S3346

What happened: On December 4, 2025, Senator Cory Booker (D-NJ) introduced S. 3346, the Freedom to Heal Act of 2025. The bill amends the Controlled Substances Act to create a special DEA registration allowing physicians to directly administer Schedule I investigational psychedelic drugs to eligible patients under the federal Right to Try law (21 U.S.C. 360bbb-0a). The bill was read twice and referred to the Senate Committee on the Judiciary. An identical companion bill, HR 6434, was introduced in the House and referred to both the Energy and Commerce and Judiciary Committees. The bill is early-stage with two cosponsors (Booker and Paul), suggesting bipartisan framing. The money trail: This bill does not authorize or appropriate any government funding. The financial impact is purely regulatory—it removes a barrier to patient access, enabling manufacturers to generate revenue from drug supply under Right to Try protocols. Patients (or their insurers) pay for the drug; the government facilitates the legal pathway. The April 2026 Executive Order on psychedelic therapies for mental health provides political tailwind, signaling administration support for the policy direction, but does not guarantee passage or appropriations. Structural winners: The pure-play beneficiaries are $CMPS (COMPASS Pathways), $GHRS (GH Research), and $ATAI (AtaiBeckley)—companies whose primary business is developing Schedule I psychedelic compounds for mental health. $CMPS leads with COMP360 in Phase 3 for TRD; $GHRS is earlier-stage with GH001; $ATAI holds a multi-asset pipeline. These companies can now generate pre-approval revenue and collect treatment data outside clinical trials, reducing capital burn and accelerating clinical validation. Large pharma ($JNJ, $NVS) have minimal direct exposure—psychiatric units treat approved drugs, not investigational psychedelics. Real market data: As of April 30, 2026, $CMPS trades at $8.44 (52-week range $2.25–$10.21), down 11.9% in 7 days but up 52.62% over 30 days—the 30-day surge aligns with the April Executive Order and growing Right to Try momentum. $GHRS at $19.43 (52-week range $9.46–$24.66) is down 4.05% in 7 days but up 38.19% in 30 days. $ATAI at $4.08 (52-week range $1.29–$6.75) is down 11.88% in 7 days but up 15.25% in 30 days. All three had a sharp rally in mid-April (peaking April 20–24) and are correcting on profit-taking, but remain well above 30-day lows. The 30-day gains of 15–53% reflect market anticipation of deregulatory progress. Timeline: The bill is at the earliest legislative stage—committee referral. Path to law requires: (1) Judiciary Committee markup and vote, (2) Senate floor vote, (3) House companion markup and vote (Energy & Commerce, Judiciary), (4) conference committee, (5) presidential signature. With a companion bill and Executive Order support, odds are above-average for a first-term bill, but passage within this Congress (2025–2027) is uncertain. The Executive Order provides near-term regulatory tailwind independently of the bill.