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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 due to conflicting but significant news, with the successful unfolding of its large BlueBird 6 satellite marking a major technological de-risking, validating its direct-to-device capability. This positive development and the stock's inclusion in the MSCI World Index are being discussed alongside a proposed $1 billion convertible senior notes offering, prompting community debate over long-term growth versus immediate capital needs and potential dilution.

AppLovin Corp. engages in the development and operation of a mobile marketing platform. It offers AppDiscovery, MAX, Adjust, and SparkLabs. Its software-based platform caters to mobile application developers to improve the marketing and monetization of applications. The company was founded by Andrew Karam, John Krystynak, and Adam Foroughi in 2011 and is headquartered in Palo Alto, CA.

Applovin Corp - Ordinary Shares - Class A

Applovin Corp

Applovin is actively discussed following a double beat on recent earnings with impressive revenue growth and an expanding Axon AI engine, yet the community is perplexed by the initial negative price action amidst broader software sector jitters, despite a prior short-seller retraction that de-risked the stock.

Viking Therapeutics, Inc. is a clinical-stage biopharmaceutical company, which engages in the development of therapies for metabolic and endocrine disorders. The company was founded by Brian Lian and Michael A. Dinerman on September 24, 2012 and is headquartered in San Diego, CA.

Viking Therapeutics Inc

Oral VK2735 advancing to Phase 3 is driving conversation for Viking Therapeutics, with the community discussing this acceleration as a major validation and fueling speculation around potential partnerships or a buyout amidst positive broader market dynamics for legitimate GLP-1 players.

QuantumScape Corp. engages in developing next-generation solid-state lithium-metal batteries. The company’s next-generation batteries are designed to enable greater energy density, faster charging, and enhanced safety to support the transition away from legacy energy sources toward a lower-carbon future. The company was founded by Jagdeep Singh, Tim Holme, and Fritz B. Prinz in May 2010 and is headquartered in San Jose, CA.

QuantumScape Corp - Ordinary Shares - Class A

QuantumScape Corp

QuantumScape is trending amidst mixed investor reactions to its latest shareholder letter and Q4 earnings, which underscore ongoing cash burn and its pre-revenue status, fueling community frustration. Simultaneously, optimistic discussions revolve around the Eagle Line pilot production as a key step towards scalable solid-state battery commercialization through licensing and future OEM partnerships.

HubSpot, Inc. engages in cloud-based customer relationship management. Its platform includes marketing, sales, service, operations and content management system, as well as other tools, integrations and native payment solutions. It operates through the following geographical segments: Americas, Europe and Asia Pacific. The company was founded by Brian Patrick Halligan and Dharmesh Shah on April 4, 2005, and is headquartered in Cambridge, MA.

HubSpot Inc

HubSpot is trending after reporting strong earnings, raising its outlook, and announcing a $1 billion share repurchase program, yet the stock experienced a significant drop, fueling investor frustration and a community debate over whether "AI fears" are unfairly impacting SaaS valuations.

Fastly, Inc. provides real-time content delivery network services. It offers edge compute, edge delivery, edge security, edge applications like load balancing and image optimization, video on demand, and managed edge delivery. The company was founded by Artur Bergman, Tyler McMullen, Simon Wistow, and Gil Penchina in March 2011 and is headquartered in San Francisco, CA.

Fastly Inc - Ordinary Shares - Class A

Fastly Inc

Fastly is surging after reporting a substantial earnings beat and robust forward guidance, prompting community excitement about the company's turnaround and its positioning to benefit from increasing AI demand at the edge. Many are discussing a potential breakout and renewed growth for the stock, though some caution profit-taking after the significant price movement.

Cisco Systems, Inc. engages in the design, manufacture, and sale of Internet Protocol-based networking products and services related to the communications and information technology industry. The firm operates through the following geographical segments: the Americas, EMEA, and APJC. Its products include the following categories: Secure, Agile Networks, Internet for the Future, Collaboration, End-to-End Security, Optimized Application Experiences, and Other Products. The company was founded by Sandra Lerner and Leonard Bosack in 1984 and is headquartered in San Jose, CA.

Cisco Systems, Inc.

Cisco is trending following an earnings beat and raised guidance, fueled by robust demand for AI infrastructure, prompting community discussion around the stock nearing its dot-com era highs and its valuation in the current tech cycle.

Shopify, Inc. is a global commerce company that provides essential internet infrastructure for commerce, offering trusted tools to start, scale, market, and run a retail business of any size. The Company's software enables merchants to run their business across all of their sales channels, including web and mobile storefronts, physical retail locations, social media storefronts and marketplaces. The Shopify platform provides merchants with a single view of their business across all of their sales channels and enables them to manage products and inventory, process orders and payments, fulfill and ship orders, build customer relationships, source products, leverage analytics and reporting and access financing, all from one integrated back office. The company was founded on September 28, 2004 and is headquartered in Ottawa, Canada.

Shopify Inc - Ordinary Shares - Class A (Sub Voting)

Shopify Inc

Shopify is trending after reporting robust Q4 earnings, strong Q1 revenue guidance, and authorizing a $2 billion share buyback program. Despite initial pre-market optimism, the stock faced a sharp market open sell-off, prompting widespread community discussion around "manipulation" and creating a "buy the dip" opportunity for long-term growth and its AI commerce vision.

Salesforce, Inc. engages in the design and development of cloud-based enterprise software for customer relationship management. Its solutions include sales force automation, customer service and support, marketing automation, digital commerce, community management, collaboration, industry-specific solutions, and salesforce platform. The firm also provides guidance, support, training, and advisory services. The company was founded by Marc Russell Benioff and Parker Harris in 1999 and is headquartered in San Francisco, CA.

Salesforce Inc

Salesforce is trending due to its deep involvement in the broader software sector's intense sell-off, where market fears about AI disruption are driving widespread panic and pushing many SaaS stocks, including CRM, to multi-year lows. While a segment of the community views this as an illogical overreaction and a generational buying opportunity, emphasizing CRM's strong fundamentals and AI integration, the prevailing sentiment remains one of extreme caution.

Vanda Pharmaceuticals, Inc. engages in the development and commercialization of therapies for high unmet medical needs. The firm intends to treat schizophrenia, jet lag disorder, atopic dermatitis, central nervous system disorders, and circadian rhythm sleep disorder. Its product portfolio includes HETLIOZ, Fanapt, Tradipitant, Trichostatin, and AQW051. The company was founded by Mihael Hristos Polymeropoulos and Argeris N. Karabelas in 2002 and is headquartered in Washington, DC.

Vanda Pharmaceuticals Inc

Vanda Pharmaceuticals is trending due to its recent FDA approval of NEREUS for motion sickness and strong anticipation for the February PDUFA of Bysanti for bipolar I and schizophrenia. Despite a recent jet lag drug rejection, the community sees immense value in its Tradipitant program for GLP-1 induced nausea, driving significant buyout speculation and a belief the company is deeply undervalued.

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REGENXBIO Inc. (NASDAQ:RGNX) Given Average Recommendation of "Moderate Buy" by Brokerages

REGENXBIO Inc. (NASDAQ:RGNX - Get Free Report) has been assigned an average rating of "Moderate Buy" from the nine ratings firms that are presently covering the stock, MarketBeat Ratings reports. One...

<ul class="summary-bullets"><li>Clear Street kept a 'Buy' rating, cut its price target to $45 from $50, and said its core thesis remains intact.</li><li>The FDA said more evidence is needed to support approval of RGX-121 for Hunter syndrome.</li><li>Regenxbio plans a Type A meeting with the FDA and aims to resubmit the BLA with additional expert input and longer-term data.</li></ul>Shares of Regenxbio, Inc. plunged about 16% after hours on Monday after the FDA issued a Complete Response Letter (CRL) for its Hunter syndrome gene therapy. Still, Clear Street kept a 'Buy' rating and said its core thesis&nbsp;on RGNX&nbsp;remains intact.<h2 class="st-heading-2">Clear Street’s Take On RGNX</h2>Clear Street lowered its price target on Regenxbio to $45 from $50, implying over a 300% upside from the stock's last close.&nbsp;The firm said the FDA cited insufficient evidence of effectiveness for RGX-121, and pointed to the strength of existing data from RGX-202 in Duchenne muscular dystrophy (DMD), the clear unmet need in the market, early data from sura-vec in wet age-related macular degeneration.Clear Street also reiterated its conviction in Adeno-associated virus (AAV) gene therapy and Regenxbio’s ability to develop “best-in-class” AAV programs.<h2 class="st-heading-2">FDA Pushes Back Approval Of RGX-121</h2>On Monday, Regenxbio said the U.S. Food and Drug Administration (FDA)&nbsp;<a href="https://stocktwits.com/news-articles/markets/equity/why-did-rgnx-shares-plummet-after-hours-today/cZbxnumR4ot">issued</a> a CRL for its Biologics License Application (BLA) for RGX-121 to treat Hunter syndrome, also known as Mucopolysaccharidosis Type II (MPS II).The BLA had been accepted under the accelerated approval pathway in May 2025. In the CRL, the FDA said it agreed with the study protocol in principle but outlined reasons for not approving the application at this stage. These included uncertainty about study eligibility criteria for clearly defining patients with neuronopathic disease, questions about the comparability of the external natural history control, and whether the biomarker used in the study can reliably predict meaningful benefit for patients.The FDA also outlined potential paths forward, including a new study, treating additional patients with longer-term follow-up, or using an untreated control arm, all of which the company noted would be challenging in an ultra-rare disease such as MPS II.In January, the FDA placed clinical holds on RGX-121 and RGX-111 after identifying a single case of a central nervous system tumor in a participant treated with RGX-111.&nbsp;<h2 class="st-heading-2">Regenxbio Targets BLA Resubmission</h2>Regenxbio said it plans to request a Type A meeting with the FDA to discuss the CRL and a potential resubmission strategy. The company said it intends to provide additional evidence from global MPS II experts, further clarify the neuronopathic patient population, and include longer-term clinical data to support evidence of effectiveness, with the goal of resubmitting the BLA as quickly as possible.CEO Curran Simpson said the company remains confident in the quality and volume of evidence supporting RGX-121’s long-term potential and described the FDA’s decision as “devastating” for families affected by the disease.<h2 class="st-heading-2">How RGX-121 Works</h2>RGX-121 is a one-time gene therapy designed to deliver a functional copy of a missing gene directly to the brain, enabling the body to produce the required enzyme on an ongoing basis. The approval application was supported by lab results, patient function data, and safety findings from the Campsiite clinical trial program, with follow-up data extending to 12 months. The company has said the treatment has been well-tolerated by all patients to date.The program has received Orphan Drug, Rare Pediatric Disease, Fast Track, and Regenerative Medicine Advanced Therapy (RMAT) designations from the FDA, as well as Advanced Therapy Medicinal Products (ATMP) classification from the European Medicines Agency.<h2 class="st-heading-2">How Did Stocktwits Users React?</h2>On Stocktwits, retail sentiment for RGNX was ‘extremely bearish’ amid ‘extremely high’ message volume.<figure class="image"><img src="https://news.stocktwits-cdn.com/rgnx_ss_png_f43d854587.webp" alt="rgnx ss.png" width="982" height="165"><figcaption>RGNX sentiment and message volume as of February 9 | Source: Stocktwits</figcaption></figure>One user questioned, “My concern now is that RGX-202 for Duchenne also does not have a control arm,” noting that companies using natural history controls have faced FDA pushback even when initially agreed. They also pointed out that Sarepta’s Elevidys included a placebo arm.<stembedurl>https://stocktwits.com/cold_beef_cake/message/644518465</stembedurl>Another user said, “This one is done. They will need to dilute &amp; raise then meet FDA. Do whole new arm. Stock is dead in the water.”<stembedurl>https://stocktwits.com/Steve_TheBull_Rogers/message/644515963</stembedurl><a href="https://stocktwits.com/symbol/RGNX">RGNX stock</a> has risen 26% over the past 12 months.For updates and corrections, email newsroom[at]stocktwits[dot]com.

RGNX stock has risen 26% over the past 12 months. (Photo credit: Getty Images)

Regenxbio Stock Still Has Over 300% Upside Despite FDA Pushback On Hunter Syndrome Drug: Clear Street

Clear Street pointed to strength in RGX-202 data for Duchenne and early results from Sura-Vec in wet AMD.

Equity

<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.

REGENXBIO Announces Regulatory Update on RGX-121 BLA for MPS II

REGENXBIO Announces Regulatory Update on RGX-121 BLA for MPS II REGENXBIO Announces Regulatory Update on RGX-121 BLA for MPS II PR Newswire ROCKVILLE, Md., Feb. 9, 2026 FDA issues Complete Response...

RGNX Investors Have Opportunity to Join REGENXBIO Inc. Fraud Investigation with the Schall Law Firm

The Schall Law Firm, a national shareholder rights litigation firm, announces that it is investigating claims on behalf of investors of REGENXBIO Inc. (Regenxbio or the Company) (NASDAQ: RGNX) for...

REGENXBIO (NASDAQ:RGNX) Lowered to Sell Rating by Wall Street Zen

Wall Street Zen cut REGENXBIO from a "hold" rating to a "sell" rating in a report on Saturday...

Regenxbio (RGNX) Soars 5.4%: Is Further Upside Left in the Stock?

Regenxbio (RGNX) was a big mover last session on higher-than-average trading volume. The latest trend in earnings estimate revisions might not help the stock continue moving higher in the near term.

INVESTOR ALERT: Pomerantz Law Firm Investigates Claims On Behalf of Investors of REGENXBIO Inc. - RGNX

INVESTOR ALERT: Pomerantz Law Firm Investigates Claims On Behalf of Investors of REGENXBIO Inc. - RGNX INVESTOR ALERT: Pomerantz Law Firm Investigates Claims On Behalf of Investors of REGENXBIO Inc...

Investigation into Regenxbio: Questions Arise Over Disclosure Completeness Prior to FDA Action

Investigation into Regenxbio: Questions Arise Over Disclosure Completeness Prior to FDA Action Investigation into Regenxbio: Questions Arise Over Disclosure Completeness Prior to FDA Action PR...

REGENXBIO (NASDAQ:RGNX) Trading 6.2% Higher - Here's Why

REGENXBIO (NASDAQ:RGNX) Shares Up 6.2% - Still a Buy...

REGENXBIO, Inc. is a clinical-stage biotechnology company, which engages in the development, commercialization, and licensing of recombinant adeno-associated virus gene therapy. Its product candidates include the NAV Technology Platform, which consists of exclusive rights to novel adeno-associated viral vectors, and therapeutic programs such as RGX-314, RGX-202, RGX-121, RGX-111, RGX-181, and RGX-381. The company was founded by Kenneth T. Mills and James M. Wilson on July 16, 2008 and is headquartered in Rockville, MD.

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