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Regulatory Daily Summary

Regulatory Daily Summary: What Happened on November 10, 2026

FDA approves Bayer’s Sunharbo to reduce recurrent stroke risk

Compass Pathways filed for its depression treatment as a possible change in FDA leadership remains in flux.

  • Updated
  • Read from 5 articles, 5 publications

Today in brief

Bayer’s Sunharbo became the first Factor XIa inhibitor approved to reduce stroke risk after certain strokes or transient ischemic attacks.1 Compass Pathways filed for FDA approval of COMP360 in treatment-resistant depression, drawing on three studies that met their primary endpoints.2

Sunharbo becomes the first approved Factor XIa inhibitor

The FDA approved Bayer’s Sunharbo with antiplatelet therapy to lower stroke risk after a recent mild-to-moderate non-cardioembolic ischemic stroke or a high-risk transient ischemic attack.1 Sunharbo blocks Factor XIa, a clotting protein, and is the first drug in that inhibitor class approved for this use.13

In the Phase 3 OCEANIC-STROKE study of 12,327 participants, Sunharbo reduced ischemic stroke risk by 26% compared with placebo, with both groups also receiving antiplatelet therapy.1 Recurrent strokes occurred in 6.2% of Sunharbo recipients and 8.4% of placebo recipients.4 Major bleeding rates were similar overall, but higher among Sunharbo recipients older than 75 and during the first 90 days of treatment.1

Gastrointestinal bleeding was more common with Sunharbo, and diarrhea was the most frequently reported adverse reaction.1 The FDA advises against using Sunharbo with certain medicines, including carbamazepine, and does not recommend it for moderate or severe liver impairment or stroke prevention in people with atrial fibrillation.1 The FDA also advises pausing treatment before elective surgery or invasive procedures and after thrombolysis for acute ischemic stroke.1

Compass files for COMP360 in treatment-resistant depression

Compass Pathways submitted an application seeking FDA approval of COMP360 for treatment-resistant depression, using results from two Phase 3 trials and one Phase 2b study.2 All three studies met their primary endpoints and enrolled more than 1,000 people with highly chronic depression.2

In COMP005, one 25 mg dose led to a 3.6-point greater reduction on the Montgomery-Åsberg Depression Rating Scale (MADRS) than placebo at six weeks.2 In COMP006, two 25 mg doses given three weeks apart led to a 3.8-point greater MADRS reduction than a 1 mg active control at six weeks.2 Both comparisons had p-values below 0.001.2

Compass said improvements began the day after dosing and continued through week 26 in both trials.2 The company said participants in COMP005 who received another 25 mg dose showed additional benefit through week 52 in an open-label follow-up.2

Compass said preparations for a possible U.S. launch in the first half of 2027 remain on schedule, conditional on approval.2 The company has said a U.S. launch would follow Drug Enforcement Administration rescheduling, while state scheduling rules could limit where it launches.2

Also worth knowing

  • After Democrats won the midterm elections, the administration’s effort to secure Senate confirmation for Heidi Overton as FDA commissioner was described as no longer viable. Sara Brenner is being considered to replace Kyle Diamantas as acting commissioner.5

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