BIIB Starts Felzartamab Phase III Study in AMR in Kidney Transplant

Biogen BIIB announced that dosing has begun in a phase III study evaluating its key pipeline candidate, felzartamab, in adult kidney transplant recipients diagnosed with late antibody-mediated rejection (AMR).AMR is a leading cause of kidney transplant failure. AMR occurs in kidney transplant recipients when the antibodies of the immune system attack the transplanted kidney, causing damage to the kidney tissue.The   52-week, double-blind, placebo-controlled, multicenter, randomized TRANSCEND phase III study will enroll approximately 120 kidney transplant recipients with late AMR and evaluate the efficacy and safety of felzartamab compared to placebo. The study’s primary endpoint is the percentage of participants who achieve resolution by biopsy of AMR at 6 months.The FDA had granted felzartamab Breakthrough Therapy designation for the AMR indication in October last year.In the past year, the stock has declined 36.6% compared with the industry’s 8.5% decline.Image Source: Zacks Investment ResearchMore Updates on BIIB’s Pipeline Program for FelzartamabBiogen is developing felzartamab across a range of immune-mediated diseases and believes the candidate has “pipeline-in-a-product” potential. Felzartamab has demonstrated proof of concept in clinical studies for multiple immune-mediated diseases.Phase II studies are ongoing for two other indications — primary membranous nephropathy (PMN) and Immunoglobulin A nephropathy (IgAN). Biogen plans to initiate phase III studies on felzartamab in PMN and IgAN in 2025.Felzartamab was added to Biogen’s pipeline with the acquisition of Human Immunology Biosciences (HI-Bio) in July last year. HI-Bio had acquired rights to felzartamab across all indications in all countries and territories excluding China (including Macau and Hong Kong and Taiwan) from MorphoSys, now a subsidiary of Novartis NVS. Felzartamab was originally developed by MorphoSys, which was acquired by Novartis in May 2024.Following the initiation of the phase III study on felzartamab in AMR, Biogen will make a milestone payment of $35 million to MorphoSys.BIIB’s Zacks Rank & Key PicksBiogen currently has a Zacks Rank #3 (Hold).Biogen Inc. Price and Consensus Biogen Inc. price-consensus-chart | Biogen Inc. QuoteA couple of better-ranked stocks are ANI Pharmaceuticals ANIP and Jazz Pharmaceuticals JAZZ, with a Zacks Rank #1 (Strong Buy) each.  You can see the complete list of today’s Zacks #1 Rank stocks here.Estimates for ANI Pharmaceuticals’ earnings per share have risen from $5.54 to $6.31, while that for 2026 have risen from $6.75 to $6.90 over the past 30 days. In the past year, ANI Pharmaceuticals’ stock has declined 7.3%.ANI Pharmaceuticals beat estimates in each of the last four quarters, delivering a four-quarter average earnings surprise of 17.32%.Estimates for Jazz Pharmaceuticals’ earnings per share have risen from $22.11 to $23.10, while that for 2026 have risen from $23.23 to $23.51 over the past 30 days. In the past year, Jazz Pharmaceuticals’ stock has risen 16.3%.JAZZ beat estimates in three of the last four quarters while missing in one, delivering a four-quarter average earnings surprise of 3.20%.5 Stocks Set to DoubleEach was handpicked by a Zacks expert as the #1 favorite stock to gain +100% or more in 2024. While not all picks can be winners, previous recommendations have soared +143.0%, +175.9%, +498.3% and +673.0%.Most of the stocks in this report are flying under Wall Street radar, which provides a great opportunity to get in on the ground floor.Today, See These 5 Potential Home Runs >>Want the latest recommendations from Zacks Investment Research? Today, you can download 7 Best Stocks for the Next 30 Days. Click to get this free report Novartis AG (NVS): Free Stock Analysis Report Biogen Inc. (BIIB): Free Stock Analysis Report Jazz Pharmaceuticals PLC (JAZZ): Free Stock Analysis Report ANI Pharmaceuticals, Inc. (ANIP): Free Stock Analysis ReportThis article originally published on Zacks Investment Research (zacks.com).Zacks Investment ResearchWeiter zum vollständigen Artikel bei Zacks Weiter zum vollständigen Artikel bei Zacks