Designation is based on the breadth of available litifilimab data, including the Phase 2 LILAC study result that showed improvements in cutaneous lupus erythematosus (CLE) skin disease activity Litifilimab has the potential to be a first-in-class therapy targeting blood dendritic cell antigen 2 (BDCA2) in CLE, a chronic autoimmune skin disease that has a substantial impact on the daily life of patients, and may result in permanent scarring and disfigurement FDA Breakthrough Therapy Designati

Proceeds support the continued clinical development of TRB-061, a novel TNFR2 agonist designed to selectively activate regulatory T cells (“Tregs”) in inflammatory diseases affecting skin and other barrier tissues, including atopic dermatitis The single ascending dose portion of the ongoing Phase 1a/b clinical trial of TRB-061 has been completed, with the multiple ascending dose portion underway Financing also enables TRB-071 and TRB-081, two mechanistically distinct preclinical programs from

Tinlarebant is the first therapeutic candidate to demonstrate clinical efficacy in Stargardt disease, having met the primary endpoint in the pivotal, global Phase 3 DRAGON trial with 36% reduction in lesion growth (p-value=0.0033) 60 adolescent STGD1 subjects enrolled in DRAGON II clinical trial across Japan, the United States, and the United Kingdom Belite Bio plans to file a New Drug Application (NDA) with the U.S. Food and Drug Administration (FDA) in 1H 2026 Jan. 27, 2026 -- Belite Bio, In

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

Jan. 27, 2026 -- Antheia, the advanced biosynthesis company delivering 21st-century pharmaceutical manufacturing and innovation, today announced it has completed a second close of its Series C financing, raising an additional $24 million. Combined with additional available capital and non-dilutive funding, including multiple project agreements with the U.S. government, the company has secured more than $175 million over the past year. Proceeds from the financing will be used to expand Antheia's

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

Jan. 26, 2026 -- Leios Therapeutics, a clinical-stage biotechnology company focused on innovative aesthetic therapies, today announced the execution of a licensing agreement for 10XB-101, its investigational product for focal fat reduction and body contouring, along with a strategic equity investment by BNC Korea (KOSDAQ:256840), a leading healthcare and aesthetics-focused company in South Korea. “We are delighted to enter this strategic partnership with BNC Korea for 10XB-101, marking a signi

- 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