Shots:
Merz has granted Kvvit exclusive license to Inbrija (levodopa inhalation powder) in mainland China, Hong Kong, & Macao for intermittent treatment of OFF episodes in adults with Parkinson’s disease receiving levodopa/dopa-decarboxylase inhibitor
Merz will supply Inbrija, oversee global quality & key regulatory activities, & act as Overseas Holder of the Drug Registration Certificate, while…
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The EC has approved Onerji (levodopa/carbidopa) infusion for advanced PD pts with uncontrolled motor fluctuations. The therapy is being developed by its wholly owned subsidiary, NeuroDerm
Approval was based on the global P-III (BouNDless) trial, which demonstrated Onerji + supplemental oral LD/CD significantly increased ON time without troublesome dyskinesia and reduced OFF time vs immediate-release oral LD/CD. Favourable long-term safety and tolerability results were also observed in the…
Shots:
The US FDA has granted clearance to Cala kIQ Plus system, a wearable neurostimulation device, for the treatment of action hand tremor in essential tremor (ET) & Parkinson's disease (PD)
The Cala kIQ device provides temporary relief of hand tremors in adults with essential tremor & Parkinson’s disease, incl. postural & kinetic tremors, using transcutaneous…
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The US FDA has granted RMAT designation to NouvNeu001 for the treatment of Parkinson's disease
The P-I data showed marked improvements in MDS-UPDRS Part III motor scores, as low-dose pts achieved 30.6 (OFF; 52.82% improvement) & 12.9 (ON; 54.67% improvement) points at 12mos. & high-dose pts 23.3 (OFF) & 9.67 (ON) at 9mos., with…
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Valo Health has entered into a strategic collaboration with Merck KGaA to accelerate therapeutic discovery for Parkinson’s disease & related neurodegenerative disorders
As per the deal, Valo Health will receive an upfront & milestone payment totaling over $3B, with royalties & R&D funding
Collaboration will use Valo’s AI-enabled human causal biology platform to discover &…
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The US FDA has received an NDA for tavapadon (QD, PO) for Parkinson’s disease (PD), supported by P-III (TEMPO-1 & 2) trials in early PD & P-III (TEMPO-3) evaluating adjunctive use with levodopa in pts with motor fluctuations, plus interim data from P-III (TEMPO-4) open label study
TEMPO-1 (n=529) & TEMPO-2 (n=304) evaluated fixed…
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Arrowhead has granted Novartis exclusive global rights to develop, manufacture, & commercialize ARO-SNCA, which leverages the TRiM platform for SC dosing & targeted gene delivery to treat synucleinopathies, incl. Parkinson’s disease
As per the deal, Arrowhead will receive $200M upfront & ~$2B in development, regulatory, and sales milestones, with tiered royalties on sales up…
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Herantis has dosed first pts with HER-096, a synthetic peptidomimetic in final arm of its P-Ib trial for Parkinson’s disease
The P-Ib trial consists of 2 parts, with the 1st assessing the safety & PK properties of 300mg HER-096 (SC) & Part 2 evaluating HER-096 vs PBO in 2 Arms along with selected biomarkers…
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Orion & Criceto have entered into an exclusive license agreement to develop & commercialize Aporon for the treatment of OFF episodes in pts with Parkinson’s disease
As per the deal, Orion will obtain global exclusive license of Aporon excl. the US & Canada in exchange for upfront payments, reimbursements for development costs & sales-based…
Shots:
The US FDA has approved Onapgo injection (SPN-830; SC infusion device) to treat motor fluctuations in adults with advanced Parkinson’s disease; commercially available in Q2’25
Approval was based on a 12wk P-III trial assessing Onapgo (n=53) vs PBO (n=51) in Parkinson’s pts (N=107), evaluating 1EP of mean change in total daily OFF time…

