Freedom to Heal Act of 2025
Summary
The Freedom to Heal Act of 2025 (HR6434) is an early-stage bill that would expand Right to Try access to Schedule I investigational psychedelic drugs by creating a new DEA registration for physicians. The bill is in committee referral stage with a companion in the Senate (S3346). A recent Executive Order (April 18, 2026) accelerating psychedelic therapies aligns with this bill's intent. Pure-play psychedelic companies — $CMPS, $GHRS, $ATAI, $MNMD — are the structural beneficiaries, though the bill authorizes no direct funding and faces a long legislative path.
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Key Takeaways
- 1.HR6434 is in early legislative stage with zero funding authorized — regulatory expansion, not a spending bill
- 2.Companion bill S3346 in Senate increases passage probability slightly but momentum is stalled (no action since December 2025)
- 3.April 18 Executive Order on psychedelic therapies is a stronger near-term catalyst than this bill
- 4.Pure-play psychedelic developers $CMPS, $GHRS, $ATAI, $MNMD are structural beneficiaries, but only if and when the bill advances
- 5.30-day market trends show significant sector gains (29-57%) driven by executive action, not this stalled legislation
Market Implications
The sector has already priced in significant bullish sentiment from the April 18 Executive Order, with $CMPS, $GHRS, and $ATAI all up 29-57% over the past 30 days. However, this specific bill has seen zero legislative momentum in 4+ months. The market is likely over-attributing legislative progress to current prices. If the bill fails to advance, sector retracement is possible. The Executive Order provides a more durable catalyst — it directly directs FDA and HHS to accelerate psychedelic therapy development, which benefits all pure-play developers regardless of this bill's fate. Investors should watch for committee hearings (Energy and Commerce, Judiciary) and cosponsor additions as the key legislative signals. Without fresh action, the bill is effectively dormant.
Full Analysis
Intelligence Surface
Cross-referenced against federal contracts, SEC insider filings & congressional trade disclosures
No confirming evidence found yet from contracts, insider trades, or congressional activity
What the bill does
Right to Try pathway expansion — establishes a special DEA registration for physicians to directly administer Schedule I investigational psychedelic drugs to eligible patients under the Federal Right to Try law, bypassing standard FDA IND and DEA registration requirements.
Who must act
DEA (Attorney General) — must create the special registration process; physicians — must apply and comply with documentation requirements from drug manufacturers; Schedule I drug manufacturers/sponsors — must provide documentation, drug supply, and administration guidance.
What happens
Creates a new commercial channel for investigational psychedelic drugs outside of the clinical trial framework. Physicians can legally access and administer these drugs to eligible patients (those with life-threatening conditions who have exhausted approved treatments) without enrolling in a clinical trial. This expands potential revenue sources for companies with ongoing Schedule I investigational drug programs.
Stock impact
COMPASS Pathways ($CMPS) is a pure-play developer of psilocybin-based therapy for treatment-resistant depression. Its investigational drug COMP360 is a Schedule I psychedelic. The bill directly expands the addressable patient population outside clinical trials, creating an early-revenue pathway before full FDA approval. $CMPS would benefit from increased physician interest and potential revenue from drug supply under Right to Try.
What the bill does
Right to Try pathway expansion — same as above. The special registration allows physicians to directly administer Schedule I investigational psychedelic drugs to eligible patients.
Who must act
DEA (Attorney General) — must create the special registration process; physicians — must apply and comply; Schedule I drug manufacturers/sponsors — must provide documentation, drug supply, and administration guidance.
What happens
Creates a new commercial channel for investigational Schedule I psychedelic drugs. GH Research's 5-MeO-DMT investigational product GH001 is a Schedule I psychedelic targeting treatment-resistant depression. The bill creates potential early-revenue and patient-access opportunities outside clinical trials.
Stock impact
GH Research ($GHRS) is a pure-play developer of 5-MeO-DMT-based therapies. Its pipeline is entirely focused on Schedule I psychedelics. The bill directly expands the commercial opportunity for GH001 by enabling physician-administered Right to Try access before FDA approval, potentially accelerating market adoption and generating drug supply revenue.
Market Impact Score
Connected Signals
Matched on shared policy language across AI analyses, with ticker & timing weight
Mental Health Research Accelerator Act of 2025
Innovative Therapies Centers of Excellence Act of 2025
Freedom to Heal Act of 2025
Veterans Health Administration Novel Therapeutics Preparedness Act
SUPPORT for Patients and Communities Reauthorization Act of 2025
ADVANCED TECHNOLOGY INTERNATIONAL: $304M Department of Health and Human Services Contract
Consolidated Appropriations Act, 2026
Protecting Health Care and Lowering Costs Act of 2025
Related Presidential Actions
Executive orders & memoranda affecting the same sectors or companies
Promoting Efficiency, Accountability, and Performance in Federal Contracting
This executive order mandates that federal agencies default to using fixed-price contracts for procurement, shifting away from cost-reimbursement models. It requires written justification and senior-level approval for any non-fixed-price contract over certain dollar thresholds (e.g., $10M for most agencies, $100M for the Department of War), and directs agencies to review and renegotiate their 10 largest non-fixed-price contracts within 90 days. The order also tasks OMB with implementation guidance and the Federal Acquisition Regulatory Council with proposing regulatory amendments within 120 days.
Accelerating Medical Treatments for Serious Mental Illness
This executive order directs the FDA to prioritize review and facilitate 'Right to Try' access for psychedelic drugs, including ibogaine compounds, that have received Breakthrough Therapy designation for serious mental illnesses. It also allocates $50 million from HHS to support state programs advancing these treatments and mandates collaboration between HHS, FDA, VA, and the private sector to increase clinical trial participation and data sharing for these drugs. The Attorney General is further directed to expedite rescheduling reviews for approved Schedule I psychedelic substances.