- LivaNova PLC LIVN could provide an update on its RECOVER difficult-to-treat depression (DTD) trial within the next few months, representing a significant catalyst.
- Unipolar enrollment in the trial is approaching 325-350 patients, which management has indicated is the "sweet spot" where the trial could meet its endpoint.
- Needham believes that LIVN shares could increase by ~25-35% from ~$60 to ~$75-80 immediately after a positive disclosure and continue to increase in the following weeks.
- But the negative outcome could immediately drag the shares by ~10-20% from ~$60 to ~$50-55.
- LIVN expects to transition from the trial phase to the registry phase in late 2022 or early 2023, allowing a significant increase in the volume of DTD procedures since up to 5,800 patients are allowed in the registry under the RECOVER trial design.
- The full data from the RECOVER trial will not be available until all patients reach 12 months of follow-up, likely in 2H of 2023.
- The company expects CMS to issue an updated national coverage determination for DTD in 2H of 2024.
- Price Action: LIVN shares are up 1.29% at $61.38 during the market session on the last check Monday.
© 2024 Benzinga.com. Benzinga does not provide investment advice. All rights reserved.
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