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BioWorld - Thursday, September 28, 2023
Home » Topics » Neurology/Psychiatric, BioWorld

Neurology/Psychiatric, BioWorld
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Central nervous system

PTC stays the course after phase III Friedreich’s miss; sky clearer for Skyclarys?

May 24, 2023
By Randy Osborne
No Comments
“We clearly see an active drug here,” PTC Therapeutics Inc. CEO Matthew Klein said of the 15-lipoxygenase inhibitor vatiquinone for Friedreich’s ataxia (FA), tested in a phase III study called Move-FA that missed the primary endpoint of statistically significant change in modified FA Rating Scale score at 72 weeks. The company will “take one step at a time” decisions about the drug, analyzing the results and then consulting with the U.S. FDA regarding how to proceed, he said. Meanwhile, Wall Street wasn’t happy, and South Plainfield, N.J.-based PTC’s shares (NASDAQ:PTCT) closed May 24 at $46.95, down $11.46, or 19.6%.
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Leqembi

Pressure mounts for CMS coverage ahead of Leqembi’s ‘full’ approval date

May 22, 2023
By Mari Serebrov
No Comments
As the clock ticks toward the “full,” or traditional, approval date for Biogen Inc./Eisai Co. Inc.’s Alzheimer’s drug, Leqembi (lecanemab), the U.S. Centers for Medicare & Medicaid Services (CMS) is facing increasing pressure to get the structures in place to ensure Medicare beneficiaries have access to the drug when the approval comes.
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Sleep apnea illustration

Apnimed moving to phase III with oral therapy for sleep apnea

May 22, 2023
By Jennifer Boggs
No Comments
Apnimed Inc. is gearing up to start phase III testing with AD-109, a once-daily combination of atomoxetine and aroxybutynin that has the potential to be the first oral therapy to treat obstructive sleep apnea, following positive results from the phase IIb Mariposa trial.
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Scribe pens $1.5B-plus CRISPR tech deal with Lilly

May 16, 2023
By Caroline Richards
No Comments
Scribe Therapeutics Inc. is selling exclusive rights to its CRISPR-based technology to Prevail Therapeutics Inc. for a figure that could top $1.6 billion as the firms team up to develop genetic therapies for serious neurological and neuromuscular diseases.
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Brain and encephalography

JCR partners with Angelini on biologic therapies for epilepsy

May 15, 2023
By Zhang Mengying
No Comments
Angelini Pharma SpA and JCR Pharmaceuticals Co. Ltd. signed an exclusive worldwide agreement for the development and commercialization of biologic therapies for epilepsy based on the J-Brain Cargo technology.
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Cross section of brain
Newco news

Nido Biosciences raises $109M to drug novel targets in neurological disease

May 15, 2023
By Cormac Sheridan
No Comments
Nido Biosciences Inc. emerged from stealth by unveiling $109 million in series A and B equity funding and a clinical-stage program in spinal and bulbar muscular atrophy.
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PET imaging of RELN-COLBOS (H3447R) carrier brain showing limited aggregation of tau
Neurology/Psychiatric

Reelin’ in druggable protective pathways with second Alzheimer’s ‘escapee’

May 15, 2023
By Anette Breindl
No Comments
Investigators have identified a second individual who remained cognitively normal into his late 60s despite having the PSEN1 E280A mutation, which causes a familial version of early-onset Alzheimer’s disease (AD). The likely source of protection, a mutation in a gene called Reelin, is distinct from the protective mechanism identified in the first case of an individual who was protected from the effects of PSEN1 E280A. That case was reported in 2019.
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Chance Pharma licenses inhalable PD treatment from Acorda in $140M deal

May 11, 2023
By Zhang Mengying
No Comments
Chance Pharmaceuticals Co. Ltd. acquired greater China rights to Inbrija (levodopa inhalation powder), used to manage Parkinson’s disease (PD), from Acorda Therapeutics Inc. in a deal worth as much as $140 million.
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Elderly man with clenched hands holding head

US FDA approves Rexulti as first drug for agitation in Alzheimer’s dementia

May 11, 2023
By Tamra Sami and Karen Carey
On its May 10 PDUFA date, the U.S. FDA approved serotonin-dopamine modulator Rexulti (brexpiprazole) from Otsuka Pharmaceutical Co. Ltd. and H. Lundbeck A/S for agitation in Alzheimer’s dementia, marking the first approved treatment for the indication.
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Kinoxis-BI deal

Kinoxis and Boehringer to develop oxytocin-targeting treatments for social dysfunction in $181M deal

May 5, 2023
By Tamra Sami
No Comments
University of Sydney spinout Kinoxis Therapeutics Pty announced a partnership and licensing agreement with Boehringer Ingelheim GmbH to develop first-in-class oxytocin-targeting precision psychiatry treatments to improve the quality of life of people living with neuropsychiatric disorders. Under the terms of the agreement, Kinoxis will receive an up-front payment and research support payments and is eligible for research, preclinical, clinical, regulatory and commercial milestones of up to AU$266 million (US$181 million), in addition to sales-based royalties.
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