PBM
Monitor DEA actions on import permit and quota applications, and the November 30, 2026 deadline for the definitive PsyLabs agreement. Any DEA quota expansion or clinical trial initiation would be a material catalyst.
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Executive Summary
Psyence BioMed's Texas subsidiary, TIRC, signed a manufacturing services agreement with DEA-registered Benuvia Operations to produce pharmaceutical-grade ibogaine API in the U.S. The partnership links TIRC's planned exclusive U.S. access to PsyLabs' ibogaine with Benuvia's existing DEA quota and cGMP facility, advancing the company's integrated U.S. supply and regulatory platform. This is a strategic operational milestone but remains subject to DEA import permits, quota expansions, and a definitive agreement with PsyLabs due by November 30, 2026.
Key Facts
- TIRC entered a manufacturing services agreement with Benuvia Operations for U.S. cGMP production of pharmaceutical-grade ibogaine API.
- Benuvia operates an 83,000-square-foot DEA-registered controlled-substance facility in Round Rock, Texas.
- Benuvia holds approximately half of the U.S. aggregate production quota for ibogaine.
- The partnership builds on TIRC's binding term sheet with PsyLabs for exclusive U.S. license, supply, and wholesale distribution of ibogaine; definitive agreement due by November 30, 2026.
- Applications for import permit and procurement quota are being advanced with the DEA by Benuvia.
- No financial terms of the manufacturing agreement were disclosed.
Financial Impact
No financial terms disclosed; partnership is operational/pre-revenue. Impact depends on future DEA quota expansion and clinical/regulatory progress.
Risk Factors
- DEA import permit or quota applications may be delayed, limited, or refused.
- Definitive agreement with PsyLabs may not be concluded by November 30, 2026, or on different terms.
- Reliance on a single manufacturing partner (Benuvia) and single supplier (PsyLabs) creates concentration risk.
- Ibogaine remains a DEA Schedule I controlled substance; no FDA-approved therapeutic use exists.
Investment Themes
Documents Analyzed
This report is based on 1 press release from GlobeNewswire.
| Document | Accession Number |
|---|---|
| PRESS-RELEASE Data (Synthetic) | press-3374408 |
Filters
| Type | Now | ||||
|---|---|---|---|---|---|
Oct 21, 2026 6d ago | 6-K | $4.52 $4.12 | ▼ −8.85% | ▼ −7.67% | $3.01 (−33.41%) |
Oct 15, 2026 12d ago | SC 13D/A | $4.32 $4.22 | ▼ −2.31% | ▼ −1.21% | $3.01 (−30.32%) |
Oct 5, 2026 22d ago | SC 13G | $5.08 $5.02 | ▼ −1.18% | ▼ −1.73% | $3.01 (−40.75%) |
Oct 5, 2026 22d ago | 6-K | $5.08 $5.02 | ▼ −1.18% | ▼ −1.73% | $3.01 (−40.75%) |
Oct 5, 2026 22d ago | Press Release | $5.08 $5.02 | ▼ −1.18% | ▼ −1.73% | $3.01 (−40.75%) |
Sep 28, 2026 29d ago | 6-K | $5.67 $5.43 | ▼ −4.15% | ▼ −3.96% | $3.01 (−46.87%) |
Sep 28, 2026 29d ago | Press Release | $5.67 $5.43 | ▼ −4.15% | ▼ −3.96% | $3.01 (−46.87%) |
Sep 23, 2026 4w ago | 6-K | $6.31 $5.86 | ▲ +7.13% | ▲ +7.05% | $3.01 (+52.30%) |
Sep 14, 2026 6w ago | 6-K | $6.00 $6.07 | ▲ +1.17% | ▲ +1.63% | $3.01 (−49.83%) |
Sep 2, 2026 7w ago | EFFECT | $4.37 $4.43 | ▲ +1.37% | ▲ +0.33% | $3.01 (−31.12%) |
US Market Status
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