Tonix Pharmaceuticals Holding Corp.’s failure last December in the phase III study called Recovery with TNX-102 SL (cyclobenzaprine HCl sublingual tablets) 5.6 mg dented hopes for patients with civilian and military-related post-traumatic stress disorder (PTSD), but other developers remain in the game.
Phase II data with San Diego-based Heron Therapeutics Inc.’s pain drug HTX-011 (Zynrelef) graced the online pages of the Journal of the American Podiatric Medical Association in early January, whetting investor thirst for an FDA decision regarding approval, slated by May 12. And the agency’s go-ahead, if it comes, could have special meaning for Pacira Biosciences Inc. with competing analgesic Exparel (bupivacaine).
LONDON – Remynd NV has extended its series B, raising a further €12 million and bringing the total for the round to €24 million (US$29 million). The new money will fund clinical proof-of-concept trials in the diverse indications of Alzheimer’s disease and diabetes.
Aging is not just wear and tear. It is an active process that is driven, at least in part, by chronic inflammation that is the result of immune cell dysfunction. Now, investigators at Stanford University have identified the metabolic switch underlying immune cell switch from function to dysfunction.
DUBLIN – Mina Therapeutics Ltd. is extending its small activating RNA (saRNA) technology into the central nervous system through a partnership with Les Laboratoires Servier SAS that could be worth as much as €220 million (US$266.5 million) in up-front and milestone payments.
Luye Pharma Group Ltd. won marketing approval in China for its risperidone microspheres for injection to treat schizophrenia, which the company said is the first formulation developed by a Chinese company in the space to get a green light. Under the trade name Ruixintuo, the long-acting drug is administered once every two weeks by intramuscular injection.
Alzheimer’s disease can be divided into multiple subtypes based on gene expression patterns, investigators at the Mount Sinai School of Medicine reported in the Jan. 6, 2021, issue of Science Advances. The work, corresponding author Bin Zhang told BioWorld, is “the first major finding of subtypes in Alzheimer’s disease.”
Shares of Eli Lilly and Co. (NYSE:LLY) leapt 11.7% to $185.94, their second biggest gain since 2010, after a phase II trial showed its beta-amyloid-targeting monoclonal antibody, donanemab, appeared to slow by 32% decline in a composite measure of cognition and daily function in patients with early symptomatic Alzheimer’s disease vs. placebo.
LONDON – Family-owned Angelini Pharma is to buy Swiss startup Arvelle Therapeutics GmbH for $960 million, acquiring full European rights to the epilepsy drug cenobamate. The first tranche, of $610 million, will be paid following the EMA’s recommendation to approve cenobamate, which is expected at either the January or February meeting of the Committee for Medicinal Products for Human Use.
DUBLIN – A re-evaluation of psychedelic drugs as potential therapies for major depressive disorder, anxiety, post-traumatic stress disorder and other neuropsychiatric conditions has been underway for some time, but this broad effort gained further momentum during 2020, as commercial firms started to raise money at the level needed to enable the field to start moving from small-scale academic studies to the kind of industry-scale trials that will be needed to convince regulators, patients and physicians that these molecules could become viable treatment options.