Biohaven Ltd. has acquired global rights, excluding China, from Highlightll Pharmaceutical Co. Ltd. to develop and commercialize a dual inhibitor of tyrosine kinase 2 (TYK2) and JAK1, BHV-8000 (TLL-041), for the treatment of brain disorders in a deal worth up to $970 million.
Just days after Karuna Therapeutics Inc. reported positive data from a third registrational trial of Karxt (xanomeline plus trospium) in schizophrenia, Puretech Health plc sold a portion of its royalty in Karxt in a potential $500 million agreement with Royalty Pharma. Puretech was a founder of Karuna and co-inventor of Karxt, an oral M1/M4-preferring muscarinic agonist.
FDA approval of Aduhelm (aducanumab), as the first disease modifying drug for Alzheimer’s, may have had a distinctly lukewarm reception in some quarters, but it is an important starting point in treating dementia, with a myriad of other avenues now being pursued in discovery and development.
If you believe the theme of the World Dementia Council (WDC) meeting in London this week, dementia is “in a new era,” where it will be possible to prevent, diagnose and treat neurodegenerative disease. That is not the case for most people living with dementia today, but the approval of the first disease-modifying drugs and the imminent arrival of new blood-based biomarkers is “a big moment,” Lenny Shallcross, executive director of WDC told the meeting on Mar. 20.
With phase III data in hand from the Emergent-3 study of Karxt (xanomeline plus trospium) in adults with schizophrenia, Karuna Therapeutics Inc. continues to target mid-2023 for an NDA submission to the U.S. FDA. The 256-subject trial met its primary endpoint, with Karxt turning up a statistically significant and clinically meaningful 8.4-point reduction in Positive and Negative Syndrome Scale total score compared to placebo at the fifth week.
Newco Teitur Trophics ApS has raised €28 million (US$30.1 million) in a series A with which it will lay out a new route to targeting sortilin in the treatment of neurodegenerative diseases. The company is targeting the sortilin-related Vps10p domain containing receptor, which plays a role in regulating a number of pathways involved in the control of neuronal viability and function.
The U.S. Veterans Health Administration (VA) is being applauded for doing what Medicare has refused to do – provide coverage for Leqembi (lecanemab) in the early stages of Alzheimer’s disease. Under the March 13 VA decision, the Eisai Co. Ltd. drug, which was partnered with Biogen Inc. and granted accelerated approval in January, will be listed as a nonformulary therapy that must be prescribed by a VA-board certified neurologist, geriatric psychiatrist or geriatrician who specializes in treating dementia.
Acadia Pharmaceuticals Inc. will make available by the end of this month Daybue (trofinetide), a synthetic analogue of the amino‐terminal tripeptide of IGF-1 for Rett syndrome (RS), which was greenlighted by the U.S. FDA March 10 and remains in the works for fragile X syndrome as well as undisclosed other indications.
Pricing won’t be known until later for Pfizer Inc.’s Zavzpret (zavegepant), which became the first and only calcitonin gene-related peptide receptor antagonist nasal spray approved by the U.S. FDA for acute treatment of migraine with or without aura in adults. The product is slated to launch this summer. Meanwhile, Wall Street has questions about New York-based Pfizer’s performance in the migraine space.
Quralis Inc. raised $88 million in series B round to fund clinical development of its two lead programs in amyotrophic lateral sclerosis (ALS) and to take forward earlier-stage pipeline projects in ALS and frontotemporal dementia.
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