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CNS

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Aptinyx Appears To Be Moving On From Pain With Fibromyalgia Miss

Lead candidate NYX-2925 has failed a pair of Phase IIb studies in diabetic peripheral neuropathy and now one in fibromyalgia, leaving Aptinyx’s likely last hopes in neuropsychiatric indications.

Clinical Trials Business Strategies

Merck Takes A New Shot At Alzheimer’s With Cerevance Deal

The major will use the biotech’s brain cell-focused platform technology to discover new targets for Alzheimer’s disease.

Deals Neurology

New Era For Schizophrenia Therapy Beckons As Karuna Soars On Promising Phase III Data

The PureTech Health-founded entity believes it has made a significant step forward in the treatment of schizophrenia with its muscarinic-receptor acting agent KarXT, which could offer a completely new way to address all three symptom domains of the disease.

Clinical Trials Companies

Future Of Acadia’s Nuplazid In Alzheimer’s Psychosis Unclear After CRL

An analyst had suggested that in the event of a thumbs-down from the FDA, the company could end up focusing on other catalysts instead. 

Complete Response Letters Business Strategies

Quick Listen: Scrip's Five Must-Know Things

In this week's podcast version of Five Must-Know Things: BMS’s new products meet early expectations; Eisai to shut a US unit in global R&D restructuring; Roche aims high for Vabysmo; US priority review for Biogen’s ALS contender; and a chat with Gennova’s CEO.

Commercial Companies

Sarepta Pursues DMD Gene Therapy Accelerated Approval To Be First To Market

Sarepta has experience pursuing accelerated approvals in the US for Duchenne muscular dystrophy therapies, but with a costly gene therapy will payers require data from a controlled Phase III study?

Gene Therapy Reimbursement

Biogen ALS Drug Granted FDA Priority Review, Triggering Aduhelm Déjà Vu

FDA accepted the NDA for tofersen based on a surrogate biomarker after a Phase III trial failure, echoing some elements of the Aduhelm experience, though in this instance the target patient population is ultra-niche.

Neurology Clinical Trials

Idorsia’s Quviviq Needs To Rise And Shine After Slow Launch

The company’s Quviviq launch has fallen short of early expectations, but Idorsia believes a patient approach will pay off for the blockbuster-tipped insomnia treatment.

Commercial Companies

Quick Listen: Scrip's Five Must-Know Things

In this week's podcast version of Five Must-Know Things: Novo obesity drugs in US cost-effectiveness spotlight; Biogen’s growth challenges; Novartis’s view on large M&A; pharma’s Q2 outlook; and MSD on Lagevrio.

M & A Business Strategies

VistaGen Staggered By Latest Clinical Setback, This Time In Social Anxiety

Failure of pherine nasal spray candidate in first of two Phase III trials for social anxiety disorder puts program in doubt, while the California biotech’s share price craters.

Clinical Trials Business Strategies

Without An Alzheimer’s Blockbuster, Biogen Is A Ship Without A Growth Rudder

In addition to its uncertain attempt at near-term revenue growth with Eisai-partnered lecanemab, Biogen recently ended multiple R&D programs and will pay $900m to settle a whistleblower lawsuit.

Business Strategies Legal Issues

CAMP4 Charts A Different Course In RNA-Based Therapeutics

Financing Snapshot: The company announced a $100m series B round that it plans to use to develop its regulatory RNA platform technology, with an eye toward entering the clinic in mid-2023.

Financing Neurology
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