While financings have reached record levels, the stocks of BioWorld’s Neurological Diseases Index are now underground by 12.5%, a trajectory shadowed by the Nasdaq Biotechnology Index, down by 3.45%. The Dow Jones Industrial Average representing the broader markets, however, is up by nearly 13%.

In 2021, no drug approval garnered as much attention and debate as Biogen Inc.’s Aduhelm (aducanumab). The FDA’s surprise, accelerated approval of Aduhelm for Alzheimer’s disease flew in the face of the recommendation by an advisory committee, causing a stir that included the resignation of three adcom members, along with publicly made claims that the company’s relationship with regulators had become too cozy.

After struggling in the past year, Ionis Pharmaceuticals Inc. will collaborate with Astrazeneca plc to develop eplontersen for treating transthyretin amyloidosis, which is systemic, progressive and fatal. At stake for Ionis is $2.9 billion in potential sales-related milestone payments.

PERTH, Australia – Neuren Pharmaceuticals Ltd.’s stock nearly doubled on positive top-line phase III results for trofinetide in Rett syndrome, meeting all primary and secondary endpoints in the pivotal phase III trial run by partner Acadia Pharmaceuticals Inc.

Far from the Groundhog Day spectacle of amyloid-targeting antibodies that do little to nothing for patients in trial after trial, researchers have reported success in reducing the risk of Alzheimer’s disease (AD) in unexpected ways. Researchers at the Cleveland Clinic Foundation have discovered that a Viagra prescription was associated with a roughly 70% reduced risk of being diagnosed with AD. And investigators from the University of Washington reported that in the prospective Adult Changes in Thought study, a long-term study into risk and protective factors for dementia, persons who underwent cataract surgery reduced their risk of AD by 30%, an effect that lasted for 10 years after surgery.

LONDON – Aviadobio Ltd. has raised $80 million in a series A round to take a precision microdosed gene therapy for treating familial frontotemporal dementia into a phase I/II clinical trial.

Novartis AG, keen to expand its central nervous system franchise as generics chase down crown jewel Gilenya (fingolimod), has secured rights from UCB SA to co-develop and commercialize two potential Parkinson's disease therapies for $150 million up front and milestone payments approaching $1.5 billion.

LONDON – Newco Loqus23 Therapeutics Ltd. has closed a £7 million (US$9.4 million) extension of its seed round, providing the means to progress its lead small-molecule program in Huntington’s disease through lead optimization. The extended round, from the Novartis Venture Fund and the U.K. government-backed Dementia Discovery Fund, follows an initial seed investment of £4.5 million by DDF in 2019, that was not made public at the time.

LONDON – Sosei Heptares is to get $100 million up front in a potential $2.6 billion deal with Neurocrine Biosciences Inc., in which the pair will develop muscarinic receptor agonists in the treatment of schizophrenia, dementia and other neuropsychiatric disorders. San Diego-based Neurocrine is taking rights to a portfolio of small molecules against specific subtypes of the muscarinic receptor family, targeting M1 and M4 alone, plus a dual M1/M4 agonist.

A European approval for Alzheimer’s drug aducanumab by year-end looks even more in doubt. A week after being called in before the EMA’s Committee for Medicinal Products for Human Use (CHMP) for an oral explanation of the trial data, Biogen Inc. said it received a “negative trend vote” on the marketing authorization application. A formal opinion by the CHMP is expected at its December meeting, but analysts are not optimistic.