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Mawson Infrastructure Group, Inc. engages in the provision of digital asset infrastructure services. The company was founded on February 10, 2012 and is headquartered in Midland, PA.

Mawson Infrastructure Group Inc

MIGI is trending due to its potential for a short squeeze, fueled by a low float and high short interest, as well as its upcoming presentation at an emerging growth conference. Community members are actively discussing the company's shift towards AI and digital infrastructure, viewing it as undervalued compared to its peers, and anticipating potential catalysts from the conference. The stock's volatile price action and history of explosive moves are also contributing to the heightened interest.

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

Oracle Corp.

Oracle is trending due to a mixed earnings report, with concerns arising from increased spending on AI infrastructure and rising debt despite strong cloud growth and a large backlog. Community discussions revolve around whether Oracle can effectively monetize its AI investments, with some questioning the long-term viability of its strategy, while others see a buying opportunity amid the selloff. The broader market is reacting, with some fearing a potential AI bubble burst.

AXIL Brands, Inc. engages in the manufacture, market, sale and distribution of hearing and audio enhancement, and protection products. It operates through the Hearing Enhancement and Protection, and Hair Care and Skin Care segments. The Hearing Enhancement and Protection segment includes ear buds, earmuffs, ear plugs, outdoor speakers, and ear care items. The Hair Care and Skin Care segment focuses on expanding its business-to-business salon sales through its network of domestic and international distributors. The company was founded on May 21, 2015 and is headquartered in Beverly Hills, CA.

AXIL Brands Inc.

AXIL Brands is trending following news of a national retail distribution agreement with Walmart, causing significant premarket gains. The community is actively discussing potential price targets and whether the stock can sustain its momentum, while also considering potential resistance levels. This development marks AXIL's largest retail placement, expanding access to its hearing protection products.

Rezolute, Inc. operates as a biopharmaceutical company, which engages in the development of drug therapies for patients with metabolic and orphan diseases. The firm's antibody therapy, ersodetug, is designed to treat all forms of hyperinsulinism. The company was founded by Nevan Charles Elam, Ho Young Huh, and Sankaram Mantripragada in March 2010 and is headquartered in Redwood City, CA.

Rezolute Inc

Rezolute Inc is trending downwards following the announcement of failed phase 3 trials, leading to a significant drop in stock price and triggering disappointment among investors who had anticipated positive data. The community is discussing the potential reasons for the data miss, possible future actions for the company given its cash reserves, and whether a rebound is possible, while some traders are exploring potential shorting opportunities or bottom-fishing strategies.

iRobot Corp. is a robot company, which engages in designing and building robots. The firm's products include robot vacuums and maps, and pool cleaners. It operates through Domestic and International geographical segments. The company was founded by Rodney Allen Brooks, Colin M. Angle, and Helen Greiner in August 1990 and is headquartered in Bedford, MA.

Irobot Corp

iRobot Corp

IRBT is trending as traders discuss a potential short squeeze, citing very high short interest and recent price movement. Community members are pointing to the difficulty in borrowing shares and high borrowing fees as further indicators of a possible squeeze. Some are expressing caution, noting the company's fundamentals and potential for a bull trap.

Sarepta Therapeutics, Inc. is a commercial-stage biopharmaceutical company, which is engaged in the discovery and development of therapeutics for the treatment of rare diseases. The company was founded on July 22, 1980, and is headquartered in Cambridge, MA.

Sarepta Therapeutics Inc

Sarepta Therapeutics is trending amid discussions about a potential buyout and the company's recent progress in its DM1 clinical study. Community members are debating the stock's valuation, upcoming milestones, and the potential impact of competitor data, while also analyzing recent analyst ratings and institutional ownership.

PayPal Holdings, Inc. engages in the development of technology platforms that enable digital payments and simplifies commerce experiences on behalf of merchants and consumers worldwide. Its solutions include PayPal, PayPal Credit, Braintree, Venmo, Xoom, and Paydiant products. The firm also enables consumers to exchange funds with merchants using funding sources, which include bank account, PayPal account balance, PayPal Credit account, credit, and debit card or other stored value products. It operates through United States and Other Countries geographical segments. The company was founded in December 1998 and is headquartered in San Jose, CA.

PayPal Holdings Inc

PayPal is trending downwards amidst analyst downgrades, most recently from BofA and JP Morgan, with concerns stemming from slowing growth in branded checkout and a perceived lack of management confidence. The community is debating the impact of buybacks, the CEO's performance, and whether the stock is undervalued or a value trap. Some traders express frustration, while others see an opportunity for long-term gains if PayPal can turn things around.

Beasley Broadcast Group, Inc. is multi-platform media company, which engages in the operation of radio stations in the United States. The firm offers marketing solutions across event platforms. It operates through the following business segments: Audio, Digital, and Other. The company was founded by George G. Beasley in 1961 and is headquartered in Naples, FL.

Beasley Broadcast Group Inc - Ordinary Shares - Class A

BBGI is trending due to a massive intraday price surge, fueled by its low float and significant volume, leading to discussions about potential short squeezes and comparisons to other recent high-flying stocks. The community is actively debating whether the run has ended or if there is potential for further gains, with some cautioning about bag holding and others anticipating after-hours momentum. Overall, traders are focused on the stock's volatile price action and potential for quick profits.

The Trade Desk, Inc. engages in the provision of a self-service and cloud-based ad-buying platform. It operates through the United States and International geographical segments. The firm offers omnichannel advertising, audience targeting, solutions for identity, application programming interface (API), custom, and programmatic, measurement and optimization. The company was founded by Jeffrey Terry Green and David Pickles in November 2009 and is headquartered in Ventura, CA.

Trade Desk Inc - Ordinary Shares - Class A

Trade Desk Inc

TTD is trending as it approaches new lows, sparking discussions about its future and potential S&P 500 exclusion. The community is debating factors like competition from Amazon, tax-loss harvesting, and the CEO's performance amid the stock's significant year-to-date decline. Some investors see a buying opportunity, while others express concerns about the company's ability to compete and innovate.

Carvana Co. is a holding company and an eCommerce platform, which engages in the buying and selling of used cars. The company was founded by Ernest Garcia, III, Benjamin Huston and Ryan Keeton in 2012 and is headquartered in Tempe, AZ.

Carvana Co. - Ordinary Shares - Class A

Carvana Co.

Carvana is trending as traders debate whether its S&P 500 inclusion justifies its high valuation, with some calling it a "scam" and others predicting further gains. Community discussions revolve around potential short squeezes, the influence of interest rate cuts, and concerns about the company's fundamentals versus market hype. Despite the debate, the stock's strong upward momentum has captured significant attention.

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<ul class="summary-bullets"><li>The company said that the fraud impacted the company’s financial statement in multiple ways and anticipates filing new financial statements shortly.</li><li>An executive said that the cost of the Lugano fraud will, by a wide margin, represent the most significant loss Cody has experienced since its inception.</li><li>Retail investors, analysts await restated financial statements.</li></ul>Shares of Compass Diversified (CODI) fell a steep 18% on Friday after the company announced it must restate its financial results for fiscal year 2022 to 2024 after its probe led to findings of fraud at its subsidiary Lugano.The company has removed financial information for the years 2022 to 2024 from its website, citing non-reliance.“I want to begin by saying that this has been, without question, the most challenging period in Cody's history,” CEO Elias Sabo said in a call. He further added that the fraud at Lugano was “pervasive, complex and isolated to that business.”<h2 class="st-heading-2">Probe And Findings</h2>Compass Diversified announced in early May that its audit committee has initiated an investigation into the financing, accounting, and inventory practices of Lugano. The subsidiary’s CEO Moti Ferder subsequently resigned from the company without any severance compensation.As per Sabo, Ferder and his family have fled the U.S. and permanently relocated to Israel. The audit committee probe has concluded and discovered “deliberate and systemic fraud,” he added.“The former Lugano CEO engaged in a scheme to significantly overstate Lugano's sales and profits, misrepresent the existence and value of Lugano's inventory, and keep potential financial liabilities off Lugano's books and records. His efforts to hide his fraud were extensive,” Sabo said. He added that Ferder created fake sales transactions to inflate Lugano’s reported revenues, claimed inventory that either didn't exist or didn’t belong to Lugano and entered numerous financing agreements with third parties that he kept off the company’s balance sheet.<h2 class="st-heading-2">Impact Of The Fraud</h2>CODI is a holding company that acquires and actively manages middle-market businesses. It acquired Lugano Diamonds &amp; Jewelry, Inc., a designer, manufacturer and marketer of one-of-a-kind jewelry in September 2021.The company said that the fraud impacted the company’s financial statement in multiple ways and anticipates filing new financial statements shortly. The company also intends to file its first, second, and third quarter 2025 financials over the coming weeks.“At a high level, the restatement significantly reduced our reported inventory. Consolidated inventory for 2024 was reduced by greater than $375 million, or nearly 40%...further, Lugano's revenue declined by more than 85% from previously reported levels following the removal of the fraudulent revenue,” a company executive said.Lugano filed for Chapter 11 protection under the U.S. Bankruptcy Code on November 16. “Regardless of what we ultimately recover from Lugano bankruptcy, the cost of the Lugano fraud will, by a wide margin, represent the most significant loss Cody has experienced since its inception,” the executive added.<h2 class="st-heading-2">Analyst Take</h2>According to William Blair, who has an ‘Outperform’ rating on the shares, Compass Diversified is worth at least $10 per share excluding Lugano. The firm said that it now awaits the restated financials.Blair's "back-of-the-envelope" estimate suggests Compass would need to raise about $500 million to reach its target leverage. Excluding Lugano, the company's 2025 subsidiary core profit results are tracking in line with expectations of mid-single-digit growth to $330 million-$360 million, the firm added.<h2 class="st-heading-2">How Did Stocktwits Users React?</h2>On Stocktwits, retail sentiment around Lugano jumped from ‘Neutral’ to ‘Bullish’ territory over the past 24 hours, while message volume stayed at ‘high’ levels.A Stocktwits user said that they will stick with the company for now and highlighted that the company’s other subsidiaries seem to be doing well and expressed anticipation for restated financials. &nbsp;<stembedurl>https://stocktwits.com/MplsBarry/message/638306243</stembedurl>Another slammed the company management for failing to identify the fraud at Lugano earlier.<stembedurl>https://stocktwits.com/SnapCrackleStop/message/638278242</stembedurl><a href="https://stocktwits.com/symbol/CODI">CODI stock</a> has dropped 74% this year.&nbsp;Also See: <a href="https://stocktwits.com/news-articles/markets/equity/new-york-times-sues-perplexity-ai-over-unauthorized-content-use-what-does-the-lawsuit-say/cLISBqyREko">New York Times Sues Perplexity AI Over Unauthorized Content Use: What Does The Lawsuit Say?</a>For updates and corrections, email newsroom[at]stocktwits[dot]com

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

Compass Diversified Stock Plunges On ‘Most Significant Loss’ After Fraud Forces Removal Of Three Years Of Financials

The company has removed financial information for the years 2022 to 2024 from its website, citing non-reliance. 

Equity

<ul class="summary-bullets"><li>Under the deal, Merck will buy Cidara for $221.50 per share in cash through a unit.</li><li>The purchase price represents a premium of about 109% from CDTX’s closing price on Thursday.</li></ul>Merck (MRK) said on Friday that it has entered into a definitive agreement to acquire Cidara Therapeutics (CDTX) for about $9.2 billion.Under the deal, Merck will buy Cidara for $221.50 per share in cash through a unit. The purchase price represents a premium of about 109% from CDTX’s closing price on Thursday. The <a class="st-link-external" target="_blank" rel="noopener noreferrer nofollow" href="https://www.merck.com/news/merck-to-acquire-cidara-therapeutics-inc-diversifying-its-portfolio-to-include-late-phase-antiviral-agent/">transaction</a> is expected to close in the first quarter of 2026, subject to the satisfaction of certain conditions.<h2 class="st-heading-2">What Does The Deal Bring For Merck?</h2>The takeover marks Merck’s latest move to fortify its drug portfolio before Keytruda, its $25 billion-per-year cancer therapy, loses patent protection in 2028. The company agreed in July to buy respiratory drug developer Verona Pharma for $10 billion as part of a broader effort to maintain revenue momentum.With the new deal, Merck would gain access to Cidara’s lead candidate CD388 designed to prevent influenza infection in individuals at higher risk of influenza complications. CD388 has been granted a breakthrough designation by the U.S. Food and Drug Administration, which could accelerate regulatory approval.The treatment is currently being evaluated in a late-stage trial among both adult and adolescent participants who are at higher risk of developing complications from influenza. The trial is expected to enroll 6000 participants by December, the company said earlier this month.“This acquisition expands and complements our respiratory portfolio and pipeline. Influenza continues to pose a significant global health threat, causing widespread illness, morbidity and death each year especially in older adults and immunocompromised individuals, such as those with cancer and chronic diseases,” said Dr. Dean Y. Li, President, Merck Research Laboratories.The deal has been approved by the board of directors of both companies, Merck said.<h2 class="st-heading-2">How Did Stocktwits Users React?</h2><a href="https://stocktwits.com/symbol/CDTX">CDTX shares</a> jumped 105% in the premarket session at the time of writing, while <a href="https://stocktwits.com/symbol/MRK">MRK shares</a> fell over 1%. On Stocktwits, retail sentiment around CDTX jumped from ‘bullish’ to ‘extremely bullish’ territory over the past 24 hours, while message volume rose from ‘normal’ to ‘extremely high’ levels.CDTX stock has nearly quadrupled in value this year, while MRK shares have fallen 7%.&nbsp;Also See: <a href="https://stocktwits.com/news-articles/markets/equity/avxl-shares-slump-pre-market-after-ema-committee-fails-to-recommend-approval-for-alzheimers-drug/cLPQ7tkRE4E">AVXL Shares Slump Pre-Market After EMA Committee Fails To Recommend Approval For Alzheimer’s Drug</a>For updates and corrections, email newsroom[at]stocktwits[dot]com

In this photo illustration, the Cidara Therapeutics logo is seen displayed on a smartphone screen. (Photo Illustration by Thomas Fuller/SOPA Images/LightRocket via Getty Images)

Merck To Buy Cidara In $9.2B Deal To Strengthen Antiviral Portfolio

With the new deal, Merck would gain access to CD388, currently in late-stage development, and designed to prevent influenza infection in individuals at higher risk of influenza complications. 

<ul class="summary-bullets"><li>For Q3, Outset Medical’s adjusted net loss came in at $0.69 per share, higher than an estimated loss of $0.66 per share.</li><li>Several analysts subsequently slashed price targets on Tuesday.&nbsp;</li><li>RBC Capital lowered its price target on Outset Medical to $17 from $22 while keeping a ‘Sector Perform’ rating on the shares.</li></ul> Shares of Outset Medical, Inc. (OM) tumbled 47% as of Tuesday afternoon after multiple analysts slashed their price targets on the stock on the heels of disappointing earnings and lowered revenue guidance.On Monday, the company <a class="st-link-external" target="_blank" rel="noopener noreferrer nofollow" href="https://investors.outsetmedical.com/news-releases/news-release-details/outset-medical-reports-third-quarter-results">reported</a> third-quarter (Q3) net revenue of $29.4 million, representing a 3% year-over-year growth, but below the analyst estimate of $30.70 million, according to estimates compiled by Fiscal AI.Adjusted net loss came in at $0.69 per share, higher than an estimated loss of $0.66 per share. The medical technology company also lowered its full-year revenue outlook to $115 million to $120 million from a prior range of $122 million to $126 million, citing a delay in the closing of deals slated for the last quarter.<h2 class="st-heading-2">Analysts’ Take</h2>On Tuesday, several analysts lowered their price targets on the stock following the disappointing earnings report.RBC Capital lowered its price target on Outset Medical to $17 from $22 while keeping a ‘Sector Perform’ rating on the shares. TD Cowen analyst Joshua Jennings lowered the firm's price target on the stock to $15 from $25. Jennings, however, kept a ‘Buy’ rating on the shares.Meanwhile, Stifel lowered its target to $14 from $17 and kept a ‘Buy’ rating on the shares. According to the firm, the company’s strong pipeline might yield better performance ahead.<h2 class="st-heading-2">How Did Stocktwits Users React?</h2>On Stocktwits, retail sentiment around <a href="https://stocktwits.com/symbol/OM">OM stock</a> rose from ‘bullish’ to ‘extremely bullish’ territory over the past 24 hours while message volume increased from ‘normal’ to ‘extremely high’ levels.A Stocktwits user expressed optimism, saying that they don't see the growth story ending by one quarter's earnings.<stembedurl>https://stocktwits.com/MikeyNJ/message/635768529</stembedurl>Another termed the drop in share price an overreaction.<stembedurl>https://stocktwits.com/Aro92564/message/635738281</stembedurl>OM stock is down 62% this year and approximately 50% over the past 12 months.&nbsp;Also See: <a href="https://stocktwits.com/news-articles/markets/equity/byd-eyes-high-double-digit-sales-growth-overseas-in-2026-report/cLPdDupREPy">BYD Eyes High Double-Digit Sales Growth Overseas In 2026: Report</a>For updates and corrections, email newsroom[at]stocktwits[dot]com

Why Did Outset Medical Stock Tumble Today?

The medical technology company lowered its full-year revenue outlook to $115 million to $120 million from a prior range of $122 million to $126 million, citing a delay in the closing of deals slated for the last quarter.

TG Therapeutics, Inc. (TGTX) on Monday raised the full-year revenue guidance for its multiple sclerosis drug, Briumvi, to reflect strong market demand.The company now <a class="st-link-external" target="_blank" rel="noopener noreferrer nofollow" href="https://ir.tgtherapeutics.com/news-releases/news-release-details/tg-therapeutics-reports-third-quarter-2025-financial-results-and">expects</a> full-year Briumvi U.S. net revenue to be approximately $585 million, up from its previous guidance of $570 million to $575 million. The company also subsequently raised its full-year overall revenue guidance to $600 million, up from its previous forecast of $585 million.<h2 class="st-heading-2">TG’s Blockbuster Drug</h2>Briumvi is a prescription medication used to treat adults with relapsing forms of multiple sclerosis (MS). Multiple sclerosis (MS) is an autoimmune disease where the immune system attacks the myelin sheath, the protective covering of nerve cells in the brain and spinal cord. This damage disrupts nerve signals, leading to a wide range of neurological symptoms, including numbness, vision problems, and difficulties with balance, coordination, and walking.“As we move through the fourth quarter, we remain focused on expanding patient awareness, advancing enrollment into our ongoing clinical trials, and driving growth and long-term value for our shareholders,” CEO Michael S. Weiss said on Monday.The company is currently undertaking two late-stage programs of Briumvi, evaluating subcutaneous and intravenous formulations of the drug.In the third quarter, the company reported total revenue of $161.7 million, of which Briumvi U.S. revenue accounted for about 95%. This also beat an analyst estimate of $152.17 million, according to data from Fiscal AI.Net income for the quarter came at $390.9 million, compared to $3.9 million in the corresponding quarter of 2024. The company ended the quarter with cash, cash equivalents, and investment securities of $178.3 million, which it expects to be sufficient to fund its business, when coupled with Briumvi revenues.<h2 class="st-heading-2">How Did Stocktwits Users React?</h2><a href="https://stocktwits.com/symbol/TGTX">Shares of TGTX</a> jumped 4% in the premarket session at the time of writing. On Stocktwits, retail sentiment around TGTX stayed within the ‘bullish’ territory over the past 24 hours, while message volume stayed within ‘high’ levels.TGTX stock is up 16% this year and approximately 43% over the past 12 months.&nbsp;Read also: <a href="https://stocktwits.com/news-articles/markets/equity/pfizer-files-second-lawsuit-against-metsera-novo-nordisk/cL2N3Z5R3zi">The Battle For Metsera Acquisition Heats Up As Pfizer Files A Second Lawsuit</a>For updates and corrections, email newsroom[at]stocktwits[dot]com.

Global stock market chart and trading board - stock photo

TG Therapeutics Stock Soars After Company Ups Guidance For Multiple Sclerosis Drug

The company now expects full-year Briumvi U.S. net revenue to be approximately $585 million, up from its previous guidance of $570 million to $575 million.

<ul class="summary-bullets"><li>Vafseo is currently indicated for the treatment of anemia due to chronic kidney disease in adults who have been receiving dialysis for at least three months.</li><li>The company said on Tuesday that it met with the U.S. Food and Drug Administration (FDA) but did not come to an agreement on a path forward for the design of a clinical trial in patients with late-stage chronic kidney disease not on dialysis.&nbsp;</li><li>Akebia believes regulatory alignment for such a trial would require a significantly larger number of patients than proposed. &nbsp;</li></ul>Shares of Akebia Therapeutics (AKBA) slumped 24% on Wednesday morning after the company said that it does not expect to pursue a broad label for Vafseo for the treatment of anemia in patients with late-stage chronic kidney disease not on dialysis.The company <a class="st-link-external" target="_blank" rel="noopener noreferrer nofollow" href="https://ir.akebia.com/news-releases/news-release-details/akebia-therapeutics-provides-update-vafseo-non-dialysis-patients">said</a> on Tuesday that it met with the U.S. Food and Drug Administration (FDA) but did not come to an agreement on a path forward for the design of a clinical trial for the use of the drug in the said patient population.While the company is yet to receive the final minutes of the meeting with the FDA, Akebia believes regulatory alignment for such a trial would require a significantly larger number of patients than proposed. This, in turn, would require “meaningfully more” time and cost to complete, and the company does not plan to initiate the trial, the company said.<h2 class="st-heading-2">What Did The CEO Say?</h2>CEO John P. Butler said that the company is “disappointed” in the meeting outcome.“We believe our decision not to pursue a broad NDD-CKD label, based on our discussion with the FDA, is in the best interests of our shareholders. We were encouraged by the discussion with FDA on smaller subgroups of CKD patients where we may be able to align on a potential clinical trial design and path forward,” he added.Vafseo is currently indicated for the treatment of anemia due to chronic kidney disease in adults who have been receiving dialysis for at least three months. In the second quarter ended June, the company reported Vafseo net product revenue of $13.3 million after nephrologists began prescribing it in January.<h2 class="st-heading-2">How Did Stocktwits Users React?</h2>On Stocktwits, retail sentiment around <a href="https://stocktwits.com/symbol/AKBA">AKBA stock</a> jumped from ‘bullish’ to ‘extremely bullish’ territory over the past 24 hours, while message volume remained at ‘high’ levels.A Stocktwits user expressed optimism for the stock, saying the FDA did not shut the door on the trial in its entirety.<stembedurl>https://stocktwits.com/JonahTheTrader/message/634144578</stembedurl>Another highlighted that the company’s product is already on the market, and it has good financials.<stembedurl>https://stocktwits.com/Popeye989/message/634137009</stembedurl>AKBA stock is up by 23% this year and by 37% over the past 12 months.&nbsp;Read also: <a href="https://stocktwits.com/news-articles/markets/equity/purple-biotech-shares-soar-on-breakthrough-for-experimental-cancer-drug/cLGZ8OAR3wS">Purple Biotech Shares Soar 92% On Breakthrough For Experimental Cancer Drug</a>For updates and corrections, email newsroom[at]stocktwits[dot]com.

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

Akebia Therapeutics Stock Slumps After FDA Meeting Ends Without Path Forward for Vafseo Label Expansion

Vafseo is currently indicated for the treatment of anemia due to chronic kidney disease in adults who have been receiving dialysis for at least three months.

CEO John P. Butler said that the company is “disappointed” with the outcome of its meeting with the FDA on a path forward for the design of a clinical trial of Vafseo in patients with late-stage chronic kidney disease not on dialysis.

<ul class="summary-bullets"><li>Limb-girdle muscular dystrophy type 2I/R9 patients treated with BBP-418 in a late-stage study demonstrated improvements in motor and pulmonary function at 12 months, the company said.&nbsp;</li><li>BridgeBio now intends to file a new drug application for the therapy's approval in the first half of 2026. &nbsp;</li></ul>BridgeBio Pharma, Inc. (BBIO) on Monday announced that limb-girdle muscular dystrophy type 2I/R9 patients treated with BBP-418 in a late-stage study demonstrated improvements in motor and pulmonary function at 12 months.Limb-Girdle Muscular Dystrophy Type 2I/R9 (LGMD2I/R9) is a rare, inherited disorder leading to progressive weakness and wasting of the arm and leg muscles, commonly later accompanied by pulmonary muscle and cardiac muscle involvement. It is caused by mutations in the FKRP gene, impairing glycosylation of alpha-dystroglycan (αDG), a protein associated with stabilizing muscle cells.<h2 class="st-heading-2">Other Trial Observations</h2>BridgeBio<a class="st-link-external" target="_blank" rel="noopener noreferrer nofollow" href="https://www.globenewswire.com/news-release/2025/10/27/3174417/0/en/BridgeBio-Reports-Positive-Phase-3-Results-for-Small-Molecule-BBP-418-in-LGMD2I-R9-FORTIFY-Study.html"> said</a> that glycosylated αDG increased by 1.8x from baseline at 3 months, whereas the placebo group showed little change. These improvements were sustained at 12 months in BBP-418-treated individuals, it further added.Furthermore, an average reduction of 82% from baseline in serum creatine kinase, a marker of muscle damage, was observed in BBP-418-treated individuals, it added.<h2 class="st-heading-2">Drug Safety</h2>BBP-418 was well-tolerated in the study with no new or unexpected safety findings observed, the company said. Overall, interim analysis data are supportive of a favorable risk-benefit profile for BBP-418, the company said.The company now intends to file a new drug application for approval of the therapy in the first half of 2026. It plans to engage with the U.S. Food and Drug Administration to discuss data from its studies later this year.<a href="https://stocktwits.com/symbol/BBIO">BBIO shares</a> traded 9% higher in the pre-market session at the time of writing. On Stocktwits, retail sentiment around BBIO jumped from ‘neutral’ to ‘bullish’ territory over the past 24 hours, while message volume rose from ‘high’ to ‘extremely high’ levels.BBIO stock has nearly doubled this year.&nbsp;Read also: <a href="https://stocktwits.com/news-articles/markets/equity/neumora-therapeutics-experimental-drug-demonstrates-weight-loss-in-preclinical-studies/cLG030zR3ML">Neumora Therapeutics’ Experimental Drug Demonstrates Weight Loss in Preclinical Studies</a>For updates and corrections, email newsroom[at]stocktwits[dot]com.

BBIO Stock Soars After Experimental Drug Shows Improvement In Inherited Muscle Disorder In Late-stage Trial

BridgeBio (BBIO) now intends to file a new drug application for the therapy's approval in the first half of 2026.

Tvardi Therapeutics (TVRD) on Monday said that its TTI-101, being evaluated in idiopathic pulmonary fibrosis (IPF), showed no benefit over placebo in a mid-stage trial.The trial was designed to assess safety, pharmacokinetics, and exploratory outcomes related to lung function in patients with IPF. Idiopathic Pulmonary Fibrosis is a progressive lung disease where lung tissue thickens and scars, making it difficult to breathe. However, the study did not meet its goals, and no statistically significant differences between placebo and treatment arms were observed after a preliminary review of exploratory efficacy, it said.Shares of the company plummeted 87% in Monday’s pre-market session. On Stocktwits, retail sentiment around <a href="https://stocktwits.com/symbol/TVRD">TVRD stock</a> rose from ‘bullish’ to ‘extremely bullish’ territory over the past 24 hours, while message volume rose from ‘low’ to ‘extremely high’ levels.Tvardi said that preliminary data showed that patients’ baseline characteristics were mostly similar across treatment arms, including those who received the two doses of TTI-101 or those who received a placebo in the trial. Furthermore, lower discontinuation rates were observed in the placebo group compared to the therapy-treated arms, it added.The company also noted that patients who demonstrated changes in the lung’s Forced Vital Capacity (FVC) were 41% for the placebo, and 39% and 44% for the 400mg and 800mg TTI-101-treated arms, respectively.“In the aggregate, we did not observe a benefit of TTI-101 treatment in this IPF study. The limited data set, high variability within treatment arms, and unexpected performance of the placebo arm make it difficult to provide more definitive conclusions at this time,” CEO Imran Alibhai said.The CEO added that the company is now conducting additional analyses to understand the trial findings further. He also noted that the company is on track to report preliminary data from the mid-stage trial of TTI-101 in hepatocellular carcinoma.TVRD stock has risen about 127% this year and more than quadrupled over the past 12 months.&nbsp;Read also:&nbsp;<a href="https://stocktwits.com/news-articles/markets/equity/tesla-reportedly-commences-production-ramp-up-at-shanghai-gigafactory/ch6SiqpR3kW">Tesla Reportedly Commences Production Ramp-Up At Its Shanghai Gigafactory</a>For updates and corrections, email newsroom[at]stocktwits[dot]com.

Why Did Tvardi Therapeutics Stock Plummet 87% Pre-Market Today?

The company said that its investigational drug did not meet its goal in a study, and no statistically significant differences between placebo and treatment arms were observed after preliminary review of exploratory efficacy. 

Cidara Therapeutics, Inc. (CDTX) on Thursday said that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy designation for its drug CD388 for the prevention of influenza A and B in adults and adolescents who are at higher risk of disease-related complications.The new designation is in addition to the Fast Track designation granted to the drug by the agency in June 2023. CEO Jeffrey Stein said that the designations underscore the importance of the drug as a potential new non-vaccine prophylactic for seasonal influenza.“Individuals who have chronic medical conditions, advanced age, or are immune compromised may not be adequately protected by current vaccines, leaving them at higher risk for infection and complications from flu. As a long-acting prophylactic drug, CD388’s activity does not rely on an immune response, making it a potential prevention option for high-risk individuals as well as those for whom vaccines are contraindicated,” he <a class="st-link-external" target="_blank" rel="noopener noreferrer nofollow" href="https://www.globenewswire.com/news-release/2025/10/09/3164062/0/en/Cidara-Therapeutics-Receives-U-S-FDA-Breakthrough-Therapy-Designation-for-CD388-in-Seasonal-Influenza-Prevention.html">added</a>.The Breakthrough Therapy designation was awarded to the drug based on the results of a study in which CD388 provided statistically significant prevention of seasonal influenza in healthy unvaccinated adults aged 18-64. The company is now looking toward advancing the drug through its ongoing late-stage trial.The Breakthrough Therapy designation is intended to expedite the review of medicines that treat a serious or life-threatening condition. Benefits of the designation include eligibility for priority review and the FDA’s organizational commitment to involving senior management to guide the company on the most efficient route to approval, the company noted.Shares of the company rose 8% at the time of writing. On Stocktwits, retail sentiment around <a href="https://stocktwits.com/symbol/CDTX">CDTX stock</a> jumped from ‘bearish’ to ‘neutral’ territory over the past 24 hours, while message volume stayed at ‘high’ levels.<figure class="image"><img style="aspect-ratio:1360/118;" src="https://news.stocktwits-cdn.com/Screenshot_2025_10_09_at_12_16_14_PM_png_11f3dc4644.webp" alt="CDTX's Sentiment Meter and Message Volume as of 12:16 p.m. ET on Oct. 09, 2025 | Source: Stocktwits" width="1360" height="118"><figcaption>CDTX's Sentiment Meter and Message Volume as of 12:16 p.m. ET on Oct. 09, 2025 | Source: Stocktwits</figcaption></figure>H.C. Wainwright analyst Sara Nik subsequently raised the firm’s price target on Cidara Therapeutics to $150 from $110 while keeping a ‘Buy’ rating on the shares. The new price target implies a potential upside of over 52% from the stock’s closing price on Wednesday.CDTX stock nearly quadrupled in value this year.&nbsp;Read also:&nbsp;<a href="https://stocktwits.com/news-articles/markets/equity/lyft-partners-with-tensor-to-deploy-hundreds-of-avs-on-its-platform/ch67uQtR3KC">Lyft Partners With Tensor To Deploy Hundreds Of AVs On Its Platform</a>For updates and corrections, email newsroom[at]stocktwits[dot]com.

Cidara Therapeutics Granted FDA Breakthrough Therapy Designation For Flu-Preventing Antiviral

The Breakthrough Therapy designation was awarded to the drug based on the results of a study in which CD388 provided statistically significant prevention of seasonal influenza in healthy unvaccinated adults aged 18-64.

Defender Capital, a long-term shareholder of STAAR Surgical Company, on Tuesday expressed opposition to the firm’s proposed acquisition by Alcon Inc.Defender Capital owns 1.5% of STAAR’s common stock. “The proposed sale of STAAR to Alcon for $28 per share significantly undervalues the company, especially when considering the STAAR board of directors' rejection of Alcon's previous offer for $58 per share in cash only sixteen months ago,” the shareholder said.Defender Capital further <a class="st-link-external" target="_blank" rel="noopener noreferrer nofollow" href="https://www.prnewswire.com/news-releases/defender-capital-opposes-staar-surgicals-proposed-sale-to-alcon-302577240.html">added</a> that it sees no compelling reason to sell STAAR at this time, with recent optimistic projections and outlook. The shareholder also expressed disappointment at the company board, alleging that the proposed transaction is ‘ill-advised’ and does not reflect STAAR’s prospects as a standalone company.Shares of <a href="https://stocktwits.com/symbol/STAA">STAAR Surgical</a> Company traded nearly 2% lower on Tuesday. On Stocktwits, retail sentiment around STAA stock stayed within the ‘bearish’ territory while message volume remained at ‘normal’ levels.Defender Capital is not the only one to oppose the proposed acquisition. Last month, Hong Kong-headquartered investment management firm Yunqi Capital, which holds a 5.1% stake in STAAR, <a href="https://stocktwits.com/news-articles/markets/equity/staar-surgical-shareholder-yunqi-capital-opposes-proposed-merger-with-alcon/chDQFDHR32a">alleged</a> in a letter to other shareholders that it would not necessarily be opposed to a potential merger of the two companies at an appropriate price or on other appropriate terms, but opposed the deal on the terms announced in August.Before Yunqi, Broadwood Partners, L.P., and its affiliates also announced their intention to vote against the proposed acquisition. Broadwood is STAAR’s largest shareholder, owning 27.5% of the company’s outstanding common shares.STAAR is a manufacturer of phakic intraocular lenses, a vision correction solution that reduces or eliminates the need for glasses or contact lenses. Alcon said in early August that the companies have entered into a definitive merger agreement under which Alcon will purchase all outstanding shares of STAAR common stock for $28 per share in cash. The transaction is expected to close in about six to 12 months and represents a total equity value of approximately $1.5 billion, it added.STAA stock is up 8% this year and down approximately 23% over the past 12 months.Read also:&nbsp;<a href="https://stocktwits.com/news-articles/markets/equity/ford-shares-slump-after-reports-of-fire-at-aluminum-supplier-plant/ch6PW0NR3ha">Ford Shares Slump 5% After Reports Of Fire At Aluminum Supplier Plant: Retail Dismisses The Dip As ‘Short-Lived’</a>For updates and corrections, email newsroom[at]stocktwits[dot]com.Editor's Note: The story has been updated to reflect Broadwood Partners' accurate stake in STAAR Surgical Company.

STAAR Surgical’s Long-Term Shareholder Says Proposed Deal With Alcon Undervalues The Company

Defender Capital, which owns 1.5% of STAAR’s common stock, highlighted STAAR’s board of directors' rejection of Alcon's previous offer of $58 per share in cash.

Lexeo Therapeutics (LXEO) announced on Tuesday that the company is considering a smaller pivotal study for LX2006 in the treatment of Friedreich's ataxia (FA) cardiomyopathy, scheduled to begin in the first half of 2026, pending finalization of the study protocol.The <a class="st-link-external" target="_blank" rel="noopener noreferrer nofollow" href="https://ir.lexeotx.com/news-releases/news-release-details/lexeo-therapeutics-announces-progress-fda-discussions">data</a> from the planned pivotal study will be pooled with data from the ongoing Phase I/II studies of LX2006 to support an approval application to the U.S. Food and Drug Administration for the therapy, the company stated after discussions with the agency.Lexeo will submit enhanced manufacturing comparability data and meet an additional nonclinical requirement before the initiation of the planned pivotal study to enable pooling, the company added.Lexeo is continuing to engage with the agency regarding the protocol of the pivotal study, it stated, adding that it believes this regulatory feedback has the potential to reduce the size and duration of the planned pivotal study. The company is also optimistic that the feedback may accelerate the overall timeline to an application submission.Updated interim clinical data from both ongoing Phase I/II studies of LX2006 show sustained or deepening improvements in the majority of participants across both cardiac and neurologic measures of Friedreich’s ataxia, the company said.FA cardiomyopathy is the leading cause of death in individuals with Friedreich’s ataxia (FA), a rare, inherited neurodegenerative disorder causing progressive damage to the nervous system, leading to impaired balance, muscle coordination, and sensory loss, often beginning in childhood. It is estimated to affect approximately 5,000 people in the U.S.Shares of the company rallied 24% at the time of writing. On Stocktwits, retail sentiment around <a href="https://stocktwits.com/symbol/LXEO">LXEO stock</a> jumped from ‘bearish’ to ‘extremely bullish’ territory over the past 24 hours, while message volume rose from ‘low’ to ‘extremely high’ levels.<figure class="image"><img style="aspect-ratio:1368/120;" src="https://news.stocktwits-cdn.com/Screenshot_2025_10_07_at_9_19_18_AM_png_3d23b7c692.webp" alt="LXEO's Sentiment Meter and Message Volume as of 9:19 a.m. ET on Oct. 07, 2025 | Source: Stocktwits" width="1368" height="120"><figcaption>LXEO's Sentiment Meter and Message Volume as of 9:19 a.m. ET on Oct. 07, 2025 | Source: Stocktwits</figcaption></figure>LXEO stock has risen 22% this year and but fallen by approximately 6% over the past 12 months.&nbsp;Read also:&nbsp;<a href="https://stocktwits.com/news-articles/markets/equity/novo-nordisk-reportedly-slashes-workforce-at-its-us-wegovy-manufacturing-plant/ch6PBqJR3WD">Novo Nordisk Reportedly Slashes Workforce At Its US Wegovy Manufacturing Plant</a>For updates and corrections, email newsroom[at]stocktwits[dot]com.

Rising stock market chart on a trading board background.

Lexeo Therapeutics Stock Rallies On Discussions With FDA To Expedite Friedreich’s Ataxia Drug Approval Process

The company stated that data from a planned pivotal study will be pooled with data from the ongoing Phase I/II studies of LX2006 to support an approval application to the U.S. Food and Drug Administration for the therapy. 

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