Jan. 28, 2026 -- TETRAPHARM, a Copenhagen-based biopharmaceutical company focused on neuroscience, psychiatry, and metabolic disorders, today announced promising preclinical data for TPC-026, a novel investigational compound being developed for the chronic treatment and long-term management of multiple metabolic disorders, including obesity. The preclinical findings support TPC-026 as a differentiated therapeutic candidate, designed to address underlying disease mechanisms, rather than symptoms

Jan. 27, 2026 -- Imviva Biotech, a clinical-stage biotechnology company developing next-generation allogeneic CAR-T cell therapies, today announced that the U.S. Food and Drug Administration has granted orphan drug designation to CTD402, the company’s investigational allogeneic anti-CD7 CAR-T cell therapy for the treatment of relapsed/refractory (R/R) T-cell acute lymphoblastic leukemia/lymphoblastic lymphoma (T-ALL/LBL). This designation underscores the significant unmet need for new treatmen

Nine-month findings show mean improvement in Composite Unified Huntington's Disease Rating Scale from baseline of +0.64 points, compared to natural history expected worsening of cUHDRS in symptomatic patients of -0.73 points over nine months, based on propensity score weighting. Skyhawk also announces SKY-0515's Phase 2/3 FALCON-HD trial has expanded worldwide. Skyhawk has now dosed more than 90 patients. Jan. 27, 2026 -- Skyhawk Therapeutics, Inc., a clinical-stage biotechnology company develo

- Cogent will submit the PEAK New Drug Application (NDA) under previously announced RTOR designation; on track to complete NDA submission in April 2026 Jan. 26, 2026 -- Cogent Biosciences, Inc. (Nasdaq: COGT), a biotechnology company focused on developing precision therapies for genetically defined diseases, today announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation (BTD) for bezuclastinib in combination with sunitinib for patients with Gastr

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