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Lead candidate NYX-2925 has failed a pair of Phase IIb studies in diabetic peripheral neuropathy and now one in fibromyalgia, leaving Aptinyx’s likely last hopes in neuropsychiatric indications.
The major will use the biotech’s brain cell-focused platform technology to discover new targets for Alzheimer’s disease.
The PureTech Health-founded entity believes it has made a significant step forward in the treatment of schizophrenia with its muscarinic-receptor acting agent KarXT, which could offer a completely new way to address all three symptom domains of the disease.
An analyst had suggested that in the event of a thumbs-down from the FDA, the company could end up focusing on other catalysts instead.
In this week's podcast version of Five Must-Know Things: BMS’s new products meet early expectations; Eisai to shut a US unit in global R&D restructuring; Roche aims high for Vabysmo; US priority review for Biogen’s ALS contender; and a chat with Gennova’s CEO.
Sarepta has experience pursuing accelerated approvals in the US for Duchenne muscular dystrophy therapies, but with a costly gene therapy will payers require data from a controlled Phase III study?
FDA accepted the NDA for tofersen based on a surrogate biomarker after a Phase III trial failure, echoing some elements of the Aduhelm experience, though in this instance the target patient population is ultra-niche.
The company’s Quviviq launch has fallen short of early expectations, but Idorsia believes a patient approach will pay off for the blockbuster-tipped insomnia treatment.
In this week's podcast version of Five Must-Know Things: Novo obesity drugs in US cost-effectiveness spotlight; Biogen’s growth challenges; Novartis’s view on large M&A; pharma’s Q2 outlook; and MSD on Lagevrio.
Failure of pherine nasal spray candidate in first of two Phase III trials for social anxiety disorder puts program in doubt, while the California biotech’s share price craters.
In addition to its uncertain attempt at near-term revenue growth with Eisai-partnered lecanemab, Biogen recently ended multiple R&D programs and will pay $900m to settle a whistleblower lawsuit.
Financing Snapshot: The company announced a $100m series B round that it plans to use to develop its regulatory RNA platform technology, with an eye toward entering the clinic in mid-2023.
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