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Servier will pick up Ojemda, which received FDA approval in 2024 to treat pediatric glioma. The drug clocked sales of $155 million for Day One Biopharmaceuticals in 2025.
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UniQure’s Path for Huntington’s Gene Therapy Clouded by Ethical Questions as Potential Phase 3 Looms
While the FDA appears to be adamant that uniQure conduct a sham surgery–controlled Phase 3 trial before AMT-130 can be considered for approval, experts believe there is an alternate path forward for the therapy, perhaps even based on precedent from the recent drama surrounding Moderna’s mRNA flu vaccine.
Poplar Therapeutics is seeking a “step change” in the treatment of food allergy and other atopic conditions, with $95 million raised to date, including a $45 million series A extension that closed Tuesday.
Infrastructure and location have helped make Holly Springs a future hub for obesity drug production, with Amgen and Roche planning to manufacture GLP-1 therapies there to compete in the growing market.
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Eli Lilly’s win in a head-to-head trial drove Novo Nordisk’s market cap to pre-Wegovy levels not long after the victor became the first pharma company to top a $1 trillion valuation. It seems one company can do no right, while the other can do no wrong.
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GSK is carving out a niche for Blenrep in the second-line multiple myeloma setting, for which it projects multi-blockbuster potential for the antibody-drug conjugate.
Following strong treatment response data for Adaptimmune’s lete-cel, the biotech is planning to initiate a rolling BLA submission to the FDA, set to start by the end of 2025.
The FDA has followed in the footsteps of its European counterparts and granted accelerated approval to PTC Therapeutics’ gene therapy Kebilidi for AADC deficiency. It is the first approved gene therapy to be delivered directly to the brain.
Following patient deaths in a lupus trial that led to the termination of that program, Kezar’s autoimmune candidate zetomipzomib faces a partial clinical hold barring four trial participants from continuing treatment in the open-label portion of the trial, though the trial itself will continue as planned.
Despite crowding in the next-gen weight loss space, Metsera has raised over $500 million since its April launch, indicating a continued appetite for these drugs.
A slow launch for Alzheimer’s medicine Leqembi, a lackluster pipeline and a challenging drug launch environment are just a few of the factors that have sent Biogen’s shares down this year.
The acquisition will give BioNTech full ownership of an investigational bispecific antibody targeting the PD-L1/VEGF-A pathways, a hot area in oncology that could potentially replace standard checkpoint inhibitors for cancer treatment.
With the Phase III failure, Syros will discontinue the study of tamibarotene for myelodysplastic syndrome and will default on its loan from Oxford Finance LLC.
Cantor Fitzgerald analyst Olivia Brayer found supplementary bone mineral density data for Amgen’s obesity candidate MariTide that could point to a potentially greater fracture risk than previously revealed, but some other analysts view the findings as a nonissue.