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Roche's phase 2b trial of prasinezumab, an anti-alpha-synuclein antibody partnered with Prothena, failed to meet its primary endpoint for treating early-stage Parkinson's disease, with a p value of 0.0657. However, Roche highlighted potential clinical efficacy in a subgroup receiving levodopa, showing a nominal p value of 0.0431. Despite the setbacks in alpha-synuclein targeting therapies, Roche plans to continue tracking patients and evaluate future steps after discussions with regulators.
Roche, the majority shareholder in Chugai Pharmaceutical, is focused on advancing treatments for neurological disorders, including Parkinson's disease, which affects over 10 million people globally. The company is investigating various approaches to slow disease progression and improve patient quality of life, while also committing to sustainability and personalized healthcare. Founded in 1896, Roche has become a leader in biotechnology and diagnostics, aiming for net zero emissions by 2045.
Roche has launched the cobas Mass Spec, a groundbreaking device for mass spectrometry that has received CE Mark approval. This innovative solution will provide over sixty analytical tests, enhancing patient care by enabling earlier detection of therapeutic responses, particularly in breast cancer patients undergoing hormonal therapy. The technology promotes automation and sustainability in laboratory workflows, aligning with Roche's strategic integration of clinical chemistry and immunochemistry testing.
Regeneron's Eylea HD has demonstrated noninferior visual acuity gains compared to the original Eylea in patients with macular edema following retinal vein occlusion, paving the way for a 2025 FDA filing. The drug, which generated $392 million in U.S. sales in Q3, faces competition from Amgen's biosimilar and Roche's Vabysmo, but its potential approval in RVO could boost sales further.
The Swiss stock market is set to open lower, with the SMI index down 0.24% ahead of the US Federal Reserve's monetary policy decision and UK inflation data. Analysts anticipate a 25 basis point rate cut from the Fed, despite concerns over inflation in a strong US economy. Roche is slightly up after receiving a CE mark for a new testing device, while Dätwyler faces a significant loss due to a restructuring plan.
Teva/Sanofi's Phase IIb data for their anti-TL1A agent in ulcerative colitis and Crohn’s disease has been described as potentially best in class, raising competitive stakes against Merck and Roche. Meanwhile, PureTech's deupirfenidone has outperformed Roche's Esbriet in a Phase IIb trial for idiopathic pulmonary fibrosis, positioning the company to finalize its Phase III program and explore financing options.
AbbVie has acquired Nimble Therapeutics for $200 million, gaining access to an oral peptide drug candidate aimed at treating psoriasis by inhibiting the IL23 receptor. This addition complements AbbVie's existing injectable drug, Skyrizi, and aims to address significant unmet medical needs in autoimmune diseases.
AbbVie is set to acquire Nimble Therapeutics, an oral peptide developer spun out from Roche, for $200 million, with potential milestone payments. Nimble, led by former Roche scientist Jigar Patel, is developing three drug candidates targeting autoimmune diseases, including therapies for generalized myasthenia gravis, psoriasis, and inflammatory bowel disease. The acquisition will enhance AbbVie's capabilities in peptide drug development, positioning it to better address the needs of patients with autoimmune conditions.
Teva and Sanofi's experimental drug, duvakitug, demonstrated significant efficacy in a Phase 2 trial for inflammatory bowel disease, with around 50% of ulcerative colitis patients and 48% of Crohn’s disease patients showing symptom resolution compared to placebo. The companies plan to advance to late-stage development, highlighting duvakitug's potential as a leading treatment in a competitive market. Following the promising results, Teva's shares surged nearly 20%, while Sanofi's rose by almost 5%.
UCB's investigational small molecule minzasolmin, developed in partnership with Novartis, has failed to meet primary and secondary endpoints in a phase 2a trial for early-stage Parkinson's disease, leading to the termination of its extension phase. The study, which involved 496 patients, showed comparable treatment-emergent adverse events across groups, with no new safety risks identified. UCB continues to explore alpha-synuclein pathology with other candidates, including UCB7583 and glovadalen, the latter of which is in a phase 2 trial with results expected in March 2025.
Hoffmann-La Roche AG
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The information provided herein is generated by experimental artificial intelligence and is for informational purposes only.
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