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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

Apple is trending as investors aggressively position themselves ahead of the upcoming earnings release and a highly anticipated leadership transition, with active debate regarding the company's AI strategy and potential impact on service revenue. Market participants are closely monitoring options flow and institutional sentiment for signs of a breakout, while the community remains divided over whether current valuations account for long-term growth expectations.

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

Sandisk Corp

Sandisk is facing intense volatility as the market digests a massive earnings beat and upward guidance, with community members fiercely debating whether this represents a sustainable structural cycle or a priced-in "sell the news" event. Traders are intensely focused on the company's aggressive data center demand and share buyback strategy, while skeptics warn of potential valuation risks and potential volatility following the recent parabolic rally.

Reddit, Inc. operates an entertainment, social networking, and news website where registered community members can submit content. The firm provides online news services where users can select and rank web content. It also offers a personalized filter on the day's story, using previous votes to determine what new things the user might like to read. The company was founded by Steven Ladd Huffman and Alexis Ohanian on June 23, 2005 and is headquartered in San Francisco, CA.

Reddit Inc. - Ordinary Shares - Class A

Reddit Inc

Reddit Inc is experiencing intense community focus ahead of its quarterly earnings, with investors debating whether the stock's recent volatility is a setup for a breakout or a signal of further downside. The community is heavily split between bulls highlighting robust advertising growth and AI data tailwinds, and skeptics who are bracing for a potential post-earnings sell-off.

Akanda Corp. is a cannabis cultivation, manufacturing, and distribution company, which engages in the provision of premium quality and ethically sourced medical cannabis products to patients. The company cultivates and processes natural cannabis at facilities in the Kingdom of Lesotho, Africa and intend to supply medicinal-grade cannabis biomass, cannabis flower, and cannabis concentrates to wholesalers. It also imports and sells medical cannabis-based products. The company was founded on July 16, 2021 and is headquartered in New Romney, the United Kingdom.

Akanda Corp

Akanda Corp is experiencing a parabolic short squeeze driven by an extremely low float and an exceptionally high cost-to-borrow, leading community members to compare it to previous major market runners. Traders are actively debating whether to hold for triple-digit targets or rotate profits into other low-float opportunities, all while closely monitoring the stock for potential dilution risks or abrupt trend reversals.

Rivian Automotive, Inc. engages in the design, development, and manufacture of category-defining electric vehicles and accessories. It operates through following segments: Automotive, Software and Services. The company was founded by Robert J. Scaringe in June 2009 and is headquartered in Irvine, CA.

Rivian Automotive Inc - Ordinary Shares - Class A

Rivian Automotive Inc

Rivian is generating significant investor interest following the start of R2 production at its Illinois plant, a key milestone in the company's transition toward a broader mass-market audience. The community is actively debating the stock's potential for a breakout, weighing the positive production news and upcoming earnings report against concerns over executive compensation and long-term cash burn.

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 market participants react to ongoing child safety concerns and high volatility surrounding its growth trajectory. While some investors argue that the stock's valuation is depressed and see potential for a rebound, many in the community remain deeply skeptical, expressing concerns about persistent financial losses and the platform's long-term sustainability.

Zeta Global Holdings Corp. operates as a marketing technology software company, which engages in the provision of enterprises with consumer intelligence and marketing automation software. It enables its customers to target, connect and engage consumers through software that delivers marketing across all addressable channels, including email, social media, web chat, connected TV and video among others. The company was founded by David A. Steinberg and John Sculley on May 9, 2012 and is headquartered in New York, NY.

Zeta Global Holdings Corp - Ordinary Shares - Class A

Zeta Global Holdings Corp

Zeta Global Holdings is trending as community members aggressively debate whether to capitalize on the stock's recent price pullback, with many pointing to a streak of consistent earnings beats and raised guidance as evidence of structural strength. Investors are closely monitoring the impact of the company's 'Athena' AI platform and the potential for a rebound, viewing the current market weakness as a buying opportunity for a long-term winner.

Atlassian Corp. is a holding company, which engages in providing team collaboration and productivity software. Its products include Jira Software, Confluence, Jira Service Management, and Loom. The company was founded by Michael Cannon-Brookes and Scott Farquhar in October 2002 and is headquartered in San Francisco, CA.

Atlassian Corporation - Ordinary Shares - Class A

Atlassian Corporation Plc

Atlassian is experiencing intense volatility and downward pressure as market sentiment shifts against the SaaS sector amid fears that AI agents may disrupt established enterprise workflows. While bearish investors are aggressively shorting the stock, citing valuation concerns and potential AI displacement, bullish participants view the current price levels as an oversold buying opportunity, highlighting the company's entrenched market position and high customer switching costs.

Micron Technology, Inc. engages in the provision of innovative memory and storage solutions. It operates through the following segments: Compute and Networking Business Unit (CNBU), Mobile Business Unit (MBU), Embedded Business Unit (EBU), and Storage Business Unit (SBU). The CNBU segment includes memory products and solutions sold into client, cloud server, enterprise, graphics, and networking markets. The MBU segment is involved in memory and storage products sold into smartphone and other mobile-device markets. The EBU segment focuses on memory and storage products sold into automotive, industrial, and consumer Markets. The SBU segment consists of SSDs and component-level solutions sold into enterprise and cloud, client, and consumer storage markets. The company was founded by Ward D. Parkinson, Joseph Leon Parkinson, Dennis Wilson, and Doug Pitman on October 5, 1978 and is headquartered in Boise, ID.

Micron Technology Inc.

Micron Technology Inc

Micron Technology is trending as investors weigh significant ongoing capital expenditure commitments from major tech hyperscalers against broader semiconductor sector volatility. The community remains focused on memory demand cycles and the potential for upward valuation adjustments as institutional sentiment remains heavily bullish.

Roku, Inc. engages in the provision of a streaming platform for television. It operates through the following segments: Platform and Devices. The Platform segment includes the sale of digital advertising and distribution of streaming services. The Devices segment is involved in the sale of streaming players, Roku-made televisions, smart home products and services, audio products, and related accessories. The company was founded by Anthony J. Wood in October 2002 and is headquartered in San Jose, CA.

Roku Inc - Ordinary Shares - Class A

Roku Inc

Roku shares are experiencing a significant rally following a robust quarterly report that beat estimates on both earnings and revenue, driven by strong growth in ad-supported streaming and premium subscription segments. Investors are actively discussing the companys path to sustained profitability, improved free cash flow, and potential long-term value as the streaming sector continues to consolidate.

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<ul class="summary-bullets"><li>While durable responses were observed in select patients through extended follow-up, the overall magnitude and consistency of activity were not sufficient to support continued development relative to other pipeline programs, it said.&nbsp;</li><li>However, the experimental therapy demonstrated a differentiated tolerability profile with fewer gastrointestinal, dermatologic, and subcutaneous adverse events as compared to other drugs belonging to its category.&nbsp;</li><li>The company also clarified that the decision to discontinue JANX008 is program-specific and part of its efforts to prioritize parts of its portfolio.</li></ul>Shares of Janux Therapeutics, Inc. (JANX) edged up 1% after hours after the company said on Monday that it will discontinue development of its experimental program called JANX008 to focus its resources on its remaining pipeline.The company said that it came to the decision after completing early-stage trials across multiple solid tumor indications and an internal review of the data. While durable responses were observed in select patients through extended follow-up, the overall magnitude and consistency of activity were not sufficient to support continued development relative to other pipeline programs, it said.However, the experimental therapy demonstrated a differentiated tolerability profile with fewer gastrointestinal, dermatologic, and subcutaneous adverse events as compared to other drugs belonging to its category, the company said. Overall safety profile also allows for outpatient dosing, the company noted.The company also clarified that the decision to discontinue JANX008 is program-specific and part of its efforts to prioritize parts of its portfolio.“Our decision to discontinue JANX008 reflects the disciplined approach we take to advancing our pipeline,” said David Campbell, Ph.D., President and Chief Executive Officer of Janux. “We evaluate each program against a high bar for safety, activity, and differentiated profile. We prioritize resources toward programs that meet these criteria and offer opportunities to deliver best-in-class outcomes.”Janux is currently also evaluating other experimental drugs for the treatment of prostate cancer as well as autoimmune diseases. Earlier this month, the company said that it dosed the first participant in an early-stage study of JANX014, one of its candidates for prostate cancer.<h2 class="st-heading-2">How Did Retail Traders React?</h2>On Stocktwits, retail sentiment around JANX fell from ‘neutral’ to ‘bearish’ territory over the past 24 hours, while message volume remained at ‘high’ levels.JANX stock has fallen 53% over the past 12 months.&nbsp;Read More: <a href="https://stocktwits.com/news-articles/markets/equity/crmd-stock-jumps-as-antifungal-drug-clears-key-trial-for-2-billion-preventive-market/cZBNx6bRePY">CRMD Stock Jumps As Antifungal Drug Clears Key Trial For $2B Preventive Market</a>For updates and corrections, email newsroom[at]stocktwits[dot]com.

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

JANX Stock Edges Up After Hours After Discontinuing Cancer Program In Favor Of Remaining Pipeline

The company said that it came to the decision after completing early-stage trials across multiple solid tumor indications and an internal review of the data.

Equity

<ul class="summary-bullets"><li>BTIG added that updated Phase 1 PK/PD data also suggest ORKA-001 could enable once-yearly maintenance dosing, which the firm believes would be a first for any monoclonal antibody.</li><li>The firm raised its price target for Oruka by 94%, to $151 from $78, and maintained a ‘Buy’ rating on the stock.</li><li>Analysts at Guggenheim also hiked their price target for Oruka to $200 from $125, while adding that the company now has the potential to reach a peak of $7 billion in global sales for the psoriasis therapy.</li></ul>Shares of Oruka Therapeutics Inc. (ORKA) were on track for their best single-day gains in more than a month after the company announced interim results from a trial of its moderate-to-severe plaque psoriasis therapy.Oruka Therapeutics announced that 40 of the 63 participants in the EVERLAST-A Phase 2a trial of ORKA-001, a novel, half-life-extended IL-23p19 monoclonal antibody, met the primary endpoint.<a href="https://stocktwits.com/symbol/ORKA">Oruka Therapeutics shares</a> were up more than 20% in Monday’s opening trade.<h2 class="st-heading-2">BTIG Turns Bullish On Oruka</h2>According to TheFly, analysts at BTIG turned bullish on Oruka Therapeutics following the company’s interim trial results. The firm raised its price target for Oruka by 94%, to $151 from $78, and maintained a ‘Buy’ rating on the stock.BTIG added that updated Phase 1 PK/PD data also suggest ORKA-001 could enable once-yearly maintenance dosing, which the firm believes would be a first for any monoclonal antibody.BTIG stated that ORKA-001 has strong potential to become the preferred IL-23 inhibitor if approved, citing best-in-class efficacy and roughly one-fourth the maintenance injection burden of AbbVie’s (ABBV) Skyrizi.Analysts at Guggenheim also hiked their price target for Oruka to $200 from $125, while keeping a ‘Buy’ rating on the stock. The firm believes ORKA-001 has multi-billion-dollar blockbuster potential, adding that Oruka now has the potential to reach a peak of $7 billion in global sales for the psoriasis therapy.<h2 class="st-heading-2">Oruka’s Findings In The Trial</h2>Oruka stated that 64% of the participants in the trial achieved complete skin clearance in the 16th week.The company stated that key secondary endpoints were also strong, with 83% reaching PASI 90 during this period.In the placebo group, one of 21 participants met these endpoints, which it said was consistent with historical psoriasis trials.Oruka stated that cross-trial comparisons suggest ORKA-001 delivers higher skin clearance rates than other IL-23p19 inhibitors and ranks among the best reported in plaque psoriasis across all treatment types.The company stated that it plans to release longer-term EVERLAST-A data in the second half of 2026, including Week 28 results for all patients, along with a 52-week follow-up for a subset. Oruka also added that it will continue to advance the Phase 2b EVERLAST-B trial, with data expected in 2027.PASI refers to the Psoriasis Area and Severity Index. It quantifies the severity and extent of psoriasis symptoms across body regions. PASI 90 refers to a 90% or more improvement. Similarly, PASI 100 denotes a 100% improvement over baseline.<h2 class="st-heading-2">How Did Retail Traders React?</h2>Retail sentiment on Stocktwits around&nbsp;<a href="https://stocktwits.com/symbol/ORKA">Oruka Therapeutics</a> trended in the ‘extremely bullish’ territory, with message volumes at ‘extremely high’ levels as of this writing.One bullish user believes ORKA stock could reach $200 per share soon.<stembedurl>https://stocktwits.com/Chiefstaff/message/651484000</stembedurl><a href="https://stocktwits.com/symbol/ORKA">ORKA stock</a> is up 172% year-to-date and 716% over the past 12 months. The S&amp;P Biotech ETF (XBI) is up 68% over the past 12 months, while the iShares Russell 2000 ETF (IWM) is up 42%.Also See:&nbsp;<a href="https://stocktwits.com/news-articles/markets/equity/microsoft-loses-exclusive-license-openai-models-taps-anthropic-claude/cZBNAqiRePg">Microsoft Loses Exclusive Access To OpenAI Models In Partnership Reset Ahead Of Q3 Earnings</a>For updates and corrections, email newsroom[at]stocktwits[dot]com.

“We are pleased to have settled our lawsuit with the United States Department of Justice,” the LYV said in a statement as its stock closed higher. 

ORKA Stock Is Soaring After Psoriasis Trial Results — Here's Why BTIG Hiked Its Price Target By 94%

Oruka Therapeutics stated that 64% of the participants in the Phase 2a EVERLAST-A trial of ORKA-001 met the study’s primary endpoint.

<ul class="summary-bullets"><li>The company stated that 62% of the patients in the trial who received lonvo-z were entirely free of HAE attacks during the six-month evaluation period, compared to 11% of patients who received placebo.</li><li>Lonvo-z is a one-time treatment administered in an outpatient setting.</li><li>Intellia Therapeutics also stated that it has initiated a rolling Biologics License Application submission to the U.S. Food and Drug Administration.</li></ul>Shares of Intellia Therapeutics Inc. (NTLA) soared in Monday’s pre-market trade after the company reported positive Phase 3 trial results in its therapy for a rare genetic condition.<a href="https://stocktwits.com/symbol/NTLA">Intellia Therapeutics shares</a> were up more than 9% before the bell on Monday, on track for the biggest gains in this month so far. NTLA was the top trending ticker on the platform at the time of writing.<h2 class="st-heading-2">Rare Genetic Condition Trial Meets All Endpoints</h2>Intellia Therapeutics stated that its Phase 3 trial of lonvoculin ziclumeran (lonvo-z) met the primary and secondary endpoints, with favorable safety and tolerability.The Cambridge, Massachusetts-based biopharmaceutical company evaluated lonvo-z for the treatment of hereditary angioedema (HAE), a rare genetic condition characterized by recurrent, sometimes life-threatening episodes of swelling (angioedema) in different parts of the body. This includes the face, upper airway, abdomen, and extremities due to bradykinin overproduction.The company designed lonvo-z as a one-time treatment that is administered in an outpatient setting. Lonvo-Z is an in vivo CRISPR gene-editing candidate designed to disable the kallikrein B1 (KLKB1) gene, aiming to permanently reduce kallikrein and bradykinin levels.“For those patients who have spent years battling unpredictable breakthrough swelling attacks, anxiety about their next attack or the many burdens associated with chronic prophylactic treatment, lonvo-z represents a potential paradigm shift in treatment,” said Intellia Therapeutics CEO John Leonard.The company stated that 62% of the patients in the trial who received lonvo-z were entirely free of HAE attacks during the six-month evaluation period, compared to 11% of patients who received a placebo.<h2 class="st-heading-2">Intellia Submits Application For FDA Approval</h2>Intellia Therapeutics also stated that it has initiated a rolling Biologics License Application (BLA) submission to the U.S. Food and Drug Administration (FDA) for approval.It is also preparing for a potential U.S. launch of lonvo-z in the first half of 2027.Intellia Therapeutics stated that it will present additional data at the 2026 European Academy of Allergy and Clinical Immunology Congress in June this year.The company said that one in 50,000 people is estimated to be affected by HAE.<h2 class="st-heading-2">How Did Retail Traders React?</h2>Retail sentiment on Stocktwits around&nbsp;<a href="https://stocktwits.com/symbol/NTLA">Intellia Therapeutics</a> trended in the ‘extremely bullish’ territory, with message volumes at ‘extremely high’ levels at the time of writing.One user stated that gene editing is the future.<stembedurl>https://stocktwits.com/2h2guard/message/651485761</stembedurl>Another bullish user recommended investing now before it is too late for the perfect buying opportunity.<stembedurl>https://stocktwits.com/JuniorStocka/message/651485649</stembedurl><a href="https://stocktwits.com/symbol/NTLA">NTLA stock</a> is up 52% year-to-date and 67% over the past 12 months. The ARK Innovation ETF (ARKK) is up 53% over the past 12 months, while the S&amp;P Biotech ETF (XBI) is up 65%.The iShares Russell 2000 ETF (IWM) is up 43% during this period, while the Vanguard Small-Cap Growth Index Fund ETF Shares (VBK) is up 36%.Also See:&nbsp;<a href="https://stocktwits.com/news-articles/markets/equity/qcom-stock-highest-level-3-months-wall-street-not-bullish-q2-earnings/cZBNZwBRe2M">QCOM Stock On Track To Open At Highest Levels In 3 Months, But Wall Street Is Cautious Ahead Of Q2 Earnings</a>For updates and corrections, email newsroom[at]stocktwits[dot]com.

Intellia Therapeutics, building exterior and company sign, Cambridge, Massachusetts, USA. (Photo by: Spencer Grant/GHI/UCG/Universal Images Group via Getty Images)

NTLA Jumps Premarket On Positive Late-Stage Trial Data For Gene-Editing Therapy — Retail Says Buy Now Before It’s Too Late

Intellia Therapeutics stated that its Phase 3 trial of lonvoguran ziclumeran met the primary and secondary endpoints, with favorable safety and tolerability.

<ul class="summary-bullets"><li>If data from a third-stage trial is supportive, the company expects to submit an application to the U.S. Food and Drug Administration (FDA) seeking approval for the therapy in the second half of 2026.&nbsp;</li><li>The company will announce the data on Monday.&nbsp;</li><li>In addition to lonvoguran ziclumeran, Intellia is also developing another therapy called Nexiguran Ziclumeran (Nex-z) for Transthyretin (ATTR) Amyloidosis.</li></ul>Shares of Intellia Therapeutics (NTLA) jumped 22% after hours on Friday after the company said that it will announce clinical data from the late-stage trial of its experimental therapy lonvoguran ziclumeran (lonvo-z) in hereditary angioedema (HAE) on Monday.Lonvo-z is designed to inactivate a gene in the liver, dramatically reducing or eliminating HAE attacks via a one-time treatment. Hereditary angioedema (HAE) is a rare, autosomal dominant genetic disorder causing recurrent, severe, non-itchy swelling in the limbs, face, intestinal tract, and airway.Intellia completed enrollment of 80 patients in the global study in September 2025, ahead of schedule. If data from the trial is supportive, the company expects to submit an application to the U.S. FDA seeking approval for the therapy in the second half of 2026, with a launch planned for the first half of 2027.In addition to lonvoguran ziclumeran, Intellia is also developing another therapy called Nexiguran Ziclumeran (Nex-z) for Transthyretin (ATTR) Amyloidosis. The U.S. Food and Drug Administration imposed a clinical hold on the company’s clinical trials in October after a patient experienced severe liver complications and subsequently died, but lifted the hold earlier this year, allowing the trials to proceed.<h2 class="st-heading-2">How Did Retail Traders React?</h2>On Stocktwits, retail sentiment around NTLA stayed within the ‘extremely bullish’ territory over the past 24 hours, while message volume rose from ‘high’ to ‘extremely high’ levels. &nbsp;A Stocktwits user highlighted that the data announcement is coming earlier than expected and wondered if the move signals confidence. In February, the company had pitched the data announcement for mid-2026.&nbsp; <stembedurl>https://www.stocktwits.com/Monkey7779192/message/651352863</stembedurl>Another user warned caution in light of the stock surge.<stembedurl>https://www.stocktwits.com/sister/message/651352429</stembedurl>A third user said that they have “a good feeling” about the upcoming readout.<stembedurl>https://www.stocktwits.com/Beyzade/message/651356875</stembedurl><a href="https://stocktwits.com/symbol/NTLA">NTLA stock </a>has gained 67% over the past 12 months.&nbsp;Read More: <a href="https://stocktwits.com/news-articles/markets/equity/ihrt-stock-soars-on-merger-talks-with-sirius-xm-report/cZBhkrJRecp">IHRT Stock Soars On Merger Talks With Sirius XM: Report</a>For updates and corrections, email newsroom[at]stocktwits[dot]com.

NTLA Stock Rockets After Hours Before Critical Data For Genetic Disorder Therapy 

Lonvo-z is designed to inactivate a gene in the liver, dramatically reducing or eliminating HAE attacks via a one-time treatment.

<ul class="summary-bullets"><li>FDA refused to approve Replimune’s melanoma drug RP1 for the second time earlier this month, citing insufficient data to provide “substantial evidence of effectiveness.”</li><li>Doctors also called for a change in leadership at the FDA over its decision not to approve Replimune’s RP1.&nbsp;</li><li>According to a report from Reuters, Health Secretary Robert F. Kennedy Jr. told a Senate hearing on Wednesday that he had little role in the FDA’s decision to reject RP1.</li></ul>Shares of Replimune (REPL) jumped 22% on Wednesday after doctors who treat melanoma expressed disappointment over the U.S. Food and Drug Administration’s rejection of the company’s experimental drug RP1.FDA refused to approve Replimune’s melanoma drug RP1 for the second time earlier this month, citing insufficient data to provide “substantial evidence of effectiveness” in the treatment of unresectable advanced cutaneous melanoma.Doctors, in an opinion piece <a class="st-link-external" target="_blank" rel="noopener noreferrer nofollow" href="https://www.wsj.com/opinion/fda-rp1-replimune-melanoma-drug-rfk-jr-vinay-prasad-marty-makary-b8d666b2?mod&amp;#61;Searchresults&amp;pos&amp;#61;1&amp;page&amp;#61;1">published</a> in The Wall Street Journal, criticized the FDA’s decision, noting that the initial panel that reviewed RP1 had recommended approval, which was later overruled by the then-FDA biologics chief, Vinay Prasad.The second team that reviewed the drug also did not say that the drug was ineffective, instead saying that it is “unclear whether the drug was effective,” the doctors said. Melanoma doctors organized and sent a letter to the FDA imploring it to approve RP1, they noted, while adding that they weren't asked by the pharma industry to do it.“Denying patients a life-saving medicine for inexplicable reasons is the wrong kind of change. If Dr. Makary doesn’t understand that, the FDA needs a change in leadership,” the doctors said.<h2 class="st-heading-2">Kennedy Distances Self</h2>According to a report from <a class="st-link-external" target="_blank" rel="noopener noreferrer nofollow" href="https://www.reuters.com/legal/litigation/us-health-secretary-kennedy-distances-himself-fdas-replimune-cancer-drug-2026-04-22/">Reuters</a>, Health Secretary Robert F. Kennedy Jr. told a Senate hearing on Wednesday that he had little role in the FDA’s decision to reject R1.He, instead, said that the decision was in the hands of FDA Commissioner Marty Makary."This decision comes out of FDA, and we trust ​the process there,” Kennedy reportedly said.<h2 class="st-heading-2">Replimune’s Efforts With RP1 Approval</h2>In late July 2025, the FDA had issued a complete response letter regarding the company’s application for RP1 in combination with Nivolumab for the treatment of advanced melanoma.The agency said in the letter then that it is unable to approve the application in its present form, and indicated that the trial conducted by the company for the drug is not considered to be an adequate and well-controlled clinical investigation that provides substantial evidence of effectiveness. It further urged that the company conduct and provide the results from a fresh trial for further consideration.Replimune subsequently resubmitted its application in October with additional information and analyses, but no additional trial.Earlier this month, the FDA said that the revised application does not alter its initial conclusion of the ineffectiveness of the trials conducted by the company. The agency also noted that the members of the team who reviewed the resubmission were different from those who reviewed the initial application to maintain objectivity.Replimune can either resubmit or withdraw its application within a year.<h2 class="st-heading-2">How Did Retail Traders React?</h2>On Stocktwits, retail sentiment around REPL stock stayed within the ‘bullish’ territory over the past 24 hours, while message volume stayed within ‘extremely low’ levels.A Stocktwits user opined that “REPL is done for the next two years” and added that the company needs a lifeline from another company.<stembedurl>https://www.stocktwits.com/CanaryMarketIntel/message/651056221</stembedurl>Another user reiterated confidence in the FDA’s decision to reject the drug.<stembedurl>https://www.stocktwits.com/PensionPulse/message/651038201</stembedurl>Another user, however, said that they are looking for 30X gains on REPL stock.<stembedurl>https://www.stocktwits.com/Rookie_investor/message/651040943</stembedurl><a href="https://stocktwits.com/symbol/REPL">REPL stock</a> has fallen 74% over the past 12 months.&nbsp;Read More: <a href="https://stocktwits.com/news-articles/markets/equity/ual-goes-silent-on-airline-merger-speculation-following-aal-snub/cZBBCayReb7">UAL Goes Silent On Airline Merger Speculation Following AAL Snub</a>For updates and corrections, email newsroom[at]stocktwits[dot]com.

Rising stock market chart on a trading board background.

REPL Ignites On Doctor Fury Against FDA’s Melanoma Drug Snub — Health Sec Steps Back

Doctors, in an opinion piece published on The Wall Street Journal, criticised the FDA’s decision, noting that the initial panel that reviewed RP1 recommended approval. 

Should You Invest in the State Street SPDR S&P Biotech ETF (XBI)?

<ul class="summary-bullets"><li>Last month, the company said that SLS009 blocks key survival pathways that normally shield acute myeloid leukemia cells from natural programmed cell death, making them more vulnerable.</li><li>Pharmacodynamic changes were observed in AML cells as early as eight hours after treatment and became more pronounced over time, the company noted.</li><li>Meanwhile, Sellas’s late-stage trial of its lead candidate GPS in Acute Myeloid Leukemia is advancing toward final analysis.</li></ul>Shares of Sellas Life Sciences Group Inc. (SLS) closed up 6% and edged up 2% after-hours on Friday, garnering heavy retail interest as investors anticipated upcoming data updates on its pipeline at the American Association for Cancer Research.According to Stocktwits platform data, retail chatter increased 36% over the past day, rising from ‘low’ to ‘normal’ levels.Sellas is slated to present preclinical data on its experimental cancer therapy SLS009 in a poster session at the conference which started on April 17 and is slated to go till April 22 at the San Diego Convention Center. Sellas will make its presentation on April 21.<h2 class="st-heading-2">Pipeline Optimism</h2>Last month, the company said that SLS009 blocks key survival pathways that normally shield acute myeloid leukemia (AML) cells from natural programmed cell death, making them more vulnerable. Pharmacodynamic changes were observed in AML cells as early as eight hours after treatment and became more pronounced over time, the company noted.“The ability to lower apoptotic threshold in AML cells by suppressing key survival pathways and enhancing potency with repeated exposure further supports the development of SLS009, including in combination regimens,” said Dragan Cicic, Chief Development Officer of SELLAS.Sellas’s lead candidate, GPS, meanwhile, is being evaluated for its potential as a monotherapy and in combination with other therapies to address a broad spectrum of blood malignancies and solid tumor indications.The company’s late-stage trial of GPS in Acute Myeloid Leukemia is advancing toward final analysis. The final analysis is slated for when the company records the 80th patient death in the trial. In December, the company announced that 72 events had been completed and it will announce when the 80th event occurs. With event-driven trials like Sellas’s, the delay highlights longer survival, indicating potential for the therapy.<h2 class="st-heading-2">How Did Retail Traders React?</h2>On Stocktwits, retail sentiment around SLS stock rose from ‘bearish’ to ‘neutral’ territory over the past 24 hours.A Stocktwits user said that the stock has two near-term catalysts in terms of the upcoming conference and update on the GPS program in AML.<stembedurl>https://www.stocktwits.com/55X_ROI_Q1_2026/message/650652881</stembedurl>Yet another sounded optimistic for the company’s pipeline, highlighting the many designations granted to Sellas’s experimental therapies.<stembedurl>https://www.stocktwits.com/gata2016/message/650649884</stembedurl><a href="https://stocktwits.com/symbol/SLS">SLS stock</a> has nearly quadrupled over the past 12 months.&nbsp;Read More: <a href="https://stocktwits.com/news-articles/markets/equity/cadl-stock-on-track-for-best-day-in-nearly-16-months-whats-driving-the-rally/cZJyGq6RIUn">CADL Stock On Track For Best Day In Nearly 16 Months — What’s Driving The Rally?</a>For updates and corrections, email newsroom[at]stocktwits[dot]com.

Last week, Baird maintained AYI’s ‘neutral’ rating but cut price target to $320 from $375. (Representative image: Getty Images)

SLS Stock Sparks Retail Buzz Ahead of AACR Presentation On Experimental Cancer Therapy

Sellas is slated to announce preclinical data on its experimental cancer therapy SLS009 in a poster session at the conference which started on April 17 and is slated to go till April 22 at the San Diego Convention Center.

<ul class="summary-bullets"><li>The company was looking for FDA’s greenlight for molgramostim in Autoimmune Pulmonary Alveolar Proteinosis.</li><li>The company had submitted certain responses to the FDA recently which the agency determined represents a major amendment to the application, the company explained.</li><li>Savara added that the agency did not cite any safety, efficacy, or manufacturing concerns in their correspondence.</li></ul>Shares of Savara Inc. (SVRA) slumped as much as 4% after-hours on Wednesday after the company said that the U.S. Food and Drug Administration has extended the review time of its application seeking approval for its experimental therapy molgramostim by three months.The company was looking for the FDA’s greenlight for molgramostim in Autoimmune Pulmonary Alveolar Proteinosis (Autoimmune PAP), a rare lung disease where autoantibodies block the clearing of surfactant in the lungs, causing a buildup that disrupts oxygen exchange, creating breathing difficulties, and chronic coughing.The agency is now slated to decide on the application by November 22, Savara said. The former deadline for a decision was August 22.<h2 class="st-heading-2">Why The Delay?</h2>The company had submitted certain responses to the FDA recently, which the agency determined represents a major amendment to the application, the company explained. The additional time will allow the agency time to review the extra materials submitted, it added.Savara added that the agency did not cite any safety, efficacy, or manufacturing concerns in its correspondence.Savara completed submission of its application to the FDA for molgramostim as a treatment for aPAP in March. It was granted priority review by the agency. &nbsp;According to Savara, molgramostim has the potential to be the first and only approved therapy for Autoimmune PAP.The company had previously submitted an application for the experimental therapy but received a “refuse to file” letter from the FDA in May 2025 due to insufficient Chemistry, Manufacturing, and Controls data. The company resubmitted the application, stating that Fujifilm Biotechnologies will manufacture the drug substance. &nbsp;<h2 class="st-heading-2">How Did Stocktwits Users React?</h2>On Stocktwits, retail sentiment around SVRA stock stayed within the ‘neutral’ territory over the past 24 hours, while message volume remained at ‘low’ levels.<a href="https://stocktwits.com/symbol/SVRA">SVRA stock</a> has more than doubled over the past 12 months.Read More: <a href="https://stocktwits.com/news-articles/markets/equity/tsla-stock-on-track-for-best-day-in-nearly-seven-months-ahead-of-q1-earnings/cZJtNmERIwY">TSLA Stock On Track For Best Day In Nearly 7 Months Ahead Of Q1 Earnings As Musk Hails AI5 Milestone</a>For updates and corrections, email newsroom[at]stocktwits[dot]com.

Global stock market chart and trading board - stock photo

SVRA Stock Slips Post-Market After FDA Delays Decision On Pulmonary Therapy

Savara Inc. (SVRA) was looking for FDA’s greenlight for molgramostim in Autoimmune Pulmonary Alveolar Proteinosis.

The agency is now slated to decide on the application by November 22, Savara said.


<ul class="summary-bullets"><li>Sana expects to seek the U.S. Food and Drug Administration’s clearance to start clinical trials and begin early stage trials for it as early as this year.&nbsp;</li><li>Sana on Monday said that Mayo purchased 7.5 million shares of the company’s common stock at a price of $3.33 per share for gross proceeds of about $25 million under the deal.</li><li>The purchase price under the agreement implies a potential upside of about 4% from the stock's closing price on Monday.</li></ul>Shares of Sana Biotechnology, Inc. (SANA) jumped 24% after-hours on Monday after the company announced a strategic collaboration with Mayo Clinic that involves an equity investment by the latter. &nbsp;The agreement is aimed at advancing the development of its investigational cell therapy SC451 for type 1 diabetes. The company expects to seek the U.S. Food and Drug Administration’s clearance to start clinical trials and begin early stage trials for it as early as this year.Sana’s SC451 is designed to support long-term glucose control without the need for ongoing insulin therapy in type 1 diabetes patients. The agreement with Mayo is aimed at accelerating development, validation, and standardization of protocols and processes for SC451, and supporting safe, scalable, and consistent delivery across diverse clinical environments.<h2 class="st-heading-2">Equity Investment in Sana Biotechnology by Mayo</h2>Sana on Monday said that Mayo purchased 7.5 million shares of the company’s common stock at a price of $3.33 per share for gross proceeds of about $25 million under the deal. It also noted that Mayo would have the option to make an additional equity investment of $25 million as part of the collaboration.The closing of the sale of the initial $25 million worth of shares is expected to occur on or about April 15, Sana said. &nbsp;The purchase price under the agreement implies a potential upside of about 4% from the stock's closing price on Monday and nearly 8% from the closing price on Friday.<h2 class="st-heading-2">Wall Street Take</h2>According to data from Koyfin, eight of the nine analysts covering SANA rate it ‘Buy’ or higher, while one rates it ‘Hold.’ The 12-month average price target on the stock is $8.43, representing a potential upside of about 163% from the stock’s last closing price.<h2 class="st-heading-2">How Did Retail Traders React?</h2>On Stocktwits, retail sentiment around SANA stock rose from ‘neutral’ to ‘bullish’ territory over the past 24 hours, while message volume increased from ‘low’ to ‘normal’ levels.<a href="https://stocktwits.com/symbol/SANA">SANA stock</a> has gained 77% over the past 12 months.&nbsp;Read More: <a href="https://stocktwits.com/news-articles/markets/equity/abde-stock-poised-for-best-rally-in-over-a-year-michael-burry/cZJ87RBRIuv">ABDE Stock Poised For Best Rally In Over A Year — What’s Michael Burry Got To Do With It?</a>For updates and corrections, email newsroom[at]stocktwits[dot]com.

SANA Stock Rallies 24% After Hours — How Much Is Mayo Clinic Investing In The Company?

Sana on Monday inked a strategic collaboration with Mayo Clinic aimed at advancing the development of its investigational cell therapy SC451 for type 1 diabetes.

<ul class="summary-bullets"><li>The FDA previously rejected approval for RP1 in July.&nbsp;</li><li>The agency noted that the members of the team who reviewed the resubmission were different from those who reviewed the initial application to maintain objectivity.</li><li>Replimune can either resubmit or withdraw its application within a year.</li></ul>Shares of Replimune Group Inc. (REPL) slumped 19% on Friday after the U.S. Food and Drug Administration refused approval for the company’s melanoma drug RP1.The agency <a class="st-link-external" target="_blank" rel="noopener noreferrer nofollow" href="https://download.open.fda.gov/crl/CRL_BLA125827_20260410.pdf">said</a> in a letter to the company that the data submitted by Replimune as part of its application seeking approval of the drug is “insufficient to conclude substantial evidence of effectiveness” in the treatment of unresectable advanced cutaneous melanoma.<h2 class="st-heading-2">Previous Rejection</h2>In late July 2025, the FDA had issued a complete response letter regarding the application for RP1 in combination with Nivolumab for the treatment of advanced melanoma.The agency said in the letter then that it is unable to approve the application in its present form, and indicated that the trial conducted by the company for the drug is not considered to be an adequate and well-controlled clinical investigation that provides substantial evidence of effectiveness. It further urged that the company conduct and provide the results from a fresh trial for further consideration.Replimune subsequently resubmitted its application in October with additional information and analyses but no additional trial.On Friday, the FDA said that the revised application does not alter its initial conclusion of the ineffectiveness of the trials conducted by the company. The agency also noted that the members of the team who reviewed the resubmission were different from those who reviewed the initial application to maintain objectivity.Replimune can either resubmit or withdraw its application within a year.<h2 class="st-heading-2">How Did Retail Traders React?</h2>On Stocktwits, retail sentiment around REPL stock stayed within the ‘extremely bearish’ territory over the past 24 hours, while message volume remained at ‘extremely high’ levels.A Stocktwits user said that a new trial will not be easy on the company.<stembedurl>https://www.stocktwits.com/counttrarian/message/649958198</stembedurl><a href="https://stocktwits.com/symbol/REPL">REPL stock</a> is down 31% over the past 12 months.&nbsp;Read More: <a href="https://stocktwits.com/news-articles/markets/equity/pltr-stock-trump-endorses-palantir-war-fighting-capabilities/cZJ008SRIt8">PLTR Stock Recovers After Trump’s Endorsement – US President Says Palantir Has Proven To Have ‘Great War Fighting Capabilities’</a>For updates and corrections, email newsroom[at]stocktwits[dot]com.

In the wake of OWL's redemption restrictions, Senator Elizabeth Warren called for tighter oversight of private credit.

REPL Stock Lost 19% Of Its Value Today – Why Did The FDA Refuse Approval For Its Experimental Melanoma Drug?

On Friday, the FDA said that the revised application does not alter its initial conclusion of the ineffectiveness of the trials conducted by Replimune.

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