This week’s Neuroscience update features regulatory decisions, pipeline progress, device innovation, clinical-trial updates, and shifts in competitive landscapes across drug development, imaging, and digital biomarkers.
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[10 Dec 2025]
Key point: Formation Bio took worldwide rights ex-Greater China to LNK01006, an allosteric TYK2 with CNS exposure; IND cleared, Phase 1 planned H1 2026. Upfront, equity, and milestones up to $605M plus royalties.
Context: Asset moves into Bleecker Bio, a Formation subsidiary; Lynk retains Greater China.
Implication: Signals pipeline investment and modality expansion.
🧲 Phase 3 CNS MRI contrast, HRS-9231 vs gadobutrol/unenhanced [2] [11 Dec 2025]
https://clinicaltrials.gov/study/NCT07275814?aggFilters=phase:3
Key point: Randomized, double-blind, crossover Phase 3 will test lesion-visualization superiority over unenhanced MRI and non-inferiority to gadobutrol (endpoint not specified).
Context: Adult CNS lesion imaging; includes population PK; interventions are HRS-9231 and gadobutrol.
Implication: Could inform practice and payer discussions; interpretation depends on study design and confounding control.
🧠 FDA clears first at-home tDCS for MDD, Flow FL-100 [3] [US • 11 Dec 2025]
Key point: FL-100 authorized as prescription at-home tDCS for adults with moderate to severe MDD, as mono- or adjunctive therapy; US availability targeted Q2 2026.
Context: Pivotal remote RCT showed greater HDRS improvement vs sham; adverse events generally mild; Breakthrough designation in 2022.
Implication: Could streamline initiation and adherence via remote prescribing and logistics.
🤝 Cycle Pharma to acquire Applied Therapeutics (govorestat) [4] [12 Dec 2025]
https://www.thepharmaletter.com/pharmaceutical/cycle-pharma-to-acquire-applied-therapeutics
Key point: Definitive agreement for Cycle to acquire APLT, adding govorestat, a CNS-penetrant aldose reductase inhibitor for rare metabolic CNS diseases.
Context: Programs include classic galactosemia, CMT-SORD, PMM2-CDG; terms not specified in source.
Implication: Signals pipeline investment and modality expansion.
⚖️ EPO revokes Biogen Tecfidera dosage patent EP 873 [5] [EU • 12 Dec 2025]
https://www.juve-patent.com/cases/boards-of-appeal-revoke-biogens-dosage-patent-for-tecfidera/
Key point: EPO Technical Board of Appeal revoked EP 2 653 873 for added matter, disrupting Biogen’s EU enforcement; generics free to proceed in markets such as Germany, France, Spain, UK.
Context: Follows late SPC setback and PI litigation across Europe; another divisional EP 4 137 819 remains under examination.
Implication: Introduces competition that may affect pricing and formulary access.
🧩 Anavex blarcamesine EU review gets CHMP negative opinion [6] [EU • 12 Dec 2025]
Key point: CHMP adopted negative opinion for blarcamesine in early Alzheimer’s; Anavex will request re-examination per EMA procedures.
Context: Follows prior negative trend vote after oral explanation; new reviewers conduct re-exam.
Implication: May influence prescriber choice and payer reviews pending full data.
🧭 NeuraLight names top scientific leaders to SAB [7] [13 Dec 2025]
Key point: Prof. Thomas Südhof joins as Scientific Co-founder and SAB member; Prof. Olivier Rascol chairs; board to guide validation and pharma trial integrations.
Context: Company reports tablet-based eye-movement biomarkers with higher sensitivity than MDS-UPDRS and deployments across PD, ALS, MS, HD.
Implication: Could inform practice and payer discussions; interpretation depends on study design and confounding control.
🌿 NeOnc NEO100 intranasal update in IDH1-mutant astrocytoma [8] [15 Dec 2025]
Key point: In 25-patient Phase 1/2a plus compassionate-use set, 24% showed radiographic remission; PFS-6 44%; 36% alive ≥18 months; no significant toxicity reported.
Context: Recurrent WHO Grade III/IV IDH1-mutant astrocytoma; assessments per RANO; single-arm observational update.
Implication: Could inform practice and payer discussions; interpretation depends on study design and confounding control.
Why it matters
- At-home neuromodulation for MDD may expand access beyond clinic-based TMS.
- EU Tecfidera ruling accelerates DMF generic competition, with pricing and access impacts.
- CNS-penetrant small molecules remain active across immunology and rare metabolic diseases.
- Digital and sensor-based biomarkers are moving into trial workflows, but require rigorous validation.
- Early neuro-oncology signals are encouraging, yet confirmatory, controlled studies are needed.
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FAQ
What is LNK01006 and who owns rights outside China?
LNK01006 is an allosteric, CNS-penetrant TYK2 inhibitor. Formation Bio licensed worldwide rights excluding Greater China from Lynk, with milestones up to $605M and royalties [1].
What does the HRS-9231 trial aim to show versus gadobutrol?
It is a randomized, double-blind, crossover Phase 3 designed to demonstrate superiority over unenhanced MRI and non-inferiority to gadobutrol in CNS lesion visualization (endpoint not specified) [2].
When will Flow’s FL-100 be available in the US and for whom?
Flow targets Q2 2026 US availability by prescription for adults with moderate to severe MDD, as mono- or adjunctive therapy, excluding treatment-refractory patients per indication language [3].
What happens to Tecfidera generics in Europe after EP 873 revocation?
With EP 2 653 873 revoked for added matter, PI and infringement efforts are disrupted and generics can proceed in key EU markets and the UK, though another divisional remains under examination [5].
What is the status of Anavex’s blarcamesine in the EU?
CHMP issued a negative opinion for early Alzheimer’s. Anavex will request re-examination, which is handled by different reviewers under EMA procedures [6].
What is govorestat and why is Cycle acquiring Applied Therapeutics?
Govorestat is a CNS-penetrant aldose reductase inhibitor for rare metabolic CNS diseases. The acquisition adds this program suite to Cycle’s portfolio; deal terms not stated in the source [4].
Entities / Keywords
Formation Bio; Bleecker Bio; Lynk Pharmaceuticals; LNK01006; TYK2; CNS-penetrant. Hengrui; HRS-9231; gadobutrol; GBCA; CNS MRI. Flow Neuroscience; FL-100; tDCS; MDD. Cycle Pharmaceuticals; Applied Therapeutics; govorestat; aldose reductase inhibitor; classic galactosemia; CMT-SORD; PMM2-CDG. Biogen; Tecfidera; dimethyl fumarate; EP 2 653 873; EPO Boards of Appeal; generics. Anavex Life Sciences; blarcamesine; CHMP; EMA; early Alzheimer’s. NeuraLight; SAB; Thomas Südhof; Olivier Rascol; MDS-UPDRS; eye-movement biomarkers. NeOnc Technologies; NEO100; intranasal; IDH1-mutant astrocytoma; RANO.