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AbbVie's QULIPTA Gains Public Reimbursement in Quebec for Migraine Prevention

Drug ApprovalNeurology
  • Quebec's RAMQ has added QULIPTA (atogepant) to its formulary for both chronic and episodic migraine prevention, expanding access to this oral CGRP receptor antagonist.
  • The reimbursement criteria have been simplified, requiring only two failed preventive medication classes instead of three, aligning with updated Canadian Headache Society guidelines.
  • This milestone provides Quebec's migraine patients faster access to targeted therapy, with an estimated 5 million Canadians affected by this neurological condition.

FDA Approves First Lamotrigine Oral Suspension for Epilepsy and Bipolar Disorder Treatment

Drug ApprovalNeurology
  • OWP Pharmaceuticals received FDA approval for SUBVENITE® Oral Suspension, marking the first and only lamotrigine oral suspension available in the United States.
  • The liquid formulation addresses unmet needs for patients with swallowing difficulties, those requiring individualized dosing, or preferring liquid medications over tablets.
  • SUBVENITE® is indicated for epilepsy treatment in patients aged 2 years and older, monotherapy conversion in patients 16 and older, and bipolar I disorder maintenance therapy.
  • The innovative formulation is expected to launch later in 2025, offering precision dosing capabilities and improved accessibility for neurological and psychiatric patients.

Servier Acquires KER-0193 for $450M to Target Fragile X Syndrome, Marking First Neurology Asset

Orphan DrugNeurologyRare Disease
  • Servier acquired KER-0193 from Kaerus Bioscience for up to $450 million, marking the company's first neurology asset acquisition as part of its 2030 strategy to establish a leading neurology franchise.
  • KER-0193 is an orally bioavailable small molecule targeting BK channels for Fragile X syndrome, the most common genetic cause of autism spectrum disorder, with no currently approved treatments available.
  • The drug has received FDA Orphan Drug and Rare Pediatric Drug Designations and successfully completed Phase 1 trials, with Phase 2 studies planned for 2026 in America and Europe.
  • Fragile X syndrome affects approximately 1 in 7,000 males and 1 in 11,000 females globally, representing a significant unmet medical need in neurodevelopmental disorders.

Octave Bioscience Secures $35.6M Series C Funding to Advance Multiple Sclerosis Precision Testing Platform

Precision MedicineNeurology
  • Octave Bioscience closed a $35.6 million Series C equity financing round and secured a $15.5 million non-dilutive term loan from Silicon Valley Bank to accelerate commercialization of its precision neurology platform.
  • The company's flagship Octave MSDA test has achieved significant commercial traction with over 325 prescribers, more than 19,000 patient tests delivered, and in-network reimbursement covering over 75 million lives.
  • Funding will support continued expansion of the first-of-its-kind MS disease activity test and advance the company's pipeline development in Parkinson's disease through its partnership with the Michael J. Fox Foundation.

PharmAla Establishes Australian Subsidiary to Advance MDMA Clinical Research and Development

Neurology
  • PharmAla Biotech has incorporated a wholly-owned Australian subsidiary, PharmAla Biotech Australia Pty Ltd., to conduct research and development activities for MDXX class molecules including MDMA.
  • The Australian entity will receive a full and perpetual license to PharmAla's lead drug candidate ALA-002 and all associated patents, positioning it to execute manufacturing development and clinical research.
  • The company has appointed Dr. Evan Lewis, a neurologist with specialized expertise in epilepsy and psychedelic medicine, to its Scientific Advisory Board effective September 1, 2025.
  • PharmAla positions itself as the only company currently provisioning clinical-grade MDMA for patient treatments outside of clinical trials, addressing the global backlog of generic MDMA for research purposes.

Kriya Therapeutics Raises $313M to Advance Gene Therapy Pipeline for Chronic Diseases

Neurology
  • Kriya Therapeutics has secured $313 million in new funding to advance its pipeline of single-dose gene therapies targeting chronic conditions including geographic atrophy and trigeminal neuralgia.
  • The company's lead candidate KRIYA-825 for geographic atrophy has completed IND-enabling studies and is ready to enter clinical testing, while KRIYA-748 for trigeminal neuralgia is also in advanced development.
  • The funding comes amid regulatory challenges facing the gene therapy sector, including recent safety concerns with AAV-based therapies and FDA restrictions on other approved gene therapies.

First Commercial Brain Gene Therapy Treatments Delivered in US Using ClearPoint Neuro's SmartFlow Cannula

FDA ApprovalRare DiseaseNeurology
  • The first commercial gene therapy treatments ever delivered directly to the brain in the United States have been successfully performed using ClearPoint Neuro's SmartFlow Neuro Cannula to administer KEBILIDI for AADC deficiency.
  • KEBILIDI (eladocagene exuparvovec-tneq) is delivered directly to the putamen region of the brain through stereotactic neurosurgery, with the SmartFlow cannula being the only FDA-authorized device for this administration.
  • ClearPoint Neuro reported record clinical activity in July with 17 global patients treated across 11 different drug platforms, while nine of the company's partners have now been accepted into FDA expedited review programs.
  • New ICD-10 codes specific to neuro infusions will become effective October 1, 2025, to assist in tracking commercial use of brain-delivered therapies.

IMA Group Acquires Medical Research Network to Expand CNS Clinical Trial Capabilities

Neurology
  • The IMA Group acquired Medical Research Network LLC, a New York City-based clinical research site specializing in psychiatry and neurology trials for central nervous system disorders.
  • The acquisition adds IMA's second research site in New York City and first East Coast location dedicated to CNS trials, expanding the company's national footprint in this therapeutic area.
  • Medical Research Network, founded in 1997, will continue operating under current leadership with Dr. Michael R. Liebowitz remaining as founder, CEO, and principal investigator.
  • The strategic move strengthens IMA's ability to deliver efficient CNS trials while addressing growing demand for mental health clinical research and improving access to underserved patient populations.

Evestia Clinical Merges with Atlantic Research Group to Create Global Specialist CRO

NeurologyOncology
  • Evestia Clinical (formerly EMAS Pharma) has merged with US-based Atlantic Research Group to create an independent global specialist CRO group in fast-growing markets.
  • The merger more than doubles Evestia Clinical's size by headcount and service delivery capability while expanding its US footprint and therapeutic offerings to include neurology and late-stage clinical trials.
  • The combined group will provide full clinical trial services from Phase 1 through Phase 3 and beyond, with enhanced technologies and specialized services across multiple therapeutic areas.
  • Following integration, the enlarged group will be headquartered in the UK (Letchworth) and USA (Charlottesville, VA) with global capabilities through its network of offices and expert partners.

Oragenics Raises $20 Million to Advance Concussion Treatment Clinical Trials

Neurology
  • Oragenics completed a $20 million preferred stock offering to fund ongoing ONP-2 concussion clinical trials and related research and development activities.
  • The biotechnology company focuses on developing intranasal pharmaceuticals for neurological disorders, including treatments for mild traumatic brain injury (mTBI).
  • The offering includes 800,000 shares of Series H Convertible Preferred Stock at $25 per share, convertible to common stock at $2.50 per share.
  • Proceeds will also support repayment of a $3 million bridge note and general corporate purposes as the company advances its neurology pipeline.

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