Primary endpoint and the key secondary endpoint were met with high statistical significance and CUE-221 demonstrated an overall favorable safety profile Clinically different efficacy profile observed relative to XOLAIR® (omalizumab) highlights potential for a fundamental mechanism-based biological difference Cue Biopharma to host conference call on Monday, September 21, at 8:00 a.m. EDT Sept. 20, 2026 -- Cue Biopharma (Nasdaq: CUE), a clinical-stage biopharmaceutical company targeting transfo

Lōkahi Therapeutics™, a subsidiary of Glucotrack, Inc. (Nasdaq: GCTK), today announced that The University of Alabama’s Culverhouse College of Business will continue its participation in the ai² Pipeline division for the upcoming academic year. The renewed collaboration extends a hands-on program in which students evaluate real-world biopharmaceutical business development and asset assessment opportunities. The program also supports Lōkahi’s strategy of identifying and evaluating promising thera

If approved, Cosentyx (secukinumab) will be first IL-17A inhibitor licensed in Europe for adults with polymyalgia rheumatica (PMR), providing new treatment option after steroids¹ Recommendation based on data showing Cosentyx doubled sustained remission rates and delivered steroid sparing effects vs placebo; safety was consistent with established Cosentyx profile² Despite being a common inflammatory rheumatic disease in people over 50, there are limited advanced treatments for PMR; extended use o

First and only approved treatment indicated for Ataxia-Telangiectasia (A-T) in the United States or anywhere in the world Second FDA-approved indication for AQNEURSA, following previous approval for Niemann-Pick disease type C (NPC) AQNEURSA is commercially available now AQNEURSA provides a long-awaited treatment option for patients living with A-T IntraBio Inc., a leader in the discovery, development, and commercialization of novel therapies for rare and common neurodegenerative diseases, tod

—sNDA Under Review for Full Approval Is Based on Positive Results From Phase 3b ENCORE Study— —Full Approval Could Bring ARIKAYCE to Patients Earlier in Their Disease Course and Would Fulfill Post-Marketing Requirement From FDA— Sept. 21, 2026 -- Insmed Incorporated (Nasdaq: INSM), a people-first global biopharmaceutical company striving to deliver first- and best-in-class therapies to transform the lives of patients facing serious diseases, today announced that the U.S. Food and Drug Administr

Sept. 20, 2026 -- Accro Bioscience Inc. (Accro Bio), a clinical-stage biotechnology company pioneering the development of novel therapeutics for immune mediated diseases, today announced the dosing of their first patient in the Phase IIb clinical trial of AC-101, a selective RIPK2 inhibitor, in patients with moderate-to-severe ulcerative colitis (UC). The Phase IIb study is a multicenter, double-blind, placebo-controlled clinical trial designed to evaluate AC-101 in patients with moderate-to-sev

Eli Lilly is sharpening its competitive edge in the crowded oral SERD arena as the FDA has approved a combination of its Inluriyo with its CDK4/6 inhibitor Verzenio. The label expansion builds on Inluriyo’s existing monotherapy indication, approved nearly a year ago to treat ER-positive, HER2-negative breast cancer that carries ESR1 mutations in previously treated patients. Given the longer progression-free survival (PFS), Jake Van Naarden, president of Lilly Oncology and head of corporate busi

mAbxience and Sandoz have entered into a collaboration agreement combining mAbxience's development and manufacturing expertise with Sandoz's global commercial capabilities for a proposed emicizumab biosimilar candidate. Emicizumab biosimilar expands mAbxience's pipeline into haemophilia A and strengthens its presence in rare diseases. The agreement is consistent with mAbxience's strategy of broadening patient access to high-quality biologic medicines through selected partnerships in global marke

Electra Therapeutics has exceeded its initial fundraising plans as it becomes the 26th biotech to debut publicly this year and outlines pivotal development plans for its monoclonal antibody ipsoprubart. Electra Therapeutics is charging toward the public markets, raising an upsized $350 million initial public offering to help push its lead asset through pivotal testing and to potential market approval. The IPO encompasses 23.3 million shares sold at $15 per share, with underwriters given 30 da

September 17, 2026 – The NationalInstitute of Diabetes and Digestive and Kidney Diseases (NIDDK), a division ofthe National Institutes of Health (NIH), has awarded SignaBlok, Inc., a biopharmaceutical company focused on developing novel peptide antagonists of cell receptors, a Phase I Small Business Innovation Research (SBIR) grant to develop a new therapeutic approach for inflammatory bowel disease (IBD). SignaBlok’s approach to IBD therapy targets TREM-1, a cell-surface receptor that has emer