Ketamine manufacturing validation strengthens launch readiness ahead of November 10 ANDA goal
- NRX-100 FiledDepression · NMDA receptor modulator
- preservative-free ketamine ANDA FiledAnesthesia
- NRX-101 Phase 3Depression · NMDA receptor modulator
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FDA decisions on relutrigine (Dec 27) and ulixacaltamide (Jan 29) approach after clean mid-cycle reviews; vormatrigine restarts after POWER1 missed
- relutrigine FiledDevelopmental And Epileptic Encephalopathy · first-in-class preferential inhibitor of persistent sodium current
- ulixacaltamide FiledEssential Tremor · selective T-type calcium channel inhibitor
- elsunersen Phase 3Scn2A Developmental And Epileptic Encephalopathy · antisense oligonucleotide selectively decreasing SCN2A expression
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Azetukalner is filed in focal epilepsy as Xenon pauses new psychiatry enrollment
- azetukalner FiledFocal Onset Seizures · Kv7 potassium channel opener
- azetukalner Phase 3Major Depressive Disorder · Kv7 potassium channel opener
- azetukalner Phase 3Primary Generalized Tonic-Clonic Seizures · Kv7 potassium channel opener
- azetukalner Phase 3Bipolar Depression · Kv7 potassium channel opener
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Durable SPS benefit supports miv-cel's filing path; FDA approval remains decisive
- miv-cel FiledStiff Person Syndrome · anti-CD19 autologous CAR T-cell therapy
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Larimar plans to complete its rolling BLA for nomlabofusp in 2H 2026, seeking accelerated approval on skin frataxin, with a mid-2027 launch target
- nomlabofusp FiledFriedreich'S Ataxia · cell penetrating peptide-fused frataxin protein replacement
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AMT-130 BLA filed on three-year data; four-year analysis missed significance on cUHDRS
- AMT-130 FiledHuntington'S Disease · gene therapy (microRNA-based huntingtin suppression)
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Biohaven licensed opakalim to SK Biopharmaceuticals and BHV-1300 in Asia to Ono, funding its Graves' disease Phase 3 after the troriluzole rejection
- BHV-8000 Phase 3Parkinson'S Disease · brain-penetrant TYK2/JAK1 inhibitor
- Opakalim Phase 3Epilepsy · Kv7.2/7.3 ion channel activator
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Ionis's own launches are growing; partner Roche reported Phase 3 sefaxersen data
- obudanersen Phase 3Angelman Syndrome · UBE3A-ATS inhibitor (RNA-targeted)
- ulefnersen Phase 3Amyotrophic Lateral Sclerosis · FUS protein reducer (RNA-targeted)
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AC Immune expects initial data by year-end on whether its NLRP3 inhibitor ACI-19764 lowers inflammation in patients, and plans FDA meetings on a Phase 2 expansion for its Parkinson's vaccine ACI-7104 in early 2027; cash of CHF 75.4 million lasts into Q4 2027
- PI-2620 Phase 3Alzheimer'S Disease · Tau-PET tracer
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Coya prioritizes ALS; FTD start moves to 2027, runway guidance unchanged
- COYA 302 Phase 3Amyotrophic Lateral Sclerosis · dual immunomodulatory biologic; Treg enhancer and monocyte/macrophage inflammation suppressor
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HLP003 pivotal readout remains expected in Q4 2026 as leadership transition continues
- HLP003 Phase 3Major Depressive Disorder · novel serotonergic agonist (NSA)
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Harrow still needs a sharp commercial ramp to deliver annual guidance
- TRIESENCE Phase 3Ocular Pain
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FDA accepted Intellia's BLA for lonvo-z in hereditary angioedema with Priority Review and a March 10, 2027 decision date; both nex-z Phase 3 trials resumed enrollment after FDA lifted its clinical holds
- nex-z Phase 3Hereditary ATTR Amyloidosis With Polyneuropathy · in vivo CRISPR-based gene inactivation; reduces TTR protein production
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Ryoncil grows; back-pain results and LVAD filing remain key
- rexlemestrocel-L Phase 3Chronic Low Back Pain · mesenchymal precursor cell (MPC) therapy
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Neuphoria is merging into Scancell, whose iSCIB1+ showed 77% 22-month PFS with ipilimumab and nivolumab in melanoma
- BNC-210 Phase 3Social Anxiety Disorder · α7 nicotinic receptor negative allosteric modulator
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OKYO's Phase 3 NEPTUNE trial of urcosimod in neuropathic corneal pain enrolled its first patients in October
- urcosimod Phase 3Neuropathic Corneal Pain · lipid-conjugated chemerin peptide agonist of ChemR23 GPCR
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Brepocitinib is approved and won two uveitis Phase 3s; FcRn data come in 2027
- IMVT-1402 Phase 3Chronic Inflammatory Demyelinating Polyneuropathy · FcRn inhibitor
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