Argenx SE (NASDAQ:ARGX) on Thursday reported upbeat fourth-quarter results and announced positive topline results from the Phase 3 ADAPT OCULUS study evaluating VYVGART in adults with ocular myasthenia gravis (oMG).Argenx reported fourth-quarter earnings of $8.02 per share, beating the consensus of $6.02. Sales jumped from $761.2 million to $1.32 billion, surpassing the consensus estimate of $1.29 billion.“Argenx delivered another standout year of execution in 2025,” said Tim Van Hauwermeiren, CEO of Argenx ...

Core Insights - Ocular Therapeutix will host a webcast on February 17, 2026, to review topline results from the SOL-1 Phase 3 clinical trial of AXPAXLI™ for wet age-related macular degeneration [1] - Detailed data from the trial will be presented at the 49 Macula Society Annual Meeting from February 25 to 28, 2026 [1] Company Overview - Ocular Therapeutix, Inc. is an integrated biopharmaceutical company focused on redefining the retina experience [3] - AXPAXLI™ (OTX-TKI) is an investigational product candidate for retinal diseases, currently in Phase 3 trials for wet AMD and diabetic retinal disease [3] - The company utilizes its proprietary ELUTYX™ technology in its commercial product DEXTENZA, an FDA-approved corticosteroid for ocular inflammation and pain [4] Product Pipeline - DEXTENZA is approved for treating ocular inflammation and pain post-surgery and allergic conjunctivitis in patients aged two years or older [4] - Ocular is also developing OTX-TIC, a travoprost intracamreal hydrogel that has completed Phase 2 trials for open-angle glaucoma or ocular hypertension [4]

Core Viewpoint - Edgewise Therapeutics is experiencing a positive market response following a bullish recommendation from analyst Yasmeen Rahimi of Piper Sandler, who has set a price target of $51 per share for the company's stock [2][3]. Company Overview - Edgewise Therapeutics' stock rose by 4% in a single day, outperforming the S&P 500 index, which only increased by 0.5% [2]. - The current stock price is $30.27, with a market capitalization of $3.1 billion [7]. Clinical Development - The company is advancing its leading cardiovascular drug candidate, EDG-7500, which targets hypertrophic cardiomyopathy (HCM) and is currently in a Phase 2 clinical trial [5][6]. - A readout from the clinical trial is expected in the second quarter of the calendar year, and the drug's novel functionality is anticipated to provide a competitive edge in the market [6]. Pipeline Potential - In addition to EDG-7500, Edgewise is developing Sevasemten, a treatment for muscular dystrophy, which is also well advanced in the development cycle [9]. - The analyst believes that several other pipeline programs have solid potential, indicating a robust future for the company's product offerings [9].

Core Insights - The presentation focuses on the 3-year top line results from the EMBARK trial, which is a pivotal Phase III study for ELEVIDYS, highlighting the significance of the year 3 results [2] Group 1 - The results from the EMBARK trial are described as remarkably important, indicating a positive trend in long-term outcomes [2]

Core Insights - Mereo BioPharma announced that neither the Phase 3 ORBIT nor COSMIC studies for setrusumab (UX143) achieved their primary endpoint of reducing annualized clinical fracture rates compared to placebo or bisphosphonates, respectively. However, both studies successfully met their secondary endpoints, showing significant improvements in bone mineral density (BMD) [1][2][3]. Study Results - In the ORBIT study, participants showed statistically significant improvements in BMD compared to placebo, consistent with Phase 2 study results, but did not see a corresponding reduction in fracture rates [3]. - The pediatric COSMIC study revealed that patients had a higher baseline fracture rate compared to those in ORBIT. Although setrusumab-treated patients showed meaningful BMD improvements and a reduction in fracture rates compared to bisphosphonate-treated patients, this reduction did not reach statistical significance [4]. Financial and Strategic Considerations - Mereo's cash balance was reported at $48.7 million at the end of Q3 2025. The company plans to manage cash resources carefully, implementing immediate reductions in pre-commercial and manufacturing activities while continuing to analyze the setrusumab data for future steps [5]. - The company is also advancing discussions for partnerships related to alvelestat, another of its drug candidates [2][9]. Product Development Context - Setrusumab is being developed for pediatric and young adult patients with Osteogenesis Imperfecta (OI) across various sub-types, with the ORBIT and COSMIC studies being pivotal in this development [6][8]. - The ORBIT study involved 159 patients aged 5 to 25 years, while the COSMIC study enrolled 69 patients aged 2 to under 7 years, both randomized to receive either setrusumab or a comparator [7][8]. Company Overview - Mereo BioPharma focuses on developing innovative therapeutics for rare diseases, with setrusumab being one of its key candidates for OI. The company has retained commercial rights in the EU and UK and has partnered with Ultragenyx Pharmaceutical for the development of setrusumab [12].

Group 1 - U.S. stocks experienced a decline, with the Dow Jones falling over 200 points on Monday [1] - Paramount Skydance Corporation launched an all-cash tender offer to acquire Warner Bros. Discovery, Inc. for $30 per share, valuing the company at $108.4 billion [1] - Paramount aims to create a scaled Hollywood leader by merging with Warner Bros. [1] Group 2 - Paramount Skydance shares increased by 9.8% to $14.68 on Monday [2] - Other notable stocks that gained include Wave Life Sciences Ltd., which rose 129.1% to $17.16 after positive interim Phase 1 data for its obesity drug [4] - Structure Therapeutics Inc. saw a gain of 100.5% to $69.30 following the announcement of topline data from its clinical program for obesity treatment [4] Group 3 - Fulcrum Therapeutics, Inc. shares rose 62.3% to $14.44 after reporting initial results from its Phase 1b trial for sickle cell disease [4] - Kymera Therapeutics, Inc. gained 51.2% to $100.75 after reporting successful trial results for its KT-621 drug [4] - Confluent, Inc. shares increased by 29.2% to $29.89 after IBM agreed to acquire the company for $31 per share [4]

Core Points - Tvardi Therapeutics, Inc. experienced a significant decline in its stock price, dropping over 80% following disappointing preliminary data from its Phase 2 REVERT clinical trial for TTI-101 in idiopathic pulmonary fibrosis [5] Group 1: Company Overview - Tvardi Therapeutics, Inc. is listed on NASDAQ under the ticker TVRD [2] - The company is currently under investigation for potential claims related to its stock performance [2] Group 2: Clinical Trial Results - The Phase 2 REVERT clinical trial aimed to evaluate safety, pharmacokinetics, and exploratory outcomes related to lung function [5] - Preliminary data indicated that the trial did not meet its goals, with changes in Forced Vital Capacity (FVC) being a key focus [5] - Patients' baseline characteristics were similar across treatment arms, except for a lower percent predicted FVC in the placebo group compared to the TTI-101 group [5]

Core Points - The company announced positive results from its Phase III PEAK trial in GIST, which were shared in a press release [2] Group 1 - The webcast was hosted by Christi Waarich, Senior Director of Investor Relations, who introduced the call and highlighted the positive trial results [2][4] - The company provided a reminder that remarks made during the webcast may include forward-looking statements, particularly regarding regulatory submissions and clinical data [3]

Core Insights - The company announced positive Phase III data from the CALIBRATE clinical trial for patients with autosomal dominant hypocalcemia type 1, marking a significant advancement for ADH1 patients [2][3]. Group 1 - The webinar was hosted by the company to present the top line results of the CALIBRATE Phase III trial [1]. - The CEO expressed gratitude towards the team and stakeholders involved in the trial, highlighting the importance of the results for patients and their families [2].

Core Insights - Tvardi Therapeutics, Inc. experienced a significant decline in its stock price, dropping over 80% following disappointing preliminary data from its Phase 2 REVERT clinical trial for TTI-101 in idiopathic pulmonary fibrosis [3]. Company Overview - Tvardi Therapeutics, Inc. is currently under investigation by Faruqi & Faruqi, LLP for potential claims related to the significant losses suffered by investors [2]. Clinical Trial Results - The Phase 2 REVERT clinical trial aimed to evaluate safety, pharmacokinetics, and exploratory outcomes related to lung function, but the preliminary data indicated that the study did not meet its goals [3]. - The preliminary data showed that patients' baseline characteristics were similar across treatment arms, except for the percent predicted Forced Vital Capacity (FVC), which was lower in the placebo group compared to the TTI-101 treatment group [3].