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QUALCOMM, Inc. engages in developing and commercializing foundational technologies and products used in mobile devices and other wireless products. It operates through the following segments: Qualcomm CDMA Technologies (QCT), Qualcomm Technology Licensing (QTL), and Qualcomm Strategic Initiatives (QSI). The QCT segment develops and supplies integrated circuits and system software based on technologies for use in voice and data communications, networking, application processing, multimedia, and global positioning system products. The QTL segment grants licenses and provides rights to use portions of the firm's intellectual property portfolio. The QSI segment focuses on opening new or expanding opportunities for its technologies and supporting the design and introduction of new products and services for voice and data communications. The company was founded by Franklin P. Antonio, Adelia A. Coffman, Andrew Cohen, Klein Gilhousen, Irwin Mark Jacobs, Andrew J. Viterbi, and Harvey P. White in July 1985 and is headquartered in San Diego, CA.

Qualcomm, Inc.

Qualcomm is facing intense selling pressure following a series of analyst downgrades that highlight long-standing concerns over smartphone demand, memory chip shortages, and the gradual loss of Apple as a modem customer. Despite active community debate over the company's valuation and its aggressive pivot toward AI, robotics, and automotive technology, the stock continues to struggle with downward momentum as investors weigh short-term margin headwinds against its long-term diversification strategy.

Trump Media & Technology Group Corp. engages in operating social media and in the technology business. Its brands include TRUTH Social, TMTG+, and TMTG News. It operates through the Media and Truth.Fi segments. The Media segment includes products and services such as advertisement through the Truth Social platform. The Truth.Fi segment relates to customized exchange-traded funds or exchange-traded products invested in America First principles, and bitcoin and similar cryptocurrencies or crypto-related securities. The company was founded on March 28, 2024 and is headquartered in Sarasota, FL.

Trump Media & Technology Group Corp.

Trump Media & Technology Group Corp. is seeing intense volatility as investors debate the impact of the ongoing conflict in Iran and subsequent energy market instability on the company's valuation. The community is sharply divided, with supporters defending the administration's strategic maneuvers while a significant portion of the retail base expresses frustration over the stock's downward trend and the broader macroeconomic uncertainty.

Schwab Strategic Trust - Schwab US Dividend Equity ETF

Schwab US Dividend Equity ETF

Investors are increasingly rotating into this ETF as a defensive hedge amid market volatility, with the community actively debating the long-term benefits of its dividend growth profile compared to pure growth alternatives. Sentiment remains focused on accumulating shares during pullbacks to leverage the fund's historical compounding power and stable yield potential.

Petróleo Brasileiro SA engages in oil and gas exploration, production, and distribution activities. It operates through the following segments: Exploration and Production; Refining, Transportation, and Marketing; and Gas and Low Carbon Energies. The Exploration and Production segment covers the activities of exploration, development, and production of crude oil, natural gas liquid, and natural gas, for the primary purpose of supplying its domestic refineries. The Refining, Transportation, and Marketing segment refers to refining, logistics, transport, and trading of crude oil and oil products activities as well as exports of ethanol. The Gas and Low Carbon Energies represents the activities of logistic and trading of natural gas and electricity, transportation and trading of liquefied natural gas, generation and electricity by means of thermoelectric power plants, as well as holding interests in transporters and distributors of natural gas. The company was founded on October 3, 1953 and is headquartered in Rio de Janeiro, Brazil.

Petroleo Brasileiro S.A. Petrobras - ADR

Petroleo Brasileiro

Petrobras (PBR) is currently trending due to heightened geopolitical tensions in the Middle East following reports of a conflict escalation involving Iran, which has sparked market speculation about potential supply disruptions in the Strait of Hormuz and a subsequent surge in oil prices. Investors are closely monitoring the stock's role as a major offshore oil producer, balancing these volatile geopolitical catalysts with discussions around the company's valuation, strong dividend yield, and its strategic production milestones in the Buzios field.

BP Plc operates as an integrated oil and gas company providing carbon products and services. It operates through the following segments: Gas and Low Carbon Energy, Oil Production and Operations, and Customers and Products. The Gas and Low Carbon Energy segment includes upstream businesses focused on natural gas production, gas marketing and trading activities, as well as solar, wind, and hydrogen ventures. The Oil Production and Operations segment comprises regions with upstream activities that predominantly produce crude oil. The Customers and Products segment includes customer-focused businesses, including convenience and retail fuels, EV charging, Castrol, aviation, B2B, and midstream, along with refining, oil trading, and bioenergy businesses. The company was founded by William Knox D'Arcy in 1908 and is headquartered in London, the United Kingdom.

BP plc - ADR

BP is trending as the energy sector faces heightened volatility amid intensifying geopolitical tensions in the Middle East, specifically threats to shipping in the Strait of Hormuz. Investors are closely monitoring the impact on global supply chains and crude oil prices, with community discussion heavily centered on the potential for long-term production constraints and the stock's status as a high-dividend income play.

Roblox Corp. engages in the provision of online gaming services. Its platform consists of Roblox Client, Roblox Studio, and Roblox Cloud. Roblox Client is an application that allows users to explore 3D digital worlds. Roblox Studio is the toolset that allows developers and creators to build, publish, and operate 3D experiences and other content accessed with Roblox Client. Roblox Cloud includes the services and infrastructure that power the human co-experience platforms. The company was founded by Erik Cassel and David B. Baszucki in March 2004 and is headquartered in San Mateo, CA.

Roblox Corporation - Ordinary Shares - Class A

Roblox Corp.

Roblox is facing significant downward pressure as investors rotate out of the gaming sector following the unveiling of Google's AI-driven 3D world creation tool, Project Genie. While some community members view the sell-off as an overreaction and a potential buying opportunity, others are actively betting on further declines, citing concerns over regulatory headwinds, platform safety, and long-term valuation.

Occidental Petroleum Corp. engages in the exploration and production of oil and natural gas. It operates through the following segments: Oil and Gas, Chemical, and Midstream and Marketing. The Oil and Gas segment explores for, develops and produces oil and condensate, natural gas liquids, and natural gas. The Chemical segment manufactures and markets basic chemicals and vinyls. The Midstream and Marketing segment purchases, markets, gathers, processes, transports and stores oil, condensate, natural gas liquids, natural gas, carbon dioxide, and power. The company was founded in 1920 and is headquartered in Houston, TX.

Occidental Petroleum Corp.

Occidental Petroleum (OXY) is trending as investors react to escalating geopolitical tensions in the Middle East and concerns over potential supply disruptions in the Strait of Hormuz. The community is actively debating the stock's role as a hedge against rising crude prices, with many participants analyzing the impact of institutional positioning and sector-wide bullish sentiment on the stock's short-term price action.

Sprott Physical Silver Trust - Units

Sprott Physical Silver Trust ET

PSLV is capturing significant market attention as investors increasingly favor its physical silver backing over paper-based ETFs amid concerns regarding COMEX vault depletions and structural supply shortages. The community is actively debating the impact of geopolitical instability and potential supply squeezes, with many members interpreting recent price volatility as a calculated attempt by financial institutions to shake out retail investors.

Centrus Energy Corp. engages in the supply of nuclear fuel and services for the nuclear power industry. It operates through the Low-Enriched Uranium (LEU) and Technical Solutions segments. The LEU segment includes various components of nuclear fuel to utilities from its global network of suppliers. The Technical Solutions segment offers advanced engineering, design, and manufacturing services to government and private sector customers, and is deploying advanced nuclear fuel production capabilities to power existing, and next-generation reactors around the world. The company was founded in October 1992 and is headquartered in Bethesda, MD.

Centrus Energy Corp - Ordinary Shares - Class A

Centrus Energy is currently in the spotlight as investors track the progress of its Piketon, Ohio facility, which recently launched domestic centrifuge manufacturing to support a multibillion-dollar uranium enrichment expansion. The community is actively debating the stock's volatility and its long-term role as the only licensed U.S. producer of HALEU, with sentiment balancing enthusiasm for its strategic importance in the domestic nuclear supply chain against concerns over capital expenditures and recent earnings performance.

Devon Energy Corp. engages in the exploration, development, and production of oil and natural gas properties. It develops and operates Delaware Basin, Eagle Ford, Heavy Oil, Barnett Shale, STACK, and Rockies Oil. The company was founded by J. Larry Nichols and John W. Nichols in 1971 and is headquartered in Oklahoma City, OK.

Devon Energy Corp.

Devon Energy is currently a primary focus among investors as market participants debate the impact of potential geopolitical shifts and energy sector consolidation on the company's valuation. While some traders are closely watching for a breakout from long-term technical patterns, the community remains divided over whether the stock is an undervalued growth play or a target for a larger energy sector acquisition.

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<ul class="summary-bullets"><li>Esperion highlighted future growth plans, including expanding U.S. market penetration and advancing its oral triple-combination program.</li><li>The company said that its acquisition of Corstasis Therapeutics also advances its Vision 2040 strategy.</li><li>Esperion also added that it plans to expand geographically through continued collaboration with its global partners.</li></ul>Esperion Therapeutics Inc. (ESPR) shares fell more than 6% in Tuesday morning’s trade after the company reported a mixed fourth quarter.Esperion reported earnings per share (EPS) of $0.22 on revenue of $168.5 million, while Wall Street expected an EPS of $0.28 on revenue of $164.7 million, according to Fiscal.ai data.“2025 was a defining year for Esperion. We delivered strong growth in our U.S. cardiovascular franchise, broadened access and adoption among statin-intolerant or statin-resistant patients, and strengthened the durability of our business with important intellectual property and market access advances,” said Esperion CEO Sheldon Koenig.<h2 class="st-heading-2">How Did Stocktwits Users React?</h2>Retail sentiment on Stocktwits around&nbsp;<a href="https://stocktwits.com/symbol/ESPR">Esperion</a> trended in the ‘extremely bullish’ territory despite the mixed fourth-quarter (Q4) performance. Message volumes were at ‘extremely high’ levels at the time of writing.One bullish user stated that the ESPR stock appears way undervalued.<stembedurl>https://stocktwits.com/DP000/message/647094104</stembedurl>Another user stated that Esperion has massive catalysts coming up.<stembedurl>https://stocktwits.com/BRLondon/message/647092901</stembedurl><h2 class="st-heading-2">Esperion Highlights Upcoming Catalysts</h2>Esperion stated that it is investing in several clear catalysts for future growth. These include deeper penetration in the U.S. market supported by strong payer coverage, as well as progress on its oral triple-combination program designed to compete with products currently on the market or in development.The firm also added that it plans to expand geographically through continued collaboration with its global partners.“We are entering 2026 with confidence, discipline, and a long-term mindset focused on creating lasting value for patients, providers, and shareholders,” Koenig added.The company said that it aims to pursue new therapeutic opportunities and develop next-generation inhibitors targeting multiple life-threatening diseases.ACLY is a metabolic enzyme involved in breaking down nutrients and producing cholesterol and fatty acids, making it a potential target for treating a range of diseases.<h2 class="st-heading-2">Koenig Says Corstasis Deal Advances Vision 2040</h2>During a post-earnings call with analysts, Koenig said that the planned acquisition of Cortasis Therapeutics advances the company’s Vision 2040.“The acquisition of Corstasis is a catalyst for additional long-term value and a testament to our commitment to building a larger and sustainably profitable company. Our priority is to grow these two franchises to their multi-billion-dollar potential,” he said.Esperion announced earlier this month that it had entered into an agreement to acquire Corstasis for an upfront payment of $75 million. Corstasis shareholders will also be eligible to receive an additional $180 million upon the attainment of certain regulatory and commercial milestones, as well as royalties on sales of Enbumyst and follow-on products.<a href="https://stocktwits.com/symbol/ESPR">ESPR stock</a> is down 21% year-to-date, but up more than 84% over the past 12 months.Also See:&nbsp;<a href="https://stocktwits.com/news-articles/markets/equity/novo-nordisk-hims-deal-turns-wall-street-bullish-hims-stock-upgrades/cZdos7IRI7d">Novo Nordisk-Hims Deal Turns Wall Street Bullish — BMO Sees Relief From Commercial Headwinds, BofA Upgrades HIMS Stock</a>For updates and corrections, email newsroom[at]stocktwits[dot]com.

In this photo illustration, the Esperion Therapeutics Inc. logo is displayed on the screen of a tablet. (Photo Illustration by Sheldon Cooper/SOPA Images/LightRocket via Getty Images)

ESPR Stock Falls After Esperion’s Mixed Q4 — Retail Remains Unfazed, Eyes ‘Massive’ Upcoming Catalysts

Esperion reported earnings per share of $0.22 on revenue of $168.5 million, while Wall Street expected an EPS of $0.28 on revenue of $164.7 million.

Equity

<ul class="summary-bullets"><li>For Q4, Arq reported total revenue of $29.4 million, reflecting an increase of 9%.</li><li>Arq said it has decided to pause GAC production to conduct a comprehensive engineering and production process optimization review.</li><li>The company said that Jay Voncannon will no longer serve as the Company’s Chief Financial Officer, effective immediately.</li></ul>Arq stock plunged 22% during extended hours of trading on Monday after it reported a larger fourth-quarter 2025 loss compared to the year-ago quarter.The company reported a net loss of $52.6 million in FY 2025, versus a net loss of $5.1 million in FY 2024. In Q4 2025, net loss came at $50.0 million, compared to a net loss of $1.3 million in Q4 2024.&nbsp;<h2 class="st-heading-2">Earnings</h2>Arq reported revenue totaling $29.4 million for the fourth quarter of 2025, reflecting an increase of 9% compared to $27.0 million in the prior year period. The increase was driven predominantly by enhanced volumes and pricing.Arq’s gross margin reduced to 13.6% for the fourth quarter of 2025, compared to 36.3% in the prior year period. The reduction in gross margin was driven by higher costs associated with GAC start-up.<h2 class="st-heading-2">GAC Strategy Updates</h2>Arq said it has decided to pause GAC production to conduct a comprehensive engineering and production process optimization review of the path forward for the company’s Granular Activated Carbon (GAC) for water, air, and industrial purification business.This decision comes after independent tests in late January 2026 revealed that the Arq’s existing thermal oxidizer can support only about 15 million pounds of GAC production per year and would need further modifications to reach the initial goal of 25 million pounds or more annually.In bid to transition away from using Corbin Wetcake for its GAC products, Arq is temporarily idling its Corbin facility and in connection recorded a non-cash impairment charge of $45 million in Q4 2025.<h2 class="st-heading-2">CFO Change</h2>The company said that Jay Voncannon will no longer serve as the company’s Chief Financial Officer, effective immediately.Stacia Hansen will serve as the company’s principal financial officer while continuing in her role as Chief Accounting Officer.&nbsp;<h2 class="st-heading-2">How Did Stocktwits Users React?</h2>Retail sentiment around ARQ trended in ‘bullish’ territory amid ‘high’ message volume.&nbsp;Shares in the company have fallen 29.3% year-to-date.For updates and corrections, email newsroom[at]stocktwits[dot]com.

Arq stock plunged 22% during extended hours of trading on Monday after it reported a larger fourth-quarter 2025 loss compared to the year-ago quarter.

Why Is ARQ Stock Plummeting?

The company reported Q4 2025 net loss of $50.0 million vs. net loss of $1.3 million in Q4 2024. 

<ul class="summary-bullets"><li>Rumble CEO said that the firm has reached an inflection point.</li><li>The company said its loss per share during the quarter was at $0.13, compared to $1.15 per share from the year-ago quarter.</li><li>The loss during the quarter marginally missed analyst estimates of loss of $0.1 per share.</li></ul>Rumble Inc.&nbsp;shares fell nearly 4% in extended hours of trading on Thursday after it reported a 10% decline in fourth-quarter (Q4) revenue compared to the year-ago quarter.&nbsp;Revenue for Q4 was $27.1 million, in line with analyst expectations, as per Fiscal.ai. The revenue was a decrease of 10% from $30.2 million reported in the second quarter of 2024.&nbsp;The decline was attributable to a decrease in Audience Monetization revenues and lower Other Initiatives revenues, the company said.&nbsp;"Rumble has reached an inflection point. The investments we made throughout 2025, in platform stability, creator monetization, short-form video, and our sales infrastructure, are beginning to bear fruit,” said Chris Pavlovski, Rumble's Chairman and CEO.&nbsp;&nbsp;<h2 class="st-heading-2">Results In Detail</h2>Net loss for the fourth quarter was $32.7 million compared to a loss of $236.8 million in the fourth quarter of 2024, principally attributable to a $184.7 million loss in the change in fair value of derivative expense related to Tether's strategic investment in Rumble.The company said its loss per share during the quarter was at $0.13, compared to&nbsp;a loss of&nbsp;$1.15 per share from the year-ago quarter. The loss during the quarter marginally missed analyst estimates of loss of $0.1 per share.The company said that during the fourth quarter, it secured a $100 million advertising commitment from Tether, structured as $50 million per year over two years beginning in Q1 2026. The efforts are designed to advance Rumble Wallet integration, expand creator monetization, and accelerate new advertising solutions on the platform.&nbsp;<h2 class="st-heading-2">How Did Stocktwits Users React?</h2>Retail sentiment around RUM stock trended in&nbsp;the ‘bullish’ territory amid ‘high’ message volume.&nbsp;One bullish user predicted that Rumble’s 2026 looks good.&nbsp;<stembedurl>https://stocktwits.com/FredettenWahoo/message/646743733</stembedurl>Another user said that they knew the results will be in line with estimates as the company has declared results early.&nbsp;<stembedurl>https://stocktwits.com/Prostar/message/646743582</stembedurl>Shares in the company have fallen 13.4% year-to-date.For updates and corrections, email newsroom[at]stocktwits[dot]com.

 In this photo illustration, a person holds a smartphone displaying the logo of Rumble Inc. 

Rumble Stock Is Diving After Hours – What Happened To Q4 Revenue?

The decline in Q4 revenue was attributable to a decrease in Audience Monetization revenues and lower Other Initiatives revenues. The revenue was in line with analyst expectations, per Fiscal.ai. 

<ul class="summary-bullets"><li>The company saw payment volumes go up by 10% year-over-year to $43.9 billion during the quarter.&nbsp;</li><li>BTIG analyst Andrew Harte said&nbsp;the firm&nbsp;sees&nbsp;an upside in PSFE shares over the next year from leverage reduction.&nbsp;</li><li>BTIG kept a ‘Buy’ rating on the shares.&nbsp;</li></ul>Paysafe stock rallied 22% on Tuesday after it reported&nbsp;an increase&nbsp;in quarterly revenues, prompting financial services firm BTIG to see an uptick in the company's shares over the next year.&nbsp;The company posted&nbsp;a 4% rise&nbsp;in Q4 revenue of $438.4 million,&nbsp;amid an uptick in payment volume, compared to $420.1 million from the year-ago period.<h2 class="st-heading-2">Q4 Snapshot</h2>The company saw payment volumes go up by 10% year-over-year to $43.9 billion during the quarter.&nbsp;Paysafe (PSFE) said that adjusted net income fell to $25.5 million or $0.46 per diluted share versus $29.5 million or $0.48 per share.&nbsp;"Paysafe’s fourth quarter results are consistent with what we outlined in November, and the full year of 2025 marks our third consecutive year of organic revenue growth,” said Bruce Lowthers, CEO of Paysafe.&nbsp;<h2 class="st-heading-2">Outlook For 2026</h2>The company said it sees 2026 revenue in the range of $1.79 billion&nbsp;to $1.83 billion, whose midpoint is in line with the consensus of $1.81 billion, as per data from&nbsp;Fiscal.ai. Paysafe sees 2026 adjusted EPS in the range of $2.12-$2.32. Analysts on average had expected profit of $2.29 per share.&nbsp;“In 2026, we are focused on creating outstanding experiences for both our customers and employees, while targeting higher revenue growth and double-digit adjusted earnings per share growth,” he added.&nbsp;<h2 class="st-heading-2">Analyst Take</h2>BTIG analyst Andrew Harte said&nbsp;the firm sees&nbsp;an upside in PSFE shares over the next year from leverage reduction.&nbsp;However, the analyst lowered the firm's price target on Paysafe to $10 from $11. BTIG kept a ‘Buy’ rating on the shares.&nbsp;The firm said the company's Q4 results were mixed as the Digital Wallet segment beat revenue expectations, while the Merchant Solutions segment missed. BTIG does not expect Paysafe to accelerate growth towards high-single-digit over the medium-term.&nbsp;<h2 class="st-heading-2">How Did Stocktwits Users React?</h2>Retail sentiment on <a href="https://stocktwits.com/symbol/PSFE">PSFE stock</a> trended in&nbsp;the ‘extremely bullish’ territory amid ‘extremely high’ message volume.&nbsp;Shares in the company have fallen 63% over the past year.&nbsp;For updates and corrections, email newsroom[at]stocktwits[dot]com.

Paysafe sees 2026 revenue in the range of $1.79 billion to $1.83 billion, whose midpoint is in line with the consensus of $1.81 billion, as per data from Fiscal.ai.

Paysafe Rallies As BTIG Sees Upside In Stock Over The Next Year

The company posted Q4 revenue of $438.4 million compared to $420.1 million from the year-ago period. 

<ul class="summary-bullets"><li>The company's total revenue was helped by growth in network services whose revenue represented 19% year-over-year growth. Security revenue showed 32% year-over-year growth.&nbsp;</li><li>Fastly also swung to profit in the fourth quarter compared to the year-ago.</li><li>Fastly said it expects total revenue in the range of $168 million to $174 million for the first quarter of 2026. Analysts expected Q1 2026 revenue of $159.6 million, as per fiscal.ai.&nbsp;</li></ul>Fastly (<a href="https://stocktwits.com/symbol/FSLY">FSLY</a>) shares soared 25% in extended hours of trading on Wednesday after its record fourth-quarter revenue beat estimates.&nbsp;The rally in the stock turned investors bullish on the stock with predictions of the stock to rise 100% by the end of Feb.&nbsp;<a href="https://stocktwits.com/BullyingTheBearss/message/644734186">https://stocktwits.com/BullyingTheBearss/message/644734186</a>The company posted a fourth quarter revenue of $172.6 million that grew 23% year over year. Analysts on average expected revenue of $161.4 million as per data from fiscal.ai.&nbsp;"Our fourth quarter results mark an inflection in Fastly’s growth as we achieved record revenue, gross margin, and operating profit,” said Kip Compton, CEO of Fastly. “In 2025 we made significant progress on Fastly’s transformation and delivered great results.”<h2 class="st-heading-2">Q4 Snapshot</h2>The company's total revenue was helped by growth in network services whose revenue represented 19% year-over-year growth. Security revenue showed 32% year-over-year growth.&nbsp;The company also swung to profit in the fourth quarter compared to the year-ago. It reported adjusted net income per diluted share of $0.12, compared to adjusted net loss per diluted share of $0.02 in the fourth quarter of 2024.The company said it generated $22.4 million of operating cash flow compared to $5.2 million of operating cash flow in the fourth quarter of 2024.&nbsp;<h2 class="st-heading-2">Outlook</h2>Fastly said it expects total revenue in the range of $168 million to $174 million for the first quarter of 2026. Analysts expected Q1 2026 revenue of $159.6 million, as per fiscal.ai.&nbsp;It said its full year-revenue is expected to be in the range of $700 million to $720 million. The higher end of the FY2026 forecast shows 15% growth in full year revenue compared to $624 million it reported for FY2025.&nbsp;It also said it expects adjusted profit to be in the range of $0.07 per share to $0.10 per share for Q1 2026. Analysts on average expected adjusted profit to be $0.01 per share.&nbsp;“As we look toward 2026, we anticipate continued momentum, with AI as an increasing tailwind for our business,” Compton added.&nbsp;<h2 class="st-heading-2">How Did Stocktwits Users React?</h2>Retail sentiment around FSLY trended in ‘bullish’ territory amid ‘high’ message volume.&nbsp;One user, however, said that Fastly’s earnings did not impress them, except for free cash flow and profitability.&nbsp;<stembedurl>https://stocktwits.com/starwarsjunkie7/message/644734123</stembedurl>Shares in the company have risen 17% over the past year.&nbsp;Read More: <a href="https://stocktwits.com/news-articles/markets/cryptocurrency/crypto-token-uni-rises-how-did-blackrock-drive-the-rally/cZb6jCHR4Ad">Crypto Token UNI Jumps 14% - How Did BlackRock Drive The Rally?</a>For updates and corrections, email newsroom[at]stocktwits[dot]com.

Employees work at Fastly's office in San Francisco on Friday, July 20, 2018. 

Why Is Retail Seeing 100% Jump In Fastly’s Stock By Month-End?

The company posted a fourth quarter revenue of $172.6 million that grew 23% year over year. Analysts on average expected revenue of $161.4 million as per data from fiscal.ai. 

<ul class="summary-bullets"><li>The FDA’s concerns were limited to packaging, labeling, and administration issues, the company said.</li><li>Aquestive has already modified the pouch design, updated instructions for use, and revised labelling.</li><li>The firm is also targeting global expansion plans for Anaphylm after initiating regulatory discussions in Canada, Europe, and the U.K last year.</li></ul>Shares of Aquestive Therapeutics (AQST) surged more than 35% on Monday morning, after receiving a Complete Response Letter (CRL) from the U.S. Food and Drug Administration (FDA) for its New Drug Application (NDA) seeking approval of Anaphylm, a sublingual film to treat severe Type I allergic reactions.A CRL indicates that while a drug has not been approved in its current form, it allows the sponsor to address the issues raised by the FDA and seek re-approval.<h2 class="st-heading-2">FDA’s Concerns</h2>The FDA’s concerns were limited to packaging, labeling, and administration issues identified in a human factors validation study. The FDA noted that some users had difficulty opening the pouch and correctly placing the film, which could pose safety risks during emergency situations. The agency did not raise questions about the drug’s comparability data or manufacturing processes, the company said.To address the feedback, Aquestive has modified the pouch design, updated instructions for use, and revised labeling. The company plans to conduct a new human factors study alongside a single pharmacokinetics (PK) study requested by the FDA. No additional trials are required.Based on the initial review, Aquestive expects to resubmit the application as early as the third quarter of 2026 and will seek a rapid review.<h2 class="st-heading-2">Europe Update</h2>Aquestive is also targeting global expansion plans for Anaphylm after initiating regulatory discussions in Canada, Europe, and the U.K. in 2025. The European Medicines Agency indicated that no additional clinical trials are required, with submissions in Europe and Canada expected in the second half of 2026. The company also anticipates feedback from the U.K.’s MHRA in the first quarter of 2026.<h2 class="st-heading-2">How Did Stocktwits Users React?</h2>Retail sentiment on Stocktwits turned ‘bullish’ from ‘neutral’ a session earlier, amid ‘high’ message volumes.&nbsp;<img src="https://news.stocktwits-cdn.com/AQST_jpg_c092cd62f6.webp" alt="AQST.jpg">One user brushed off concerns about the CRL, noting there were no key issues.<stembedurl>https://stocktwits.com/BigGainTom/message/643649716</stembedurl>While the stock has gained nearly 35% over the past year, its year-to-date losses are around 40%.Read also: <a href="https://stocktwits.com/news-articles/markets/equity/precious-metals-extend-historic-rout/cZbg8EJR4kf">Gold, Silver Continue To Decline – Analysts Warn Of Crowded Trades As Precious Metals Extend ‘Historic Rout’</a> For updates and corrections, email newsroom[at]stocktwits[dot]com.

A candlestick chart can be seen in a trading platform on a smartphone. Top U.S. firms announced record buybacks this year. (Photo by Silas Stein/picture alliance via Getty Images)

Why Did AQST Stock Jump 35% Today?

The company received a Complete Response Letter from the U.S. Food and Drug Administration for its New Drug Application seeking approval of Anaphylm, a sublingual film to treat severe Type I allergic reactions.

Should iShares Russell 2000 Value ETF (IWN) Be on Your Investing Radar?

<ul class="summary-bullets"><li>Anaphylm is Aquestive’s sublingual epinephrine film for allergic reactions.</li><li>The Anaphylm application is supported by 11 clinical studies involving 411 subjects, the company said.</li><li>Aquestive is working with the agency to better understand and address the issues ahead of the PDUFA date on January 31, it added.</li></ul>Shares of Aquestive Therapeutics (AQST) plunged 40% in pre-market trading on Friday after the company announced that it received a letter from the U.S. Food and Drug Administration (FDA) identifying deficiencies that currently prevent labeling discussions on Anaphylm.Anaphylm is Aquestive’s sublingual (under the tongue) epinephrine film for allergic reactions.However, the FDA also confirmed its review of the New Drug Application (NDA) remains ongoing, and no final decision has been made.Aquestive is working with the agency to better understand and address the issues ahead of the PDUFA (Prescription Drug User Fee Act) date on January 31, noting that delays in receiving details could impact the approval timeline. A PDUFA date is the FDA's target date to make a decision on a drug application.The Anaphylm application is supported by 11 clinical studies involving 411 subjects, demonstrating pharmacokinetics comparable to epinephrine auto-injectors and a similar safety profile, Aquestive added.“As part of its ongoing review of the Company’s NDA for Anaphylm, the FDA notified us that it had identified deficiencies in the NDA that preclude discussion of labeling and post-marketing commitments at this time. Although the notification did not specify the deficiencies, Aquestive is working to understand and resolve the concerns. The FDA stated that the notification does not reflect a final decision on the pending application and the FDA’s review remains ongoing,” said Dan Barber, President and Chief Executive Officer of Aquestive.<h2 class="st-heading-2">How Did Stocktwits Users React?</h2>Despite the strong intraday decline, retail sentiment on Stocktwits for <a href="https://stocktwits.com/symbol/AQST">AQST</a> turned 'extremely bullish' from 'bullish' a day earlier, amid 'extremely high' message volumes.&nbsp;<img src="https://news.stocktwits-cdn.com/AQST_jpg_2de986106b.webp" alt="AQST.jpg">Over the past year, the stock has gained 23%.For updates and corrections, email newsroom[at]stocktwits[dot]com.&nbsp;

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Why Did AQST Stock Plunge 40% In Pre-Market Today?

The company said the U.S. FDA identified deficiencies that prevent labeling discussions for a drug to treat allergic reactions.

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