults-with-recurrent-respiratory-papillomatosis-302530957.html">said</a>.On Stocktwits, retail sentiment around <a href="https://stocktwits.com/symbol/PGEN">Precigen</a> jumped from ‘neutral’ to ‘extremely bullish’ over the past 24 hours, while message volume rose from ‘high’ to ‘extremely high’ levels. Shares of the company traded 50% higher in the pre-market session at the time of writing.“With the landmark FDA approval of Papzimeos and broad label, all adult RRP patients are now eligible for access to the first and only approved therapy that targets the root cause of the disease," said CEO Helen Sabzevari. Management of RRP, the company said, previously primarily consisted of repeated surgeries that did not address its root cause.The FDA approval was supported by data from an open-label, single-arm study in adult patients with RRP in which 51% of study patients required no surgeries in the 12 months after treatment with Papzimeos. Further, the therapy was well-tolerated in the trial with no serious treatment-related adverse events.Precigen noted that no confirmatory clinical trial is required for the therapy, which is delivered via four subcutaneous injections over a 12-week interval. The company added that it will begin promoting Pazimeos immediately.H.C. Wainwright subsequently raised its price target on Precigen to $8.50 from $6 while keeping a 'Buy' rating on the shares. The firm expects the drug to generate sales of $1.1 billion in 2033 from $138 million in 2026.PGEN stock is up by 65% this year and by about 73% over the past 12 months.&nbsp;Read also: <a href="https://stocktwits.com/news-articles/markets/equity/apple-stock-climbs-premarket-even-after-warren-buffett-s-berkshire-trims-stake/chsPjsBRdf9">Apple Stock Climbs Premarket Even After Warren Buffett’s Berkshire Trims Stake</a>For updates and corrections, email newsroom[at]stocktwits[dot]com.

Precigen Stock Shot Through The Roof On Friday Morning – Here’s Why

The company stated that Papzimeos is now the first and only FDA-approved therapy for the treatment of adults with recurrent respiratory papillomatosis. 

Aquestive Therapeutics, Inc. (AQST) on Thursday said that it has entered into a $75 million strategic funding agreement with funds managed by RTW Investments, LP, subject to U.S. Food and Drug Administration (FDA) approval of Anaphylm Sublingual Film.The financing will become available upon approval of Anaphylm by the FDA and satisfaction of certain refinancing and other customary conditions. Aquestive CEO Dan Barber <a target="_blank" rel="noopener noreferrer nofollow" href="https://www.globenewswire.com/news-release/2025/08/14/3133251/0/en/Aquestive-Therapeutics-Announces-75M-Strategic-Funding-Agreement-with-RTW-to-Support-the-Potential-Launch-of-Anaphylm-epinephrine-Sublingual-Film.html">said</a> that the financing will support the company through 2027 and allow it to successfully bring Anaphylm to market.Under the terms of the agreement, RTW will receive a tiered single-digit percentage of annual net sales of Anaphylm in the U.S. for the treatment of type I allergic reactions, including anaphylaxis, subject to a cap.On Stocktwits, retail sentiment around <a href="https://stocktwits.com/symbol/AQST">AQST</a> jumped from ‘bullish’ to ‘extremely bullish’ territory over the past 24 hours, while message volume stayed at ‘high’ levels. Shares of the company traded 6% higher in the pre-market session.<figure class="image"><img style="aspect-ratio:631/62;" src="https://news.stocktwits-cdn.com/Screenshot_2025_08_14_at_7_57_19_AM_png_2d91151e35.webp" alt="AQST's Sentiment Meter and Message Volume as of 8:07 a.m. ET on Aug. 14, 2025 | Source: Stocktwits" width="631" height="62"><figcaption>AQST's Sentiment Meter and Message Volume as of 8:07 a.m. ET on Aug. 14, 2025 | Source: Stocktwits</figcaption></figure>A Stocktwits user believes uncertainty about funding is out of the way.<stembedurl>https://stocktwits.com/SonOfLionel19/message/625113435</stembedurl>Another, however, opined that the company would need more funds to launch the drug.<stembedurl>https://stocktwits.com/ae1213/message/625112218</stembedurl>Anaphylm Sublingual Film is a polymer matrix-based epinephrine prodrug product candidate. It is similar in size to a postage stamp and begins to dissolve on contact. No water or swallowing is required for administration.According to Aquestive, Anaphylm has the potential to be the first and only orally delivered epinephrine product for the treatment of severe allergic reactions in the U.S. The FDA is expected to decide on the candidate by January 31, 2026.Separately, the company also announced pricing of an underwritten offering of 21.25 million shares of its common stock at an offering price of $4.00 per share. The gross proceeds of the offering to Aquestive are expected to be $85 million.The company <a target="_blank" rel="noopener noreferrer nofollow" href="https://www.globenewswire.com/news-release/2025/08/14/3133263/0/en/Aquestive-Therapeutics-Announces-Pricing-of-85-Million-Underwritten-Offering-of-Common-Stock.html">said</a> it intends to use the net proceeds received from the offering primarily to advance the launch and commercialization of Anaphylm.AQST stock is up by 13% this year and by about 4% over the past 12 months.&nbsp;Read also: <a href="https://stocktwits.com/news-articles/markets/equity/eli-lilly-inks-up-to-1.3-billion-deal-with-superluminal-medicines/chsRS3IRdO7">Eli Lilly Inks Up To $1.3B Deal With Superluminal Medicines To Develop Obesity Drugs</a>For updates and corrections, email newsroom[at]stocktwits[dot]com.

Aquestive Therapeutics Stock Is Rising Pre-Market – Its $75M Funding Agreement Draws Divided Opinions From Retail

Aquestive CEO Dan Barber said that the $75 million financing will support the company through 2027 and allow it to successfully bring Anaphylm to market.

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