Asundexian Approved for Secondary Stroke Prevention, Fast Track Designations Granted to 2 Investigational Therapies, New CTE Findings Emerge

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Welcome to the Neurology News Network, my name is Louie Pasculli and here’s a look at some of the top stories in Neurology.

TheFDA was quite busy this week, approving Bayer's asundexian, an oral factor XIa (FXIa) inhibitor, to reduce the risk of recurrent stroke in adults following a noncardioembolic ischemic stroke or high-risk transient ischemic attack (TIA). Marketed as Sunharbo, the therapy becomes the first FXIa inhibitor approved for secondary stroke prevention.

Asundexian was approved in 50 mg tablet forms and is to be used in combination with antiplatelet therapy. The decision was based on data from the pivotal phase 3 OCEANIC-STROKE trial (NCT05686070), in which once-daily asundexian added to antiplatelet therapy reduced ischemic stroke without a statistically significant increase in major bleeding.^1,2

Asundexian is not approved for stroke prevention in patients with atrial fibrillation, and is not recommended in patients with moderate or severe hepatic impairment. According to the FDA’s release, concomitant use with medicines that are combined P-gp and strong CYP3A4 inducers are not recommended with asundexian as they may decrease the medication’s effectiveness. Additionally, the agency recommended that the therapy be withheld at least 24 hours before elective surgery or invasive procedures and for at least 24 hours after thrombolysis for acute ischemic stroke.

Beyond the approval of asundexian, the FDA also issued Fast Track designations to two investigational therapies targeting conditions with significant unmet treatment needs, including Long COVID and Friedreich ataxia, with both candidates now advancing toward phase 2 clinical evaluation.

First, Front Range Pharmaceuticals has received Fast Track designation for FRP-003, an investigational oral botanical drug candidate being developed for Long COVID. The designation follows FDA clearance of the company's investigational new drug application in October, allowing the company to move forward with a planned phase 2 trial enrolling approximately 220 adults with fatigue-predominant Long COVID.^3,4

In a separate development, the FDA has also granted Fast Track designation to GV101, an investigational oral therapy from Graviton BioScience being developed for Friedreich ataxia. GV101 is a selective ROCK2 inhibitor designed to increase production of frataxin, a mitochondrial protein that is deficient in individuals with Friedreich ataxia. The company is planning a phase 2a dose-ranging study evaluating 3 doses of the therapy, with US enrollment expected to begin in the fourth quarter of 2026.^5,6

Both Fast Track designations are intended to facilitate more frequent communication with the FDA and potentially expedite clinical development for serious conditions with unmet medical needs. Although both programs remain in the investigational stage, their planned phase 2 studies will provide important opportunities to further evaluate their respective therapeutic approaches.

In other news, A new study published in JAMA Network Open is offering an updated estimate of chronic traumatic encephalopathy, or CTE, prevalence among former National Football League players. Investigators examined 2,362 former NFL players who died between 2008 and 2023. Among 387 brain donors with known CTE status, 362, or 93.5%, had evidence of CTE neuropathology. After accounting for potential selection bias associated with brain donation, researchers estimated that 74.5% of the overall cohort had CTE pathology at death, with a more conservative sensitivity analysis producing an estimate of 63.7%.⁷

Despite these findings, important questions remain about how CTE pathology translates into clinical symptoms, particularly because cognitive impairment in older adults can have several potential causes. Currently, CTE can only be definitively diagnosed through postmortem examination of brain tissue. To address this limitation, an ongoing phase 3 study, CMK-0301, is evaluating an investigational PET imaging approach using F-18 flornaptitril in approximately 230 participants with suspected CTE, Alzheimer disease, or no cognitive impairment. The study will examine whether imaging can help distinguish CTE-associated changes from Alzheimer-related pathology and predict subsequent clinical progression.⁸

To further examine these findings and the challenges surrounding CTE diagnosis, NeurologyLive spoke with Rory Siegel, DO, a brain injury medicine physician at Burke Rehabilitation Hospital, and Julian Bailes, MD, chief medical officer of CereMark Pharma and system executive physician for neurosurgery at Endeavor Health. Both discussed the clinical significance of CTE neuropathology, the difficulties distinguishing CTE-related symptoms from other causes of cognitive decline, and the potential role of emerging PET imaging approaches in identifying the disease during life.

To read the full pieces and to get more direct access to expert insight, head to NeurologyLive.com. Be sure to tune in next week to remain informed on the latest in neurology. I’m Louie Pasculli, thanks for watching Neurology News Network.

REFERENCES

3. 1. Front Range Pharmaceuticals receives FDA fast track designation for FRP-003 in long COVID. Business Wire. November 6, 2026. https://www.businesswire.com/news/home/20261106110330/en/Front-Range-Pharmaceuticals-Receives-FDA-Fast-Track-Designation-for-FRP-003-in-Long-COVID
4. Front Range Pharmaceuticals announces FDA clearance to initiate phase 2 trial of FRP-003 in long COVID. News release. Front Range Pharmaceuticals; October 6, 2026. Accessed November 11, 2026. https://www.businesswire.com/news/home/20261006387219/en/Front-Range-Pharmaceuticals-Announces-FDA-Clearance-to-Initiate-Phase-2-Trial-of-FRP-003-in-Long-COVID
5. Graviton BioScience. Graviton BioScience announces FDA fast track designation for GV101 for the treatment of Friedreich’s ataxia. PR Newswire. Published November 3, 2026. November 11, 2026. https://www.prnewswire.com/news-releases/graviton-bioscience-announces-fda-fast-track-designation-for-gv101-for-the-treatment-of-friedreichs-ataxia-302926880.html
6. GV101 for Friedreich’s Ataxia (FA) Treatment. ClinicalTrials.gov identifier: NCT07870590. Accessed November 11, 2026. https://clinicaltrials.gov/study/NCT07870590
7. Gallini J, Alosco ML, Abdolmohammadi B, et al. Bias-adjusted prevalence of chronic traumatic encephalopathy among deceased National Football League players. JAMA Netw Open. 2026;9(10). doi:10.1001/jamanetworkopen.2026.40884
8. Visualizing brain proteinopathies using [F-18]flornaptitril-PET in the prediction of clinical progression of mild cognitive impairment with either suspected chronic traumatic encephalopathy or Alzheimer's disease. ClinicalTrials.gov. NCT06254469