Biogen
🇺🇸United States
- Country
- 🇺🇸United States
- Ownership
- Private
- Established
- 1978-01-01
- Employees
- 7.5K
- Market Cap
- $29.6B
- Website
- https://www.biogen.com
- Introduction
Biogen, Inc. is a biopharmaceutical company, which engages in discovering, developing, and delivering therapies for neurological and neurodegenerative diseases. Its products include TECFIDERA, VUMERITY, AVONEX, PLEGRIDY, TYSABRI and FAMPYRA for the treatment of MS, SPINRAZA for the treatment of SMA, ADUHELM for the treatment of Alzheimer's disease, and FUMADERM for the treatment of severe plaque psoriasis. The company was founded by Charles Weissmann, Heinz Schaller, Kenneth Murray, Walter Gilbert, and Phillip Allen Sharp in 1978 and is headquartered in Cambridge, MA.
Biogen Receives U.S. FDA Breakthrough Therapy Designation for Felzartamab
Biogen's felzartamab, an anti-CD38 monoclonal antibody, received FDA Breakthrough Therapy Designation for treating late antibody-mediated rejection (AMR) in kidney transplant patients, based on clinical development data. Felzartamab aims to address unmet medical needs in AMR, with Phase 3 trials planned for 2025 across AMR, IgA nephropathy, and primary membranous nephropathy.
Biogen Receives U.S. FDA Breakthrough Therapy Designation for Felzartamab for the Treatment of Late Antibody-Mediated Rejection in Kidney Transplant Patients
Felzartamab, an anti-CD38 monoclonal antibody, received FDA Breakthrough Therapy Designation for treating late antibody-mediated rejection (AMR) in kidney transplant patients, based on clinical data showing potential for substantial improvement over existing therapies. Phase 3 trials are planned for 2025 across AMR, IgAN, and PMN.
Felzartamab Receives Breakthrough Therapy Designation
Biogen's felzartamab receives FDA Breakthrough Therapy Designation for treating late antibody-mediated rejection in kidney transplant patients. Biogen plans to initiate Phase 3 trials in 2025 across AMR, IgAN, and PMN. Originally developed by MorphoSys for multiple myeloma, felzartamab's rights were exclusively licensed to HI-Bio, acquired by Biogen in July 2024.
Biogen: Felzartamab Receives Breakthrough Therapy Designation - Quick Facts
Biogen's felzartamab receives FDA Breakthrough Therapy Designation for treating late antibody-mediated rejection in kidney transplant patients. Biogen plans Phase 3 trials in 2025 for AMR, IgAN, and PMN. Originally developed by MorphoSys for multiple myeloma, felzartamab was licensed by HI-Bio, acquired by Biogen in 2024.
Biogen Gets FDA Breakthrough Designation for Kidney-Transplant Drug
Biogen receives FDA breakthrough-therapy designation for felzartamab, its treatment for late antibody-mediated rejection in kidney-transplant patients. The designation aims to expedite development and review of drugs that may offer substantial improvement over existing therapies. Biogen plans to initiate Phase 3 studies for felzartamab next year.
Biogen Receives U.S. FDA Breakthrough Therapy Designation for Felzartamab for the ...
Biogen's felzartamab receives FDA Breakthrough Therapy Designation for treating late antibody-mediated rejection (AMR) in kidney transplant patients without T-cell mediated rejection. Felzartamab, an anti-CD38 monoclonal antibody, aims to address serious conditions with potential for substantial improvement over existing therapies. Biogen plans to initiate Phase 3 trials for felzartamab in AMR, IgA nephropathy, and primary membranous nephropathy in 2025.
Scholar Rock soars on spinal muscular atrophy phase III data
Scholar Rock shares surged 319% on positive phase III data for apitegromab in spinal muscular atrophy. Astrazeneca acquired a preclinical Lp(a) disruptor from CSPC for up to $2B. The 2024 Nobel Prize in Physiology or Medicine was awarded for the discovery of microRNA. PBMs' private labels in biosimilars raise antitrust concerns. Judo Bio showcased its kidney-targeted siRNA platform at OTS. Astellas' Claus Zieler predicts gene and cell therapies will drive innovation. Novo Nordisk plans to launch Wegovy in South Korea in mid-October.
Aflibercept Biosimilar Updates in Europe
EMA's CHMP adopted positive opinions for Sandoz's AFQLIR and Samsung-Biogen's OPUVIZ aflibercept biosimilars, both recommended for treating neovascular AMD, macular oedema, DME, and myopic CNV.
The Positive Topline Results From Phase III Study of UCB/Biogen's Dapirolizumab Pegol
UCB and Biogen report positive Phase III PHOENYCS GO trial results for dapirolizumab pegol in moderate-to-severe SLE, with a second Phase 3 trial, PHOENYCS FLY, planned for 2024. The SLE market is expected to grow from USD 3.2 billion in 2023, driven by emerging therapies like Litifilimab, Ianalumab, and Cenerimod.
Muscle-Directed Therapy Apitegromab Meets Primary End Point in Phase 3 SAPPHIRE Trial
Apitegromab met primary endpoint in phase 3 SAPPHIRE trial, showing significant motor function improvement in SMA patients. Scholar Rock plans to submit a BLA to FDA and EU for marketing authorization in Q1 2025.
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