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BIIB Starts Felzartamab Phase III Study in AMR in Kidney Transplant
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Biogen (BIIB - Free Report) 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 Research
More Updates on BIIB’s Pipeline Program for Felzartamab
Biogen 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 - Free Report) . 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.
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%.
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BIIB Starts Felzartamab Phase III Study in AMR in Kidney Transplant
Biogen (BIIB - Free Report) 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 Research
More Updates on BIIB’s Pipeline Program for Felzartamab
Biogen 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 - Free Report) . 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 Picks
Biogen currently has a Zacks Rank #3 (Hold).
Biogen Inc. Price and Consensus
Biogen Inc. price-consensus-chart | Biogen Inc. Quote
A couple of better-ranked stocks are ANI Pharmaceuticals (ANIP - Free Report) and Jazz Pharmaceuticals (JAZZ - Free Report) , 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%.