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

Statistically-significant reduction in the relative change from baseline in 24-hour objective cough frequency observed across all dose groups of nalbuphine ER at Week 6 with statistically-significant cough reduction as early as Week 2, the first time point measured Over 60% of nalbuphine ER-treated patients achieved at least a 50% reduction in 24-hour cough frequency at Week 6 vs baseline Patient-reported outcome measure of cough frequency was consistent with reduction observed with objective

Jan. 22, 2026 -- Protara Therapeutics, Inc. (Nasdaq: TARA), a clinical-stage company developing transformative therapies for the treatment of cancer and rare diseases, today announced that updated interim data from the cohort of BCG-Unresponsive non-muscle invasive bladder cancer (NMIBC) patients in the ongoing Phase 2 ADVANCED-2 trial of TARA-002 will be featured at the upcoming American Society of Clinical Oncology (ASCO) Genitourinary (GU) Cancers Symposium, taking place from February 26, 20

Rznomics, a biopharmaceutical company specializing in RNA-based gene therapies (CEO Seong-wook Lee), announced today that its lead anti-cancer candidate, RZ-001, has been selected as a clinical-stage project for the “2025 1st National New Drug Development Project” by the Korea Drug Development Fund (KDDF). The National New Drug Development Project is a pan-governmental R&D initiative aimed at strengthening the global competitiveness of the Korean pharmaceutical and biotech industries. Following

The Austin, TX-based biotech told Endpoints News it plans to submit an application to the FDA in April that would seek approval for its drug, Aqneursa. Known generically as N-acetyl-L-leucine, Aqneursa was first approved in 2024 to treat neurological symptoms related to another rare disease called Niemann-Pick disease type C. There are currently no approved treatments specifically for ataxia-telangiectasia. Seventy-three patients with the disorder were enrolled as part of the Phase 3 trial, an

Novartis has announced that the US Food and Drug Administration (FDA) has granted breakthrough therapy designation to ianalumab, a treatment for Sjögren’s disease, the second most prevalent rheumatic autoimmune condition. Ianalumab is a fully human monoclonal antibody that targets B-cells and inhibits their activation and survival by blocking B-cell activating factor receptor (BAFF-R). Novartis intends to submit ianalumab for regulatory approval globally in early 2026. If approved, it would re

Jan. 22, 2026 -- Mabwell (688062.SH), an innovation-driven biopharmaceutical company with a fully integrated industry chain, announced that the first patient has been dosed in a clinical trial in the U.S. of its independently developed novel CDH17-targeting antibody-drug conjugate (ADC) (R&D code: 7MW4911) for the treatment of advanced colorectal cancer and other advanced gastrointestinal tumors. The Phase I/II study (NCT07216560) represents the first-in-human (FIH) study of 7MW4911 in the Unit

Jan. 22, 2026 -- Hoth Therapeutics, Inc. (NASDAQ: HOTH), a clinical-stage biopharmaceutical company focused on advancing innovative therapies for cancer patients with significant unmet needs, today announced positive interim results from the open-label pharmacokinetic (PK) cohort of its ongoing CLEER-001 clinical trial evaluating HT-001 in cancer patients receiving EGFR inhibitor therapy. In the open-label PK cohort, 100% of evaluable patients achieved clinical response by Week 6, accompanied b

January 21, 2026 – 6pm CET - OSE Immunotherapeutics SA (ISIN: FR0012127173; Mnemo: OSE), today acknowledges the announcement by its partner Veloxis Pharmaceuticals, Inc. that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation to pegrizeprument (VEL-101) for the prevention of organ rejection in patients undergoing liver transplantation. Pegrizeprument (also known as VEL-101) is a novel investigational immunomodulatory monoclonal antibody fragment originally discovere

Jan. 21, 2026 -- BPGbio, Inc ., a leading biology-first, AI-powered clinical-stage biopharma company, today announced that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation (ODD) to its lead candidate, BPM31510, for the treatment of primary oenzyme Q10 (CoQ10) deficiency (PCQD). Primary CoQ10 deficiency is an ultra-rare, life-threatening mitochondrial disorder affecting fewer than one in 100,000 individuals. The condition severely impairs cellular energy product