Topline data expected in 1Q 2028 Phase 2 bipolar depression trial initiation follows positive Phase 2 results in acute schizophrenia Jan. 26, 2026 -- LB Pharmaceuticals Inc (“LB Pharmaceuticals” or the “Company”) (Nasdaq: LBRX), a clinical-stage biopharmaceutical company developing novel therapies for schizophrenia, bipolar depression, and other neuropsychiatric diseases, today announced the initiation of a Phase 2 trial evaluating the efficacy and safety of LB-102 in patients with bipolar dep

Company expands its ADC pipeline and patent estate for novel, differentiated ADCs New pipeline candidate AKTX-102 leverages Akari’s proprietary PH1 spliceosome payload and a novel antibody construct to address one of oncology’s most challenging and valuable solid tumor targets, CEACAM5 Jan. 26, 2026 -- Akari Therapeutics, Plc (Nasdaq: AKTX), an oncology biotechnology company pioneering next-generation antibody drug conjugates (ADCs) powered by novel RNA-splicing payloads, today announced the f

Jan. 25, 2026 -- BioArctic AB's (publ) (STO: BIOA B) partner Eisai announced today that the supplemental Biologics License Application (sBLA) for Leqembi Iqlik subcutaneous autoinjector (SC-AI) as a weekly starting dose has been granted Priority Review by the U.S. Food and Drug Administration (FDA). Leqembi is indicated for the treatment of Alzheimer's disease in patients with Mild Cognitive Impairment (MCI) or mild dementia stage of disease (collectively referred to as early Alzheimer's disease

Unlocks path towards registrational Phase 3 trial planned to start in 2026 Data from Phase 2 SCOPE trial show iSCIB1+ has potential to redefine standard of care (SoC) iSCIB1+ shows an interim 24%-point improvement in progression free survival (PFS) over real world SoC and historic controls Jan. 26, 2026 -- Scancell Holdings plc (AIM: SCLP), the developer of active immunotherapies to treat cancer, announces the U.S. Food and Drug Administration (FDA) has cleared its Investigational New Drug (

Jan. 25, 2026 -- Eisai Co., Ltd. (Headquarters: Tokyo, CEO: Haruo Naito, "Eisai") and Biogen Inc. (Nasdaq: BIIB, Corporate headquarters: Cambridge, Massachusetts, CEO: Christopher A. Viehbacher, "Biogen") announced today that the U.S. Food and Drug Administration (FDA) has accepted for review Eisai's Supplemental Biologics License Application (sBLA) for lecanemab-irmb (U.S. brand name: LEQEMBI®) subcutaneous autoinjector (SC-AI), LEQEMBI IQLIK, as a weekly starting dose. LEQEMBI is indicated for

Jan. 23, 2026 -- Alveus Therapeutics, Inc. (“Alveus”), a clinical-stage biotechnology company developing next-generation therapies for obesity and metabolic diseases, today announced that the U.S. Food and Drug Administration (FDA) has cleared its Investigational New Drug (IND) application for ALV-100, the company’s lead investigational therapy for chronic weight management, enabling initiation of a Phase 1b clinical study. The first patient was dosed last week. ALV-100 is a bifunctional gluco

-Topline data from the Phase II study for the treatment of diabetes are expected in the third quarter of 2026. -ASC30 demonstrated placebo-adjusted weight loss of up to 7.7% in a recently completed 13-week U.S. Phase II study in participants with obesity or overweight, with better gastrointestinal tolerability. No hepatic safety signal was observed. Jan. 25, 2026 -- Ascletis Pharma Inc. (HKEX: 1672, "Ascletis") announces today that the first participants have been dosed in a U.S. 13-week Phase

Merz Therapeutics, a leading player in neurology-focused specialty pharma, today announced that it has completed the regulatory submission for XEOMIN® (incobotulinumtoxinA) for the treatment of spasticity of the lower and upper limb in children and adolescents aged 2–17 years in the European Union (EU) and European Economic Area (EEA). If approved, the indication would expand access to an established botulinum neurotoxin therapy for some of the youngest and most vulnerable patients across Europe

Jan. 22, 2026 -- CVRx, Inc. (NASDAQ: CVRX), a medical device company focused on developing, manufacturing and commercializing innovative neuromodulation solutions for patients with cardiovascular diseases, today announced initiation of the BENEFIT-HF clinical trial, a landmark randomized study supported by CMS Category B IDE coverage and designed to evaluate the impact of Barostim™ in a significantly expanded heart failure population. Barostim™ is an implantable device that delivers electrical

Sanofi's amlitelimab confirms its potential in atopic dermatitis In the SHORE phase 3 study, amlitelimab in combination with topical therapies met all primary and key secondary endpoints at Week 24 with efficacy progressively increasing throughout the treatment period with some patients improving as early as Week 2 In the COAST 2 phase 3 study, amlitelimab demonstrated statistically significant efficacy on vIGA-AD 0/1, the primary endpoint as assessed for the US and US reference countries, and