Positive top-line data from the phase IIb study of BNC-210 to treat post-traumatic stress disorder (PTSD) supercharged Bionomics Ltd.’s stock. Shares (NASDAQ:BNOX) closed trading a dramatic 243.8% higher at $3.37 each on Sept. 28. The oral, selective negative allosteric modulator of the alpha7 nicotinic acetylcholine receptor stumbled last December in a phase II trial for treating social anxiety disorder but now has regained momentum.
Acurastem Inc. said on Sept. 25 that it struck an out-licensing deal potentially worth $580 million with Takeda Pharmaceutical Co. Ltd. to develop drugs for amyotrophic lateral sclerosis (ALS) and other PIKfyve gene-targeting therapeutics. Under the terms, Tokyo-headquartered Takeda obtains exclusive worldwide rights to Acurastem’s PIKfyve-targeting therapeutics, including Acurastem’s lead AS-202 asset, an antisense oligonucleotide therapy to treat ALS.
Thanks to a raft of new approvals by Japan’s Ministry of Health, Labor and Welfare (MHLW), patients in Japan will soon have access to Biogen Inc./Eisai Co. Ltd.’s Leqembi (lecanemab), an amyloid-beta binder, for slowing progression of mild cognitive impairment and mild dementia due to Alzheimer's disease.
New and updated clinical data presented by biopharma firms at the International Association for the Study of Lung Cancer, 2023 World Conference on Lung Cancer, including: Astrazeneca, Daiichi.
Otsuka Pharmaceutical Co. Ltd. announced plans to acquire Mindset Pharma Inc. for C$80 million (US$50.76 million) in an all-cash deal that will see Otsuka strengthen its neurology and psychiatric pipeline. Mindset, of Toronto, is developing next-generation psychedelic therapeutics to treat psychiatric and neurological disorders with high unmet needs.
Incannex Healthcare Ltd. is gearing up to begin a pivotal phase II/III trial in the U.S. for its lead asset, IHL-42X (dronabinol/acetazolamide), a synthetic cannabinoid combination drug for sleep apnea.
China’s National Medical Products Administration (NMPA) accepted Luye Pharma Group Ltd.’s NDA for rotigotine (LY-03003) extended-release microspheres and granted it priority review for treating Parkinson’s disease.
Viage Therapeutics Inc. – formerly Digestome Therapeutics Inc. – on July 26 unveiled positive data from its phase I study on DGX-001 for mild cognitive impairment in Alzheimer’s disease (AD) and Parkinson’s (PD). The randomized, double-blind, placebo-controlled study demonstrated changes in brain activity according to quantitative electroencephalography (qEEG) measurements in 68 healthy volunteers dosed with single ascending and multiple ascending doses.
Top-line results show a disappointing placebo effect that resulted in Sumitomo Pharma Co. Ltd./Otsuka Pharmaceutical Co. Ltd.’s ulotaront (SEP-363856) missing the primary endpoints in both the Diamond (Developing Innovative Approaches for Mental Disorders) 1 and Diamond 2 trials in schizophrenia.
Kissei Pharmaceutical Co. Ltd. has withdrawn its NDA in Japan for rovatirelin (KPS-0373) for the treatment of spinocerebellar degeneration. Kissei, of Osaka, Japan, said it temporarily withdrew the application for marketing approval and would discuss the possibility of conducting additional clinical trials with Japan’s Pharmaceuticals and Medical Devices Agency (PMDA), because the PMDA expressed concern about the approval based on the current clinical trial data.
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