HUTCHMED (China) Limited (NASDAQ:HCM) on Tuesday shared data from the Phase 3 registration part of the ESLIM-02 clinical trial of sovleplenib in adult patients with warm antibody autoimmune hemolytic anemia (wAIHA).wAIHA is a condition where the immune system mistakenly makes IgG antibodies that attack and destroy red blood cells at normal body temperature, leading to anemia, fatigue, paleness, and shortness of breath.The trial conducted in China met its primary endpoint of durable hemoglobin (Hb) response ...

Several biotechnology and pharmaceutical names posted notable gains in after-hours trading on Monday, driven by clinical trial updates, regulatory progress, and investor anticipation ahead of key data releases.Alumis Inc. (ALMS) surged 17.33% to $9.75, adding $1.44 after announcing that topline data from its Phase 3 ONWARD clinical program evaluating envudeucitinib in patients with moderate-to-severe plaque psoriasis will be reported on January 6, 2026. The company also confirmed it will host a conference ...

® SAN DIEGO, Dec. 22, 2025 /PRNewswire/ -- Neurocrine Biosciences, Inc. (Nasdaq: NBIX) today announced that its Phase 3 KINECT-DCP study evaluating the efficacy, safety, and tolerability of valbenazine in pediatric and adult participants who have dyskinetic cerebral palsy (DCP) did not meet primary or key secondary endpoints. The primary objective of the study was to assess improvement in chorea, a type of involuntary movement, in individuals with DCP. "These results are disappointing, as there are no appro ...

Core Viewpoint - Tvardi Therapeutics, Inc. experienced a significant decline in stock value, 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 a publicly traded company listed on NASDAQ under the ticker TVRD [4]. - The company is currently under investigation by Faruqi & Faruqi, LLP, a national securities law firm, for potential claims related to the significant losses suffered by investors [4]. Group 2: Clinical Trial Results - The Phase 2 REVERT clinical trial aimed to evaluate the safety, pharmacokinetics, and exploratory outcomes related to lung function of TTI-101 [5]. - Preliminary data indicated that the trial did not meet its goals, with changes in Forced Vital Capacity (FVC) not showing the expected efficacy [5]. - The baseline characteristics of patients were similar across treatment arms, except for a lower percent predicted FVC in the placebo group compared to those treated with TTI-101 [5].

Core Insights - Tenax Therapeutics announced that the Blinded Sample Size Re-estimation (BSSR) of the LEVEL trial shows it is adequately powered to detect a 25-meter change in the 6-minute walk distance (6MWD), confirming that the target enrollment remains unchanged and is expected to complete in the first half of 2026 [1][2][3] Group 1: LEVEL Study Details - LEVEL is a Phase 3 clinical trial evaluating TNX-103 (oral levosimendan) for patients with pulmonary hypertension in heart failure with preserved ejection fraction (PH-HFpEF) in the U.S. and Canada [2] - The BSSR results indicated that the observed change in 6MWD from the first 150 randomized patients was less than the assumed 55 meters [2] - The company expects to share topline data in the second half of 2026 and remains confident in executing its Phase 3 development plan for TNX-103 [3] Group 2: LEVEL-2 Study Initiation - Tenax has initiated LEVEL-2, a global Phase 3 study of TNX-103, aiming to enroll approximately 540 PH-HFpEF patients with a 2:1 randomization to receive TNX-103 or placebo [3][4] - The primary endpoint for LEVEL-2 is the change in 6MWD at Week 26, with secondary endpoints including changes in Kansas City Cardiomyopathy Questionnaire (KCCQ) and New York Heart Association (NYHA) Functional Class [3] Group 3: Global Study Sites and Safety Observations - Over 100 sites across 15 countries have been selected for participation in LEVEL-2, with a rigorous process implemented to ensure consistency in patient hemodynamic assessments [4] - The LEVEL-2 study includes a 6-month blinded safety observation following the 26-week efficacy assessment to provide a robust safety database for regulatory review [4] Group 4: Levosimendan Overview - Levosimendan is a first-in-class K-ATP channel activator/calcium sensitizer being evaluated for treating PH-HFpEF, with market authorization in 60 countries for intravenous use in acutely decompensated heart failure [5] - The Phase 2 HELP study demonstrated the potential of both intravenous (TNX-101) and oral (TNX-103) formulations to improve exercise capacity and quality of life in patients with PH-HFpEF [5] Group 5: Company Background - Tenax Therapeutics is a Phase 3 development-stage pharmaceutical company focused on novel cardiopulmonary therapies, holding global rights to develop and commercialize levosimendan for PH-HFpEF, which currently lacks approved treatments [7]

Continues to drive enrollment with increase to 78% now consentedBlinded response activity tracking within expected range Consented subjects now across seven countries supporting the expansion of the MIRACLE trial HOUSTON, Dec. 09, 2025 (GLOBE NEWSWIRE) -- Moleculin Biotech, Inc., (Nasdaq: MBRX) (“Moleculin” or the “Company”), today provided an update on enrollment from its November report with an increase to 78% of the target number of subjects for the first planned interim unblinding of data having consent ...

Core Insights - Ocular Therapeutix plans to submit a New Drug Application (NDA) for AXPAXLI for wet age-related macular degeneration (wet AMD) following positive year one data from the SOL-1 Phase 3 clinical trial, expected in Q1 2026 [1][2] - AXPAXLI could be the first tyrosine kinase inhibitor (TKI) approved for wet AMD, potentially offering best-in-class durability and a superiority label [1][2] - The company aims to utilize the 505(b)(2) regulatory pathway to expedite the review process for AXPAXLI [1][2] Company Overview - Ocular Therapeutix is an integrated biopharmaceutical company focused on redefining the retina experience, with AXPAXLI being a key investigational product for retinal diseases [10] - The company has developed AXPAXLI as a bioresorbable intravitreal hydrogel incorporating axitinib, which has anti-angiogenic properties [5][10] Clinical Trial Details - The SOL-1 trial is a registrational Phase 3 study designed to evaluate the safety and efficacy of AXPAXLI, involving over 100 clinical trial sites in the U.S. and Argentina, with 344 treatment-naïve subjects randomized [6][8] - The primary endpoint of the SOL-1 trial is the proportion of subjects maintaining visual acuity at Week 36, with evaluations for durability extending to Week 52 [8] Market Context - Wet AMD is a leading cause of blindness, affecting approximately 14.5 million individuals globally and 1.8 million in the U.S., with many patients requiring frequent injections [4][9] - Current anti-VEGF therapies often lead to treatment discontinuation rates of up to 40% within the first year, highlighting the need for therapies with longer dosing intervals [4][9] Potential Impact - AXPAXLI aims to extend dosing intervals to every 6 to 12 months, potentially improving treatment adherence and long-term visual outcomes without altering current treatment procedures [3][4] - If successful, AXPAXLI could significantly reduce treatment discontinuation and redefine the treatment landscape for wet AMD [3][4]

Core Insights - The ADEPT-2 study will continue with the enrollment of additional patients following the identification of irregularities during clinical trial site reviews [1] - The company reported the irregularities to the data monitoring committee and the FDA, leading to the exclusion of certain sites and patients from the study [1] - An agreement was reached with the FDA and the DMC to conduct an interim analysis of the study [2]

Core Viewpoint - Bristol Myers Squibb (BMY) is expanding patient enrollment in the ADEPT-2 Phase 3 study for Cobenfy, a drug aimed at treating psychosis associated with Alzheimer's disease dementia, following a recommendation from the Data Monitoring Committee (DMC) after an interim analysis [1][6]. Study Details - The ADEPT-2 study is a multicenter, randomized, double-blind, placebo-controlled trial focused on assessing the safety and efficacy of Cobenfy in patients with Alzheimer's-related psychosis [2]. - The primary endpoint of the study is the change in the Neuropsychiatric Inventory-Clinician (NPI-C): Hallucinations and Delusions (H+D) score, while the key secondary endpoint is the Clinical Global Impression-Severity (CGI-S) [3]. Clinical Trial Adjustments - Irregularities were identified in the clinical trial execution at a few study sites, leading the company to exclude data from these sites from the primary analysis after consulting with the FDA [4][5]. - The DMC recommended continuing the study with additional patient enrollment, and Bristol Myers will proceed as advised while remaining blinded to the study data [6]. Market Reaction and Analyst Insights - Analysts view the ADEPT-2 study as crucial due to the significant market opportunity and the need for positive momentum following recent setbacks in other late-stage programs [7]. - The backing from the DMC and FDA for continued enrollment is seen as a potentially positive signal, especially given the pressure on Bristol Myers shares [7][8]. - Additional results from the ADEPT program, including ADEPT-1 and ADEPT-4, are expected to be released by the end of 2026, which is later than previously anticipated [8]. Stock Performance - Bristol Myers Squibb shares experienced a 5.77% increase, reaching $51.03 at the time of publication [10].

Core Viewpoint - ADC Therapeutics SA has announced updated results from the LOTIS-7 clinical trial, highlighting the potential of ZYNLONTA in treating DLBCL (Diffuse Large B-cell Lymphoma) [2][3]. Group 1: Clinical Trial Update - The LOTIS-7 clinical trial results were shared in a press release and are available on the company's website [2]. - The Chief Medical Officer, Mohamed Zaki, will provide detailed insights into the LOTIS-7 clinical trial and its updated results during the call [3]. Group 2: Strategic Overview - Ameet Mallik, the Chief Executive Officer, will present a strategic overview and discuss the opportunity for ZYNLONTA in the DLBCL market [3].