Findings from the Phase III EMPOWER-Lung 3 trial, announced Aug. 5 by Regeneron Pharmaceuticals and Sanofi, show that a combination regimen comprising the PD-1 inhibitor Libtayo and platinum-doublet chemotherapy significantly improved overall survival compared with chemotherapy alone in patients with metastatic or locally advanced non-small cell lung cancer (NSCLC).

Global pharmaceutical giant Pfizer Inc. announced that the company’s trial on a potential treatment for alopecia areata achieved the study’s primary efficacy endpoint.

International eye-care products manufacturer Allergan announced positive outcomes from the AbbVie company’s Phase 3 study of a new treatment for presbyopia, as the ophthalmic solution AGN-190584 met primary and key secondary endpoints.

Boston-based Alexion Pharmaceuticals announced positive topline data from the company’s Phase III trial of Ultomiris (ravulizumab-cwvz) in adults with generalized myasthenia gravis.

Galapagos announced new post-hoc analyses for the Belgium-based company’s Phase III SELECTION program for the JAK1 inhibitor filgotinib for ulcerative colitis, touting rapid symptom improvement and sustained steroid-free remission. 

Gilead Sciences is aiming to win regulatory approval for the first HIV-1 treatment administered twice per year as the company submitted a New Drug Application to the U.S. Food and Drug Administration for lenacapavir, an investigational, long-acting HIV-1 capsid inhibitor.

Pivoting from conflicting and controversial press over the company’s approved Alzheimer’s disease treatment, Biogen announced that its gene therapy drug timrepigene emparvovec failed to show a clinically meaningful benefit for a rare inherited eye disease in a Phase III trial.

Topline results from the Phase III TULIP study show an antibody-drug conjugate (ADC) from the Netherlands-based Byondis B.V. significantly prolonged progression-free survival (PFS) in patients with pretreated HER2-positive unresectable locally advanced or metastatic breast cancer (MBC).

Novartis announced Phase II primary endpoint data showing the investigational, first-in-class, oral, targeted factor B inhibitor iptacopan reduced protein in the urine – an increasingly recognized surrogate marker correlating with progression to kidney failure – and showed promise in stabilizing kidney function in patients with IgA nephropathy (IgAN).

NGM Biopharmaceuticals’ aldafermin failed to hit the primary endpoint in the company’s Phase IIb ALPINE 2/3 trial for non-alcoholic steatohepatitis (NASH) with stage 2 or 3 liver fibrosis.